ML20214H690

Amend 10 to License SNM-1605 for Veterans Admin Medical Ctr, Amending License in Entirety

ML20214H690
Person / Time
Site:	07002199
Issue date:	05/14/1987
From:	Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20214H692	List: ML20214H690 ML20214H697
References
NUDOCS 8705270466
Download: ML20214H690 (2)

Text

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] M84I U.S. NUCLEAR RE!ULATORY COMMISSl; w

MATERIALS LICENSE Amendment No. 10 f Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-4 j Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y

1, heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess,and transfer byproduct, Ig lj source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to y

1 h; deliver or transfer such material to persons authorized to receive it in accordance with the regulatio l

R license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is R

f subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in eff 3( conditions specified below.

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Licensee I

3 In accordance with letter dated f

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March 25 1987, il

!I-Veterans Administration Medical Center 3 W"5" umber SNM-1605 is amended in J

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

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5. Docket or

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2. 50 Irving Street, N.W.

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{jj Washington, D.C.

20422

4. Expiration date August 31, 1991 g-4_

Reference No. ' 070-02199 g.

h{ 6. Byproduct, source, and/or

7. Chemical and/or physical

8. Maxunum amount that licensee f

special nuclear material form may passess at any one time i

. under this license fA. Plutonium (principal A. Sealed Source A. 1.25 grams (5 individual f,j i

RadionuclidePu-238) sources not to exceed 250 milligrams each) a g

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Authorized use L

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Implantation in humans as a component of Coratomic Mocel C-101 or C-101-P nuclear-E 4

powered cardiac pacemakers for clinical evaluation.

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CONDITIONS y

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10.

Licensed material shall be used only at Veterans Administration Medical Center, 50 E-Irving Street, N.W., Washington, D.C.

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b h11. The specified possession limit includes all 1.icensed material possessed by the h

1 licensee under this license whether in storage, implanted in patients, or g;

I otherwise in use.

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lj t-h12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, flE ATTN: Chief. Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, 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 h

of any nuclear pacemaker patient, and any adverse reaction and/or malfunction

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involving a pacemaker system, including the leads. A written report giving g

at o details of the adverse reaction and/or malfunction shall be submitted within E

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30 days.

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13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I,

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co ATTN: Chief Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, g

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King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a g_

yo, nuclear pacemaker patient.

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

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'bwz the nuclear pacemaker during the life of the patient.

Procedures for recovery (3jlj{[!

and authorized disposal of the nuclear pacemaker by return to the manufacturer l

shall be followed upon the death of the patient.

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

procedures contained in the documents including any enclosures, listed below.

l The Nuclear Regulatory Commission's regulations shall govern unless the state-ments, representations and procedures in the licensee's application and corre-i spondence are more restrictive than the regulations.

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A.

Letter with application dated December 15, 1975 I

B.

Letter dated Decerrber 17, 1976 I

C.

Letter dated January 18, 1977 D.

Letter dated September 12, 1978 i

i E.

Letter dated January 22, 1981 1

F.

Letter dated July 29, 1982 i

G.

Letter dated January 23, 1984 N

H.

Letter dated September 12, 1985 l

I.

Section I. (Items C. and I.) and Section II (Item I.) of Radiation Safety Guide enclosed with letter dated September 9, 1985 y

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Letter dated January 29, 1986 i

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Letter dated March 9, 1987 i

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Letter dated March 25, 1987 1l l

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For the U.S. Nuclear Regulatory Commission l

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l Date By I

Nuclear Materials Safety and l

Safeguards Branch, Region I h

King of Prussia, Pennsylvania 19406 f

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EAR RE",1ULATORY COMMISSION g

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PAGES

${ N[C Forrn 374A PAGE I* U g

Lic;nse number

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MATERIALS LICENSE g,,,,,,, g,f,,,,,,,,[,,f E SUPPLEMENTARY SHEET Y

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Amendment No. 10

>I (Con nued)

CONDITIONS

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15.

ealed sources or detector cells containing licensed material shall not be p

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i u \\pened 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 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

-l conduct its program in accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below, i

l The Nuclear Regulatory Commission's regulations shall govern unless the state-f:

g ments, representations and procedures in the licensee's application and corre-i I.

spondence are more restrictive than the regulations.

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A.

Letter with application dated December 15, 1975 E

l B.

Letter dated December 17, 1976

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l C.

Letter dated January 18, 1977 q

D.

Letter dated September 12, 1978 g}

q E.

Letter dated January 22, 1981 gj I

F.

Letter dated July 29, 1982 pt i

G.

Letter dated January 23, 1984 hl I

H.

Letter dated September 12, 1985 I.

Section I. (Items C. and I.) and Section II (Item I.) of Radiation Safety f

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Guide enclosed with letter dated September 9, 1985 g

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Letter dated January 29, 1966 pi

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K.

Letter dated March 9, 1987 gi

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Letter dated March 25, 1987 b

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For the U.S. Nuclear Regulatory Commission g1 m

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Date By f

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l Nuclear Materials Safety and j'-

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q Safeguards Branch, Region I q

King of Prussia, Pennsylvania 1940G p

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