ML20129G608
| ML20129G608 | |
| Person / Time | |
|---|---|
| Site: | 07003077 |
| Issue date: | 09/24/1996 |
| From: | Henderson P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| References | |
| 123472, NUDOCS 9610070234 | |
| Download: ML20129G608 (9) | |
Text
7 7 w w w w w Tapagsgegagage7 apan w w w w w w w w w w w w wTana Tananana7 w w w w w w w Tanar Ta j NR FORM 374 ' U.S. NUCLEAR REGULATORY COMMISSION PAGE 1 OF 2 PAGES j g MATERIALS LICENSE Amendment No. 04 y
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( g Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of jl g Federal ReFulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations heretofore made jj g by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear 8
m .terial designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to ; }ll l persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions $l l
N specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the tj
$ Nuclear ke:'ulatory Commission now or hereafter in effect and to any conditions specified below. El 3 ORIGINAL SIGNED BY: El 5
5 LIC'"S**
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In accordance with the letter dated $1
!2 July 16, 1996, $
- 1. Allegheny University Hospitals, East Falls 3. License Number SNM-1996 is amended in El 5 Radiation Safety Office its entirety to read as follows: El 5 ei
_a N 2.3300 Henry Avenue t B
m Philadelphia, Pennsylvania 19129 4. Expiration Date September 30, 2002 $ )
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- 5. Docket or 3i '
!5 Reference No. 070-03077 tl t'
l 3 6. Byproduct, Source, and/or 7. Chemical and/or Physical 8. Maximum Amount that Licensee gl I g Special Nuclear Material Form May Possess at Any One Time sl .
Under This License l 9 El R A. Plutonium (principal A. Sealed source A. Not to exceed 250 El 5 radionuclide Pu-238) milligrams per source and Ej 9 0.25 grams total Ej 9
fl 1 5 9. Authorized use El l B El 5 A. As a component of Coratomic Model C-101 nuclear-powered cardiac pacemakers for Ej R clinical evaluation in accordance with manufacturer's protocol dated November 1, El 9 1975, this authorization includes: follow-up, explantation, recovery disposal, but not implantation. (l 9 ( i a tl h CONDITIONS @
a sl h 10. Licensed material may be used caly at the licensee's facilities at 3300 Henry Avenue, @
i 3 Philadelphia, Pennsylvania. sl 3 si l 9 11. A. The physician responsible for follow-up, explantation, and return to the 2l 3 manufacturer for proper disposal is John Fontaine, M.D. @
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B. The Radiation Safety Officer for this license is Theodore Villafana, Ph.D. $,ll a nl i 12. The specified possession limit includes all licensed material possessed by the ;l s licensee under this license whether in storage, implanted in patients, or otherwise ;l j in use.
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a s 13. The licensee shall continue patient follow-up and replacement procedures for the [
s nuclear pacemaker during the life of the patient. Procedures for recovery and 2l j authorized disposal of the nuclear pacemaker by return to the manufacturer shall be sl a followed upon the death of the patient. il>
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s 14. Sealed sources or detector cells containing licensed material shall not be opened or Q.j i sources removed from source holders or detector cells by the licensee. Ql h! 9610070234 960924 9 b!
g! PDR ADOCK 07003077 I i5!
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- _w.wJuirp_wMcm wM wiWw w_ ^ aw w wSEEA wER_w w up U.S. NUCETAR REGULATORY COMMISS3ON AwsEEEE w WEEE.g NRC FORM NOA, PAGE 2 OF PAGES g 7
_1 ucene Numb g l SNM-1996 g MATERI Al.S 1,ICENSE turen Referrace Numher g SUPPLEMENTARY SHEET 070-03077 q
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[__ Amendment No. 04 g
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- 15. The licensee may transport licensed material in accordance with the provisions of g
- 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." g
!16. Except as specifically provided otherwise in this license, the licensee shall conduct l
tts program in accordance with the statements, representations, anti procedures l l4 contained in the documents, including any enclosures, listed below. The Nuclear y
y p; Regulatory Commission's regulations shall govern unless the statements, y representations, and procedures in the licensee's application and correspondence are g
[ more restrictive than the regulations.
g I A. Letter dated March 31, 1976 I I lb2 I E
B.
C. Applicatie:!
Two lette 5 dated Aprti dated 16, April J0r,"1992Q R {g(/[ I N 0. Letter dated July 10 p d92 I Nj E. Application datedfebruary 5,1993 I N.
N F. LetterdatedJandapy5,1995 O.
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- for the U.S. Nuclear Regulatory Comission ;
I I Original Signed By:
l Late SEP 2 41996 By Pamela J. Henderson g Nuclear Materials Safety Branch l g Region I l l
g King of Prussia, Pennsylvania 19406 m IN l'- - - - - - - - n,soncrm - - - - - - - - - m - - - - - - - - - - - - - - - - - - - -
M Ptward an recyc ord paper u - _ -
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SEP 2 41996 i
Christine Nezu, Ph.D.
Vice Provost for Research Allegheny University Hospitals East Falls '
3300 Henry Avenue Philadelphia, PA 19129 ;
Dear Dr. Nezu:
This refers to your license amandment request. Enclosed with this letter is the amended license. Please note that as part of this amendment, in ,
accordance with 10 CFR 30.36, effective February 15, 1996, the expiration date -
of your license has been extended by a period of five years. Your new expiration date is stated in Item 4 of the license.
Conditions 13,14 and 18 which appear in Amendment No. 03 of your license were deleted with the issuance of this Amendment (No. 04). It is no longer the policy of the NRC to use these. conditions, j Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended li. cense.
If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region I Office, Licensing Assistance Team, (610) 337-5093 or 5239, so that we can provide appropriate corrections and .
answers.
Thank you for your cooperation.
Sincerely, j ORIGINAL SIGNED BY: ;
Pamela J. Henderson Division of Nuclear Materials Safety License No. SNM-1996 Docket n). 070-03077 Control No. 123472
Enclosure:
Amendment No. 04 l
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OFFICIAL RECORD COPY l
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O C. Nezu, Ph.D. Allegheny University Hospitals.
East Falls 1 l
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Theodore Villafana, Ph.D. j l Radiation Safety Officer l Allegheny University Hospitals East Falls Radiation Physics and Safety Office 3300 Henry Avenue Philadelphia, PA 19129 I
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. To seoelve a copy of this docungindicat'r in the box: *C" = Copy w/o attach /enet *E' = Copy w/ attach /enct *N" = No copy
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l OFFICE DNMS/RI (4f N DNMS/RI l NAME PHendersoT() "
DATE- 08/01/96 08/ /96 08/ /96 08/ /96 ;
0FFICIAL RECORD COPY l ,
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SENT BY: 9:37AM; 2157621572 o 610 337 5324; #2/3 PROVOSTOFC2ndFLR;O_8-596 O
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August 2,1996 W
ALLEC HEN Y U N I V E It S I T Y eis tilf 64t.AL (1I Wit NCLS nwi s v,.c 2,8$Y '* "
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Ms. Pamela Henderson Nuclear Regulatory Commission '
475 Allendale Road King of Prussia, PA 19406
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Dear Ms. Henderson:
The following is a supplement to our letter of July 16,1996 sent by our Radiation Safety Officer (Dr. Theodore Villafana) Informing the NRC of the name change of our institution from the Medical College of Pennsylvania and Halmemann University to Allegheny University of the Health Sciences.
Amendments New management person over all licenses to be Christine Nezu, Ph.D., Associate Provost for Research. Dr. Nezu replaces Dr. Vincent Cristofalo.
Dr. Nezu concurs with name changes on all licenses as specified in letter of July 16, 1996.
Theodote Villafana, Ph.D. to be listed as Radiation Safety. Officer on all licenses.
Mailing address for correspondence to be:
Allegheny University Hospitals, East Falls Radiation Safety Office 3300 Henry Avenue Philadelphia, PA 19129 Please feel free to contact Dr. Villafana it 215-842 6066 for any further information you may need concerning these amendment requests. In the future, Dr. Villafana will follow-up on any subsequent correspondence concerning our licensing, incerely, L
Christine Nezu, Ph.D. e Associate Provost for Research dd cc: Theodore Villafana, Ph.D.
Radiation Safety Officer
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OFFICIAL RECORD COPY
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O O TELEPHONE CONVERSATION RECORD Conversation Date: July 29, 1996 Mail Control No.: 123470, 123471, License No.: Docket No.:
123472, 123473, 123474 37-07438-15 030-12998 37-02562-01 030-03022 SNM-1996 070-03077 37-00467-35 030-20830 SNM-1369 070-01362 Person Called: Ted Villafana, Ph.D. Organization: Telephone Radiation Safety Officer Allegheny Number:
University - (215) 842-6588 Various Parson Calling: Pamela J. Henderson
Subject:
License Amendments dated July 16, 1996 Summary:
Licensee requested name changes on five licenses. However, there were inconsistencies in mailing address, RSO, and management contact. Also, Dr.
Villafana signed the letter requesting the name changes.
Licensee will send a letter requesting that the mailing address, RSO, and management contact be the same on all licenses. In addition, licensee will have management concur on the name change requests.
Action RequiyadfTaken: Await response.
Signature Date: July 29,1996 l
'nn ., a 0FFICIAL RECORD COPY l i k l U.' ;
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'.O Radiation Physics
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- f:ty Office j 4
3300 Henty Avenue PNiaMpNa PA 19179 215 842-6000 phone 215 842 6588 fax 215-843-5734 l ALLEGHENY l
- UNIVERSITY H O 5 PIT A LS EAST FALLS 30 July 16, 1996 OTO'0 l
1 Nuclear Regulatory Commission l 475 Allendale Road l King of Prussia, PA 19406
Dear Sir / Madam:
Please be advised that our institute has recently undergone name changes. We request that our license be amended to reflect these changes.
Former Name NRC License i New Name Medical College of 37-07438-15 Allegheny University Pennsylvania and (Broad License) of the Health Hahnemann University Sciences East Falls Campus East Falls Campus Medical College of 37-02562-01 Allegheny University Pennsylvania Hospital (Medical License) Hospitals and East Falls 1996 SNM Medical College of 37-00467-34 Allegheny University Pennsylvania and (Broad License) of the Health Hahnemann University 37-00467-35 Sciences Center City Campus and Center City Campus 1369 SNM Hahnemann University (Medical license) Allegheny University Hospital Pending Hospitals separation from Center City broad license control #116791 There will be no changes or transfers in administrative ownership, management, controls or commitment to compliance with all applicable regulatory and license conditions. It is strictly a name change. ?/ I .g n 123472 0FFICIAl. RECORD COPY d"s av JUL 2 21996 Allegheny Health, Education and Research Foundation A4eg*eny Generai Harrtai
- Auereev integrated Hea:th OFOup . Aneg ery Unive'sity of the Hea !* 5; e%es
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O O Nuclear Regulatory Commission July 16, 1996 Page Two Additionally, there are no changes in the Radiation Safety Program, Radiation Safety Committee nor in the assignment of radiation safety responsibilities.
One additional change is that Dr. Christine Nezu has replaced Dr. Vincent Cristofalo as Vice Provost for Research. The Radiation Safety Office now reports administratively to Dr. Nezu.
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Theodo(r,e V - fana, Ph.D.
Radiation' afe y Officer TV:dmt cc: Christine Nezu, Ph.D.
Kent Lambert, M.S.
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- (FOR LFMS USE)
- INFORMATION FROM LTS BETWEEN: : -_---------_--------
LICENSE FEE MANAGEMENT' BRANCH, ARM- : PROGRAM CODE: 22160 j .. AND : ST ATUS CODE: 0 REGIONAL LIC ENSING SECTIONS : . FEE' CATEGORY: EX 7C
- EXP. DATE: 20020930
- FEE COMMENTS: P ACEM AK E R/ 37-07438-15
- DECOM FIN.ASSUR REQD: N l- ::::::::::::::::::::::::::::::::::::::
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! LICENSE FEE; TRANSMITTAL l
r A. REGION [
- 1. APPLICATION ATTACHED !
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APPLIC ANT / LICENSEE: MEDICAL COLLEGE HOSPITALS !
!' RECEIVED DATE: 960722 L DOCKET NO: 7003077 CONTROL NO.: 123472 l LICENSE NO.: SNM-1996 ACTION TYPE: AMENDMENT l2 FEE ATTACHED AMOUNT: ___ _____
CHECK NO.: . ______
- 3. COMMENTS SIGNED _______'_____,__ _
DATE _. ._ _ _ _ _ _7_pf. _______
S.. LICENSE. FEE MANAGEMENT BRANCH (CHECK'WHEN MILEST 3 /__/)
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- 1. FEE C ATEGORY AND AMOUNT: _( _I_ _ _7_k_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _@_ '___
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! 2. CORRECT. FEE PAID. APPLIC ATION M AY BE PROCESSED FOR: i AMENDMENT ________ g____ !
RENEWAL ______________
LICENSE ,,_____________
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- 3. .0THER _________________________________. l
__________________________________ i SIGNED ________. _______________________ l DATE __________ __________,___________ i l
rOCFJVED DY LFDCD l !
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