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I C. Letter dated January 18, 1977 8 I D. Letter dated September 12, 1976 E. Letter dated January 22, 1981 l f Letter dated July 29, 1982 i l | I C. Letter dated January 18, 1977 8 I D. Letter dated September 12, 1976 E. Letter dated January 22, 1981 l f Letter dated July 29, 1982 i l | ||
F. | F. | ||
l G. Letter dated January 23, 1984 6 I H. Letter dated September 12, 1985 f I I. Section 1. (Items C. and I.) and Section'II (Item I.) of Radiation Safety b I Guide enclosed with letter dated September 9, 1985 > | l G. Letter dated January 23, 1984 6 I H. Letter dated September 12, 1985 f I I. Section 1. (Items C. and I.) and Section'II (Item I.) of Radiation Safety b I Guide enclosed with {{letter dated|date=September 9, 1985|text=letter dated September 9, 1985}} > | ||
J. t.etter dated Januarj 29, 1986 l l | J. t.etter dated Januarj 29, 1986 l l | ||
l > | l > |
Latest revision as of 15:04, 4 May 2021
ML20214M414 | |
Person / Time | |
---|---|
Site: | 07002199 |
Issue date: | 08/29/1986 |
From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
To: | |
Shared Package | |
ML20213D562 | List: |
References | |
NUDOCS 8609110105 | |
Download: ML20214M414 (2) | |
Text
,p a m.m_m m m m m ara m m m m mm am maammmmmmmmmmmmma - mm . m mmmmm m -
NOC Form 374 } M 2 (a] 4 84 .S. NUCLE AR RETULATZRY COMMISSCN E N ES 4
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MATERIALS LICENSE Amendment No. 08 Pursuant to the Atomic Energy Act of 1954. as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), ar d Title 10, g Code of Federal Regulations Chapter I, Parts 10,31,32,33,34,35,40 and 70, and in reliance on statements and representations ;
4 heretofore made by the bcensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer by product, '
4, source, and special nuclear material designated below; to use such material for the purpose (s)and at the place (s) designated below;to !
Ni deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the appheable Part(sh This !'
f license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as ame g subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any l-4 conditions specified below. p k Ucensee i In accordance with letter dated January 29
[(:
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I- Veterans Administration Medical Center Radiation Safety Office (115)
- 3. Ucense number,1986, SNM-1605 is amended in its entirety to read as follows: I I
N' .
50 Irving Street, N.W. i I.- "c -
- 4. Expiration date August 31, 1991 4{2.Washington, D.C.
4 20422
- 5. Docket or l
Reference No. ,070-02199 !
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4 6. Ilyproduct, source, and/or 7, Chemisal and/or physical 8. Maximum amount that licensee M
% special nuclear matertal form may possess at any one time I
under this license
.i A. Plutonium (principal A. Sealed Source A. 1.25 grams (5 indivioual ?
g' RadionuclidePu-238) sources not to exceed I i 250 milligrams each) !
- 9. Authorized use ;
A. Implantation in hur'ans as a component of Coratomic Mocel C-101 or C-101-P nuclear-g i powered cardiac patemakers for clinical'eveluation. -
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($
CONDITIONS
- 10. Licensed material shall be used only at Veterans dminis'tration Medical Center, 50 4
Irving Street, N.W., Washington, D.C. g
- 11. The specified possession limit includes,all-lice sed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise in use.
, E 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region 1 !{
g o- ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, o King of Prussia, Pennsylvania 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 gl l
$ of any nuclear pacemaker patient, and any adverse reaction and/or malfunction i involving a pacemaker system, including the leads. A written report giving m
o rs details of the adverse reaction and/or malfunction shall be submitted within t
@$ _J e 30 days.
E J 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region 1 M
a m tn ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, b31 Park Avenue, King of Prussia Pennsylvania 19406, within 10 days of loss of contact with a l
i nuclear pacemaker patient. l'
- 14. The licensee shall continue patient follow-up and replacement procedures for , t ,
q( the nuclear pacemaker during the life of the patient. Procedures for recovery
( and authorized disposal of the nuclear pacemaker by return to the manufacturer f; <
h 11 be followed upon the death of the patient.s'
_ _ _ . _ ,,. _ _ RI. E % [ g - ij
l p-------------- -- ------ --- ------ -----------.m -y U. S. NUL,_3 C EIULATORY COMMISSION w 2 2 l l R Form 374A pggg g, 74gg3 I
1 License nurnber SNM-1605 I MATERIALS LICENSE l
> l l sUPPLEM ENTARY SHE ET 070-02199 g q
p I
i Amendment No. 08 g I h I CONDITIONS
, (Continued) l l 15. Sealed sources or detector cells containing licensed material shall not be $
I opened or sources removed from detector cells by the licensee. p i i l
i 16. The licensee may transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material". l ,
l I
! 17. Except as specifically provided otherwise in this license, the licensee shall ;
I conduct its program in accordance with the statements, representations, and i i procedures contained in the documents including any enclosures, listed below. I l
I The Nuclear Regulatory Commission's regulations ~shall govern unless the state- 8 ments, representations and procedures in the licensee's application end corre-l spondence are more restrictive than the regulations. -
l 1
I I A. Letter with application dated December 15, 1975 p I B. Letter dated December 17, 1976 I h
I C. Letter dated January 18, 1977 8 I D. Letter dated September 12, 1976 E. Letter dated January 22, 1981 l f Letter dated July 29, 1982 i l
F.
l G. Letter dated January 23, 1984 6 I H. Letter dated September 12, 1985 f I I. Section 1. (Items C. and I.) and Section'II (Item I.) of Radiation Safety b I Guide enclosed with letter dated September 9, 1985 >
J. t.etter dated Januarj 29, 1986 l l
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I I For the U.S. Nuclear Regulatory Commission j Originni signed Dyl y l
John E. Glenn >
1 Date AUG 2 91996 By >
Nuclear Materials Safety and b l
I Safeguards Branch, Region 1 P ,
King of Prussia, Pennsylvania 19406 g l ,
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