ML20214H690
| 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: |
| 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.
I I
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
q J.
Letter dated January 29, 1986 i
K.
Letter dated March 9, 1987 i
L.
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
q J.
Letter dated January 29, 1966 pi
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K.
Letter dated March 9, 1987 gi
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L.
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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