ML20214M414

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: ML20213D559 ML20214M414 ML20214M423 ML20214M431 ML20214M447 ML20214M456 ML20214M466 ML20214M473 ML20214M477 ML20214M482 ML20214M487 ML20214M490 ML20214M495 ML20214M519 ML20214M531 ML20214M535 ML20214M542 ML20214M545 ML20214M553 ML20214M559 ML20214M563
References
NUDOCS 8609110105
Download: ML20214M414 (2)

Text

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NOC Form 374

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M N ES a]

.S. NUCLE AR RETULATZRY COMMISSCN 4

q MATERIALS LICENSE Amendment No. 08 i

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 am 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.

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Ucensee i

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In accordance with letter dated

3. Ucense number,1986, January 29 I-SNM-1605 is amended in q

Veterans Administration Medical Center I

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Radiation Safety Office (115) its entirety to read as follows:

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50 Irving Street, N.W.

i Washington, D.C.

20422

4. Expiration date August 31, 1991 l

5. Docket or 4

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Reference No.

,070-02199 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 under this license I

.i A. Plutonium (principal A. Sealed Source A. 1.25 grams (5 indivioual

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g' RadionuclidePu-238) sources not to exceed I

250 milligrams each) i Authorized use 9.

A.

Implantation in hur'ans as a component of Coratomic Mocel C-101 or C-101-P nuclear-g 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 Irving Street, N.W., Washington, D.C.

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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

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g o-ATTN:

Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, gl l

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 o

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

30 days.

_J e E J 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region 1 M

ATTN:

Chief, Nuclear Materials Safety and Safeguards Branch, b31 Park Avenue, l

a m tn King of Prussia Pennsylvania 19406, within 10 days of loss of contact with a i

nuclear pacemaker patient.

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14. The licensee shall continue patient follow-up and replacement procedures for t

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the nuclear pacemaker during the life of the patient.

Procedures for recovery

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and authorized disposal of the nuclear pacemaker by return to the manufacturer f; <

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_ _ _. _,,. _ _ RI. E % [ g j h 11 be followed upon the death of the patient.s'

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S. NUL,_3 C EIULATORY COMMISSION 2

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l R Form 374A U.

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License nurnber I

SNM-1605 I

MATERIALS LICENSE l

sUPPLEM ENTARY SHE ET 070-02199 g

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p Amendment No. 08 g

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(Continued)

CONDITIONS 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.

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16. The licensee may transport licensed material in accordance with the provisions l

of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".

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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.

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I The Nuclear Regulatory Commission's regulations ~shall govern unless the state-8 l

ments, representations and procedures in the licensee's application end corre-spondence are more restrictive than the regulations.

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A.

Letter with application dated December 15, 1975 p

I B.

Letter dated December 17, 1976 I

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C.

Letter dated January 18, 1977 8

I D.

Letter dated September 12, 1976 f

E.

Letter dated January 22, 1981 l

l F.

Letter dated July 29, 1982 i

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

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t.etter dated Januarj 29, 1986 l

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I For the U.S. Nuclear Regulatory Commission j

Originni signed Dyl y

l John E. Glenn 1

Date AUG 2 91996 By l

Nuclear Materials Safety and b

I Safeguards Branch, Region 1 P,

l King of Prussia, Pennsylvania 19406 g

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Iy y,