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
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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
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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
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
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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~
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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
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
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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
------
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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
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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
- 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
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Covance CRU Study Nft~~l~
Protocol Number ELND006-HS105
-~ ~
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-==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
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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 ~
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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
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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~____
CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010
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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
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____
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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
RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011
Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J
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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
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Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt
N~~-I PBID
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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
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RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011
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
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11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000
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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
(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
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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 ~
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~AjWl-1 lti 01- I N fLL6 f bull ihIa
8 9 10 11
12
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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
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cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY
Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___
MSN
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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
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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)
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EA EA EIS EIS
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jqQ Yes
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Yes
Safety Evaluation Report
NRC Fonn 314 or
8~ specific
Yo
Yes
Sarety E~a1uation Report
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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
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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
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
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
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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
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
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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
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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
------
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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
- 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
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Covance CRU Study Nft~~l~
Protocol Number ELND006-HS105
-~ ~
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-==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
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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 ~
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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
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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~____
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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
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
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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
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RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn
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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)
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(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
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bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t
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License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34
FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI
TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
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SURVEY RESULTS
0
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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Table 1~2
Unrestricted use
No
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
Method for Demonstrating Site Survey or is Suitable for demonstration Release
Confinnatoty or Side-by Side Survey
EA EA EIS EIS
Ulte$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
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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
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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
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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
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
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
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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
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TERIAlS lICENSING BAANCH US NUClEAR REGULATORY COMMISSION REGIO~ 2441 _lIl ROllO SUTlEZ10 LISlE IL (l(l543S2
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
------
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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
- 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
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-
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
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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
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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~____
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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
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))
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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____
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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
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or equivalent
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Safety Evaluation Report
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Sarety E~a1uation Report
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equivalent
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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
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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
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
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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
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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
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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
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APPUCAmH FOR MTRIBUTION OF EXEMPT PROO(JCTS Ale APPIICATlON$ NTH
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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
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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
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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
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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
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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
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Protocol Number ELND006-HS105
-~ ~
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-==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 ~~
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Title ~VA-NQ c~ (Z-Sd) l~)
Date of Signature 0$ 0f~ ~O l
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Protocol Number ELND006-HS105
CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION
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Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution
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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
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____
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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
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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
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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
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
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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
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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
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
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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
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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
------
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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
- 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
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Covance CRU Study Nft~~l~
Protocol Number ELND006-HS105
-~ ~
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-==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
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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 ~
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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
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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~____
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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
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
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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
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RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn
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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)
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(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
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bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t
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License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34
FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
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TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
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SURVEY RESULTS
0
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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Unrestricted use
No
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
Method for Demonstrating Site Survey or is Suitable for demonstration Release
Confinnatoty or Side-by Side Survey
EA EA EIS EIS
Ulte$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
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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
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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
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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
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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
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
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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
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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
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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
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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
------
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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
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Protocol Number ELND006-HS105
-~ ~
lt~ ~
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-==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
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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
CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010
fISIv) o N UI I o o
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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 ~
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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
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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~____
CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010
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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
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
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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
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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
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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
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
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
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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
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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
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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
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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
------
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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
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Protocol Number ELND006-HS105
-~ ~
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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 ~~
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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
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Protocol Number ELND006-HS105
CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION
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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
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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
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
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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
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Yes
Yes
Safety Evaluation Report
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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
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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
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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$CONSJNj ElMRONMENTAl MANAGEtIampIi PRtlIGRAtAS OFFICE CF FEtERALamp STATE MATERALS AND
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SEND AlPIJCAlIONS TOSEND APPUCATIOlIS TO
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2 NAMeANDMAlIJNGAOlRESSOFAFUCAAT (_ZiP)1 TIltIS 1SPPUCAllON FOR ra-BpJItlIlMleIlomJ
Covance Clinical Research Unit Inc Clinical Development Services Covanctgt-Evansville Clinic
A NEWllCENSE
13-26640middot01 617 Oakley Street [] S AMENDMENT TO lICENSE NUiBER
o c RENEWAL OF liCENSE NUMBER Evansville IN 47710
a ACORESS HERE ucENSEO MATERlAL WLL BE USED OR POSSESSED 4 NAME ()F PERSON To BE CONTACTEO ABOJT THIS APPLICATiON
Robert G Kocban PhD (US RSO)
Covance - Evansville Clinic BU$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
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
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
------
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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
- 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
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Protocol Number ELND006-HS105
-~ ~
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-==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
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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 ~
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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
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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~____
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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
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
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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
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RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn
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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)
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(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
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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
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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____
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TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
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SURVEY RESULTS
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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
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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
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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
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
------
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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
- 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
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Protocol Number ELND006-HS105
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-==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
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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 ~
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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
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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~____
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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
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
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RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn
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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)
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(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
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bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t
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License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34
FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
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SURVEY RESULTS
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Unrestricted use
No
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
Method for Demonstrating Site Survey or is Suitable for demonstration Release
Confinnatoty or Side-by Side Survey
EA EA EIS EIS
Ulte$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
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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
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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
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
------
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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
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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
- 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
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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
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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
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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
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
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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____
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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
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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
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
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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
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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
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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
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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
------
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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
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Protocol Number ELND006-HS105
-~ ~
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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 ~~
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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
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Protocol Number ELND006-HS105
CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION
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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
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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
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))
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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
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EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
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equivalent
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Safety Evaluation Report
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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
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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
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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
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
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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
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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
- 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
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Protocol Number ELND006-HS105
-~ ~
lt~ ~
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-==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
CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010
fISIv) o N UI I o o
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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 ~
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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
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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
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
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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____
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SURVEY RESULTS
0
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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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
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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
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
------
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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
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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
- 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
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Covance CRU Study Nft~~l~
Protocol Number ELND006-HS105
-~ ~
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-==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
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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 ~
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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
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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~____
CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010
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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
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____
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For Ii and 1c dpm re tta~ from lSC p11ntout (NOTE For transcribing I8$UHs for BKGl1 UIIII CPMs rom cI1ann1 A Inalqd) bActlOIl8 are N = If dPmo200 dprnl1OOltlnf dlsposellllndl as non-lIdloaCllve material
RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011
Date ofslalt on LSC Printout I ~bullzQ1shy a fi- (J
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Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L
TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy
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Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt
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For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial
RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn
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RIl-I01 North America Fonn 1 V_Ion 0203 EfIecIIva 20 Mar 2011
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
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11 (fs 1$1 ~ (1~(f1 tlf 12 (fip n- DMVltIICWJ l~ t lLe I lhllt- J 000
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For Ii and middotC dpm are trul1lCllbed from LSC Plfntout (NOTE For IIlImlCfibing result for 81lt01 use CPMa from mannel A il1SIead) ActIons Are Ndpm s 200 dpmf oOcmdiaposeihandle lUI non-radloactiw material
(i) ~IA+- vC -- Jgtt U 1110 lt9 tv vrrrIft poundgtfr- 2C 1ZA l f RD-Ii01 North America Fonn 1 Vraion 0203 EffeGtive 20 May 2011
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Clinical Site 0 EVVor ~ HNL or MSN
Study No _ _Jr____
Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--
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~ fI)I I ~
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~AjWl-1 lti 01- I N fLL6 f bull ihIa
8 9 10 11
12
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ashyashy~ -I fgt fI)-00 ~
~ For~ nd C dpm 1I1lII1nI~CIibed from lSC printout (NOTE For tranaoribillg reampull$ for BKG1 use CPMs from annel Alns1ead) I
bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t
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cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY
Clinical Site 0 EW or l(I HNL or 0 Study No_yl- ___
MSN
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RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy
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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
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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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
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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
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
------
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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
- 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
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Protocol Number ELND006-HS105
-~ ~
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-==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
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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
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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
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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
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____
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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
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Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
Method for Demonstrating Site Survey or is Suitable for demonstration Release
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EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
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equivalent
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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
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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
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
------
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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
~
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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
- 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
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Title ~VA-NQ c~ (Z-Sd) l~)
Date of Signature 0$ 0f~ ~O l
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CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010
fISIv) o N UI I o o
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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
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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~____
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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
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
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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
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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
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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
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
------
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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
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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
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Protocol Number ELND006-HS105
-~ ~
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-==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
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Date of Signature 0$ 0f~ ~O l
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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 ~
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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
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))
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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____
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TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It
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Unrestricted use
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Method for Demonstrating Site Survey or is Suitable for demonstration Release
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EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
jqQ Yes
or equivalent
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Safety Evaluation Report
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8~ specific
Yo
Yes
Sarety E~a1uation Report
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equivalent
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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
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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
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
------
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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
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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
- 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
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Protocol Number ELND006-HS105
-~ ~
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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
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CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010
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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 ~
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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
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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~____
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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
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
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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
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EA EA EIS EIS
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Yes
Yes
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equivalent
Site specific
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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
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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
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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
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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
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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)
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CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION
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Test Material Form (eg tablet patch etc) iruiQ 4Packaging (eg bull kits vials bottles etc) remain ing eCl-ELND006 IV Solution
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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
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))
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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
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EA EA EIS EIS
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Sarety E~a1uation Report
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Safety Evaluation Report
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Yes
Yes
Safety Evaluation Report
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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
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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
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515G21OC341AA44
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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
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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)
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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
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
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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____
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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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
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or equivalent
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Safety Evaluation Report
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Sarety E~a1uation Report
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equivalent
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Safety Evaluation Report
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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
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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
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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
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PBID Drum VBO Stud Pharmaceutical Pno( to Transfer Solvent Calculated Other Exclplenls Absorbent Radioaclivity Radioactivity ~ VI
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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
- 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
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Protocol Number ELND006-HS105
-~ ~
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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~~$~ ~~~II confirm that the test material(s) listed in the table above has been securely destroyed ~~
~aJfm~~~ Method of Destruction )IJI FwM -jw- LCVtL ~M-C-TtVk tJO+~Tc ~(~ PICJ(~ IDate of Destruc~n -r~rfy~fl~f t ~ CSignature ~lt0~ Name of disposal service tffM(ifirfjJ~l l MiArr gteRucc-S INC EtJEP-t-Y
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Title ~VA-NQ c~ (Z-Sd) l~)
Date of Signature 0$ 0f~ ~O l
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CO-502 North America Form 10 Version 0304 Effective 22 Dec 2010
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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~____
CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010
CD~)511
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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
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))
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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
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EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
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Yes
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Safety Evaluation Report
NRC Form 314 or
equivalent
Site specific
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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
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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
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
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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
- N n ~ -lt o~ MM 2SFeb2011 RGK 25Feb2011 822amp-978 114C)-ELN0006 Ethanol amp Water 25 0 9~1~~~m 0012 03001 0
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Protocol Number ELND006-HS105
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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
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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 ~
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AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and filed with this form if available electronically from the service)
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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
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
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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____
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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$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
jqQ Yes
or equivalent
SUlley or demonstration
Yes
Safety Evaluation Report
NRC Fonn 314 or
8~ specific
Yo
Yes
Sarety E~a1uation Report
NRC Fonn ll4 or
equivalent
Site specific
Ves
Yo
Safety Evaluation Report
NRC Fonn314 or
Site specific
Yes
Yes
Safety Evaluation Report
NRC Form 314 or
equivalent
Site specific
Yes
License Amendment I License Amendment I License Amendment I License Amendment I License Amendment
the different decommlsionins aroups It doe not describe aU ofthe requiretnel1lS NRC stllffsctlonpound and licensee actions for Licenees and NRC staff should rerer to tbe detailed descriptions in etICh ofbe chaplets of thi NUREO report
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Page 1 of 1
From (608) 442-8200 Origin ID MSNA Robert Kochan COVANCE CLINICAL RESEARCH UNIT 3402 Kinsman Blvd
MADISON WI 53704
JI220 1207160325
Ship Date 31AUG12 AetNgt 10 LB CAD 1985309llNET3300
Delivery Address Bar Code
1111111111111111111111111111111111111111111111111111111111111111111111 Ref RKRSO Invoice PO Dept
SHIP TO (000) 000-0000 BILL SENDER
Materials licensing Sections US Nuclear Regulatory Commission 2443 WARRENVILLE RD STE210 LISLE IL 60532
TRK 7988 7329 7574 10201
TUE shy 04 SEP Ai STANDARD OVERNIGHT
60532
XH ENLA IL-US
ORO
515G21OC341AA44
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-==CLINICAL PHARMACOLOGY CERTIFICATE OF TEST MATERIAL DESTRUCTION
z Investigator Name ~~I ()K S1Efl-eN fLAcJl(lIIIshy Test Material Form (eg tablet patch etc) liquid
Packaging (eg kits vials bottles etc) remain ing [14CJ-ELND006 IV Solution
Reason for Destruction study ended
Permission to destroy material was obtained from Sponsor on 05NOV2010 Comments Per e-mail from sponsor
AREA TO BE COMPLETED BY DISPOSAL SERVICE (or printed and flied with this form if available electronically from the service)
~lt~~~~~l~~$~ ~~~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
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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~____
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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
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
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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
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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
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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
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~____
CO-S02 North America Form 10 Version 0304 Effective 22 Dec 2010
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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
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____
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RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$lclroumstanoes ([) VltIf- fLA4 f IgtW-JAI(~ fAn
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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
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(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
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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--
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bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$posehandie as non-radioacliw matllral RIL -Ifdprn 200 dpmf100 em notlfyRSO (or designee) ASAP to disouss optionscircumstances Q) AI- rltfpfjlot(e- tPt ~ amp011shy ~ IROO (or _ign Review PBID fII Vi Irj W11-shy -t
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[ ~ I-or- - Map Area - LSC dpml100cm EvaluationlActIon
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License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34
FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
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TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
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SURVEY RESULTS
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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Unrestricted use
No
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
Method for Demonstrating Site Survey or is Suitable for demonstration Release
Confinnatoty or Side-by Side Survey
EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
jqQ Yes
or equivalent
SUlley or demonstration
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Safety Evaluation Report
NRC Fonn 314 or
8~ specific
Yo
Yes
Sarety E~a1uation Report
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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
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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
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
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 ~
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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
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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
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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
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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
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))
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FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
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EA EA EIS EIS
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equivalent
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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
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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
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))
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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____
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
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SURVEY RESULTS
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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Unrestricted use
No
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
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EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
jqQ Yes
or equivalent
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Yes
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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
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Yes
Yes
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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
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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
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))
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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
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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
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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
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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
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RD-Kl1 North America Form 1 VerSion 0203 EIItctIYIt 20 May 2011
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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
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FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
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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
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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 $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide
License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVElOPMENT SERVICES COMPANY Application dated 31 August 2012 Page 25 of34
Reference Maps to Evaluate FSSR results at Covance-Honolulu Clinical Site C-H-4-Aml
License Amendment Per NUREG-I556 amp NUREG-1757 cov~middot For Covance CRUInc NRC License No 13-26640-01 Application dated 11 March 2010 Page 90f18
Item 9 Facility Diagram Map C-H-4-Aml Marked-up South End of 4 Floor (Covance-Honoluluj)
License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY
Application dated 31 August 2012 Page 26 of 34
Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-5-Aml
License Amendment Per NUREGmiddot1556 amp NUREGmiddot1757 cov~ For Covance CRU Inc NRC License NomiddotB-26640-01middotmiddot Application dated 11 March 2010 Page 10 ofl8
Item 9 Facility Diagram (Map C-H-5-Aml Ulimarked North End of4 Floor ICovllnee-Honolola])
License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY
Application dated 31 August 2012 Page 27 of34
Reference Maps to Evaluate FSSR results at Covance--Honolulu Clinical Site C-H-6-Aml
License Amendment Per NUREG-1556 amp NUREG-1757 cov~ ForCovance CRU Inc NRC License No 13-26640-01 Application dated 11 March 2010 Page 11 of 18
Item 9 Facility Diagram (Map C-H-6-Aml Marked-up North End of 4tJo Floor ICovance-Bonolulll))
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FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
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EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
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or equivalent
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equivalent
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Yes
Yes
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equivalent
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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
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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
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))
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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
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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
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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
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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
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FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
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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
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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 $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide
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License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34
FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI
TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
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SURVEY RESULTS
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RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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EA EA EIS EIS
Ulte$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
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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 $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide
Study No _lIA_ ___ Chedlt applicable lSC ro No 0 CEWl 1f4 4024112 iHNbl or 0 4l424 MSN) lSC TOWERIPROGRAM NO-L
TYPEiOFSURIEY __loutrnaSlIlWYofUnitsorOlherV (explaIn) JU~f ~u OP Itt-~ VVlPeTESTPeRFORMEO BY (lnltials)lOATE ~ z ~m arttme on lSC PIIntouIA If VIALS PLACED INTO LSC BV (initilllamp)IOATE - l-~~ Dale oftart on LSCPrfTltM t~bull2Il11shy
12-_ +0 bull Ro~ 6 + R SURVEY RESULTS
Descnptlon Of SlIrwy ItAIm ellaluatlorelAclion Bas9d on ResUlt
N~~-I PBID
Ol~
Ot1 QSJ oIS
For H and c dpm are ~ IMm lSC PriniOrlt (Ne For t1anllCriblr1 results for BKG1 use OPUS from channel A instead) Actions N If clpm 200 dpml10Q0rn dlsposehandle Ell non-nclloaotive malarial
RITL = Itclpm gt 200 dPml1oo~ notify RaO (ordeignee) ASAP tOdiscuu optloll$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
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
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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)
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FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
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EA EA EIS EIS
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equivalent
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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
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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
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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 $art on ~SC Prfn1out~-~~
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License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34
FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI
TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
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SURVEY RESULTS
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Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
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Confinnatoty or Side-by Side Survey
EA EA EIS EIS
Ulte$trcted use UnrestriCted use Unrestricted use Unrestricted use Restricted U Restricted use
jqQ Yes
or equivalent
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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
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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 $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide
10 cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY
Clinical Site 0 EVVor ~ HNL or MSN
Study No _ _Jr____
Ch~~1e LSC 10 No 0 t lEW) or ~4024S2 (HNLI or 0 115424 MSN LSC TOWERIPROGRAM NO J TYPEOFSURVEY __RoutineSurvayolUni1s orOtller V (explain) Sy It~~ t_(1I- r fhvt- ~Imiddotk lVlPETeST PERFORMeO BY (Inltlals)IDATE ~lL~-~ lime on LSC Priotoullf-pound VIALSPLACED INTO LSC SV (lnilillle)DATE ~~l7--A1 Dale oIstart on lSC Priotou~-4-Al--
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bullActions lire N ~ If dprn 200 dpmf100ltlm2 di$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
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cov~ CLINICAL PHARMACOLOGY WIPE TEST UNIT SURVEY
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MSN
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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 $art on ~SC Prfn1out~-~~
__ __ ___SlL~~ OfIOHAll-shy
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NIl NI+~
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For H and c dpm are trariscribed Tom LSC printout (NOTE For transorlbng l1IltIulls for BKG1 use CPMs from channel A Irntead) middotAotIornr ale N=If dpml 200 dpml1~ dlspoMlhlndle ae non-radioaciive matertal
RTL = If dpmo gt 200 dpmI100 ct notify RSO (or daeignee) ASAP to dlseuSll optlonsc1rcumatances () (tIQt- fI-wUlt rraquo-- ut A 11shy ~IRSO(orde$lgnae~PBID p ~ Avo 1A1l shy
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etJecllve 20 May 2011
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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
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2 3 4 Ii 6 7 8 9
SURVeY MAP (OPTIONAL)
SURVEY RESULTS
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Unrestricted use
No
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
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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
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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 $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide
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FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
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Unrestricted use
No
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
Method for Demonstrating Site Survey or is Suitable for demonstration Release
Confinnatoty or Side-by Side Survey
EA EA EIS EIS
Ulte$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
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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 $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide
License Amendment Request cov~ For Covance CRU Inc NRC License No 13-26640-01 THE DEVELOPMENT SERVICES COMPANY Application qated 31 August 2012 Page 33 of 34
FSSR Survey Meter Test Results at Covance--Honolulu Clinical Site SM-l
cov~ CLINICAL PHARMACOLOGY
SURVEY METER UNIT SURVEY 5M-1 Clinical Site D EVV or JXf HNL or 0 MSN
Clinical Phannacology Study No __tJfgt____
Check Survey MeIer Used ludlum McdeI2401f SeIaf NoO 221424 EWlodif2316JO IHNLI or 0 159841 ~) ludlum MocfelI4C Serial No 01lliM with attachedludlum Mcdel44-9 DeIecIilr Serial No PR28lI189MSNI
TYPEOFSURVEY __RautineSurveyofUniIsorother ~(expIa8l) ampIryf ofu1gl_ f 1M- rf-k
SURIlEYPERFORlIIED BY Onilials)DATE ~E~- 20 It
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CAUBRA110N STICKER INDlCAlES SURVEY METER LASTCAUBRATED ON ~-~-2Q--t-------shy
NA
2 3 4 Ii 6 7 8 9
SURVeY MAP (OPTIONAL)
SURVEY RESULTS
0
bull Rsad 131es 1 jtCI cI1eckiOUrCil uaIng ~scalitwih label side of check source facing melNlICfeet b AcIl()(ls 8111 N H$ 01 mremlhr eurn to normal useldlsposlll
RD-S01 North America Fonn 3 Version 0204 Effective 20 May 2011
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~
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
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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 $500 eg jewelry precious metals negotiable instruments and other items listed in our ServiceGuide Written claims must be filed within strict time limits see current FedEx Service Guide
Plan Review NA Documentation Radioactive Moterial Disposition or Documentation equivalent
Method for Demonstrating Site Survey or is Suitable for demonstration Release
Confinnatoty or Side-by Side Survey
EA EA EIS EIS
Ulte$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
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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
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