ML20214M414

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Amend 8 to License SNM-1605 for Veterans Admin Medical Ctr, Amending License in Entirety
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)
v • d • e


Text

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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

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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

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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 ,

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! 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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