Top Banner
Covance Clinical Research Unit Inc. Clinical Development Services Covance - Evansville Clinic 617 Oakley Street THE DEVELOPMENT SERVlCES COMPANY Evansville, IN 47710 Tel: 812-474-5000 Fax: 812-469-5404 31 August 2012 Page 1 of2 NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road, Suite 210 Lisle,IL 60532-4351 Re: Request to Decommission Honolulu, HI site (1 of 2 "separate buildings") Request to Extend License for 24-months at Evansville, IN site (2 nd "separate building") pursuant to "Timeliness Rule" ("Materials License" No. 13-26640-01) Dear NRC License Reviewer: The previous principal activity for the above-referenced license occurred on 02 Nov 2010; therefore, consistent with the "Timeliness Rule", Covance CRU Inc. is requesting the following: 1) Due to the decision to permanently cease principal activities in the Honolulu, HI clinic, i.e., in 1 of the 2 "separate buildings" on the current license, the Honolulu, HI site is being decommissioned-applicable decommissioning documents are attached. 2) Since, as of 02 Nov 2012, no principal activities will have been conducted on the license for 24-months, Covance CRU Inc. hereby petitions the NRC to approve an additional 24-month continuation/extension of the license for the remaining Evansville, IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below. Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and pertains to "uptake, dilution, and excretion studies permitted by 10 CFR 35.100", involving administration of only 14C_ or 3H-radiolabeled drug materials, Le., as part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies. Covance CRU Inc. also maintains an active Agreement State license of the same type with WI DHS (License No. 025-1075-01) for its Madison, WI clinic, where in fact the highest number of contracted clinical studies of this type are performed in the world, currently conducting 20 to 30 separate studies of this type per year. Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison, WI clinic, Covance CRU Inc. needs the flexibility to conduct/contract some of these specialized clinical studies at their Evansville, IN clinic. However, since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc. to respond within a short 1-2 month timeframe to start their contracted clinical study, it would not be possible to get timely approval of a "new" NRC license for the Evansville, IN clinic due to the lengthy NRC review/approval process required for a new license. Thus, although the Evansville, IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part of Amendment No. 12), Covance CRU Inc. needs almost instantaneously to be able to resume these principal activities at the Evansville, IN clinic and therefore requests that NRC grant a continuation/extension of the current NRC license for a minimum 24-month period, subject to subsequent timely request and extension in accordance with the Timeliness Rule, if/as appropriate. RECElVED SEP 0 4 2012 THE AMERICAS EUROPE ASIA/PACIFIC AFRICA
39

Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

May 23, 2020

Download

Documents

dariahiddleston
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Page 1: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

Covance Clinical Research Unit Inc Clinical Development Services cov~ Covance - Evansville Clinic 617 Oakley Street THE DEVELOPMENT SERVlCES COMPANY Evansville IN 47710 Tel 812-474-5000 Fax 812-469-5404

31 August 2012 Page 1 of2

NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road Suite 210 LisleIL 60532-4351

Re Request to Decommission Honolulu HI site (1 of 2 separate buildings) Request to Extend License for 24-months at Evansville IN site (2nd separate building)

pursuant to Timeliness Rule (Materials License No 13-26640-01)

Dear NRC License Reviewer

The previous principal activity for the above-referenced license occurred on 02 Nov 2010 therefore consistent with the Timeliness Rule Covance CRU Inc is requesting the following

1) Due to the decision to permanently cease principal activities in the Honolulu HI clinic ie in 1 of the 2 separate buildings on the current license the Honolulu HI site is being decommissioned-applicable decommissioning documents are attached

2) Since as of 02 Nov 2012 no principal activities will have been conducted on the license for 24-months Covance CRU Inc hereby petitions the NRC to approve an additional 24-month continuationextension of the license for the remaining Evansville IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below

Covance CRU Incs NRC license No 13-26640-01 is in the Specific Use Type 7C category and pertains to uptake dilution and excretion studies permitted by 10 CFR 35100 involving administration ofonly 14C_ or 3H-radio labeled drug materials Le as part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies Covance CRU Inc also maintains an active Agreement State license of the same type with WI DHS (License No 025-1075-01) for its Madison WI clinic where in fact the highest number of contracted clinical studies of this type are performed in the world currently conducting 20 to 30 separate studies of this type per year Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison WI clinic Covance CRU Inc needs the flexibility to conductcontract some of these specialized clinical studies at their Evansville IN clinic However since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc to respond within a short 1-2 month timeframe to start their contracted clinical study it would not be possible to get timely approval of a new NRC license for the Evansville IN clinic due to the lengthy NRC reviewapproval process required for a new license Thus although the Evansville IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part of Amendment No 12) Covance CRU Inc needs almost instantaneously to be able to resume these principal activities at the Evansville IN clinic and therefore requests that NRC grant a continuationextension of the current NRC license for a minimum 24-month period subject to subsequent timely request and extension in accordance with the Timeliness Rule ifas appropriate

RECElVED SEP 0 4 2012 THE AMERICAS EUROPE ASIAPACIFIC AFRICA

Covance Clinical Research Unit Inc Clinical Development Services cov~ Covance - Evansville Clinic 617 Oakley Street THE DEVELOPMENT SERVICES COMPANY Evansville IN 47710 Tel 812-474-5000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perform the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staff and almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentlup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however if we are incorrect please just let us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning ofthe Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ifwhen the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance-since the RSO is 10catedJbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Thank you in advance for your timely evaluation of these requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office TeL No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu HI facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (05-2012) 10 CFR 30 32 33 34 35 36 39 and 40

APPLICATION FOR MATERIALS LICENSE

APPROVED BY OMB NO 31500120 EXPIRES (053112015)

Estimated burden per response 10 comply with this mandatory collection request 43 hours Submittal of the application is necessary to determine that the applicant is qualified and that adequate procedures exist to protect the public health and safety Send comments regarding burden estimate to the Information Services Branch (H F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by internet emiddotmail to InfocollectsResourcenrcgov and 10 the Desk Officer Office of Information and Regulatory Affairs NEOBmiddotl0202 (315()OI20) Office of Management and Budget Washington DC 20503 If a means used to impose an information collection does not display a currently valid OMS control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND lWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPLICAnON FOR DISTRIBunON OF EXEMPT PRODUCTS FILE APPUCA nONS WITH

OFFICE OF FEDERAL amp STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555-0001

ALL OTHER PERSONS ALE APPUCA noNS AS FOLLOWS

IF YOU ARE LOCATED IN

ALABAMA CONNEcnCUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA KENTUCKY MAINE MARYLAND MASSACHUSETTS NEW HAMPSHIRE NEW JERSEY NEW YORK NORTH CAROUNA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH CAROUNA TENNESSEE VERMONT VIRGINIA VIRGIN ISLANDS OR WEST VIRGINIA

SEND APPUCA nONS TO

LICENSING ASSISTANCE TEAM DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PA 19406-2713

IF YOU ARE LOCATED IN

ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN SEND APPLICA nONS TO

MATERIALS LICENSING BRANCH us NUCLEAR REGULATORY COMMISSION REGION III 2443 WARRENVILLE ROAD SUITE 210 LISLE IL 60532-4352

ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH DAKOTA OKLAHOMA OREGON PACIFIC TRUST TERRITORIES SOUTH DAKOTA TEXAS UTAH WASHINGTON OR WYOMING

SEND APPUCA nONS TO

NUCLEAR MATERIALS LICENSING BRANCH uS NUCLEAR REGULATORY COMMISSION REGION IV 1600 E LAMAR BOULEVARD ARLINGTON TX 76011-4511

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

2 NAME AND MAILING ADDRESS OF APPLICANT (InclucJe ZIP code)1 THIS IS AN APPLICATION FOR (Check appropriate item)

0 A NEW LICENSE Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 13-26640-01l] B AMENDMENT TO LICENSE NUMBER 617 Oakley Street

c RENEWAL OF LICENSE NUMBER Evansville IN 47710

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION3 ADDRESS WiERE LICENSED MATERIAL WILL BE USED OR POSSESSED

Robert G Kochan PhD (US RSO)

Covance - Evansville Clinic BUSINESS TELEPHONE NUMBER IBUSINESS CELLULAR TELEPHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochancovancecom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11 PAPER THE TYPE AND SCOFE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE

s RADIOACTIVE MATERIAL a Element and mass number b chemical andor physical form and c maiximum amount 6 PURPOSE(S) FOR WiICH LICENSED MATERIAL WILL BE USED

which will be possessed at anyone time

7 INDlVlDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDIVIDUALS IIORKING IN OR FREQUENTING RESTRICTED AREASTRAINING EXPERIENCE

9 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM

12 LICENSE FEES (See 10CFR 170anci Section 17031) 11 WASTE MANAGEMENT AMOUNT

FEE CATEGORY 7C $ 000ENCLOSED

13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 CODE OF FEDERAL REGULAnONS PARTS 30 32 3334 35 36 39 AND 40 AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWlEDGE AND BELIEF WARNING 18 USC SECTION 1001 ACT OF JUNE 25 194862 STAT 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION

CERTIFYING OFFICER - TYPEDPRINTED NAME AND TITLE DATE

Ted Broering BS MBA Executive Director Clinical Development Services Covance Clinical Research Unit Inc 3 Ir4~middot1o1zI~~

7

FOR NRC USE ONLY ~

TYPE OF FEE bullCHECK NUMBER ICOMMENTSIFEE LOG IFEE CATEGORY l~OUNT RECEIVED

APPROVED BY DATE

NRC FORM 313 (Q52012)

APPROVED BY OMB NO 3150-0028 EXPIRES 10312013 (05-2012) NRC FORM 314 US NUCLEAR REGULATORY COMMISSION

Estimated burden per response to comply with this mandatory collection request 30 minutes10 CFR 3O36fj)~1) 40 42Jll(1) This submittal is used by NRC as part of the basis for its detennination that the facility is7038(j)(1) and 254(kX (1)(1)

released for unreslJicted use Send comments regarding burden estimate to the Information Services Branch (T-5 F53) Us Nuclear Regulatory Commission Washington DC 20555-0001 or by internet e-mail to InfocoliectsResourcenrcgov and to the Desk OffICer Office ofCERTIFICATE OF DISPOSITION OF MATERIALS Information and Regulatory Affairs NEOB-10202 (3150-0028) Office of Management and Budget Washington DC 20503 If ameans used to impose an infOlTT1ation collection does nol display acurrenlly valid OMB control number the NRC may nOI conduct or sponsor and a person is not required to respond to the information colleclion

LICENSEE NAME AND ADDRESS LICENSE NUMBER DOCKET NUMBER

13-26640-01Covance Clinical Research Unit Inc Covance-Evansville Clinic 617 Oakley Street LICENSE EXPIRATION DATE Evansville IN 47710 January 312016

A LICENSE STATUS (Ch~ck the appropriate[f) This licpnzt~ is ceasing act vity D This license has expired D This license has not yet expired please terminate it X in 1 of 2 buildings-see attJched

B DISPOSAL OF RADIOACTIVE MATERIAL (Check the appropriate boxes and complete as necessary If additional space is needed provide attachments)

The licensee or any individual executing this certificate on behalf of the licensee certifies that

1 No radioactive materials have ever been procured or possessed by the licensee under this license D 2 All activities authorized by this license have ceased d all radioactive materials procured andor possessed by the licensee 0

under this license number cited above have been disposeu ltJf- ~ following manner

o a Transfer of radioactive materials to the licensee listed below to See attached complete summary of transfers from Honolulu HI facility Covance-Honolulu HI clinical siJe

in 1 of 2 buildings ONLY applief

0b Disposal of radioactive materials see attached o 1 Directly by the licensee

Via sanitary sewer (residual amounts of 14C-radioactivity [lt00001 mCi] on glasswareobjects used in dose preparation washeddecontaminated and released to sanitary sewerage system)

2 By licensed disposal site

D 3 By waste contractor

0c All radioactive materials have been removed such that any remaining reSidual radioactivity is within the limits of 10 CFR Part 20 Subpart E and is ALARA

C SURVEYS PERFORMED AND REPORTED

o 1 A radiation survey was conducted by the licensee The survey confirms

0 a the absence of licensed radioactive materials

o b that any remaining residual radioactivity is within the limits of 10 CFR 20 Subpart E and is ALARA

o 2 A copy of the radiation survey results

o a is attached or Db is not attached (Provide explanation) or D c was forwarded to NRC on Date

3 A radiation survey is not required as only sealed sources were ever possessed under this license and

D a The results of the latest leak test are attached andor D b No leaking sources have ever been identified

The person to be contacted regarding the information provided on this form NAME TELEPHONE (Include Alee Code) E-MAIL ADDRESS

ITLE (608) 310-8268 robertkochancovancecom

Mail all future correspondence regarding this license 10

Robert G Kochan PhD (Clinic RSO) Covance CRU Inc Covance-Evansville Clinic 617 Oakley Street Evansville IN 47710

Robert G Kochan PhD Covance US RSO

C CERTIFYING OFFICIAL I CERTIFY UNDER PENALTV OF PERJURY THAT THJFOREGOING IS TRUE AND CORRECT

PRINTED NAME AND TITLE I SIG~ ~IDATEdTed Broering Executive Director Clinical Develop Services bull A 31middot Au- -La (2 WARNING FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO C~IL ANbOR CRIMINAL PENALTIESI~cLATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECT 18 USc SECTION 1001 MA ACRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY Of THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION NRC FORM 314 (05-2012)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 1 of34

TABLE OF CONTENTS FOR LICENSE AMENDMENT REQUEST

Page

Table ofContents for License Amendment Request dated 31 August 2012 1

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section C Item 2a Final Status Survey Report (FSSR)

License Amendment Request Letter (dated 31 August 2012) 2

Completed Form NRC 313 (05-2012) for Covance CRU Inc 4 Form NRC 313 Item 5 Radioactive MateriaL 5

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used 5

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program

amp Their Training and Experience 5

Form NRC 313 Item 7 Radiation Safety Officer 5

Form NRC 313 Item 7 Authorized User 5

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas 6

Form NRC 313 Item 9 Facility Diagrams-Discussion 6

Form NRC 313 Item 9 Radiation Monitoring Instruments 6

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages

ofUnsealed Radioactive Material 6

Form NRC 313 Attachment 94 Other Equipment and Facilities 7

Form NRC 313 Item 10 Occupational Dose 7

Form NRC 313 Item 10 Area Surveys 7

Form NRC 3l3 Item 10 Safe Use of Unsealed Licensed Material 7

Form NRC 313 Item 10 Spill Procedures 7

Form NRC 313 Item 11 Waste Management 7

Completed Form NRC 314 (05-2012) for Covance CRU Inc 8

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2 9

Form NRC 314-Section A License Status (Addendum) 11

Form NRC 314-Section B Item 2 Disposal of Radioactive Material (Addendum) 11

Transfer Disposals from Covance-Honolulu site) 12

Disposal via Radioactive Waste Broker-Philotechnics) 13

Waste Manifest No 0125-040511 EN for Covance-Honolulu Clinical Site 05 Apr 2011 14

Waste Manifest No 0125-040511EN Accountability for Covance CRU Study No 8226978 17

for Covance-Honolulu Clinical Site 20

Summary of Restricted Area-HOT LABS in Covance-Honolulu Clinical Site 21

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site 22

FSSR LSC Swipe Test Results at Covance-Honolulu Clinical Site 28

FSSR Survey Meter Test Results at Covance-Honolulu Clinical Site 33

NUREG-1757 VoL I Rev 2 Table 12 Principal Regulatory Features of Decommissioning

Groups Applicable Group for Covance-Honolulu Clinical Site Group 2 34

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 2 of34

License Amendment Request Letter (dated 01 February 2008) - Page 1 of2

Covance Clinical Reseanh Unit loc Clinical Development Services cov~ Covance - Evansville Cftnic 617 Oakley Street EvansvillE IN 47710 Tel $12474-5000 Fax 812469-5404

31 August 2012 Page 1 of2

NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road Suite 210 Lisle IL 60532-4351

Re Request to Decommission Honolulu ill site (1 of 2 separate buildings) Request to Extend License for 24-months at Evansville IN site (2nd separate building)

pursuant to Timeliness Rule (Materials License No 13-26640-01)

Dear NRC License Reviewer

The previous principal activity for the above-referenced license occurred on 02 Nov 2010 therefore consistent with the Timeliness Rule Covance CRU Inc is requesting the following

1) Due to the decision to permanently cease principal activities in the Honolulu ill clinic ie in I of the 2 separate buildings on the current license the Honolulu HI site is being decommissioned-applicable decommissioning documents are attached

2) Since as of 02 Nov 2012 no principal activities will have been conducted on the license for 24-months Covance CRU Inc hereby petitions the NRC to approve an additional 24-month continuationextension of the license for the remaining Evansville IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below

Covance CRU Incos NRC license No 13-26640-01 is in the Specific Use Type 7C category and pertains to uptake dilution and excretion studies permitted by 10 CPR 35100 involving administration of only 14C_ or ~-radiolabeled drug materials ieas part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies Covance CRU Inc also maintains an active Agreement State license ofthe same type with WI DHS (License No 025-1075-0I) for its Madison WI clinic where in fact the highest number of contracted clinical studies of this type are performed in the world currently conducting 20 to 30 separate studies ofthis type per year Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison WI clinic Covance CRU Inc needs the flexibility to conductcontract some of these specialized clinical studies at their Evansvil1e IN clinic However since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc to respond within a short 1-2 month timefuune to start their contracted clinical study it would not be possible to get timely approval of a new NRC license for the Evansville IK clinic due to the lengthy NRC reviewapproval process required for a new license Thus although the Evansville IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part ofAmendment No 12) Covance CRU Inc needs almost instantancously to be able to resume these principal activities at the Evansville IN clinic and therefore requests that NRC grant a continuationextension of the current NRC license for a minimum 24-month period subject to subsequent timely request and extension in accordance with the Timeliness Rule ifas appropriate

THE AMERICAS EUROPE ASINPACIFlC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 3 of34

License Amendment Request Letter (dated 01 February 2008) - Page 2 of2

cov~ CovanCil Clinical Research Unit Inc Clinical Development Services CovanCil - Evansville Clinic

THe DEiIrioPMENTsERVWCOMIIlNY 617 Oakley Street Evansville IN 47710 Tel 812-474-6000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perfonn the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staffand almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however ifwe are incorrect please just Jet us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning of the Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ipoundwben the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance~since the RSO is locatedlbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Tbank you in advance for your timely evaluation ofthese requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office Tel No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu In facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 2: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

Covance Clinical Research Unit Inc Clinical Development Services cov~ Covance - Evansville Clinic 617 Oakley Street THE DEVELOPMENT SERVICES COMPANY Evansville IN 47710 Tel 812-474-5000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perform the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staff and almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentlup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however if we are incorrect please just let us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning ofthe Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ifwhen the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance-since the RSO is 10catedJbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Thank you in advance for your timely evaluation of these requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office TeL No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu HI facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (05-2012) 10 CFR 30 32 33 34 35 36 39 and 40

APPLICATION FOR MATERIALS LICENSE

APPROVED BY OMB NO 31500120 EXPIRES (053112015)

Estimated burden per response 10 comply with this mandatory collection request 43 hours Submittal of the application is necessary to determine that the applicant is qualified and that adequate procedures exist to protect the public health and safety Send comments regarding burden estimate to the Information Services Branch (H F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by internet emiddotmail to InfocollectsResourcenrcgov and 10 the Desk Officer Office of Information and Regulatory Affairs NEOBmiddotl0202 (315()OI20) Office of Management and Budget Washington DC 20503 If a means used to impose an information collection does not display a currently valid OMS control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND lWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPLICAnON FOR DISTRIBunON OF EXEMPT PRODUCTS FILE APPUCA nONS WITH

OFFICE OF FEDERAL amp STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555-0001

ALL OTHER PERSONS ALE APPUCA noNS AS FOLLOWS

IF YOU ARE LOCATED IN

ALABAMA CONNEcnCUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA KENTUCKY MAINE MARYLAND MASSACHUSETTS NEW HAMPSHIRE NEW JERSEY NEW YORK NORTH CAROUNA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH CAROUNA TENNESSEE VERMONT VIRGINIA VIRGIN ISLANDS OR WEST VIRGINIA

SEND APPUCA nONS TO

LICENSING ASSISTANCE TEAM DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PA 19406-2713

IF YOU ARE LOCATED IN

ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN SEND APPLICA nONS TO

MATERIALS LICENSING BRANCH us NUCLEAR REGULATORY COMMISSION REGION III 2443 WARRENVILLE ROAD SUITE 210 LISLE IL 60532-4352

ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH DAKOTA OKLAHOMA OREGON PACIFIC TRUST TERRITORIES SOUTH DAKOTA TEXAS UTAH WASHINGTON OR WYOMING

SEND APPUCA nONS TO

NUCLEAR MATERIALS LICENSING BRANCH uS NUCLEAR REGULATORY COMMISSION REGION IV 1600 E LAMAR BOULEVARD ARLINGTON TX 76011-4511

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

2 NAME AND MAILING ADDRESS OF APPLICANT (InclucJe ZIP code)1 THIS IS AN APPLICATION FOR (Check appropriate item)

0 A NEW LICENSE Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 13-26640-01l] B AMENDMENT TO LICENSE NUMBER 617 Oakley Street

c RENEWAL OF LICENSE NUMBER Evansville IN 47710

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION3 ADDRESS WiERE LICENSED MATERIAL WILL BE USED OR POSSESSED

Robert G Kochan PhD (US RSO)

Covance - Evansville Clinic BUSINESS TELEPHONE NUMBER IBUSINESS CELLULAR TELEPHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochancovancecom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11 PAPER THE TYPE AND SCOFE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE

s RADIOACTIVE MATERIAL a Element and mass number b chemical andor physical form and c maiximum amount 6 PURPOSE(S) FOR WiICH LICENSED MATERIAL WILL BE USED

which will be possessed at anyone time

7 INDlVlDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDIVIDUALS IIORKING IN OR FREQUENTING RESTRICTED AREASTRAINING EXPERIENCE

9 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM

12 LICENSE FEES (See 10CFR 170anci Section 17031) 11 WASTE MANAGEMENT AMOUNT

FEE CATEGORY 7C $ 000ENCLOSED

13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 CODE OF FEDERAL REGULAnONS PARTS 30 32 3334 35 36 39 AND 40 AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWlEDGE AND BELIEF WARNING 18 USC SECTION 1001 ACT OF JUNE 25 194862 STAT 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION

CERTIFYING OFFICER - TYPEDPRINTED NAME AND TITLE DATE

Ted Broering BS MBA Executive Director Clinical Development Services Covance Clinical Research Unit Inc 3 Ir4~middot1o1zI~~

7

FOR NRC USE ONLY ~

TYPE OF FEE bullCHECK NUMBER ICOMMENTSIFEE LOG IFEE CATEGORY l~OUNT RECEIVED

APPROVED BY DATE

NRC FORM 313 (Q52012)

APPROVED BY OMB NO 3150-0028 EXPIRES 10312013 (05-2012) NRC FORM 314 US NUCLEAR REGULATORY COMMISSION

Estimated burden per response to comply with this mandatory collection request 30 minutes10 CFR 3O36fj)~1) 40 42Jll(1) This submittal is used by NRC as part of the basis for its detennination that the facility is7038(j)(1) and 254(kX (1)(1)

released for unreslJicted use Send comments regarding burden estimate to the Information Services Branch (T-5 F53) Us Nuclear Regulatory Commission Washington DC 20555-0001 or by internet e-mail to InfocoliectsResourcenrcgov and to the Desk OffICer Office ofCERTIFICATE OF DISPOSITION OF MATERIALS Information and Regulatory Affairs NEOB-10202 (3150-0028) Office of Management and Budget Washington DC 20503 If ameans used to impose an infOlTT1ation collection does nol display acurrenlly valid OMB control number the NRC may nOI conduct or sponsor and a person is not required to respond to the information colleclion

LICENSEE NAME AND ADDRESS LICENSE NUMBER DOCKET NUMBER

13-26640-01Covance Clinical Research Unit Inc Covance-Evansville Clinic 617 Oakley Street LICENSE EXPIRATION DATE Evansville IN 47710 January 312016

A LICENSE STATUS (Ch~ck the appropriate[f) This licpnzt~ is ceasing act vity D This license has expired D This license has not yet expired please terminate it X in 1 of 2 buildings-see attJched

B DISPOSAL OF RADIOACTIVE MATERIAL (Check the appropriate boxes and complete as necessary If additional space is needed provide attachments)

The licensee or any individual executing this certificate on behalf of the licensee certifies that

1 No radioactive materials have ever been procured or possessed by the licensee under this license D 2 All activities authorized by this license have ceased d all radioactive materials procured andor possessed by the licensee 0

under this license number cited above have been disposeu ltJf- ~ following manner

o a Transfer of radioactive materials to the licensee listed below to See attached complete summary of transfers from Honolulu HI facility Covance-Honolulu HI clinical siJe

in 1 of 2 buildings ONLY applief

0b Disposal of radioactive materials see attached o 1 Directly by the licensee

Via sanitary sewer (residual amounts of 14C-radioactivity [lt00001 mCi] on glasswareobjects used in dose preparation washeddecontaminated and released to sanitary sewerage system)

2 By licensed disposal site

D 3 By waste contractor

0c All radioactive materials have been removed such that any remaining reSidual radioactivity is within the limits of 10 CFR Part 20 Subpart E and is ALARA

C SURVEYS PERFORMED AND REPORTED

o 1 A radiation survey was conducted by the licensee The survey confirms

0 a the absence of licensed radioactive materials

o b that any remaining residual radioactivity is within the limits of 10 CFR 20 Subpart E and is ALARA

o 2 A copy of the radiation survey results

o a is attached or Db is not attached (Provide explanation) or D c was forwarded to NRC on Date

3 A radiation survey is not required as only sealed sources were ever possessed under this license and

D a The results of the latest leak test are attached andor D b No leaking sources have ever been identified

The person to be contacted regarding the information provided on this form NAME TELEPHONE (Include Alee Code) E-MAIL ADDRESS

ITLE (608) 310-8268 robertkochancovancecom

Mail all future correspondence regarding this license 10

Robert G Kochan PhD (Clinic RSO) Covance CRU Inc Covance-Evansville Clinic 617 Oakley Street Evansville IN 47710

Robert G Kochan PhD Covance US RSO

C CERTIFYING OFFICIAL I CERTIFY UNDER PENALTV OF PERJURY THAT THJFOREGOING IS TRUE AND CORRECT

PRINTED NAME AND TITLE I SIG~ ~IDATEdTed Broering Executive Director Clinical Develop Services bull A 31middot Au- -La (2 WARNING FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO C~IL ANbOR CRIMINAL PENALTIESI~cLATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECT 18 USc SECTION 1001 MA ACRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY Of THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION NRC FORM 314 (05-2012)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 1 of34

TABLE OF CONTENTS FOR LICENSE AMENDMENT REQUEST

Page

Table ofContents for License Amendment Request dated 31 August 2012 1

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section C Item 2a Final Status Survey Report (FSSR)

License Amendment Request Letter (dated 31 August 2012) 2

Completed Form NRC 313 (05-2012) for Covance CRU Inc 4 Form NRC 313 Item 5 Radioactive MateriaL 5

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used 5

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program

amp Their Training and Experience 5

Form NRC 313 Item 7 Radiation Safety Officer 5

Form NRC 313 Item 7 Authorized User 5

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas 6

Form NRC 313 Item 9 Facility Diagrams-Discussion 6

Form NRC 313 Item 9 Radiation Monitoring Instruments 6

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages

ofUnsealed Radioactive Material 6

Form NRC 313 Attachment 94 Other Equipment and Facilities 7

Form NRC 313 Item 10 Occupational Dose 7

Form NRC 313 Item 10 Area Surveys 7

Form NRC 3l3 Item 10 Safe Use of Unsealed Licensed Material 7

Form NRC 313 Item 10 Spill Procedures 7

Form NRC 313 Item 11 Waste Management 7

Completed Form NRC 314 (05-2012) for Covance CRU Inc 8

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2 9

Form NRC 314-Section A License Status (Addendum) 11

Form NRC 314-Section B Item 2 Disposal of Radioactive Material (Addendum) 11

Transfer Disposals from Covance-Honolulu site) 12

Disposal via Radioactive Waste Broker-Philotechnics) 13

Waste Manifest No 0125-040511 EN for Covance-Honolulu Clinical Site 05 Apr 2011 14

Waste Manifest No 0125-040511EN Accountability for Covance CRU Study No 8226978 17

for Covance-Honolulu Clinical Site 20

Summary of Restricted Area-HOT LABS in Covance-Honolulu Clinical Site 21

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site 22

FSSR LSC Swipe Test Results at Covance-Honolulu Clinical Site 28

FSSR Survey Meter Test Results at Covance-Honolulu Clinical Site 33

NUREG-1757 VoL I Rev 2 Table 12 Principal Regulatory Features of Decommissioning

Groups Applicable Group for Covance-Honolulu Clinical Site Group 2 34

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 2 of34

License Amendment Request Letter (dated 01 February 2008) - Page 1 of2

Covance Clinical Reseanh Unit loc Clinical Development Services cov~ Covance - Evansville Cftnic 617 Oakley Street EvansvillE IN 47710 Tel $12474-5000 Fax 812469-5404

31 August 2012 Page 1 of2

NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road Suite 210 Lisle IL 60532-4351

Re Request to Decommission Honolulu ill site (1 of 2 separate buildings) Request to Extend License for 24-months at Evansville IN site (2nd separate building)

pursuant to Timeliness Rule (Materials License No 13-26640-01)

Dear NRC License Reviewer

The previous principal activity for the above-referenced license occurred on 02 Nov 2010 therefore consistent with the Timeliness Rule Covance CRU Inc is requesting the following

1) Due to the decision to permanently cease principal activities in the Honolulu ill clinic ie in I of the 2 separate buildings on the current license the Honolulu HI site is being decommissioned-applicable decommissioning documents are attached

2) Since as of 02 Nov 2012 no principal activities will have been conducted on the license for 24-months Covance CRU Inc hereby petitions the NRC to approve an additional 24-month continuationextension of the license for the remaining Evansville IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below

Covance CRU Incos NRC license No 13-26640-01 is in the Specific Use Type 7C category and pertains to uptake dilution and excretion studies permitted by 10 CPR 35100 involving administration of only 14C_ or ~-radiolabeled drug materials ieas part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies Covance CRU Inc also maintains an active Agreement State license ofthe same type with WI DHS (License No 025-1075-0I) for its Madison WI clinic where in fact the highest number of contracted clinical studies of this type are performed in the world currently conducting 20 to 30 separate studies ofthis type per year Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison WI clinic Covance CRU Inc needs the flexibility to conductcontract some of these specialized clinical studies at their Evansvil1e IN clinic However since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc to respond within a short 1-2 month timefuune to start their contracted clinical study it would not be possible to get timely approval of a new NRC license for the Evansville IK clinic due to the lengthy NRC reviewapproval process required for a new license Thus although the Evansville IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part ofAmendment No 12) Covance CRU Inc needs almost instantancously to be able to resume these principal activities at the Evansville IN clinic and therefore requests that NRC grant a continuationextension of the current NRC license for a minimum 24-month period subject to subsequent timely request and extension in accordance with the Timeliness Rule ifas appropriate

THE AMERICAS EUROPE ASINPACIFlC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 3 of34

License Amendment Request Letter (dated 01 February 2008) - Page 2 of2

cov~ CovanCil Clinical Research Unit Inc Clinical Development Services CovanCil - Evansville Clinic

THe DEiIrioPMENTsERVWCOMIIlNY 617 Oakley Street Evansville IN 47710 Tel 812-474-6000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perfonn the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staffand almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however ifwe are incorrect please just Jet us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning of the Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ipoundwben the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance~since the RSO is locatedlbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Tbank you in advance for your timely evaluation ofthese requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office Tel No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu In facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 3: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (05-2012) 10 CFR 30 32 33 34 35 36 39 and 40

APPLICATION FOR MATERIALS LICENSE

APPROVED BY OMB NO 31500120 EXPIRES (053112015)

Estimated burden per response 10 comply with this mandatory collection request 43 hours Submittal of the application is necessary to determine that the applicant is qualified and that adequate procedures exist to protect the public health and safety Send comments regarding burden estimate to the Information Services Branch (H F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by internet emiddotmail to InfocollectsResourcenrcgov and 10 the Desk Officer Office of Information and Regulatory Affairs NEOBmiddotl0202 (315()OI20) Office of Management and Budget Washington DC 20503 If a means used to impose an information collection does not display a currently valid OMS control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND lWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPLICAnON FOR DISTRIBunON OF EXEMPT PRODUCTS FILE APPUCA nONS WITH

OFFICE OF FEDERAL amp STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555-0001

ALL OTHER PERSONS ALE APPUCA noNS AS FOLLOWS

IF YOU ARE LOCATED IN

ALABAMA CONNEcnCUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA KENTUCKY MAINE MARYLAND MASSACHUSETTS NEW HAMPSHIRE NEW JERSEY NEW YORK NORTH CAROUNA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH CAROUNA TENNESSEE VERMONT VIRGINIA VIRGIN ISLANDS OR WEST VIRGINIA

SEND APPUCA nONS TO

LICENSING ASSISTANCE TEAM DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PA 19406-2713

IF YOU ARE LOCATED IN

ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN SEND APPLICA nONS TO

MATERIALS LICENSING BRANCH us NUCLEAR REGULATORY COMMISSION REGION III 2443 WARRENVILLE ROAD SUITE 210 LISLE IL 60532-4352

ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH DAKOTA OKLAHOMA OREGON PACIFIC TRUST TERRITORIES SOUTH DAKOTA TEXAS UTAH WASHINGTON OR WYOMING

SEND APPUCA nONS TO

NUCLEAR MATERIALS LICENSING BRANCH uS NUCLEAR REGULATORY COMMISSION REGION IV 1600 E LAMAR BOULEVARD ARLINGTON TX 76011-4511

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

2 NAME AND MAILING ADDRESS OF APPLICANT (InclucJe ZIP code)1 THIS IS AN APPLICATION FOR (Check appropriate item)

0 A NEW LICENSE Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 13-26640-01l] B AMENDMENT TO LICENSE NUMBER 617 Oakley Street

c RENEWAL OF LICENSE NUMBER Evansville IN 47710

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION3 ADDRESS WiERE LICENSED MATERIAL WILL BE USED OR POSSESSED

Robert G Kochan PhD (US RSO)

Covance - Evansville Clinic BUSINESS TELEPHONE NUMBER IBUSINESS CELLULAR TELEPHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochancovancecom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11 PAPER THE TYPE AND SCOFE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE

s RADIOACTIVE MATERIAL a Element and mass number b chemical andor physical form and c maiximum amount 6 PURPOSE(S) FOR WiICH LICENSED MATERIAL WILL BE USED

which will be possessed at anyone time

7 INDlVlDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDIVIDUALS IIORKING IN OR FREQUENTING RESTRICTED AREASTRAINING EXPERIENCE

9 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM

12 LICENSE FEES (See 10CFR 170anci Section 17031) 11 WASTE MANAGEMENT AMOUNT

FEE CATEGORY 7C $ 000ENCLOSED

13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 CODE OF FEDERAL REGULAnONS PARTS 30 32 3334 35 36 39 AND 40 AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWlEDGE AND BELIEF WARNING 18 USC SECTION 1001 ACT OF JUNE 25 194862 STAT 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION

CERTIFYING OFFICER - TYPEDPRINTED NAME AND TITLE DATE

Ted Broering BS MBA Executive Director Clinical Development Services Covance Clinical Research Unit Inc 3 Ir4~middot1o1zI~~

7

FOR NRC USE ONLY ~

TYPE OF FEE bullCHECK NUMBER ICOMMENTSIFEE LOG IFEE CATEGORY l~OUNT RECEIVED

APPROVED BY DATE

NRC FORM 313 (Q52012)

APPROVED BY OMB NO 3150-0028 EXPIRES 10312013 (05-2012) NRC FORM 314 US NUCLEAR REGULATORY COMMISSION

Estimated burden per response to comply with this mandatory collection request 30 minutes10 CFR 3O36fj)~1) 40 42Jll(1) This submittal is used by NRC as part of the basis for its detennination that the facility is7038(j)(1) and 254(kX (1)(1)

released for unreslJicted use Send comments regarding burden estimate to the Information Services Branch (T-5 F53) Us Nuclear Regulatory Commission Washington DC 20555-0001 or by internet e-mail to InfocoliectsResourcenrcgov and to the Desk OffICer Office ofCERTIFICATE OF DISPOSITION OF MATERIALS Information and Regulatory Affairs NEOB-10202 (3150-0028) Office of Management and Budget Washington DC 20503 If ameans used to impose an infOlTT1ation collection does nol display acurrenlly valid OMB control number the NRC may nOI conduct or sponsor and a person is not required to respond to the information colleclion

LICENSEE NAME AND ADDRESS LICENSE NUMBER DOCKET NUMBER

13-26640-01Covance Clinical Research Unit Inc Covance-Evansville Clinic 617 Oakley Street LICENSE EXPIRATION DATE Evansville IN 47710 January 312016

A LICENSE STATUS (Ch~ck the appropriate[f) This licpnzt~ is ceasing act vity D This license has expired D This license has not yet expired please terminate it X in 1 of 2 buildings-see attJched

B DISPOSAL OF RADIOACTIVE MATERIAL (Check the appropriate boxes and complete as necessary If additional space is needed provide attachments)

The licensee or any individual executing this certificate on behalf of the licensee certifies that

1 No radioactive materials have ever been procured or possessed by the licensee under this license D 2 All activities authorized by this license have ceased d all radioactive materials procured andor possessed by the licensee 0

under this license number cited above have been disposeu ltJf- ~ following manner

o a Transfer of radioactive materials to the licensee listed below to See attached complete summary of transfers from Honolulu HI facility Covance-Honolulu HI clinical siJe

in 1 of 2 buildings ONLY applief

0b Disposal of radioactive materials see attached o 1 Directly by the licensee

Via sanitary sewer (residual amounts of 14C-radioactivity [lt00001 mCi] on glasswareobjects used in dose preparation washeddecontaminated and released to sanitary sewerage system)

2 By licensed disposal site

D 3 By waste contractor

0c All radioactive materials have been removed such that any remaining reSidual radioactivity is within the limits of 10 CFR Part 20 Subpart E and is ALARA

C SURVEYS PERFORMED AND REPORTED

o 1 A radiation survey was conducted by the licensee The survey confirms

0 a the absence of licensed radioactive materials

o b that any remaining residual radioactivity is within the limits of 10 CFR 20 Subpart E and is ALARA

o 2 A copy of the radiation survey results

o a is attached or Db is not attached (Provide explanation) or D c was forwarded to NRC on Date

3 A radiation survey is not required as only sealed sources were ever possessed under this license and

D a The results of the latest leak test are attached andor D b No leaking sources have ever been identified

The person to be contacted regarding the information provided on this form NAME TELEPHONE (Include Alee Code) E-MAIL ADDRESS

ITLE (608) 310-8268 robertkochancovancecom

Mail all future correspondence regarding this license 10

Robert G Kochan PhD (Clinic RSO) Covance CRU Inc Covance-Evansville Clinic 617 Oakley Street Evansville IN 47710

Robert G Kochan PhD Covance US RSO

C CERTIFYING OFFICIAL I CERTIFY UNDER PENALTV OF PERJURY THAT THJFOREGOING IS TRUE AND CORRECT

PRINTED NAME AND TITLE I SIG~ ~IDATEdTed Broering Executive Director Clinical Develop Services bull A 31middot Au- -La (2 WARNING FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO C~IL ANbOR CRIMINAL PENALTIESI~cLATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECT 18 USc SECTION 1001 MA ACRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY Of THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION NRC FORM 314 (05-2012)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 1 of34

TABLE OF CONTENTS FOR LICENSE AMENDMENT REQUEST

Page

Table ofContents for License Amendment Request dated 31 August 2012 1

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section C Item 2a Final Status Survey Report (FSSR)

License Amendment Request Letter (dated 31 August 2012) 2

Completed Form NRC 313 (05-2012) for Covance CRU Inc 4 Form NRC 313 Item 5 Radioactive MateriaL 5

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used 5

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program

amp Their Training and Experience 5

Form NRC 313 Item 7 Radiation Safety Officer 5

Form NRC 313 Item 7 Authorized User 5

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas 6

Form NRC 313 Item 9 Facility Diagrams-Discussion 6

Form NRC 313 Item 9 Radiation Monitoring Instruments 6

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages

ofUnsealed Radioactive Material 6

Form NRC 313 Attachment 94 Other Equipment and Facilities 7

Form NRC 313 Item 10 Occupational Dose 7

Form NRC 313 Item 10 Area Surveys 7

Form NRC 3l3 Item 10 Safe Use of Unsealed Licensed Material 7

Form NRC 313 Item 10 Spill Procedures 7

Form NRC 313 Item 11 Waste Management 7

Completed Form NRC 314 (05-2012) for Covance CRU Inc 8

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2 9

Form NRC 314-Section A License Status (Addendum) 11

Form NRC 314-Section B Item 2 Disposal of Radioactive Material (Addendum) 11

Transfer Disposals from Covance-Honolulu site) 12

Disposal via Radioactive Waste Broker-Philotechnics) 13

Waste Manifest No 0125-040511 EN for Covance-Honolulu Clinical Site 05 Apr 2011 14

Waste Manifest No 0125-040511EN Accountability for Covance CRU Study No 8226978 17

for Covance-Honolulu Clinical Site 20

Summary of Restricted Area-HOT LABS in Covance-Honolulu Clinical Site 21

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site 22

FSSR LSC Swipe Test Results at Covance-Honolulu Clinical Site 28

FSSR Survey Meter Test Results at Covance-Honolulu Clinical Site 33

NUREG-1757 VoL I Rev 2 Table 12 Principal Regulatory Features of Decommissioning

Groups Applicable Group for Covance-Honolulu Clinical Site Group 2 34

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 2 of34

License Amendment Request Letter (dated 01 February 2008) - Page 1 of2

Covance Clinical Reseanh Unit loc Clinical Development Services cov~ Covance - Evansville Cftnic 617 Oakley Street EvansvillE IN 47710 Tel $12474-5000 Fax 812469-5404

31 August 2012 Page 1 of2

NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road Suite 210 Lisle IL 60532-4351

Re Request to Decommission Honolulu ill site (1 of 2 separate buildings) Request to Extend License for 24-months at Evansville IN site (2nd separate building)

pursuant to Timeliness Rule (Materials License No 13-26640-01)

Dear NRC License Reviewer

The previous principal activity for the above-referenced license occurred on 02 Nov 2010 therefore consistent with the Timeliness Rule Covance CRU Inc is requesting the following

1) Due to the decision to permanently cease principal activities in the Honolulu ill clinic ie in I of the 2 separate buildings on the current license the Honolulu HI site is being decommissioned-applicable decommissioning documents are attached

2) Since as of 02 Nov 2012 no principal activities will have been conducted on the license for 24-months Covance CRU Inc hereby petitions the NRC to approve an additional 24-month continuationextension of the license for the remaining Evansville IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below

Covance CRU Incos NRC license No 13-26640-01 is in the Specific Use Type 7C category and pertains to uptake dilution and excretion studies permitted by 10 CPR 35100 involving administration of only 14C_ or ~-radiolabeled drug materials ieas part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies Covance CRU Inc also maintains an active Agreement State license ofthe same type with WI DHS (License No 025-1075-0I) for its Madison WI clinic where in fact the highest number of contracted clinical studies of this type are performed in the world currently conducting 20 to 30 separate studies ofthis type per year Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison WI clinic Covance CRU Inc needs the flexibility to conductcontract some of these specialized clinical studies at their Evansvil1e IN clinic However since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc to respond within a short 1-2 month timefuune to start their contracted clinical study it would not be possible to get timely approval of a new NRC license for the Evansville IK clinic due to the lengthy NRC reviewapproval process required for a new license Thus although the Evansville IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part ofAmendment No 12) Covance CRU Inc needs almost instantancously to be able to resume these principal activities at the Evansville IN clinic and therefore requests that NRC grant a continuationextension of the current NRC license for a minimum 24-month period subject to subsequent timely request and extension in accordance with the Timeliness Rule ifas appropriate

THE AMERICAS EUROPE ASINPACIFlC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 3 of34

License Amendment Request Letter (dated 01 February 2008) - Page 2 of2

cov~ CovanCil Clinical Research Unit Inc Clinical Development Services CovanCil - Evansville Clinic

THe DEiIrioPMENTsERVWCOMIIlNY 617 Oakley Street Evansville IN 47710 Tel 812-474-6000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perfonn the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staffand almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however ifwe are incorrect please just Jet us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning of the Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ipoundwben the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance~since the RSO is locatedlbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Tbank you in advance for your timely evaluation ofthese requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office Tel No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu In facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 4: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

APPROVED BY OMB NO 3150-0028 EXPIRES 10312013 (05-2012) NRC FORM 314 US NUCLEAR REGULATORY COMMISSION

Estimated burden per response to comply with this mandatory collection request 30 minutes10 CFR 3O36fj)~1) 40 42Jll(1) This submittal is used by NRC as part of the basis for its detennination that the facility is7038(j)(1) and 254(kX (1)(1)

released for unreslJicted use Send comments regarding burden estimate to the Information Services Branch (T-5 F53) Us Nuclear Regulatory Commission Washington DC 20555-0001 or by internet e-mail to InfocoliectsResourcenrcgov and to the Desk OffICer Office ofCERTIFICATE OF DISPOSITION OF MATERIALS Information and Regulatory Affairs NEOB-10202 (3150-0028) Office of Management and Budget Washington DC 20503 If ameans used to impose an infOlTT1ation collection does nol display acurrenlly valid OMB control number the NRC may nOI conduct or sponsor and a person is not required to respond to the information colleclion

LICENSEE NAME AND ADDRESS LICENSE NUMBER DOCKET NUMBER

13-26640-01Covance Clinical Research Unit Inc Covance-Evansville Clinic 617 Oakley Street LICENSE EXPIRATION DATE Evansville IN 47710 January 312016

A LICENSE STATUS (Ch~ck the appropriate[f) This licpnzt~ is ceasing act vity D This license has expired D This license has not yet expired please terminate it X in 1 of 2 buildings-see attJched

B DISPOSAL OF RADIOACTIVE MATERIAL (Check the appropriate boxes and complete as necessary If additional space is needed provide attachments)

The licensee or any individual executing this certificate on behalf of the licensee certifies that

1 No radioactive materials have ever been procured or possessed by the licensee under this license D 2 All activities authorized by this license have ceased d all radioactive materials procured andor possessed by the licensee 0

under this license number cited above have been disposeu ltJf- ~ following manner

o a Transfer of radioactive materials to the licensee listed below to See attached complete summary of transfers from Honolulu HI facility Covance-Honolulu HI clinical siJe

in 1 of 2 buildings ONLY applief

0b Disposal of radioactive materials see attached o 1 Directly by the licensee

Via sanitary sewer (residual amounts of 14C-radioactivity [lt00001 mCi] on glasswareobjects used in dose preparation washeddecontaminated and released to sanitary sewerage system)

2 By licensed disposal site

D 3 By waste contractor

0c All radioactive materials have been removed such that any remaining reSidual radioactivity is within the limits of 10 CFR Part 20 Subpart E and is ALARA

C SURVEYS PERFORMED AND REPORTED

o 1 A radiation survey was conducted by the licensee The survey confirms

0 a the absence of licensed radioactive materials

o b that any remaining residual radioactivity is within the limits of 10 CFR 20 Subpart E and is ALARA

o 2 A copy of the radiation survey results

o a is attached or Db is not attached (Provide explanation) or D c was forwarded to NRC on Date

3 A radiation survey is not required as only sealed sources were ever possessed under this license and

D a The results of the latest leak test are attached andor D b No leaking sources have ever been identified

The person to be contacted regarding the information provided on this form NAME TELEPHONE (Include Alee Code) E-MAIL ADDRESS

ITLE (608) 310-8268 robertkochancovancecom

Mail all future correspondence regarding this license 10

Robert G Kochan PhD (Clinic RSO) Covance CRU Inc Covance-Evansville Clinic 617 Oakley Street Evansville IN 47710

Robert G Kochan PhD Covance US RSO

C CERTIFYING OFFICIAL I CERTIFY UNDER PENALTV OF PERJURY THAT THJFOREGOING IS TRUE AND CORRECT

PRINTED NAME AND TITLE I SIG~ ~IDATEdTed Broering Executive Director Clinical Develop Services bull A 31middot Au- -La (2 WARNING FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO C~IL ANbOR CRIMINAL PENALTIESI~cLATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECT 18 USc SECTION 1001 MA ACRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY Of THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION NRC FORM 314 (05-2012)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 1 of34

TABLE OF CONTENTS FOR LICENSE AMENDMENT REQUEST

Page

Table ofContents for License Amendment Request dated 31 August 2012 1

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section C Item 2a Final Status Survey Report (FSSR)

License Amendment Request Letter (dated 31 August 2012) 2

Completed Form NRC 313 (05-2012) for Covance CRU Inc 4 Form NRC 313 Item 5 Radioactive MateriaL 5

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used 5

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program

amp Their Training and Experience 5

Form NRC 313 Item 7 Radiation Safety Officer 5

Form NRC 313 Item 7 Authorized User 5

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas 6

Form NRC 313 Item 9 Facility Diagrams-Discussion 6

Form NRC 313 Item 9 Radiation Monitoring Instruments 6

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages

ofUnsealed Radioactive Material 6

Form NRC 313 Attachment 94 Other Equipment and Facilities 7

Form NRC 313 Item 10 Occupational Dose 7

Form NRC 313 Item 10 Area Surveys 7

Form NRC 3l3 Item 10 Safe Use of Unsealed Licensed Material 7

Form NRC 313 Item 10 Spill Procedures 7

Form NRC 313 Item 11 Waste Management 7

Completed Form NRC 314 (05-2012) for Covance CRU Inc 8

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2 9

Form NRC 314-Section A License Status (Addendum) 11

Form NRC 314-Section B Item 2 Disposal of Radioactive Material (Addendum) 11

Transfer Disposals from Covance-Honolulu site) 12

Disposal via Radioactive Waste Broker-Philotechnics) 13

Waste Manifest No 0125-040511 EN for Covance-Honolulu Clinical Site 05 Apr 2011 14

Waste Manifest No 0125-040511EN Accountability for Covance CRU Study No 8226978 17

for Covance-Honolulu Clinical Site 20

Summary of Restricted Area-HOT LABS in Covance-Honolulu Clinical Site 21

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site 22

FSSR LSC Swipe Test Results at Covance-Honolulu Clinical Site 28

FSSR Survey Meter Test Results at Covance-Honolulu Clinical Site 33

NUREG-1757 VoL I Rev 2 Table 12 Principal Regulatory Features of Decommissioning

Groups Applicable Group for Covance-Honolulu Clinical Site Group 2 34

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 2 of34

License Amendment Request Letter (dated 01 February 2008) - Page 1 of2

Covance Clinical Reseanh Unit loc Clinical Development Services cov~ Covance - Evansville Cftnic 617 Oakley Street EvansvillE IN 47710 Tel $12474-5000 Fax 812469-5404

31 August 2012 Page 1 of2

NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road Suite 210 Lisle IL 60532-4351

Re Request to Decommission Honolulu ill site (1 of 2 separate buildings) Request to Extend License for 24-months at Evansville IN site (2nd separate building)

pursuant to Timeliness Rule (Materials License No 13-26640-01)

Dear NRC License Reviewer

The previous principal activity for the above-referenced license occurred on 02 Nov 2010 therefore consistent with the Timeliness Rule Covance CRU Inc is requesting the following

1) Due to the decision to permanently cease principal activities in the Honolulu ill clinic ie in I of the 2 separate buildings on the current license the Honolulu HI site is being decommissioned-applicable decommissioning documents are attached

2) Since as of 02 Nov 2012 no principal activities will have been conducted on the license for 24-months Covance CRU Inc hereby petitions the NRC to approve an additional 24-month continuationextension of the license for the remaining Evansville IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below

Covance CRU Incos NRC license No 13-26640-01 is in the Specific Use Type 7C category and pertains to uptake dilution and excretion studies permitted by 10 CPR 35100 involving administration of only 14C_ or ~-radiolabeled drug materials ieas part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies Covance CRU Inc also maintains an active Agreement State license ofthe same type with WI DHS (License No 025-1075-0I) for its Madison WI clinic where in fact the highest number of contracted clinical studies of this type are performed in the world currently conducting 20 to 30 separate studies ofthis type per year Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison WI clinic Covance CRU Inc needs the flexibility to conductcontract some of these specialized clinical studies at their Evansvil1e IN clinic However since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc to respond within a short 1-2 month timefuune to start their contracted clinical study it would not be possible to get timely approval of a new NRC license for the Evansville IK clinic due to the lengthy NRC reviewapproval process required for a new license Thus although the Evansville IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part ofAmendment No 12) Covance CRU Inc needs almost instantancously to be able to resume these principal activities at the Evansville IN clinic and therefore requests that NRC grant a continuationextension of the current NRC license for a minimum 24-month period subject to subsequent timely request and extension in accordance with the Timeliness Rule ifas appropriate

THE AMERICAS EUROPE ASINPACIFlC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 3 of34

License Amendment Request Letter (dated 01 February 2008) - Page 2 of2

cov~ CovanCil Clinical Research Unit Inc Clinical Development Services CovanCil - Evansville Clinic

THe DEiIrioPMENTsERVWCOMIIlNY 617 Oakley Street Evansville IN 47710 Tel 812-474-6000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perfonn the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staffand almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however ifwe are incorrect please just Jet us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning of the Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ipoundwben the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance~since the RSO is locatedlbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Tbank you in advance for your timely evaluation ofthese requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office Tel No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu In facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 5: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 1 of34

TABLE OF CONTENTS FOR LICENSE AMENDMENT REQUEST

Page

Table ofContents for License Amendment Request dated 31 August 2012 1

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-

Form NRC 314-Section C Item 2a Final Status Survey Report (FSSR)

License Amendment Request Letter (dated 31 August 2012) 2

Completed Form NRC 313 (05-2012) for Covance CRU Inc 4 Form NRC 313 Item 5 Radioactive MateriaL 5

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used 5

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program

amp Their Training and Experience 5

Form NRC 313 Item 7 Radiation Safety Officer 5

Form NRC 313 Item 7 Authorized User 5

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas 6

Form NRC 313 Item 9 Facility Diagrams-Discussion 6

Form NRC 313 Item 9 Radiation Monitoring Instruments 6

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages

ofUnsealed Radioactive Material 6

Form NRC 313 Attachment 94 Other Equipment and Facilities 7

Form NRC 313 Item 10 Occupational Dose 7

Form NRC 313 Item 10 Area Surveys 7

Form NRC 3l3 Item 10 Safe Use of Unsealed Licensed Material 7

Form NRC 313 Item 10 Spill Procedures 7

Form NRC 313 Item 11 Waste Management 7

Completed Form NRC 314 (05-2012) for Covance CRU Inc 8

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2 9

Form NRC 314-Section A License Status (Addendum) 11

Form NRC 314-Section B Item 2 Disposal of Radioactive Material (Addendum) 11

Transfer Disposals from Covance-Honolulu site) 12

Disposal via Radioactive Waste Broker-Philotechnics) 13

Waste Manifest No 0125-040511 EN for Covance-Honolulu Clinical Site 05 Apr 2011 14

Waste Manifest No 0125-040511EN Accountability for Covance CRU Study No 8226978 17

for Covance-Honolulu Clinical Site 20

Summary of Restricted Area-HOT LABS in Covance-Honolulu Clinical Site 21

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site 22

FSSR LSC Swipe Test Results at Covance-Honolulu Clinical Site 28

FSSR Survey Meter Test Results at Covance-Honolulu Clinical Site 33

NUREG-1757 VoL I Rev 2 Table 12 Principal Regulatory Features of Decommissioning

Groups Applicable Group for Covance-Honolulu Clinical Site Group 2 34

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 2 of34

License Amendment Request Letter (dated 01 February 2008) - Page 1 of2

Covance Clinical Reseanh Unit loc Clinical Development Services cov~ Covance - Evansville Cftnic 617 Oakley Street EvansvillE IN 47710 Tel $12474-5000 Fax 812469-5404

31 August 2012 Page 1 of2

NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road Suite 210 Lisle IL 60532-4351

Re Request to Decommission Honolulu ill site (1 of 2 separate buildings) Request to Extend License for 24-months at Evansville IN site (2nd separate building)

pursuant to Timeliness Rule (Materials License No 13-26640-01)

Dear NRC License Reviewer

The previous principal activity for the above-referenced license occurred on 02 Nov 2010 therefore consistent with the Timeliness Rule Covance CRU Inc is requesting the following

1) Due to the decision to permanently cease principal activities in the Honolulu ill clinic ie in I of the 2 separate buildings on the current license the Honolulu HI site is being decommissioned-applicable decommissioning documents are attached

2) Since as of 02 Nov 2012 no principal activities will have been conducted on the license for 24-months Covance CRU Inc hereby petitions the NRC to approve an additional 24-month continuationextension of the license for the remaining Evansville IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below

Covance CRU Incos NRC license No 13-26640-01 is in the Specific Use Type 7C category and pertains to uptake dilution and excretion studies permitted by 10 CPR 35100 involving administration of only 14C_ or ~-radiolabeled drug materials ieas part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies Covance CRU Inc also maintains an active Agreement State license ofthe same type with WI DHS (License No 025-1075-0I) for its Madison WI clinic where in fact the highest number of contracted clinical studies of this type are performed in the world currently conducting 20 to 30 separate studies ofthis type per year Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison WI clinic Covance CRU Inc needs the flexibility to conductcontract some of these specialized clinical studies at their Evansvil1e IN clinic However since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc to respond within a short 1-2 month timefuune to start their contracted clinical study it would not be possible to get timely approval of a new NRC license for the Evansville IK clinic due to the lengthy NRC reviewapproval process required for a new license Thus although the Evansville IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part ofAmendment No 12) Covance CRU Inc needs almost instantancously to be able to resume these principal activities at the Evansville IN clinic and therefore requests that NRC grant a continuationextension of the current NRC license for a minimum 24-month period subject to subsequent timely request and extension in accordance with the Timeliness Rule ifas appropriate

THE AMERICAS EUROPE ASINPACIFlC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 3 of34

License Amendment Request Letter (dated 01 February 2008) - Page 2 of2

cov~ CovanCil Clinical Research Unit Inc Clinical Development Services CovanCil - Evansville Clinic

THe DEiIrioPMENTsERVWCOMIIlNY 617 Oakley Street Evansville IN 47710 Tel 812-474-6000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perfonn the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staffand almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however ifwe are incorrect please just Jet us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning of the Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ipoundwben the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance~since the RSO is locatedlbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Tbank you in advance for your timely evaluation ofthese requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office Tel No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu In facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 6: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 2 of34

License Amendment Request Letter (dated 01 February 2008) - Page 1 of2

Covance Clinical Reseanh Unit loc Clinical Development Services cov~ Covance - Evansville Cftnic 617 Oakley Street EvansvillE IN 47710 Tel $12474-5000 Fax 812469-5404

31 August 2012 Page 1 of2

NRC License Reviewer Materials Licensing Branch US Nuclear Regulatory Commission-Region III 2443 Warrenville Road Suite 210 Lisle IL 60532-4351

Re Request to Decommission Honolulu ill site (1 of 2 separate buildings) Request to Extend License for 24-months at Evansville IN site (2nd separate building)

pursuant to Timeliness Rule (Materials License No 13-26640-01)

Dear NRC License Reviewer

The previous principal activity for the above-referenced license occurred on 02 Nov 2010 therefore consistent with the Timeliness Rule Covance CRU Inc is requesting the following

1) Due to the decision to permanently cease principal activities in the Honolulu ill clinic ie in I of the 2 separate buildings on the current license the Honolulu HI site is being decommissioned-applicable decommissioning documents are attached

2) Since as of 02 Nov 2012 no principal activities will have been conducted on the license for 24-months Covance CRU Inc hereby petitions the NRC to approve an additional 24-month continuationextension of the license for the remaining Evansville IN clinic-reason for extension request (instead of decommissioning the entire NRC license) is given below

Covance CRU Incos NRC license No 13-26640-01 is in the Specific Use Type 7C category and pertains to uptake dilution and excretion studies permitted by 10 CPR 35100 involving administration of only 14C_ or ~-radiolabeled drug materials ieas part of Covance contracts with Study Sponsors (pharmaceutical companies) for these types of clinical studies Covance CRU Inc also maintains an active Agreement State license ofthe same type with WI DHS (License No 025-1075-0I) for its Madison WI clinic where in fact the highest number of contracted clinical studies of this type are performed in the world currently conducting 20 to 30 separate studies ofthis type per year Since it is anticipated that this contract work will continue to grow and potentially exceed the current capabilities of the Madison WI clinic Covance CRU Inc needs the flexibility to conductcontract some of these specialized clinical studies at their Evansvil1e IN clinic However since after the actual contract is awarded the pharmaceutical company expects Covance CRU Inc to respond within a short 1-2 month timefuune to start their contracted clinical study it would not be possible to get timely approval of a new NRC license for the Evansville IK clinic due to the lengthy NRC reviewapproval process required for a new license Thus although the Evansville IN clinic facility has never conducted any principal activities since initially being added to the current NRC license in 2008 (as part ofAmendment No 12) Covance CRU Inc needs almost instantancously to be able to resume these principal activities at the Evansville IN clinic and therefore requests that NRC grant a continuationextension of the current NRC license for a minimum 24-month period subject to subsequent timely request and extension in accordance with the Timeliness Rule ifas appropriate

THE AMERICAS EUROPE ASINPACIFlC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 3 of34

License Amendment Request Letter (dated 01 February 2008) - Page 2 of2

cov~ CovanCil Clinical Research Unit Inc Clinical Development Services CovanCil - Evansville Clinic

THe DEiIrioPMENTsERVWCOMIIlNY 617 Oakley Street Evansville IN 47710 Tel 812-474-6000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perfonn the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staffand almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however ifwe are incorrect please just Jet us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning of the Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ipoundwben the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance~since the RSO is locatedlbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Tbank you in advance for your timely evaluation ofthese requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office Tel No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu In facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 7: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 3 of34

License Amendment Request Letter (dated 01 February 2008) - Page 2 of2

cov~ CovanCil Clinical Research Unit Inc Clinical Development Services CovanCil - Evansville Clinic

THe DEiIrioPMENTsERVWCOMIIlNY 617 Oakley Street Evansville IN 47710 Tel 812-474-6000 Fax 812-469-5404

Page 2 of2

It should be noted that under the authority of their respective NRC and WI DHS medical use licenses the Evansville IN clinic and the Madison WI clinic both perfonn the same activities with the 14C and 3H radiolabeled materials use the same radiation safety program employ the same set of harmonized Standard Operating Procedures and have the same RSO This explains why it would be possible to quickly retrain the Evansville IN clinic staffand almost immediately re-institute the various specialized procedures needed at the Evansville IN clinic ie since Covance CRU Inc is able to utilize the currentup-to-date and extensive experience and proven radiation safety program in place at the sister clinic in Madison WI and instantly transfer these to the Evansville IN clinic

It is our understanding that there is no accompanying fee required for the 2 requests listed above however ifwe are incorrect please just Jet us know what the fee is so that we can forward you a check for the appropriate amount

Covance plans to cease all clinical operations at the Honolulu HI clinic in mid November 2012 we hope that the decommissioning of the Honolulu HI site and extension of the license for the Evansville IN clinic can both be completedapproved prior to the end of November 2012 Covance CRU Inc understands that it must continue to maintain the lease at the Honolulu HI clinic until the entire decommissioning process for this separate buildingfacility is complete

The contact for any questionsissues related to these requests is the license-listed RSO Robert G Kochan PhD (608-310-8268) In addition ipoundwben the NRC plans to visit the Honolulu HI site as part of the overall NRC decommissioning activities for this specific facility we respectfully request that the NRC visitationinspection plansdates be communicated in advance if possible to the RSO (eg via email atrobertkochancovancecom ) so that the RSOs travel plans can be made in advance~since the RSO is locatedlbased on the US mainland and needs to book a flight to Honolulu HI in order to be presenton-site during the NRC visit

Tbank you in advance for your timely evaluation ofthese requests

Ted Broering BS MBA Robert G Kochan PhD Executive Director Clinical Pharmacology Services Covance US Clinical Pharmacology RSO Covance Clinical Research Unit Inc Covance Clinical Research Unit Inc

Office Tel No (608) 310-8268 24-hr RSO Cell No (608) 695-0229

Enclosure Form NRC 313 (request to extend license for Evansville IN sitefacility) Form NRC 314 (and applicable decommissioning forms for Honolulu In facility)

xc Thomas E Murtaugh MD and AU at Honolulu HI sitefacility Randall R Stoltz MD and AU at Evansville IN sitefacility

THE AMERICAS EUROPE ASIAPACIFIC AFRICA

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 8: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 4 of34

Completed Form NRC 313 (05-2012) for Covance CRU Inc

APPROVED BY OMB NO 3160-0120 EXPIReS (amp513112015)NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (lraquo-2ll12) Eamp__per_PiY 1Ilis1llllldaltlry_IOqUestUhOonSUlwnillalltll 10 CAA 30 32 33 343536 39 lIIInd 40 lloapplcoljco lIo_thotlllbullbullppllIlUsquolilodamIIII11~-u eltist

10 pmIacI th pvbt 1111 am saiety Sea COIIl11IOIlIsaiItJ bIlnleo _ to 1he _

S Brinb (T-5 F53) ~s _Regulalay ecnm- WosImgllo DC~ airt iolema _ail 10 I_~gov end to Ibo look 0_ 0fIce oIl111om1a11on Rogulalay _ NEOB-ll202 (3151)l112Ol 0fIce or MaM~ and Budge w~ DC 2IJ503 K_means inpooe an inbmaion __ not dOpIoy OC1lrel11i1 vld OMS _1IIeNRC maynol_t-_ _bnot_IoOIe--

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPUCATION shySEND TWO COPIES OF THE ENTIRE COMPLETlED APPUCATION TO THE NRC OFFICE SPECIFIED BELOW

IF YOU ARE L()(jlED INAPPIICA1lON f()R DlS1Rl1llll1OH0f EXeMPT PIOIJUCTS FIIE APPUCAnONS WITlI

IUINOISINOfANA IOWA MICliIGAN MINNESOTA assDURJ CHO OR Wf$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND

SEND APPllCA110NS TO LWJS10N OF MATERWS SAFETY NJDSTAiE AGREENSNTS US NlClEAR REGULATORY COMMISSION MATERlALS UCENSiNG BRA~H

US NLJCtEAR Re6UlA~Y COWMISSIOI( REGION III 3443 Y8gtRREH1LLE RQAO SurrE 210

llSHINGTON DC 2CJ555OOOt

ALL entER PERSOHS RIpound APPUCAllON$ A$ FOUOWS UStEILIlIl532~

IF yOU ARE LOCAlalIN

ALASIAARIZONAAOISASCAUFORNIACOLORADOIIAWAIIHWIO- K9fllICKY MAINE MAAYLAND MASSACHUSETIS NEWIlAMPSHIRE NIW JERSEY A1ABAIIA CONNECTICIJT DElAWAIU IISTIOICr Of COLUMBIA ~ GEORGIA

LOIJISIAHA MlSSlSSllgtPJ MONTANA NEBIWiIltA NEVADA NEW MIOOCOIOORTH NEW YORK NORTH CIROLINA PEHNSYVANIA PUERTO RJCO RHODE ISlAND SOUTtl DAKOTA OKlAl106lA OREGON PACIFIC TRUST_OllIE$ SOUTH DAKOTA TEXAS CAROIJNA lENNIiSSIiE VERMONT V1R1l1N1A VIRGIN JSANDS OR WEST VIRGINIA UTAH WASttINGTON ORWVOMlNG

SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO

uceNSltIG ASSISTAI(E TEAM NlYIEAR IMTERIIIIS LlCfJltSING BRANCHIJMSION OF cLEAR lOATERIAIS SAFE1Y US NUCLEAR REGUlAT~Y COMMISSfON REGl(Jtj IV Us NlCUAA REGlIA1OfltY COMMISSION REGION I 15001~ OOUlElAAD 2100 RENAISSANCE BOULEVARD SUiTE 100 ARWltG1ON lX 76011511 KING OF PRUSSIA PA 19400-2713

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE Us NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO UsNUCLEAR REGULA TORY COMMISSION JURISDICTIONS

2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ

Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic

A NEWllCENSE

13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER

o c RENEWAL OF liCENSE NUMBER Evansville IN 47710

a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON

Robert G Kocban PhD (US RSO)

Covance - Evansville Clinic BU$IIIESS1REPHliiE NUMBER IBUSINESS CELUILAR TEISHONE NUMBER

617 Oakley Street (608) 310-8268 (608) 695-0229 Evansville IN 47710 BUSINESS EMAIL ADDRESS

robertkochanrovancerom SUBMfi ITEMS 51tflOlKlH 11 ON 9--112 X11 PAPER THE TYPE ANI) SCCWE OF INfORMATION TO BE PROVIDED JS DESCRIBED IN THE UCENSE APPUCAnON GUIDE

5 RADlOACllVE MATERiAl 1 Element ill41118amp$ nmblr b chenJcallIIlCUlaquo ~ Iofft and C maUQlTIJ1IIi iiMOUlt 6 IIJIIOSES) FOR HIQI UCElltSED IAATERlAI MU 1pound USED wtlaquohwllbe~a(lMrJmetime

7 INDfIJOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINItlt) FOR INlJIVIDUAtSORKING IN OR FREQUENiltiG RESTRlCTEDAREAS TRAINING EXPE~

10 RAtXATIOI SAFETY PROGRAMbull FAClUTIES AND EDUIPMENT

12 UCENSE FEES (See 1()CFR 17()anc SectIon 11O11j 11 VtSTe MANAGEMatI OONT

FEE CATEClORY 7C ENCLOSE) $ 000

13 CERllFlCATKlN (Mustbe~byapplleantJ THEAPPUCANTlINDIRSTANDS THAT ALL STATalENTSANO REPRESENTATIONS MADEN THIS APPUCA71ONARE8IMgtINfJ fJPtCm THE APPlJCANT

1lpoundAPPJCANT AND AN( OFFICiAL EXEClmNG THIS CERTIFtCATIQN (YII BEHALF OF THE APPLICANT NAMEJ) IN ITEM 2 CERTIFYiHAT THlS APPUCATION IS PREPAReD IN CONFORMliYMTHl1TlE 10 COOEOF1OIFW REGOLA11ONS PARTS 30 32 33)5 l6 AND4() ANDTHAT AU1NFltlRMATlONCCMAEDHEREIN 1$ TlWEAND CORRECl TO THE BEST OF TrEIR KrgtwsooE AND BEUEF WARNI~ 1auSC SECllONOO1 ACT OF JlJNE25 1948$2 STAT 7491AAKES IT ACRlMtNALOFFfNSE TO MAKE A V4LFJUY FALSE srATeMENTOR~5NTAnONO PNf DEPARTMENTORAG-NCr OF THE UNITED STATES AS TO ANV MATTER YJlTHlN rTSJUISDICTJON

CERTIFYING OFFICER - TYPetlIPRliiED NIIIo1E ANO l1Tlpound Dt-TE

Ted Broering BS MBA Elceculi~e Director Clinical Development s~~ L ~ 1-lDicServices Cavance Clinical Research Unit Inc ) FOR NRC USE ONLY

TYlEOFlEE FEE LOG IFEE CATEGORY I~ RECEIVED ICHECK NUMBER ICOMfIENTS --shyI

APPROID ElY DATe

J J NRC fORlt 33 ~2)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 9: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 5 of34

Form NRC 313 Item 5 Radioactive Material

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

200605 Dec 200601 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensed-approved

facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and being

decommissioned (see NRC form 314 and accompanying decommissioning documents) all the

previously-approved possession limits on the license will apply to ONL Y the remaining licensedshy

approved facility ie at the Covance-Evansville IN clinical site as follows

Byproduct Material ChemicallPhysical Form Maximum Amount

Carbon-14 Any Form 90mCi

Hydrogen-3 Any Form 90mCi

Form NRC 313 Item 6 Purpose(s) for which Licensed Material Will Be Used

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Individual(s) Responsible for Radiation Safety Program and Their

Training and Experience

Form NRC 313 Item 7 Radiation Safety Officer

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 7 Authorized User

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities Le Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) we

request that the previously approved Authorized User (AU) for the Covance--Honolulu HI

clinical site ie Thomas E Murtaugh MD be removed from the license Thus the previouslyshy

approved AU for the Covance-Evansville IN clinical site Randall R Stoltz MD shall be the

ONL Y AU listed on the license

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 10: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 6 of 34

Form NRC 313 Item 8 Training for Persons Working In or Frequenting Restricted Areas

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 9 Facilities Diagrams-Discussion

NO CHANGE for Covance-Evansville IN clinical site

REMOVEIDECOMMISSION the Covanc~Honolulu HI clinical site

Since 1 of the 2 licensed-approved facilities ie Covance-Honolulu HI clinical site is ceasing

principal activities and being decommissioned (see NRC form 314 and accompanying

decommissioning documents) the Covance-Honolulu HI clinical site should be removed from

the license in its entirety

Form NRC 313 Item 9 Radiation Monitoring Instruments

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site shall be moved to the remaining previously-approved facility at the Covance-Evansville IN

clinical site As previously requested Covance CRU Inc reserves the right to upgrade these

survey instruments as deemed necessary and as long as they are adequate to measure the type and level of radiation for which they are used related to this 35100 medical use (Le 14C and 3H use only)

Form NRC 313 Item 9 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Radioactive Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 11: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 7 of34

Form NRC 313 Attachment 94 Other Equipment and Facilities

NO CHANGE EXCEPT AS NOTED BELOW (refer to previous applications dated 11 Jan

2006 05 Dec 2006 01 Feb 2008 and 11 Mar 2010) NOTE Since 1 of the 2 licensedshy

approved facilities ie Covance-Honolulu HI clinical site is ceasing principal activities and

being decommissioned (see NRC form 314 and accompanying decommissioning documents) the

Covance-Honolulu HI clinical site should be the only remaining previously-approved facility

All radiation monitoring instruments previously used at the Covance-Honolulu HI clinical site

shall be moved to the remaining previously-approved facility at the Co vance-Evansville IN

clinical site All equipment previously used at the Covance-Honolulu HI clinical site shall be

moved to the remaining previously-approved facility at the Covance-Evansville IN clinicalmiddot site

ie no equipment will be left behind after decommissioning the Co vance-Honolulu HI clinical

site

Form NRC 313 Item 10 Occupational Dose

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Area Surveys

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Safe Use of Unsealed Licensed Material

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 10 Spill Procedures

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

Form NRC 313 Item 11 Waste Management

NO CHANGE (refer to previous applications dated 11 Jan 2006 05 Dec 2006 01 Feb 2008

and 11 Mar 2010)

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 12: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

-----

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 80f34

Completed Form NRC 314 (05-2012) for Covance CRU Inc

NRC FORM 313 us NUClEAR REGULATORY COMMISSION (l6-ltl12) OCFR303233 3435363amp tnj 40

APPLICATION FOR MATERIALS LICENSE

APPROVED IIY OMII NO31ampCHl120 EXPIRes (0513112015) __ _toCOl1ljllylllillllhislllOllda1llly_requeotU-S_or III appIcaIion is Y 10 __ that ppIegt is 1mocI and tbata6oq_fId_ ampis IoprulSCtpublilleslC1 and safely Send_~__lotllel_ s Ilrnoh (loS F53) us Ho_RePIIIY Can_IXI WasIigtgk)n DC 2J5S60001 is by _a III 1~nIPi end 10 tnt Deslt 0_ Ofb 011_ and ReguIaDy Afton NEOamp-lQ2O1 (J15ampl)1Q) 0IIilte a lIonagomenl and BudgoI Warilglon DC 21)503 W 10 m_ inJonnmnltDi_ _ not display culr_ ClolB cooIrol _IlIeNRCmaynltll ___endnotrequiodlo1Oldtolheillfonmltion tDIediIn

INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPUCATION GUIDE FOR OETAiLEO INSTRUCTIONS FOR COMPLETING APPlICAnON SEND iWO COPIES OF THE ENTIRE COMPlETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW

APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH

OFFICi OF FitERALamp STATE MATERIALS AND ENVlRONMEHTAI MANAGENEWT PROGRAMS DtVlSlON OF MATERIALS SAFETY AH)STATE AGReaAENTS Us NtXtEAR REGULATORY COMMlSSION VlltSHlNGTON DC 2Q555OO(n

AlL OTHER PERSONS ALE APPlJCATIONS AS FOLLOWS

If YOU ARE LOcAlliIllN

A1ASAIIA CONNECflCIJT DElAWAIE OIimltICI 01 COLU FIORIDI GeORGIlI KemJCKY MAINE MARVLAHIgt MASSACHUSETTS NEW --NEW JERSEY HEW VORllt HOfmj CAROIlNA PENNSYLVANIA PUERTO RICO RHODEISlAIOP SOUTH CAROLINA TeIHpoundSSSE VERMONT VIRGINIA 1SlA_ OR WESTIIIRGINIA

IlEIfD APPUCATIOIIS TO

UCENS ASSISTANCE TEAM lMSIOO OF NUCLEAR IITERIALS SAfEY US NlOpoundAA REGUlATORY COfOMlSSltON REGION I 2100 RENAISSANCE 1IOUlEVARD SUITE 100 KING OF PRUSSIA PA 1~713

YOU MEIOCATEP IN

IllJNOIS DIANA IOWA ~ _TA_Rl OlIO OR gtIISCOtltSIN SEHD APPUCAllONS TO

TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2

ALASKA ARIZONAARIWltiAS CAUFORNlA COUlRADOWAII_ KANSAS LOUISWiA SSISSIPP IlaquoraquoITAAJI _ NevADA NEWIftElOCXl NOImI twltOTA 0Ilt1AII0IIIA OREGON PACIFIC TRUST lERRITORIES BOUT IWltOTA TEXAS UTA WASHINGTON ORWiOIIIING

SBltD AIItICAOOIIS 10

NUCLEAR MATERW-S UCENSING EIlWCH US NlXlEAR REGUtATCIlY COMSSION REGION IV 1600 E lAMAR BOJLElARD AIlIlrlaquolTON TX 7St)l1

PERSONS LOCATED IN AGREEMENT STATIiS SIiND APPUCATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSlSS AND USE UCENSEO MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURISDICTIONS

1 mSISArAPPUCIITIONFltlR (Chert~m)

D A NEWLICENSE

0 13middot26640middot01a AMENDMENT TO LtCENSpound HUMBER

c RENEWL OF LICENSE _BEllt0 3 ADDRESS MiERE ocaSEO MATERIAL WLL BE USED OR POSSESSED

Covance bull Evansville Clinic 617 Oakley Street Evansville TN 47710

2 NAME AND UNG ADDRESS OF APfuCANT 1_11PJ

Covance Clinical Research Unit Inc Clinical Development Services Covance-Evansville Clinic 617 Oakley Street Evansville IN 4771 0

4 NAME OF PERSON TO BE CONTACTED ABOUT THIS AWLICATION

Robert G Kochan PhD (US RSO) _---_

BUSINESS TaEPtfJNE NlMaeR IBUSIN$S CEllUlAA TELEPHONE NUMpoundpoundR

(608) 310-8268 I (608) 695-0229 BUSlNISS EMAIL ADORESS

robertkochanoovanceoom SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11~ PAPER THE TYPE AND scoPE OF INfORMITION TO BE PROVIDED IS DESCRIBED IN THE lICENSE APPUCAncm GUIDE

5 RADiOACTIIE MATERIAl a Element and 0liI$$ runber ~chemkaI andIcr phySlai foIm and c maiXinUn amounl ~wJlbe~atanyonetirne

7 lNDfVlWAl(S) RpoundSPONSIBLE fOO FWAAT1ON SAFETY PROGRAW AND THEIR lRAlN() EXPERIENCE

bull ~AClunESANDEOOIPMeuroNT

11 WASTE MANAGEMerr

PJRPOSE(S) FOR VlHICH UCENSED IAATeRW vtU USED

a TRAINING FOR INOIvtrxJAlSWJRKING I~ OR FREOUErfi1NG RESTRJCTEl)A~

10 RADIATlON SAFETY PROGRAM

12 1JCEN$EFEES (See 10CFR170endSel1lon 11t131)

AMOItJTFEE cP1EGORY 7C ENClOSeo $ 000

13 CElmFlcPT1ltlIlt (_be~by_ THEAPPUCANTUNDEfSTANDS rvrALL STA1EM2NJSIWOREPRESENTATfONSMADfEINTHiS AlPUCA1lONARE3iNDIIgtIG UFON THE APlJJCAIT

THEAPPUCANT AND ANY OFFCLAl EXECtJT1h1G THiS CERTIFICATION ON 8BWFOF 1l-E APPUCANT NfltMEO IN ITEM 2 CERTIFYTHA7 tHIS APPuAnON IS PREPARED IN CONFORIIIITYlitTH TITlE 10 cooe OF FEDERAL REGUATIO~ PARTS 30 gt2 33 34 3536 39 AND laquoI AlD _ AlL JNFORIITJON COIi1ANEOHEREIN S TRUEAND OORRECT TO THE BEST OF THEIR -eoGEANO BELIEF MRNJNG 18UsCSECTION 1001 ACTOr JUNE2S194862STAT i49WAKESJT AC RlMlNAlOFFEN$E TO MAKE A WlLFlIUY FAlSE STATEMen OR REPRESENTATION TO AHY OEPARTlIENi QRAGENCY OF THE lJffTED STATES AS TO AN( MATTER WITHIN frSJURfSDICTaoN

CERTIFYING OFFtcER - TYPEtlIPRINTEO NAME AND mLpound DATE

Tcd Broering BS MBA Executive Director Clinical Development 31middot4~middotlofcServices Covance Clinicalllesearoh Unit Inc [~~ J FOR NRC USE ONLY

TIlEOFiEE iFEELOO COMNENrS

1$ IFEE CATEGORY AMOU~~O ICrlECKNlOABER

I NIROVEOBI IDAlE

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 13: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEIIELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 9 of34

Decommissioning Process Steps-per NUREG-1757 Vol 1 Rev 2 Decommissioning Group 2

bull Licensed operations have ceased in only 1 of2 license-approved facilities ie operations

ceased ONLY at Covance-Honolulu HI clinical site see Form NRC 314 Section A

bull A chronological summary of all license amendments occurring since the time that

Co vance-Honolulu HI clinical site was added to the license ie as of license amendment No 12 approved by the NRC on 01 May 2008 is provided below NOTE A

summary of NRC license activities and uses prior to amendment No 10 (approved by

NRC on 02 Mar 2007) was provided in the license application dated 01 Feb 2008

i

i

Date

02

Mar

middot2007

06

Nov

2007

01

May

2008

18

Jul

2008

18

May

2010

i

I

License No

13-26640-0 I

Amend 10

13-26640-01

Amend 11

13-26640-01

Amend 12

13-26640-01

Amend 13

13-26640-01

Amend 14

13-26640-01

Amend 15

I

I

Licensee

Name

Covance

CRUInc

Covance

CRUlnc

Covance

CRU Inc

Covance

CRUInc

Covance

CRUInc

Covance

CRUInc

Change

Add 2M facility

(Honolulu HI) plus

add sites AU

TE Murtaugh

RemoveMW

Graves as AU at IN

facility amp add new AU at IN RR Stoltz

Decommission 800 St

Marys Drive (IN)

facility amp add

617 Oakley st (IN)

facility

NRC administrative

change Any

chemicaVphysical

form

Expand Honolulu

HI facility on 4th

floor of leased space

building I

Decommission

Honolulu HI facility

amp extend license for

Evansville IN facility

Approved ActivityStaff

Uses 14Camp 3H (180 mCi)

14ClH AU-IN MW Graves

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (I 80 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

I

Uses 14C amp 3H (180 mCi)

14C3HAU_IN RR Stoltz

i 14CPH AU-HI TE Murtaugh

I RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14CPH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

14ClH AU-HI TE Murtaugh

RSO RG Kochan

Uses 14C amp 3H (180 mCi)

14CPH AU-IN RR Stoltz

RSO RG Kochan

FacilitySite

1)800 St Marys

Evansville IN

Dr

2)One Waterfront Plaza i

i 500 Ala Moana Blvd I Suite 400 Honolulu HI

1)800 St Marys Dr

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I

bull Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd

Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

1500 Ala Moana Blvd Suite 400 Honolulu HI

1)617 Oakley Street

Evansville IN

2)One Waterfront Plaza

500 Ala Moana Blvd I Suite 400 Honolulu HI bull

1)617 Oakley Street

Evansville IN

i

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 14: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 10 of34

Decommissioning Process Steps-per NUREG-l757 Voll Rev 2 Decommissioning Group 2

(continued)

bull NRC is being notified within 60 days of the 30 Nov 2012 date when radioactive use operations at 1 of the 2 license-approved facilities ie at the Covance-Honolulu

clinical sitefacility are planned to officially cease o A summary of the 14C transfers is provided in the Historical Site Assessment

(HSA) on page XX of this application

o There were no 3H receipts or uses at the Covance-Honolulu clinical site

therefore no HSA for 3H is neededprovided

bull No residual concentrations of remaining 14C radiological contamination exist (see Final

Status Survey Report [FSSR] attached-pages XX-XX of this application)

bull Since Decommissioning Group 2 applies to this type of use a Decommissioning Plan

(DP) is not required for the licensed 35100 medical use

bull National Environmental Policy Act (NEPA) Compliance No unmonitored releases into the environment expected no DP is required

bull FSSRs were completed and are attached (see pages XX-XX of this application) The

FSSRs were perfonned utilizing calibrated survey equipment as follows

o Packard Tri-Carb 1900TR Liquid Scintillation Analyzer Model 1900TR Serial

No 402452 was used at the Covance-Honolulu clinical site

o Ludlum Model 2401-P Pocket Radiation Survey Meter Model 2401-P Serial No

238530 was used at the Covance-Honolulu clinical site

bull NOTE Covance CRU Inc requests that ONLY 1 of the 2 facilities be decommissioned ie Covance-Honolulu clinical site should be decommissioned and removed from the NRC License No 13-26640-01 but the remaining currently-approved facility at

Covance-Evansville clinical site should remain as the ONLY approved facilitysite

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 15: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 11 of 34

NRC Form 314-Section A License Status (Addendum)

bull Licensed operations have ceased in only 1 of 2 license-approved facilities ie operations

ceased at Covance--Honolulu HI clinical site however licensed operations will

continue as previously approved at the 2nd license-approved facility at the Covanceshy

Evansville clinical site

NRC Form 314-SectioD B Item 2 Disposal of Radioactive Material (Addendum)

bull 14C disposal at Covance-Honolulu clinical site occurred via 4 approved methods

o 14C disposal via transfer to a person authorized to receive such byproduct material

per 10 CFR 3041 (b)(5)-see summary below

o 14C disposal via transfer to an authorized recipient (ie waste processor licensee)

per 10 CFR 202006-see Uniform Low-Level Radioactive Waste Manifest No

0125-040511EN attached

o 14C disposal of specific wastes (ie liquid scintillation counting medium) per 10

CFR 202005

o 14C disposal by release into sanitary sewerage system per 10 CFR 202003

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 16: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANV

Application dated 31 AUgust 2012 Page 12 of34

NRC Form 314-Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Transfer Disposals from Covance-Honolulu site)

bull 14C disposals via transfer to a person authorized to receive such byproduct material are

summarized below There was only 1 clinical research study (Co vance CRU Study No 8226978) that was plannedscheduled at the Covance-Honolulu clinical site for which 14C-active pharmaceutical ingredient (API) was received a total of 15135 mCi of

[14C]-ELND006 was received on 06 Aug 2012 on 09 Aug 2010 radioactive doses were

compoundedprepared as part of a mock prep which were subsequently

shippedtransferred for testing at MicroTest Laboratories (Agawam MA) and at Covance Laboratories Pharmaceutical Analysis (Madison WI) however the compounded 14C_API

doses were not subsequently administered to research subjects because the investigational

drugs development program was discontinued by the Study Sponsor [Elan

Pharmaceuticals Inc] prior to dosing subjects As a result of discontinuing the clinical

study the remaining stock e4C]-ELND006 drug powder was returned to Elan Pharmaceuticals Inc and the remaining compounded mock prep solution was shipped to

Covance CRU Inc (Madison WI) for potential further testing Since Elan

Pharmaceuticals Inc decided to not conduct any further testing of the mock prep solution

the remaining mock prep solutions that were each compounded at the CovanceshyHonolulu clinical site and the Co vance-Madison clinical site were pooled and disposed

of through a radioactive waste broker (Philotechnics Inc) Date of

Transfer

Form amp

Amount

Transferred

IName of Licensee i Recipient

Contact Name amp

Tel No

of Recipient

NRC or Agreement State

RAM License No

Purpose of

Transfer

09

I Aug 2010

lampmLmock

prep solution

00045 mCi

MicroTest Labs

AgawamMA

Shawn Sherry

413-76amp-16amp0

Ext 1amp6

Dept Publ Hlth (MA)

No 4amp-0469

Sterility

pyrogenecity

testing

and

09 12 mL mock

Aug prep solution

20lO 00030mCi

Covance

Laboratories Inc

Madison WI

Rich Schmidt Dept Hlth Servo (WI)

60amp-242-7975 No 025-1076-01

Dose

analysisstability

02 Remaining Elan Jim Klys Hlth Hum Servo Ag (CA) Return remaining

Nov drug powder Pharmaceuticals 650-553-7195 No 4215-41 stock drug powder

2010 12059 mCi Inc South San

Francisco CA

02

Nov

2010

Remaining

mock prep

solution

03001 mCi

Covance CRU Inc

Madison WI

Robert Kochan

60amp-310-amp26amp

Dept Hlth Servo (WI)

No 025-1075-01

i

Planned further

testing stopped

disposed via

radioactive waste

broker

(Philotechnics)a I

Total 15135 mCi

bull See attached mformatlOn on Manifest No 0125-04051lEN

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 17: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Applicatic)U dated 31 August 2012 Page 13 of 34

NRC Form 314--Section B Item 2a Disposal of Radioactive Material (Addendum-HAS-Disposal via Radioactive Waste Broker-Philotechnics)

bull 14C disposals via transfer to an authorized recipient (ie waste processor licenseeshy

Philotechnics Ltd) is summarized below Since the study sponsor Elan Pharmaceuticals

Inc ultimately decided to not conduct any further testing of the mock prep solution the

remaining mock prep solutions that were each compounded at the Covance-Honolulu

clinical site (total 03001 mCi) and the Covance-Madison clinical site (total = 02520

mCi) were each disposed of through a radioactive waste broker (Philotechnics Inc)-see

manifest No 0125-040511EN attached (next pages)

Contact Name amp I NRC or Agreement StateDate of Form amp Name of Purpose of I

Transfer Amount Licensee Tel No bull RAM License No Transfer

r Transferred

05 Remaining

Apr mock prep

2011 solution

03001 mCi

(from prep

at Cov-HNL on

09 Aug 2010)

05 Remaining

Apr mock prep

2011 solution

Recipient

Philotechnics Ltd

Oak Ridge TN

Philotechnics Ltd

Oak Ridge TN

of Recipient

Kimberly Page

800-424-9300

Pickup by

Radioactive waste

broker

T -TN024-Dll

i

Kimberly Page

800-424-9300

T-TN024-Dll Pickup by

Radioactive waste

broker

02520 mCi

(from prep

at Cov-MSN on i

bull 09 Aug 2010) i bull See attached information on Manifest No 0125-040511EN

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 18: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

------

~ Il tIgt

~ = ~ (Il Z ltgt N

=t5~5~=A=~~~-p=a~i~~~=~~=~==~~~~~=~~==~=S~1~~ [C- UI I

PAQEIOF

NON

Ph1oIampQhJIos Ud 201 RMovare elyenltl Tralklrt

1 Oall fIId9amp TN 3183Q

CONTACT Thltlll to e-rlllY ItItIIM11frnlllellall~dmVredfttcllbMpaelCgMmelttolf cI~llIJ 1r~nIPr~rt~rdnvlolhttP(llJtabOoIIlQWdkrMI~IJhltO~Qfl~

1shy 17 Ill TOTAl-WIiGHT INbrIDUAl

AA1lI0NOOUDC

Ttiia ltlflphtb_ltf_R~~rMokdtMlJbtldMdb~lIQodItlontor tt~IMIn~lilII1~iII1o~ftIaotJ8terllqUlvll~

DO

- gt-

ltAlSOO OR VoIUMIE ClASS (Va -wro_e unh4)1

tOEHnIfCATlOtl NUM8EROF PACkAOE

NI

ltgt FORM 540 Enttgy SolunoneJBeM cmekl5 $HIPpER -MAJtEAND FACILITY 71ORM5aAHD~

~

FORM 541 AHD 541 FORM au AND 54tAUNIFORM LOW-tEVI1~ RADIOACTIVE _ 0 nc Of2$-C40511EN ltgt

WASTe MANlP1ST ~fl5=i ADOfTlONALllfQftMATIQN UISHiPPING PAPEFt ~____ Imiddot PROCt$GOR 9 CON8IQNII~NlfM-andRIilyAddm

1 EHA(UNCYTlEPHQNE NUtn1iR (fndItch ANe Code) USER PpoundAMIT HUMBER iSHIPMEN1 NUMBER 1OeH5ATOA tVPI iW~ CrMk ~24-4Sno ~ _ T~TN024ot1 I 012S-Gil0511EN Ilsptetty) OpetattdampEOYSoIuIolUI trj

CONTACT mJPHONE NUMBER lMO enr Crk ~ ORGANIZATION (lnoklde Atp C~ oak RIdga TM 31131l Z

eH6MTREO Ed)ltOcbn ew)3t O-S2SJl IwwiAruAIA~OQtSlgMiltltkJl~gln ~ 2 tSTH1BAHlXCUJ8NEUSl~$HlPMENn TOTALNUMMlftOP1 A OARflIampR NiIIIllIIIiAddrMa Trudc IPAlDNUMlJEI weste1IIIIfpt I( I ySS PACI(AGES lOimFIED

IX] NO OH Tf(18 MAHIfUf ()I - ~4 DOES EPA RfiGUlTEIJ t IYES IPAMAHlFUTMJAflJ1A

lt=~e~rM~NY XI NO fIITHrS$HIPMEa11 If V ~ provide Mantftbullbull Numt ~ =f)

11 ua DEPAA1MlNTOF TRANSPOAfA11OH DBampeRlP11QH (tngludinll pnlp1Ir Npphg bullbull flmrd lt1111 UN 10 nLlftlbat tIdany 8ddlIlmud InflaquoJMUon)

hS~tt8 l1ooos46fltmmiddotR~rOor ~~50OOOOO jb (OCRUmiddotl)

~~ = ~ ~~l V$1gt~ -= = () -=-f)

fII-00- tIgt

fOR OONWNU USE ONlY ltgt UI

1Wtn -lJOftnFor ory No ________

SOldh~TnlMportFlmtmiddotNq __---c~____ ~ lISacobullbullnoenlorN~ ___________ t) JgttIfa fHpound( I US Iogy Pwmft 1110 N

ltgtmmS40t ~

i m

TJ gtQ o ()

2 0 () lt la sect0 = ()8

amp~sCI)gshy

gtZcsect ~ t1amp () () -+- t1 gl25 sect ~ =gtNgJ8

Z(1)

o = d 0-8iJJ lf (1) (1) N a -OI~ ~ ~(1) o 0gt9 ~ I 1)0(1)

~-~

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 19: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

-- --

~ Iraquo ~n(Igt (I) 10~ Iraquo iltbull= ~

(I (Igt ~ Z ~ F I- N

=It1t~==~=~middot~i=~T~~r~~-~9~~~~Ii=r~IIt=r=~=~-==-~~~~~r~~~r-oe~~fl~~ til

= om-III-t_BuQetW~nbc2D5laquol tt m_uudl ~jln lkl~ loItrotkIn dll MttlbpfayaWreNJrnlld ONl oafllUl~umbertMNAClWfnvtl~orllpOn MIIIlIt_~Id11 lOrdO ~oIJI~ I

FORMli41 111 = UNIFORM LOWmiddotLli1El RAOIOACTIVE til=

WASTE MANIFEST I- COHfAJNEf1 AND WA$11 D2SCFIPTJON Nfl NPI HI HP to StfPH~ _ bullbull -1 ~ I-

AddltltIIfluaIutIIOUIMor1(jOmmrn~I(ne)ptttqUhmlntsfo(CordrotTrlnM ~~c US 11 PNIoteehrIcfO~w~ ~ IIrtd 0leP1I1111 FlacflolllOtlftWto TIUTIUN o-it )middotlQ OURca HlPMtiITIONVMnR

NI UP NP Z ~ 1

0 ~NiEAATlOH o

liJSTAHb 8~CI I bDI411ONMIGHT l

- a (j rj

lt Q gtgIraquo gn fj -0= -lt

l asect (Ig (I) Q

Q fr itn= (tC --= P-S = W(I (j-=bull ~~t ~ n8- a t = rn

00 N(I(I)

gbull O(l)~(I) =

N~

til= e___ w~laaII ~ggt dStot v1hrmshy

~ ~1mtiJ-Ift~ 0 ~ W (I)~(ItA4~lIoIfIJIIJlo~- N ~ ~ a

O~I-= VI 0 (I)I- o ~o

I-foo) I ~ WOrnjshy

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 20: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

I

~ ~ IIl

tit ~ r= IIl Z = I- N

~=R~~==n~~~~tu=-Ul~=~n~amp~~C~=~~~~=~~~~-=~r=~~=1=1~ VI OftIceGfN~I~Watbtftllolgtj l)ct(I(IL111IIIII11I ~klflllFCMlIIIllhltmtIoIICld~bullbullt rmd~~mIyYIllI1dOM 00PfdnI1 11ft NACfIIlInotorondlla1 _and bull notPIndto _OfIdumkt~klftooMJntta

NRCFOIIIU42 Enttgy Solutlonsl9aer Cruk t a MAHiFUTNlUHR

(7-20111) WASTE COllECTO~OCIiSSOR UNIFORM LOWLEV5L RADIOACTIVE 0130QHIiN

WASTE MANIFEST JItIPIA UftQ~IY ~C~Wkl ~

MANIFIampT INPIX AHlllUGIONAl COMPACT TABUlAnll laquo~TION NlMeVl PAGel OF PAOI(8)

Uttail odgtnIII PRocesssnWAnE ~ 1ft)) SHPPfHGl)An IbefonI-COlJECTEEJWA8T1i UlSMlffltot

~ it 7 bull ~ ltG ~ ~ A~ iROQESSfiDlCQhLECTEO TOTAL

AAIPIOCfSsligt TE IOEnIlUroR ONERA1OIIt HAIII OlNlUfOf MAHInA NUIUI~ IJHOIR 0fUQ1N4TfHQ AIOUOG 8MM CAC1MTY oVOUNII

fUiilO1AQt1tl(lH M~N~-==~ FAOUTY MMAfEASALI WiilCHWA3T1i (OA MATINALJ I OOMP4Cr lIlIIlAl ~BIJIR AOCAI$8 VOLWI AliClllEtl ANO 04T1 IOCDS

I 0-- ORSTATti I (lt01 yen ~1IHc lU1~fltvd 4I1U OnftI~Gf(ampI bull W1 D1$1I11 1)11

~~I1 ~Wl531 I I

I I

I

I II I

I I I I I I I I I I I I I I I I II I

TOTALS OF ALL PAGIlS (FORMS 542 AND S42A) uP I

Ut1~ ~11

IRtV Fotm 541 7-2001)

cb = VI I- I-

~ ~ ~ ~ ~

==

~ ltgt== =-= ~ = ==

-~ ~ 00 ~ = VI

~ N

I- I- =

~ m

rj

gtgg n -0Omiddot lt 1=1 sect n g 0

~n 1=10 a C

~ gt~s t ~ nO t gN enogG 1gt N~3

ZG o sect

d ~ 1JJ 0ONa

0100101 0 o 0 H-)YSWOo jgt ~

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 21: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

~ t n~ m ------ ~ Cott ~

Madison CRU Radioactive Drug Disposaiinfo Via Radioactive Waste Broker (Phiiotechnics) 05 Apr 2011 ~ ~lt~ ~

Sol lent used to Approx Drug 11 m_Transfer into Drum Transfer Into Covance CRU Study Spons~rs I S~lubilize Drug If Alcohol Is Amount in Amount of 1 C Amount or lH

~

PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI

Y Companys Drug Name Inlo Absorbent Alcohol Matenal in mCi in mei 1 ~ Material in G

2f1ltkTc~~~tlfi~~i1~lPfSlif~~~ai)ij~(~~~1WriJ~lii1fJ~~~~~~i~~I-ili1~ijitr~W1ff~1tNili~fii~cjf~~wi~~a Single numerical entries or NA phosphoric acidl o 8

SJS 25Jan2011 RGK 25Jan2011 6220437 [CI-LY2606920 water 0 NA 3 06015 0 Q ~ jl

SJS 25Jan2011 RGK25Jan2011 8235229 [CarOOxyl-CI VX-222 melhYIC~iaUryl 0 NA 9 10215 0 ~ ~ I

SJS 25Jan2011 RGK 25Jan2011 8226451 IC)-CC-4047 water 0 NA 0024 11661 0 Q ~ Q

SJS 2SJan2011 RGK 25Jan2011 6228093 [C)-LY2484595 PEG4000raplu 0 NA 06 06126 0 UlSJS 04FEB2011 RGK 04FEB2011 8228093 IC)-LY2484595 ethanol 25 NA NA 00024 0

~ SJS 25Jan201 t RGK 25Jan2011 8228998 CCj-B1671600 Trislvit E Na2C03 0 NA 00013 14669 0 2 SJS 11Feb2011 RGK 11Feb2011 6236-969 ~~~~~~~~~~i~7~3 05W amp EtOH 5 NA 01 02237 0 I gt SJS 11 Feb2011 RGK l1Feb2011 6236-969 c~~~~~i~~~~~i_~~3 05W 8 EtOH 5 NA 01 02262 0 I n Ij

SJS 18Mar2011 RGK 29Mar2011 6214-351 [14C)-LY2452473 05W 8 EtOH 5 NA 012 0n36 0 g gt- ~ = 0 n JOB 31Mar2011 RGK31Mar2011 8202-99~ 11~C)-TR701FA Waler 0 Na2HP04 076 04149 0 i a ~o

~ - lt0 n ~ JOB 31Mar2011 RGK 31Mar2011 8235-306 114Cj-GS-9667 Ethanol amp Waler 25 NA 00029 00585 0 I ~I-- c () 0 ~ JOB 31 Mar2011 RGK 31Mar2011 8235-306 [14Cj-GS-9867 Ethanol amp Water 25 NA 000212 02632 0 ~ In

JOB 31 Mar2011 RGK 31tAar2011 8230-863 [OXad~~o~~C[-S- Water 0 HPC-SL 0006 04248 0 J 0 o~ ~ c JOB 31Mar2011 RGK 31tAar2011 6230-863 car~i~-~-)-S- Water 0 HPC-SL 0006 04191 0

(j os oWnJOB 31Mar2011 RGK 31Mar2011 6218-161 114) BMS-813160-05 Water 0 Si~it~~tl 18 00024 0 I ~

JOB 31 Mar2011 RGK 31 Mar2011 6216-181 [14) BMS-813160-05 Water 0 NA 149 00021 0 ~ gt-Zl n c ~_ JOB 31Mar2011 RGK 31 Mar2011 8239-516 114C) GSK22467G1 B Water 0 SLS HPM 1 04253 0 ~ (TO nn

(j amplgMM 25Feb2011 RGK 25Feb2011 8228-978 114CI-ELN0006 Ethanol ampWater 25 09C~I~~~m 00101 0252 0 0 _ Vl

- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0

1J) ~gt - N ~ 3MM 25Feb2011 RGK 25Feb2011 6225-139 114CI-R05190591 Alcohol and Water 25 PEG400 045 04366 0 = Z ~ Q 0 I~~~~ d fm~~Ul~I~~~~~~~cir~tl~~~tftamp~~~~rblrw~lil~~ii1~rttK~~~~1~~~ 1668442 76815 0 Im~~fJt~~tl f _1t~ttbrj~ _ ttlt _ ~_~~-JfIttbullA~~l~-fi~~~~~~~)flt]f~lWf~s ~~poundmiddot~~ ti r Imiddot~~I lt 8shy2 ~ ij o cffl~g

~ N 00 O~ N -lo~ ~ O~D C YC -l woO00 ~

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 22: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

-

cov~

Covance CRU Study Nft~~l~

Protocol Number ELND006-HS105

-~ ~

lt~ ~

~ ~

-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid

Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)

~lt~~~~~l~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~

~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y

Print Name ~ltY-fl- K~~

Title ~VA-NQ c~ (Z-Sd) l~)

Date of Signature 0$ 0f~ ~O l

Address of disposal service two+i 58- CE1IP)-B~ t 131oP

oft-K laquo~ GA 1N ~~e3o

Verified ByDate (if applicable) -N-A_---r~---------_

DRMJv PCKAJgt VB) ~dJ)t( ~l( ([e1fep~1Jo

CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010

fISIv) o N UI I o o

I p ~-t~~ UI t1 ~i ~ I j trlz~ I- 1 I ( -

II ~ ) f J gti -~ j n

CI I ~ n C

II ~ == I ~ ~ -I I lgt 0shy i I 1 1 = shy I ~ LL_____ ~

lt pound0 Lullo(5

~

n== ~Campr=AR (j

qJUgt=k) ~

-~ 1J1 C Q

-lt z 00 N N ~ l) -J 00

~n ~O0ltg m ~ til

~ 8 3 ~ ~

Tj

~ 0 pound0n - -lt n sect ~ n o (D l n o~ ~e 05 wn

i~l nn- l g

- InN n (D

lO(D~NIn

(D

Z(Do l

tJS ~ t-gt g(]) N O~ OOO(]) o ~o

degcwb~ ~

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 23: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

I

cov~

Covance CRU Study No 8226-978

Protocol Number ELND006-HS105

CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION

Investigator Name Dr Tom Murtaugh ~~rIN) (f)R iCPIhJ FLAG (Ccvshy

Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution

Reason for Destruction study ended

Permission to destroy material was obtained from Sponsor on 05NOV201Q Comments Per e-mail from sponsor

shy - J ~ I ~

NA

AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)

(YktJ F-E SoT =- 0 i )5 - ) 40S i 1 c~I ( 1) l I confirm that the test material(s) listed in the table above has been securely destroyed - - _bull _-_1

Date of Destruction 0 S +f R- d-D t Method of Destruction -)I 110 121 losw - ~AJ~ RAJgtlOActJ t w-n1F ~1ltftVt PICK-P

Signature ~~~ Name of disposal service lIlI~TiC N U ( I r-J1rC-T gtbltv CbS (tv (

Print Name ROcY-flT Koc~-1 Address of disposal service lWA-i 58 - (~nfgt - ~~laquot- nl olV~

Title UVA-N Cpound c~ (4-0 c~) 19 r+K R Cck TN ) 1- 8 3 0

Date of Signature () S PrP(2 d-O l Verified ByDate (i f applicable) -NA---~___---r~____

D~ lGkvJgt v~t) J~q rcr-1h((( ()5AffJJ1o C) Wlt-ON( A5gt8M 110CJ oJM-Li ASF-b r=O(2 i-~r-J CVAbStCj)~ OSAf2~I

CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010

CD~)511

~-~Ci Ii~ i ~ c II ~ I t I - 1 jQ) 111 I ~ I 1gt

I ~

~ ~

~ -~

-= ~

Z c N VI I

C ~ C VI tj Z gt ~

o ~

c = ~ -r ~ 0 (j o -lt ~ = ~ ~

(j

-~ JJ C Q laquo Z QO N N 0 C -I QO

~n ~O ~lt ~

Tj

raquoQ0 n ~~ gsect- ()o (I)

s n 0-f7j

~C

-0-5

w()

raquoZt= f7j - ~ n g ~-N c() (I)

O(l)~-s N~

o Z(I)5shy

jSPl W (I)

(fQ s (I) Nshy-0f7j00(1) o 4gt-0 0= (I) WO Vl4gt--_

I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 24: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

A lication dated 31 August 2012 Page 20 of34

NRC Form 314--Section C Item 2aFinal Status Survey Report (FSSR)

for Covance--Honolulu Clinical site

The following pages contain the FSSR organized as follows

bull Swnmary of Restricted Area-HOT LABS in both the Covance-Evansville clinical site

and the Covance-Honolulu clinical site - see page XX

bull Reference maps of entire 4th floor and highlightedexpanded sections of floor - see pages

XX-XX

bull LSC survey results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see pages

XX-XX

o FSSR that is labeled Wipe Test - 1 or WT -1 is a survey of the reception desk area

(Type of Use is Receipt depicted on Attachment 91) and is where excepted

packagesshipment (shipped via UN291O) arrive-this is designated as

RoomArea 442 on the reference maps

o FSSR labeled WT-2 is a survey of the storage freezer (8) and storage

refrigeratorfreezer (Type of Use is Storage depicted on Attachment 91) and is

where the 14C_drug powder and 14C dose preparation solutions were stored after

receipt and prior to disposaltransfer off-site-this is designated as Room 403

on the reference maps FSSR labeled WT-2 also contains survey information for

the package shipping area in the laboratory (Type of Use is Shipment depicted

on Attachment 91) where shipments containing aliquots of the prepared 14C_drug

dose were packaged-this is designated as Room 415 Lastly FSSR labeled

WT-2 contains survey information for the phlebotomylblood sample collection

area (Type of Use is Collection [blood samples] depicted on Attachment 91) and

is where blood samples are collected from subjects-this is designated as Room

416 on the reference maps)

o FSSRs labeled WT-3 WT-4 and WT-5 are surveys of the pharmacy area (Type of Use is Preparation of Unit Doses depicted on Attachment 91) and is where the

bulk of activity was performed since this is where the compounding of the 14C_

drug doses by the Authorized Nuclear Pharmacist occurred-this is designated as

Room 407 on the reference maps

bull Survey meter results in FSSR for all Restricted Area-HOT LABS at Covance-Honolulu

clinical site where activities associated with mock dose preparation occurred - see page

XX Thus FSSR that is labeled SM-l is a survey of all the areas summarized above for

wipe test surveys ie reception area (Room 442) storage area (Room 403) blood draw

room (Room 416) and pharmacy (Room 407)

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 25: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~middot For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 21 of 34

Summary of Restricted Area-HOT LABS in Covance--Honolulu Clinical Site

License Amendment Per NUREG-1556 amp NUREG-I757 cov~middot For Covance CRU Inc NRC License No 13-26640-0I Application dated 11 March 20I 0 Page 13 of 18

Attachment 91 Restricted Area HOT LAB Areas and Uses at Covan_Evansville and at CovIn_Honolulu

i

CavIlDce-Evansville SiIe Map in RcmodeWIEpooded Map lis in Type oC Malerlal Type of Use RoomIArea on Map 141 2008 CHooolnl Site 11 Mar 2010

(UNCHANGED) application) ArRoom Map ulialIiOll Byproduct Reoetpl 2 floor ReceptionPesk C-E-14 4 ftor Reaption Desk C-R-I-Aml C-H-l-Aml _erial Sbipping Dock C-EmiddotIO (UN2910 sbipments) C-H-l-Aml C-R-4-AmI

(Radioactive Shipment i SIDppingDoek CB-IO 18lt Area iu MaiD img C-R-I-Aml C-R-l-AmJ Drug Material) (Room 1(1) La (Roruu 415)1 C-HmiddotS-AmI C-H+Aml

Storage (at -7fJC -20Q F Room 169 C-EmiddotIO Fnerer Roo (Roruu 403~ C-II-I-Am C-H-l--Aml Phannacy Room 177 CH-ll or1IIannacy (Rorun 407) C-H-S-Aml C-H+AmI

Storage (at 5C or 25C) Pbannacy Room 174 C-B-II Frtezer Room (Rorun 403) C-R-I-AmI CU-l--Aml Phannacy Room 177 C-E-II or Pharmaq (Room 407) C-H-S-Am C-U+AmI

i Proparalion ofunit doses i

PIwmocy Room 174 CampII ihannacy (Room 407) C-B-I-Aml C-B-l-Aml

C-H-5-Am1 C-H+Aml

ClUJ-Prepared Storage (at-nrc OJ -2OC) Freeztr Room 169 C-E-IO Fr Room (Rom 403) CoB-loAm C-H-2-AmI

Radioaltlhi Phannacy Room 177 C-J311 or 1IIannacy (Rorun 407)1 C-B-S-Aml C-B+Aml Unit_ Storage (at 5C Of 25C) Pharmacy Room 1i4 CE-lI Fr Room (Room 4(3) C-B-I-Aml C-H-2-AlILl I

Pharmacy Room 177 C-E-ll or Pblirmaey (Room 407) C-H-S-Aml C-B+AmI

Uraquoitdose vorilication tsc in Main Processing CE-IO LSC III Main ng Lab C-B-I-AmI C-B-Z-Aml Lab (Room 170) (Room 415) CB-5-Aml C-H+Aml

Admin~ to subjects DiSJgtllSlt Room 175 C-E-II 0raJ lJoses-lE (Room 406) C-H-I-Aml C-H-Z-Aml I (ora~ topical SCIV) Volunteer RoornIo 6-12 C-E-6 C-E-7

Pa terallJo___ CB-3-AmI C-H-4-Aml

(Rooms 154-160) ampCE-8 (Room 41Ss 41SC 419 C-U-5-AmI C-B+Aml 420425428)

Radioattiv CoUection (blood samples) PhleOOolll)l Room 171 C-E-II Plokbommy (Room 416) C-B-I-Aml cH-l--AmI I

biologkol Volunteer RoornIo 6-12 C-B-5 C-B-7 or BedrooJQ C-H-3-AmI C-B-4-Aml mpes (Rooms 154-160) ampC-E-8 (Room 41sB 418c 419 C-B-S-Aml C-K+AmI I

4lO 425 428)

Collemon (urine samples) Restrooms 172 amp 173 C-E-ll _om C-H-I-Aml C-R-l-Aml Toilets I 23 4amp 5

I (Room 410 4Il 4u 427)

ICli-3-Aml C-H-4-AmI

(Rooms 184 185 186 187 CE-12 CIImiddotS-Aml C-H-6-AmI amp 188)

~~ Collection (feces samples) Reslrooms 172 amp 173 C-E-l1 Restroom C-B-I-Aml CR-2-Am i

Toilets I 2 3 4 amp 5 (Ro 410 411 423427) C-H-3-AmI C-B-4-AmI

(Rooms 184 185 186187 C-E-12 C-H-S-Aml C-H+AmI amp 188)

Processing (blood samples) Main Processing Lab C-B-IO MaiD P_iDg La C-B-ImiddotAml C-H-l--AmI (Room 170) (Room 415) C-H_S-Aml C-H+AmI

Processing (all 0_ Maln Processing Lab C-B-IO Main Lab C-BI-AmI C-Hel-Aml samples) (Room 170) (Room 415) CB-S-Aml C-H-6-Aml

Storage (all samples) feezerRooml69 CB-1O Freezer Room C-B-I-Aml CH-l--Aml

(Room 403) C-H-5-Aml C-H-6-Aml

Shipment (all samples) Shipping Dock C-B-IO MaiuPII Lab C-B_I_Aml C-R-2-AmI (Room 167) i (Room 415) C-H-S-Am C-H+Aml

Su SwipdWipe Tem viatsc Main Processing Lab CE-IO l8C iu MaiD Protessiug La CH-I-AmI CU-2-Aml

(Removable surface (Room 170) (Room 415) C-S-5-Aml CmiddotB+Aml Contamination)

SurvcyMeIer Main Processing Lab C-E-IO Slt3 MeIer MaiD C-H-I-Am cH-l--Aml (Ambient Radiation) (Room 170) p~ Lagt (Roruu 415) C-H-S-AmI C-H+Am

Room used foral1ivity was dUIDed from previonIinitiaI missio (_05 Doc 2OOi) as r1t C ddiDg

Numlgter oCrooms for activity _ expanded from previoustiDitlaJ Sllbm_ (dated 05 Dee lOO6) os It ofdiDg

NOTE ions 1 for mctd IndlltaUd usia dashed Hoe (see Maps CH-l--Aml C-R-4-Am1 d C-R-6-AmI)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 26: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 AUgust 2012 Page 22 of 34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-I-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 - COVJffCE For-CovanceCRUJncNRCUcenseNo13-26640-01shyApplication dated 11 March 2010 Page 6 ofl8

Item 9 Facility Diagram (Map C-H-I-Aml Unmarked Entire 411gt F100r [Covance-HonolnlnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 27: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated ~1August 2012 page 23 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-2-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 For Covance CRUInc NRC License No 13-26640Q1

Application dated 11 March 2010 Page 7ofl8

Item 9 Facility Diagram (Map C-H-2-Aml Marked-lip Entire 411t Floor [Covaace-HoJlolulu])

BUILDING LAYOUT

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 28: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 24 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-3-Aml

License Amendment Per NUREG-1556 amp NUREG-1757cov~ For GovanceCRU Inc NRC License No- 13-2664O-()-middotmiddot Application dated 11 March 2010 Page 8 of 18

Item 9 Facility Dianun (Mal C-H-3-Aml Unmarked South End of 4th Floor [Covance-HonolulnJ)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 29: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34

Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml

License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18

Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 30: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 26 of 34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml

License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8

Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 31: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY

Application dated 31 August 2012 Page 27 of34

Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml

License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18

Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 32: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

COy~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or ~ HNL or 0 Study No _ -t1A____

~ rJ)

~ t rJ) (J

~ C ~

~MSN ~

=shy~

Chad applICable LSC 10 No 0 j EVVlOCS(4I52IHNU or 0 4015424 IMiNI LSC 10WERIPROGRAM NO L r ~OFSURVEY__RoutineSuMIYoIUnilsorOther v (explain) JA~ f dlaquo-ilJv (If f1M-Jk =

~WiPe TEST PIAFORMEO BY (Inltlab)IDAIE ~--A -lQf It time en LSC Prtntut if to MLS PIACEOlKlO lSC BY (Inftlals)IDATE --2-- -~

BS r

Map shy LSC or IIem No Vial stot

No No

NA BKG 1 1

3 of S

c 7 t~

I

bullIf n

bull amp ref

SURVEY MAP (OpTIONAL)

1 1 4

Pi ~e3 yenll ~ At $lfhr ~ SURVEY RESULTS

Deacriptlon of SUIWy IIIIm

BackgmUlld (Clean AIIlohoi Swab)

fU~~P~1c Fl -r CYFln) ~~ R_t I ltfI-Fl-~) ufpfn Dell n ~l rltfl ~1gt41- fto 6V (fIk~ Jlicpoundn4 Dell ~ 4r CFlshy

~c Pt- ~ ltPiaecUh- tltr-RH 8 ti1IN J

1)ftJo-~CVIfptlt-l ~ Du t- lid ( ( ~rl It 1 Itl ~J lQ)II~ 14 ~L Ioiblro 11gt l oW r __~~I=pound l fZlt~ PedlC- _~ ~L v-1~Jt )

For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material

RlTL Ifdpmmiddot gt200 dpmll 00 om~ nollfy RSO (or designee) ASAP 10 dllrcuM optionlllclrcumllairne6

IRSO(crde8lgneeRIlvfewPBID gt- l-4 JZcllshy

RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011

Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J

~ 111)

Ji Po_4 eo--- if-PfJ_

dptlllOO em From LBC PrIntout

000

Qil 000

ltMIl) 000

ooqC)E7 OG~ 000 o~o

021 000 ~C

rj

gtgg ()_0 (i lt e sectomiddot 8 I ()

amp~ (1) c 05w() gtz ~ t )Q ()

~ t 8 ~ ~ o8ti) 1gt N~a

Z(1)

o sect Ij a

Jci W (1)

(1) ~ a NO

~~Egt= w 0 (1) ~~~

1 2 3 4 5 e 7 8 9 10 11 12

m lit ttl II liS tt m Itt lIq 121gt 17-1

-

EvaluationlAcllon BasGd on Raault

TBID N or RI11bull PBD

IiItf ro1 NA NA

IV N

poundIpound~I I

N N fJ N N N (J (I N

J fI II

pound -4bull

11

l tl

egt 11 egt-e = (J -11 tl

rJ) ~

~ I ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 33: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or li1 HNL or 0 MSN

Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L

TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy

12-_ +0 bull Ro~ 6 + R SURVEY RESULTS

Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt

N~~-I PBID

Ol~

Ot1 QSJ oIS

For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial

RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn

IReO (or dealgnea) Review PaID jlt -zPI M VII t- UJ ~ooJ flNgtry tq ~ 1-lt11shy

RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011

It

Ioj 00 00 c t 00 rl 00 ~ -So t)

~ Colgt

~ Colgt

= Colgt

= rl ~ 11=

l ()

egt 11 egt-=-= rl -11 ()

=-00

~ ~ IY

~

~n ~O ilt

rj

gtg g(j ~

amp- sect()o (l)

li~ (j ~~ pC

~~ gtZ

OCI _=~t= ()~ ~ ~tgI-) _ til

8g gtshyI-)~S

Z(l)o ~ ~9cffl w (l) I ~ wI-)

I-)O~Gl0(l) o ~cgt-i)=WO(l) ~ ~

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 34: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVV or ~ HNL or 0 MSN

Study No _ A ____

Checliapplloable LSCID No 0 iEVIIl orrXJZ4sectZ l1NblgrO 405424 misN) lSC TOWERJPROORAM NOL

lYPEOF SURVEY __RoUline SlIrvey of Unb or OIher V (explain) Jv7art+- ~el-t f Htvt Jik WlPETEST PERFORMED ~Qnltiallo)lDATe ~ a--~ time on LSC PrintoutG2sect VIAlS PlACED INTO lSC ~y ~nlllalS)IOATE ~lL-~-2Id Date of SlIirt on LSC FrinOutlL-ampj-M3-shy

SIJRVEY MAP (0P110NAL)

I Rbullbull +01- _ MapAlea LSC dpmIfDOemZ

ocllillm No VitII Slot Dascliption ofSurwy Item FromLSC No I No Prit1tout

NAt (i) M f M Pf 11 1-0~wNoJ I ~ -ITt0( + - 111 ) 000 2 tgc 18 ~-l lt ~IflJ ~ () 13 3 i3T -Vi (ji Jw r ~ Ilt1) Fl- ~ bOS 4 In bull ~o ~Q_J( rz ltloin) ~~s 000 5 Iii ~I lI_~ (~Ei7) Pt-~t avel G (ffo I~ Ptdv1 C-~ ( poundck+-J 000 7 IIff middotn II~_) r J (M)(((t- I 00 8 letshy 11f PI ltgt Coo t (ltt1l J 6~6 9 11E3 ~ PLutv1Uc 0 ~ V (TIo ~fJ O cQ 10 If iie hQ 12 +a-shy (vl~Ilt s~J1 OQ)

11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000

J

For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material

RITL aprilmiddot ~ 200 dpm1 00 em- noIIfY RSO (or deign) ASAP to dlsCU$s optlonsclrcumstances

EvaluatlonActiOl1

BEad on Result TBiD Na-RITL PBID

)v~I4Ii- NA NA

~~ ( f (I

N N F1- r N IIt (

IRSO(ordeslgnee)RevlllwP8IO I 9iI- 2Pt AjVI1

(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011

~ 00shyd r 00shy()

~ -9 ~

~ ~ til ~ = i a

I ()

~ 1= 11 t)

~ 11 Q

I = = ()

5r shy~

00shy-bull ~

~

~ ~

U

rl gt~

lg _0n 0 lt

0a_ sect o (1)n ~Esect05Wo ~z I~ ~[ ~ o f6 (1) ~gt N~S

S[ d S ~ W(1)

(1) N S WO 00( o jgtogtYt W 0(1) jgt ~

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 35: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EVVor ~ HNL or MSN

Study No _ _Jr____

Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--

SURVEY MAP (0P110NAl)

~ fI)I I ~

Q t-tgt1- IURWY

l fgt

LSCMapAru dpmlOOom valuationAction orltam No Slot Description of Surwy IIBmVIal FIIlm LSC Based on Result

No No Printout TBIO Nor RIL PBID

~AjWl-1 lti 01- I N fLL6 f bull ihIa

8 9 10 11

12

lt)

INA NA NA lt)

ashyashy~ -I fgt fI)-00 ~

~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I

bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t

IRD-501 North America Fo 1 Version 0203 EffectIVe ao May 2011

~ 00 00 ~ r 00 ~ 00 ~ 06 (II

~ ~ ~ = = fI)

~n

3lt ~

ri gtQ g(J -0 ltgsect (l o (1) I (J

~e 05 W(l gtz C~t

Csect (J ~ t ~ N (l (1)

O(1)~1NUl

(1)

zg d~S ~ W (1) (1)Na WO1 0(1)

o ~g0-- I (1) WOClj

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 36: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

------

cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY

Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___

MSN

CIled appbble LSC 10 No 0 fiWlOf Q(4024sect2IHNLl or D 40fj424 IMsectNI ~sc TOWERJPROORAM NOL

TYPeOFSURIEY __ RouIineSu~ofUnllsorOther r (In) r7 pound gltco_-Im_ ~ efM- IlL WIPE TEST PERFORMED BY (Inltials)IDATE ~L--~ 2011 art time on LSC Printout 11 qltl VIALS PlACED INTO LSC BY (InltlalB)OATE -- lL-~-lli Oltteof $art on ~SC Prfn1out~-~~

__ __ ___SlL~~ OfIOHAll-shy

[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon

orllem No Vial middot Slot Deacliption of Survey Item FromLSC Based on RQut No No Printout TBID NorRTL PSID

NIl NI+~

~T NIl NAi

1 1~ 51 JAt-s c ( 10) shy f f+ rfc -([( I IV

~r 2 IrO Stshy CAtTlt (ltM lro - i~ (Co IIltWIII 0110 ~ 3 fitL middot Sl lmr( I_ ) _ -lJI J 4 lil middot f V Jhdeg fV 6 lcl srshy )J (IcO IV 6 V 7 6 -1 10 II 11 fOit~I 12

011

For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal

~ ILl ILle r ILl ()

~ -a ()

gt-3 () ttl-~ ttl = ~ =I -() ~ = = tCgt = Cgt =-= () -=

-~-ILl ~

~ I til

RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy

~ JlIl1)501 North America Form 1 Vemon 0203

etJecllve 20 May 2011

r1 gt~

g n -

asect0 lt

nsect G

n ~~ oSWn- gtZts ~ n n ttl t g - rJ1

N n G

8~gt NGS

ZG o 5shy

CS $ol W g~ N WO N i (l)

o OsectgtWdeg G

ttlj- I

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 37: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34

FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l

cov~ CLINICAL PHARMACOLOGY

SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN

Clinical Phannacology Study No __tJfgt____

Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI

TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k

SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It

BAlTERY CHECK PERFORMED BY (Irltlals)DATE lPI -~-~ RESUlT (cilde OK or ndicaIe thekN dial readingiresuttSfor rshy

CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy

NA

2 3 4 Ii 6 7 8 9

SURVeY MAP (OPTIONAL)

SURVEY RESULTS

0

bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll

RITt Ifgt 01 ITIfIImIhr TRIGGER LEVel reacIIetI--noI RSO (or designee) ASAP to discuss optiodrcumslances

I RSO (or designee) Review PBIO

Q)CUvr-thw Ne1tivmiddot~ S~gtA~ VflaquodJ lt1ft3JI-1Po~AIlshy ~~ 1l xl) rall-4t 1)1lt 1- ftj tshy

g) ~v ~ I k-d jq IoltJlt- V ~VOshybull

RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 38: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

[ii

~ i -g shy shy

~

Table 1~2

Unrestricted use

No

Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent

Method for Demonstrating Site Survey or is Suitable for demonstration Release

Confinnatoty or Side-by Side Survey

EA EA EIS EIS

Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use

jqQ Yes

or equivalent

SUlley or demonstration

Yes

Safety Evaluation Report

NRC Fonn 314 or

8~ specific

Yo

Yes

Sarety E~a1uation Report

NRC Fonn ll4 or

equivalent

Site specific

Ves

Yo

Safety Evaluation Report

NRC Fonn314 or

Site specific

Yes

Yes

Safety Evaluation Report

NRC Form 314 or

equivalent

Site specific

Yes

License Amendment I License Amendment I License Amendment I License Amendment I License Amendment

the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report

~

~ o

~ ~

~

I ~

~

~ d g f-l

0gt 0 -t)

-~ = (II

d ~

g S (l ltgtlt ~ T == ltgt 11

z

~ r ~

I

-ltltgt shy

~ N

-~ ~

= (II

N

~ 11O

0 ~-~ ~ ltgt

s~ e ~ = (II~ (l - = 11 (II f-l t) ltgt CIi g~ =

ltgt ~ e e ltgt = ~0

ltgtN 11

er ~

~n

1degmlt Ii

Tj

gtglg (1 0 ltasect 0 o 0 l (10

~~ otrWo gtZrIi ~ sect - r l CINoo loo~ N~

Z(II

~ cI s ~ W 0 (J) wa WO j~~ o Og+) I 0 w0Cl j shy

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012

Page 39: Covance Clinical Research Unit Inc. cov~, Clinical ...Covance CRU Inc.'s NRC license No. 13-26640-01 is in the Specific Use Type 7C category and ... instantaneously to be able to resume

Page 1 of 1

From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd

MADISON WI 53704

JI220 1207160325

Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300

Delivery Address Bar Code

1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept

SHIP TO (000) 000-0000 BILL SENDER

Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532

TRK 7988 7329 7574 10201

TUE shy 04 SEP Ai STANDARD OVERNIGHT

60532

XH ENLA IL-US

ORO

515G21OC341AA44

After printing this label 1 Use the Print button on this page to print your label to your laser or inkjet printer 2 Fold the printed page along the horizontal line 3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Warning Use only the printed original label for shipping Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges along with the cancellation of your FedEx account number Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide available on fedexcomFedEx will not be responsible for any claim in excess of $100 per package whether the result of loss damage delay non-deliverymisdeliveryor misinformation unless you declare a higher value pay an additional charge document your actual loss and file a timely claim Limitations found in the current FedEx Service Guide apply Your right to recover from Fed Ex for any loss including intrinsic value of the package loss of sales income interest profit attorneys fees costs and other forms of damage whether direct incidentalconsequential or special is limited to the greater of $1 00 or the authorized declared value Recovery cannot exceed actual documented 10ssMaximum for items of extraordinary value is $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide

httpsllwwwfedexcomshippinghtmllenllPrintIFramehtml 83112012