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
. _ _ _ _
TE F AiAiAiT IATAif bRC FORM 374 Triinansmannnit37Wr4fTI cm U.S. NUCLEAR REGULATORY COMMISSION I
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3 4
NIATERIALS LICENSE t
$e Amendment No. 11 Pursuant to the Atomic linespy Act of 1954 e amended. the Enery) Reorgani/ahon Act of 1974 (P Q Federal Regulatiom. Chapter I. Parts 3n. 31,3133,34. 35,36. 39. 40, and 70. and in re
. anJ Title 10. Code o by the been ec, a license a hereby issued authonzing the beensee to w..a acquire, possess and tran C
material designated below; to use such material for the puipose(s) and at the place (s) designated be
, source, and special nuclem prsons authoriied to receive it in accordance with the regulations of the applicable Part(s).This licen material tt E
specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all app N
Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
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0FFICIAl.RECORDCOP7 p
Licensee In accordance with the letter dated L
.Dece
- 3. License g>er23, 1997,
.The George Washington University 8
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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P
.j June 30. 2003
- 5. Docket or
'e Reference No.
070-01795
- 6. Byproduct. Source, and/or 3
- 7. Chemical and/or Physical
- 8. Maximum Amount : hat Licensee Form g
May Possess at Any One Time Under This License 5
A. Plutonium (Principal A. Sealed Sources radionuclides Pu-238)
A. 0.750 grams (individual 5
sources not to exceed 2!
R milligrams each) g B
T Authorized use s
s A.
As a component of Coratomic Model C-101-nuclear powered cardiac pacemakers fo B
clinical evaluation.
This authorization includes:
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recovery and disposal, but not implantation.
follow-up, explanation, 5
E CONDITIONS 5
10.
Licensed material may be used only at the licensee's facilities at 901 23rd g
Street, N.W., Washington, D.C.
a, n
11.
The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or g
y otherwise in use.
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12.
A.
Physician responsible for follow-up, explantation and return of nuclear-
. g powered pacemakers to the manufacturer for proper, disposal is Hans Moore, g
M.D.
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!y B.
The Radiation Safety Officer for this license is Terry A. John
'i iai 13.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I,/
ATTN:
y Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, Pennsylvania 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
nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a g
pacemaker system, including the leads.
g A written report giving details of the adverse reaction and/or malfunction shall be submitted within 30 days.
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g License Number ey a
SNM-1499 p
MATERIALS LICENSE noctet or neren nce Number g
SUPPLEMENTARY SHEET l
g' 070-01795 g
Amendment No. 11 R
I 14.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, 3
ATTN:
Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of g
Prussia, Pennsylvania 19406, within 10 days of loss of contact with a nuclear g
pacemaker patient.
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15.
The licensee shall continue patient follow-up and replacement procedures for the l
g 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.
Sealed sources or detector cells containing licensed material shall not be opened g
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 Thelicenseeshal1Tbtreceiveortransferinanysingletransactionone(1) gram 18.
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or more of plutonium 238 contained in nuclear-powered pacemakers without notifying the Division of,Safeguardsi;U.S. Nuclear Regulatory Commission, Washington, D.C.
~
8 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.
N Except as specifically provided otherwise inithis license, t'he' licensee shall N
conduct its program inlaccorda'nce5/ith~the" stat 6 mints, repre.sentations, and a
procedures coatainediin;the documents-incl [fding any' enclosures, listed below.
The T
R Nuclear Regulatory Commission's regulation's shall govern unless the statements, B
representations'and p~rocedures in the licerisee's application, and correspondence are more restrictive than)the-reg,ulations. J g
q!
s A.
Letter dated ~ December 21, 1977 h
B.
Letter dated-January 10, 1983 B
C.
Letter dated March 19, 1993 y
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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 R -2 E 0FFICIALRECORDCOPY ML 10
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.f fFOR LFMS USE) k L, $RMATION FROM LTS f\\#*
BETWEEN -
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 5.__ _A1 Signed Date
/
JK_____________
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 O?.
w 3.
OTHER
=.
w Signed i
Date n-Rf!CEjVED DY 1JDCB_
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