ML20238F428
| ML20238F428 | |
| Person / Time | |
|---|---|
| Site: | 07001795 |
| Issue date: | 02/23/1998 |
| From: | Tara Weidner NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| References | |
| 125328, NUDOCS 9809030360 | |
| Download: ML20238F428 (6) | |
Text
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, TE F AiAiAiT IATAif bRC FORM 374 Triinansmannnit37Wr4fTI
, cm U.S. NUCLEAR REGULATORY COMMISSION I 2#
4 3
t NIATERIALS LICENSE
$e Amendment No. 11 Pursuant to the Atomic linespy Act of 1954 e amended. the Enery) Reorgani/ahon -
Act of 1974 (P
. anJ Title 10. Code o Q Federal Regulatiom. Chapter I. Parts 3n. 31,3133,34. 35,36. 39. 40, and 70. and in re C
by the been ec, a license a hereby issued authonzing the beensee to w..a acquire, , possess and tran
, source, and special nuclem material designated below; to use such material for the puipose(s) and at the place (s) designated material tt bel E prsons authoriied to receive it in accordance with the regulations of the applicable Part(s).This licen N specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all app 9 Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. ,
g 0FFICIAl.RECORDCOP7 p Licensee
" L In accordance with the letter dated
.Dece g>er23, 1997, 8 .The George Washington University 3. License Medical Center SNM-1499 is amended in its entirety to read as follows:
$ 2.
901 23rd Street, N.W.
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. Washington, D.C. 20037
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j 5. Docket or June 30. 2003
'e Reference No.
& 6. Byproduct. Source, and/or 070-01795 Special Nuclear Material 7. Chemical and/or Physical 3
- Form 8. Maximum Amount : hat Licensee g May Possess at Any One Time
% Under This License 5
A. Plutonium (Principal
!5 radionuclides Pu-238)
A. Sealed Sources A. 0.750 grams (individual R
sources not to exceed 2!
g milligrams each)
B T Authorized use s
s A.
B As a component clinical evaluation. of Coratomic Model C-101- nuclear powered cardiac pacemakers for W This authorization includes: follow-up, explanation, N
recovery and disposal, but not implantation.
5 E CONDITIONS 5 10.
g Licensed material may be used only at the licensee's facilities at 901 23rd Street, N.W., Washington, D.C.
a, n 11.
g The specified possession limit includes all licensed material possessed by the y licensee under otherwise in use.this license whether in storage, implanted in patients, or E
3 12. A.
. g Physician responsible for follow-up, explantation and return of nuclear-g powered pacemakers to the manufacturer for proper, disposal is Hans Moore, M.D.
iB
!y B. i ia The Radiation Safety Officer for this license is Terry A. John '
y i 13.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I,/
ATTN:
g Prussia, Pennsylvania Materials Safety Branch, 475 Allendale Road, King of Chief, Nuclear g 19406, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any I g nuclear pacemaker patient, and any adverse pacemaker system, including the leads. A written report giving details of the reaction and/or malfunction involving : a s
p adverse reaction 4
and/or malfunction shall be submitted within 30 days. C 5
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License Number ey a
p SNM-1499 MATERIALS LICENSE noctet or neren nce Number g
l SUPPLEMENTARY SHEET 070-01795 g'
- g R
Amendment No. 11 I 14.
3 The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN:
g Prussia,Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Pennsylvania 19406, within 10 days of loss of contact with a nuclear g pacemaker patient.
I p 15.
g The licensee shall continue patient follow-up and replacement procedures for the l
nuclear pacemaker during the life of the patient. Procedures for recovery and y
authorized disposal of the nuclear pacemaker by return to the manufacturer shall y be followed upon the death of the patient.
l 16.
g Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source! holders'oride;t}ector cells by the licensee.
l 17.
The licensee may transp' ort'" licensed material in accordance with the provisions of j 10 CFR Part 71, " Pack, aging and Transportation of Radioactive Material".
5 18.
N Thelicenseeshal1Tbtreceiveortransferinanysingletransactionone(1) gram N or more of plutonium 238 contained in nuclear-powered pacemakers without notifying
~
8 the Division of ,Safeguardsi;U.S. Nuclear Regulatory Commission, Washington, D.C.
20555, and, in'sddition,*cospleting and distributing Form NRC-741 as required by l Section 70.54 'of- 10 CFR 70. ? -
7
(" 4 N
- 19. Except as specifically provided otherwise inithis license, t'he' licensee shall N
N conduct its program inlaccorda'nce5/ith~the" stat 6 mints, repre.sentations, and a procedures coatainediin;the Tdocuments-incl [fding any' enclosures, listed below. The R Nuclear Regulatory Commission's regulation's shall govern unless the statements, B representations'and p~rocedures in the licerisee's application, and correspondence g
are more restrictive than)the-reg,ulations. J ,
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s A. Letter dated ~ December 21, 1977 <
h B. Letter dated-January 10, 1983 B C. Letter dated March 19, 1993 y g ;j ,
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For the U.S. Nuclear Regulatory Commission i
ORIGINAL SIGNED BY:
! Date FEB 231998 By TARA L. WEIDNER I h Nuclear Materials Safety Branch y Region I q King of Prussia, Pennsylvania 19406 t
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t FEB 231998 Astra Bain-Dowell Director, Office of Research The George Washington University Medical Center 90123rd Street, N.W.
Washington, D.C. 20037 j
Dear Ms. Bain-Dowell:
This refers to your license amendment 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 i of the license.
l Please review the enclosed document carefully and be sure that you understand and l fully implement all the conditions incorporated into the amended license. If there are l any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region l - 1 Office, Licensing Assistance Team, (610) 337-5093 or 5239, so that we can provide appropriate corrections and answers.
Thank you for your cooperation.
Sincerely, Original Signed By:
Tara L. Weidner Division of Nuclear Materials Safety License No. SNM-1499 ,
Docket No. 070-01795 l Control No. 125328 l
Enclosure:
Amendment No.11 .
OFFICIAL RECORD COPY ML 10
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DOCUMENT NAME: R:\WPS\MLTR\LSNM-1499 To receive a copy of this document, Indicate in the boa: 'C' = Copy w/o attach /enci "E" = Copy w/ attach /enci "N" = No copy OFFICE DNMS/RI j j lN DNMS/Ri l NAME Weidnerg4AV DATE 01/14/95 01/ /98 01/ /98 01/ /98 OFFICIAL RECORD COPY l
lA' O The O oro-ot w eor ali ton nive ity W A S HIN G T O N DC l
IM 2 DEPARTMENTAL MEMORANDUM '
December 23,1997 U. S. Nuclear Regulatory Commission Regional Administrator, Region I 475 Allendale Road King of Prussia, PA 19406-1415 Attn: Materials Licensing Section Division of Radiation Safety and Safeguards Re: License Number SNM-1499 Docket Number 070-1795 Gentlemen:
This letter is to apply for amendment to our special nuclear material license:
License condition 12.A.:
The Physician responsible for follow-up, explantation, and return of nuclear-powered pacemakers to the manufacturer for proper disposal is Hans Moore, M.D.
Hans Moore, M.D., is the Director of the Electrophysiology Laboratory (Pacemaker Clinic).
If you have any questions, please contact Terry Johnson at 202-994-2630.
Sincerely, Astra Bain-Dowell, M.P.A.
Director, Office of Research cc: Bmd Jones Katherine Kennedy, Ph.D.
Hans Moore, M.D.
Alan Wasserman, M.D.
John F. Williams, M.D., Ed.D.
125328 0FFICIALRECORDCOPY ML 10 R -2 E
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BETWEEN -
k .. : L, $RMATION FROM LTS y :
License Fee Management Branch, ARM : Program Code: 22160 and : Sta tus Code: 0
, Regional Licensing Sections : Fee Category: EX 7C
- Exp. Date: 20030630
- Fee Comments: PACEMAKER /08-OO216-22
- Decom Fin Assur Reqd: N LICENSE FEE TRANSMITTAL
- A~. . REGION I
1.
APPLICATION ATTACHED
-- Appl icant/ Licensee: GEORGE WASHINGTON UNIV. MEDICAL CTR Received Date: 980102 Docket No: 7001795 i
Control No.: 125328 License No.: SNM-1499 Action Type Amendment
- 2. FEE-ATTACHED
-Amount: _________
Check No.: __ _ _ _ _ . _ _
3.. COMMENTS Signed Date _
/ 5JK_____________
.__ _A1 __ _________
B. LICENSE ~ FEE' MANAGEMENT BRANCH iCheck:when milesto 03 is entered /__/)
1.. Fee Category and Amount: I__ _k________ _ - 7 ___
c-.
- 2. Correct Fee Paid.. .ip1ication may,be processed for SE Amendment.' ___.____ ______ -
Renewal _ _ _ _ _ _ _ _ _ _ _ _ . _
-i License ______________
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- 3. OTHER _ _ _ _ _ _ _ _ _ _ _ _ - - _ -_________________
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w Signed ______ __________________________
i Date ________ _______________________
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