--yp'T] - , ! I-;/ !?: 45 -,a , ~ c Sentara CarePlex Hospital 3000 Coliseum Drive Hampton Virginia 23666 www sentara com -,..,- . e . . S E N T A R A. December 6,2005 Mr. Mike Perkins Licensing Assistant U.S. Nuclear Regulatory Commission Division of Nuclear Materials Safety Region I 475 Allendale Road King of Prussia, PA 19406 97 1 I Reference: Radioactive Materials License No. 45-09087-0 1 31, f , -I 0 0 2 3 -) Dear Mr. Perkins: We would like to request our radioactive materials license be amended to make the following changes: 1. We would like to change the Radiation Safety Officer fiom David Weimer, M.S. to Sandy Wolff, M.S. Ms. Wolff is already listed as RSO on our Sentara Hospitals, Southside NRC license, No. 45-001 3 1 - 02. Please reference this license for documentation of training and experience. 2. We would like to add Dr. Michael Miller to our list of authorized users for byproduct material as specified under 10 CFR 35.300 and 35.400. Please reference the attached NRC Form 3 13A and related documentation. 3. We would like to remove Dr. Adedamola Omogbehin, M.D. fiom our list of authorized users. We would appreciate it if the processing and approval of this application could be expedited. With Dr. Omogbehin taking a position in the D.C. area and Dr. Williams being transferred to cover another Sentara facility, Dr. Miller will be the only authorized user readily available for therapies involving byproduct material. If you should have any questions or comments regarding any of the information, please do not hesitate to contact David E. Weimer, M.S., at (757) 827-2444. Sincerely, Tamika Jefferson Director, Facilities and Patient Care Services Irfii, 7 3 NMSSlRGNl MATERIALS-002
25
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S E N T A R A. -, I-;/ !?: 45IRC FORM 313A U.S. NUCLEAR REGULATORY COMMISSION 020051 MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) 6a. WORK OR PRACTICAL
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- - y p ' T ]
- , ! I-;/ !?: 45
- , a , ~
c Sentara CarePlex Hospital 3000 Coliseum Drive Hampton Virginia 23666
www sentara com
-,..,- . e . . S E N T A R A.
December 6,2005
Mr. Mike Perkins Licensing Assistant U.S. Nuclear Regulatory Commission Division of Nuclear Materials Safety Region I 475 Allendale Road King of Prussia, PA 19406
9 7 1 I Reference: Radioactive Materials License No. 45-09087-0 1 31, f , -I 0 0 2 3 -)
Dear Mr. Perkins:
We would like to request our radioactive materials license be amended to make the following changes:
1. We would like to change the Radiation Safety Officer fiom David Weimer, M.S. to Sandy Wolff, M.S. Ms. Wolff is already listed as RSO on our Sentara Hospitals, Southside NRC license, No. 45-001 3 1 - 02. Please reference this license for documentation of training and experience.
2. We would like to add Dr. Michael Miller to our list of authorized users for byproduct material as specified under 10 CFR 35.300 and 35.400. Please reference the attached NRC Form 3 13A and related documentation.
3. We would like to remove Dr. Adedamola Omogbehin, M.D. fiom our list of authorized users.
We would appreciate it if the processing and approval of this application could be expedited. With Dr. Omogbehin taking a position in the D.C. area and Dr. Williams being transferred to cover another Sentara facility, Dr. Miller will be the only authorized user readily available for therapies involving byproduct material.
If you should have any questions or comments regarding any of the information, please do not hesitate to contact David E. Weimer, M.S., at (757) 827-2444.
Sincerely,
Tamika Jefferson Director, Facilities and Patient Care Services
Irfii, 7 3 NMSSlRGNl MATERIALS-002
3C FORM 313A US. NUCLEAR REGULATORY COMMISSION '-2005)
MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION
1
PART I -- TRAINING AND EXPERIENCE
APPROVED BY OMB: NO. 3150-012( EXPIRES: 1013112008
ofe: Descriptions of training and experience must contain sufficient detail to match the training and experience criteria in the applicable regulation (10 CFR Part 35)
Name of Individual, Proposed Authorization (e.g., Radiation Safety Officer), and Applicable Training Requirements (e.g., 10 CFR 35.50)
p y , r &FAA)
For Physicians, Podiatrists, Dentists, Pharmacists -- State or Terrltory Where Licensed
G R G Lv5& 3. CERTIFICATION
Provide a copy of the board certification. (Stop here if applying under IO CFR Part 35, Subpart J or 35.590fa); continue if applying under other subparts.) Provide documentation in appropriate items 4 through 10 of training or clinical case work required by 35.50(e); 35.51 (c); 35.290(c)( l)(ii)(G) for AU seeking 35.200 authorization; 35.390(b)(l Xii)(G); 35.396(d)(l) and 35.396(d)(2); 35.590(c); or 35.690(c). Provide completed Part II Preceptor Attestation, Items 1 l a through 1 Id . Stop here after completing items 3a, 3b, and 3c when using board certification to meet 10 CFR Part 35 training and experience requirements.
4. INDIVIDUALS IDENTIFIED ON A LICENSE OR PERMIT AS RADIATION SAFETY OFFICERS (RSO), AUTHORIZED USERS (AU), AUTHORIZED MEDICAL PHYSICISTS (AMP), OR
AUTHORIZED NUCLEAR PHARMACISTS (ANP) SEEKING ADDITIONAL AUTHORIZATIONS Provide a copy of the license or broadscope permit listing the current authorization and (b) or (c)
Complete items 6c (and 10 when training is provided by an RSO, AMP, ANP, or AU) and preceptor items 11 b through 1 I d to meet requirements for: RSO in 35.50(~)(2) or 35.50(e); or AU in 35.290(c)(l)(ii)(G) or 35.390(b)(l)(ii)(G) or 35.590(c) or 35.690(c); or AMP under 35.51(c).
Complete items 5, 6a, 6b, 10, and Preceptor items I l a through 1 I d to meet AU requirements in 35.396(a)
5. DIDACTIC OR CLASSROOM AND LABORATORY TRAINING (optional for Medical Physicists)
Description of Training
adiation Physics and strumentation
adiation Protection
athematics Pertaining to the Use id Measurement of Radioactivity
adiation Biology
iemistry of Byproduct Material for edical Use
THER
C FORM 313A (10-2005) PRINTED ON RECYCLED PAPER PAGE 1
IRC FORM 313A U.S. NUCLEAR REGULATORY COMMISSION
MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) 020051
6a. WORK OR PRACTICAL EXPERIENCE WITH RADIATION Location and
Corresponding Name of ' Materials License Description of Experience Supervising
Individual(s) Number
M- 0. IJiS-O013\ v o p c w.wt = f t f i Jn-x&b, !hqc\L 5I1Adt5, 5 d w
Dates andlor Clock
Hours of Experience
7 I I l O l - 6 - 3 ; - 05
I (
6b. SUPERVISED CLINICAL CASE EXPERIENCE (describe experience elements in sa) Location and Dates andlor Name of
Individual Number Experience
Corresponding Clock No. of Cases,
Involving Personal
Particbation Supervising Materials License Hours of Radionuclide Type of Use
RC FORM 313A 1-2005)
U.S. NUCLEAR REGULATORY COMMISSION
MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
6c. TRAINING FOR SECTIONS 35.50(e), 35.51 (c), 35.590(c), or 35.690(c)
Training Element Type of Training * Location and Dates
2/ .) J3 j 7 - i - JHf r*u+src,'4A t/(;n/fyJ IZ 7 / 4 0 I lifi.+wy QLt*y
NOrsl-.C-lC L. l,:n/LfwL I%&+@
7. FORMAL TRAINING Physicians (for uses under 35.400 and 35.600) and Medical Physicists
Name of Organization that Approved the Program
(e.g., Accreditation Council for Graduate Medical Education)
and the Applicable Regulation (e.g., 10 CFR 35.490)
Name of Program and Location with
License Number
Degree, Area of Study or Corresponding Dates
Residency Program Materials
- A j r E w EVMJ '7/1/3 I RLLflL ~ L C . S ~ ~ I + m e , o m C 5 F\3 G t 4 -
SClt-A? L. 1 a- 0.) 95 - go(31- 2 4/+' 2 &)\ HI ilbJ 0 h ) C C ) L o G Y
Completed 1 year of full-time radiation safety experience (in areas identified in item sa) under supervison
9. MEDICAL PHYSICIST -- ONE-YEAR FULL-TIME TRAlNlNGMlORK EXPERIENCE
Completed 1 year of full-time training (for areas identified in item 6a) in therapeutic radiological physics
who is a medical physicist (35.961) or meets requirements for Authorized Medical Physicists (35.51);
gAs (35.961) or medical physics (35.51) under the supervision of
and
3 YES
dN,A Completed 1 year of full-time work experience (at location providing radiation therapy services described and for topics identified in item 6a) for (specify use or device)
under the supervision of who is a medical physicist (35.961) or meets
requirements for Authorized Medical Physicists (35.51) (specify use or device)
NRC FORM 313A U.S. NUCLEAR REGULATORY COMMISSION (10-2005)
MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
I I O . SUPERVISING INDIVIDUAL - IDENTIFICATION AND QUALIFICATIONS
The training and experience indicated above was obtained under the supervision of (if more than one supervising individual is needed to meet requirements in IO CFR Part 35, provide the followng information for each) :
I
A. Name of Supervisor
_ & r n s H A !!EL!Y.!D d h o r i z e d User Authorized Medical Physicist
C. Supervisor meets requirements of Part 35, Section(s)
for medical uses in Part 35, Section@) 30 0 b o & --+ 43 . _. .
Sentara Norfolk General Hospital 600 Gresham Drive Norfolk, VA 23507 ~ 4 5 - G O l 3 l r 0 2 -
Note: This part must be completed by the individual's preceptor. If more than one preceptor is necessary to document experience, obtain a separate prece tor statement from each. This part is not required to meet training requirements in 35.590 or Part 35. &bDart J lexceot 35.980).
rHn I 11 -- rnebcr I un n I rESTATlON
I attest the individual named in Item 1:
has satisfactorily completed the requirements in Part 35, Section(s) and Paragmph(s) 3C-Q -f -b. 'i 0 1
as documented in section(@ q-, (p -, 7 of this form. Ltq 0 - .................................................................................................................
meets the requirements in 35.50(e) 35.51(c) &5.390(b)(l)(ii)(G) &5.690(c) for - h 0 NIA types of use, as documented in section@) 5) 6 ~ 7 ofthis form. ........................................................................................................................ 1 IC.
0 has achieved a level of competency sufficient to independently operate a nuclear pharmacy (for 35.980); Or
has achieved a level of competency sufficient to function independently as an authorized M 5 c ?h s i CI u ,for 311 p . v+ u h ' ~ uses (or units); Or
has achieved a level of radiation safety knowledge sufficient to function independently as a Radiation Safety Officer for a medical use licensee ; Or n NIA
1 Id .
0 d I meet the requirements of 3 9 0 y 9 0 b 9 0
I am an Authorized Nuclear Pharmacist; Or 0 I am a Radiation Safety Officer; Or
section@) of 10 CFR Part 35 ----. ~-~ ~
or equivalent Agreement State requirements to be a preceptor
for the following byproduct material uses (or units): -&, f,fq e cLb c - a \ \ or 0 AMP
~~ .~~ . -~ ~ . ............. .............................................................. A. Address Sentara Norfolk General Hospital B. Materials License Number
600 Gresham Drive Norfolk, VA 23507
Q, L
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Radiation Oncology Resident Record Report
Program ID: 43051 11 105 Program Name: Eastern Virginia Medical School Program at All Institutes
Michael L. Miller
For All Types in Brachytherapy - Intracavi area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Resident Name: Miller, Michael L. Current Year: 3
Procedure Date: 1/9/2002 Resident Year: 2 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 41 1643284
Radiation Oncology - Area IYE Q ~ Y Brachytherapy - Intracavitary Cerv i f l te rus - Low Dose Rate 1
I *
Procedure Date: 1/9/2002 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 02/004
Radiation Oncology Area IYE Q ~ Y Brachytherapy - Intracavitary Endobronchial - High Dose Rate 1
I *
Procedure Date: 1/15/2002 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 01/374
Radiation Oncology Area DE Q ~ Y Brachytherapy - Intracavitary Endobronchial - High Dose Rate 1 Brachytherapy - Intracavitary Endobronchial - High Dose Rate I
2 *
I 1 Procedure Date: 1/16/2002 Resident Year: 1 Role: Performed
Institution: Sentara Norfolk General Hospital Case ID: 02/004/2
I I Radiation Oncology - Area IYJK Q ~ Y Brachytherapy - Intracavitary Endobronchial - High Dose Rate 1
1 *
10:11:32Ahl 11/29/2005 1
Radiation Oncology Resident Record Report Program ID: 43051 1 I105 Program Name: Eastern Virginia Medical School Program
at All Institutes Michael L. Miller
For All Types in Brachytherapy - lntracavi area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Resident Name: Miller, Michael L. Current Year: 3
Procedure Date: 1/23/2002 Resident Year: 1 Role: Performed Case ID: 02/004/3 Institution: Sentara Norfolk General Hospital
I 1 Radiation Oncology - Area IYE Q ~ Y Brachytherapy - Intracavitary Endobronchial - High Dose Rate 1
I *
Procedure Date: 2/25/2002 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 02/018/1
Radiation Oncology Area Brachytherapy - Intracavitary
XYES CervixNterus - High Dose Rate
Q ~ Y 1 1 '
Procedure Date: 2/25/2002 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 002/218/2
Radiation Oncology Area XYES Q ~ Y Brachytherapy - Intracavitary CervixNterus - High Dose Rate 1
I *
I Procedure Date: 3/4/2002 Resident Year: 1 Role: Performed
Institution: Sentara Norfolk General Hospital Case ID: 02/018/3
Radiation Oncology - Area Brachytherapy - Intracavitary
IYE CervixlCIterus - High Dose Rate
Q ~ Y I I *
Procedure Date: 3/14/2002 Resident Year: 2 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 26491231 1
Radiation Oncology Area EiE Q ~ Y Brachytherapy - Intracavitary CervixNterus - Low Dose Rate 1
I *
1O:l I:32AM 11/29/2005 2
Radiation Oncology Resident Record Report
Program ID: 43051 1 1105 Program Name: Eastern Virginia Medical School Program at All Institutes
Michael L. Miller
For All Types in Brachytherapy - Intracavi area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Resident Name: Miller, Michael L. Current Year: 3
Procedure Date: 3/26/2002 Resident Year: I Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 02/155/2
I I
Radiation Oncology - Area DE Q ~ Y Brachytherapy - Intracavitary Cervix/Uterus - High Dose Rate 1
I *
Procedure Date: 4/1/2002 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 55304162811
I I
Radiation Oncology - Area w Q ~ Y Brachytherapy - Intracavitary CervixNterus - Low Dose Rate 1
I *
Procedure Date: 4/2/2002 Resident Year: 1 Role: Performed Case ID: 021155 Institution: Sentara Norfolk General Hospital
Radiation Oncology - Area Brachytherapy - Intracavitary
DIE CervixLJterus - High Dose Rate
Q ~ Y I 1 *
Procedure Date: 4/8/2002 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 55304162812
I I
Radiation Oncology - Area DE Q ~ Y Brachytherapy - Intracavitary CervixAJterus - Low Dose Rate 1
Radiation Oncology - Area DIE Q ~ Y Brachytherapy - Intracavitary CervixAJterus - High Dose Rate I Brachytherapy - Intracavitary CervixNterus - High Dose Rate 1
2 *
Procedure Date: 12/31/2002 Resident Year: 2 Role: Performed Case ID: 0211 128 Institution: Sentara Norfolk General Hospital
Radiation Oncology Area Brachytherapy - Intracavitary
IYJs CervixAJterus - High Dose Rate
Q ~ Y 1 I *
10:11:32AM lll29/2o(M 4
Radiation Oncology Resident Record Report
Program ID: 43051 11 105 Program Name: Eastern Virginia Medical School Program at All Institutes
Michael L. Miller
For All Types in Brachytherapy - lntracavi area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Procedure Date: 4/30/2003 Resident Year: 2 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 04/465
Procedure Date: 4/30/2003 Resident Year: 2 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 99/074
Area Brachytherapy - Intracavitary
xYE!s CervixAJterus - High Dose Rate
Q ~ Y 1 I *
Procedure Date: 6/16/2003 Resident Year: 2 Role: Performed Case ID: 03/483 Institution: Sentara Norfolk General Hospital
Radiation Oncology -- Area Brachytherapy - Intracavitary
IYE Esophagus - High Dose Rate
Q ~ Y 1
Procedure Date: 7/2/2003 Resident Year: 2 Role: Performed Case ID: 03/516 Institution: Sentara Norfolk General Hospital
Radiation Oncology Area IYE Q ~ Y Brachytherapy - Intracavitary Cervix/Uterus - High Dose Rate 1
I *
IO:II:3tA.M llR9R005 5
Radiation Oncology Resident Record Report
I
Procedure Date: 12/22/2003 Resident Year: 3 Role: Observed Case ID: 03745 Institution: Sentara Norfolk General Hospital
Program ID: 43051 1 1 105 Program Name: Eastern Virginia Medical School Program at All Institutes
Michael L. Miller
For All Types in Brachytherapy - lntracavi area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Resident Name: Miller, Michael L. Current Year: 3
Procedure Date: 12/8/2003 Resident Year: 3 Role: Observed Case ID: 03745 Institution: Sentara Norfolk General Hospital
Radiation Oncology - Area Brachytherapy - Intracavitary
I Radiation Oncology - Area m Qtr Unsealed Sources 1-131 Oral I
I *
Procedure Date: 7/26/2001 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 01/471
Radiation Oncology - Area IYE Q ~ Y Unsealed Sources 1-131 Oral 1
I *
Procedure Date: 7/26/2001 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 011393
I Radiation Oncology Area IYE Q ~ Y Unsealed Sources 1-131 Oral 1
I *
Procedure Date: 8/3/2001 Resident Year: 1 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 011503
1
Radiation Oncology - Area Unsealed Sources
m 1-131 Oral
Q ~ Y 1 I *
I 1 Procedure Date: 11/12/2002 Resident Year: 2 Role: Performed
Institution: Sentara Norfolk General Hospital Case ID: 021902
I I Radiation Oncology - Area IuE Q ~ Y Unsealed Sources SR-89 1
I *
I
Radiation Oncology Resident Record Report
Program ID: 43051 11 IO5 Program Name: Eastern Virginia Medical School Program at All Institutes
Michael L. Miller
For All Types in Unsealed Sources area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Resident Name: Miller, Michael L. Current Year: 3
Procedure Date: 12/20/2002 Resident Year: 2 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 02/1057
Radiation Oncology - Area Unsealed Sources
I!UE 1-131 Oral
Q ~ Y 1 I *
Procedure Date: 12/20/2002 Resident Year: 2 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 02/1132
Radiation Oncology - Area Unsealed Sources
IYJE 1-131 Oral
Q ~ Y I I *
I 1 Procedure Date: 12/24/2002 Resident Year: 2 Role: Performed
Institution: Sentara Norfolk General Hospital Case ID: 02/601
I I
Radiation Oncology - Area DE Q ~ Y Unsealed Sources SR-89 1
I *
Procedure Date: 4/14/2004 Resident Year: 3 Role: Performed Case ID: 03/075 Institution: Sentara Norfolk General Hospital
Radiation Oncology Area Unsealed Sources - I!m
1-131 Oral Q ~ Y
1 I *
I 1 Procedure Date: 6/2/2004 Resident Year: 3 Role: Performed
Institution: Sentara Norfolk General Hospital Case ID: 04/336
I I
Radiation Oncology - Area BE Q ~ Y Unsealed Sources 1-13] Oral 1
I *
10:I3:06AM 11/29/2005 2
Radiation Oncology Resident Record Report Program ID: 43051 11 105 Program Name: Eastern Virginia Medical School Program
at All Institutes Michael L. Miller
For All Types in Unsealed Sources area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Resident Name: Miller, Michael L. Current Year: 3 r 1
Procedure Date: 9/17/2004 Resident Year: 4 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 04/427
I I Radiation Oncology - Area I Y E Q ~ Y Unsealed Sources 1-131 Oral 1
I *
Procedure Date: 10/12/2004 Resident Year: 4 Role: Performed Institution: Sentara Norfolk General Hospital
Case ID: 04/400
I I
Radiation Oncology Area Unsealed Sources - I Y E
1-131 Oral Q ~ Y
I 1 *
Procedure Date: 3/9/2005 Resident Year: 4 Role: Performed Institution: Virginia Beach General Hospital
Case ID: SO5099
Radiation Oncology - Area IYN Q ~ Y Unsealed Sources 1-131 Oral I
I *
Procedure Date: 3/9/2005 Resident Year: 4 Role: Performed Institution: Virginia Beach General Hospital
Case ID: M05023
Radiation Oncology Area Unsealed Sources -
Radiolabeled Drugs Q ~ Y
1 I *
I I Procedure Date: 5/10/2005 Resident Year: 4 Role: Performed
Institution: Virginia Beach General Hospital Case ID: PO5175
I I Radiation Oncology - Area 3!.E Q ~ Y Unsealed Sources Radiolabeled Drugs 1
I *
10:13:06AM 31/29/2005 3
Radiation Oncology Resident Record Report
Program ID: 43051 11 105 Program Name: Eastern Virginia Medical School Program at All Institutes
Michael L. Miller
For All Types in Unsealed Sources area Done Between 7/1/2001 And 6/30/2005
For Procedures in All Years For All Resident Roles
Number of Procedures for Resident: 15
Grand Total: 15
10:13:06AM I1129/2005 4
This is to acknowledge the receipt of your letter/application dated
, and to inform you that the initial processing which includes an administrative review has been performed.
/+li\xu 3 %l,t - F W ~ 7-6 I Is) There were no a ministrative omissions. Your application was assigned to a technical reviewer. Please note that the technical review may identify additional omissions or require additional information.
Please provide to this ofice within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee &Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.
Your action has been assigned Mail Control Number [ <,$073 When calling to inquire about this action, please refer to this control number You may call us on (610) 337-5398, or 337-5260.