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
pi____ -_-----_--_-- ------_--__----_-----_--_-w 1 NRC Forr'n d/4
] M84I U.S. NUCLEAR RE!ULATORY COMMISSl; NE y w mcs l
! 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
l R h; deliver or be license shall transfer deemed to such contain material to persons the conditions specified inauthorized Section 183 oftothe receive it in accordance Atomic Energy with theand Act of 1954, as amended, regulation 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. g l
Licensee I 3
In accordance with letter dated f f!I- Veterans Administration Medical Center 3 March 25 1987, W"5" umber I
J 1 Radiation Safety Office (115) its entirety to read as follows:
SNM-1605 is amended in ily al 2.
50 Irving Street, N.W. E'
{jj Washington, D.C. 20422 4. Expiration date
- 5. Docket or
~
August 31, 1991
{lr g-4_ Reference No. ' 070-02199 g.
- 7. Chemical and/or physical 8. Maxunum amount that licensee h{ 6.special Byproduct, source, and/or nuclear material form fi may passess at any one time
. under this license fA. Plutonium (principal A. Sealed Source A. 1.25 grams (5 individual i
a RadionuclidePu-238) sources not to exceed 250 milligrams each) f,j g
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1 9. Authorized use ,. ., .; < -- L 1 , - <
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[A. Implantation in humans as a component of Coratomic Mocel C-101 or C-101-P nuclear- E 4
L powered cardiac pacemakers for clinical evaluation.
' fW 1 CONDITIONS , y 1 %
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T 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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h11. The specified possession limit includes all 1.icensed material possessed by the 1 licensee under this license whether in storage, implanted in patients, or h g;
I otherwise in use. 5:
lj t-h12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, 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 flE h
of any nuclear pacemaker patient, and any adverse reaction and/or malfunction g
at o involving a pacemaker system, including the leads. A written report giving %[
details of the adverse reaction and/or malfunction shall be submitted within E E
o
"' 30 days. E E
S 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, co ATTN: Chief Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, [;
g l& King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a g_
yo, nuclear pacemaker patient. I rd - l
, M . 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 (
- and authorized disposal of the nuclear pacemaker by return to the manufacturer (3jlj{[!
shall be followed upon the death of the patient.
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I 16. The licensee may transport licensed material in accordance with the provisions i
of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material". ll 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 procedures contained in the documents including any enclosures, listed below.
The Nuclear Regulatory Commission's regulations shall govern unless the state-l 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 i
D. Letter dated September 12, 1978 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 ,
I.Section I. (Items C. and I.) and Section II (Item I.) of Radiation Safety l 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 1
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Id [,,I,',[ ]$3/ For the U.S. Nuclear Regulatory Commission
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l Date By I Nuclear Materials Safety and
, l Safeguards Branch, Region I h King of Prussia, Pennsylvania 19406 f I
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, qI U.S. EAR RE",1ULATORY COMMISSION g PAGE 2 OF k PAGES
${ I*N[CU Forrn 374A g Lic;nse number l~ MATERIALS LICENSE SUPPLEMENTARY SHEET g,,,,, ,, g,f,,,,,, ,,[,,f E i ! Y 4 ? Amendment No. 10 >I (Con nued) CONDITIONS
, ,1 q 15. ealed sources or detector cells containing licensed material shall not be p i
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u \pened or sources removed from detector cells by the licensee.
l 16. The licensee may transport licensed material in accordance with the provisions q , of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".
q f I 17 Except as specifically provided otherwise in this license, the licensee shall .
conduct its program in accordance with the statements, representations, and
-l procedures contained in the documents including any enclosures, listed below, i l The Nuclear Regulatory Commission's regulations shall govern unless the state-g ments, representations and procedures in the licensee's application and corre- f:
i I. spondence are more restrictive than the regulations. p; y
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A.
B.
Letter with application dated December 15, 1975 Letter dated December 17, 1976 n)'
E C. Letter dated January 18, 1977 l
q D. Letter dated September 12, 1978 [!
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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 >
Section I. (Items C. and I.) and Section II (Item I.) of Radiation Safety l
g I.
Guide enclosed with letter dated September 9, 1985 fg q J. Letter dated January 29, 1966 pi
( K. Letter dated March 9, 1987 gi
( L. Letter dated March 25, 1987 b 8 F 4 W N E 4 k 4
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i k i t i k 4 i 4 ti 4 t1 4 El d I i I 4 i i [
4 i q m ,l/ For the U.S. Nuclear Regulatory Commission g1 r
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d Date By I!
l Nuclear Materials Safety and Safeguards Branch, Region I j'- ,
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q King of Prussia, Pennsylvania 1940G fp 1
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