ML20236G198
| ML20236G198 | |
| Person / Time | |
|---|---|
| Site: | 07001366 |
| Issue date: | 10/20/1987 |
| From: | Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20236G200 | List: |
| References | |
| NUDOCS 8711020454 | |
| Download: ML20236G198 (2) | |
Text
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NRC Frism 374 g PA" PA D (5*84f: ,S. NUCLE AR REGULATORY COMMISSION 1 "--- 2
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MATERIALS UCENSE Amendment No. 13 i
Pursuant t'o'the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, f
j Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations g heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, I. h y source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to i
{ deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions speciGed in Section 183 of the Atomic Energy Act of 1954, as amended, and is l
]c subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any 1
f conditions specified below.
E Licensee E
l In accordance with application dated ]
p i' Department of Health and Human Services 3'[e@'s*mber2,1987, e
""*b*r SNM-1345 is amended in 9
i National Institutes of Health its entirety to read as follows: W 2 '- E 6 ' Building 21, Room 110 4. Expn.adon dat Bethesda, Maryland 20205 March 31, 1988 E h-
- 5. Docket or Reference No. '070-01366
__6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee special nuclear material form may possess at any one time under this license A. Plutonium (principal A.gSealed sources A. 1.00 grams (4 individual N radionuclidePu-238) sources not to exceed ,
250 milligrams each)
- 9. Authorized use j A. As a component of Coratomic'Model C-101 nuclear.-powered. cardiac pacemakers for i clinical evaluation purposes'in;accordance;with'" Human ~ Clinical Protocol for the k
Coratomic C-101 Radioisotope Powered Cardiac Pacer," dated November 1, 1975. This f license authorizes possession of the pacemaker for purposes of explantation, recovery, storage and disposal but not for implantation, f
il y CONDITIONS y 10. Licensed material shall be used only at the National Institutes of Health, k Bethesda, Maryland. .
- 11. The specified possession limit includes all licensed material possessed by the j licensee under this license whether in storage, implanted in patients, or otherwise
- in use, k
e 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region 1, ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, k{ 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 of any nuclear pacemaker patient, and any adverse reaction and/or malfunction Q
5 involving a pacemaker system, including the leads. A written report giving details of the adverse reaction and/or malfunction shall be submitted within 30 days.
- 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, l King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a j nuclear pacemaker patient.
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Amendment No. 13 _
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(Continued) CONDITIONS k
- 14. The. licensee shall continue patient follow-up and replacement procedures for the
-nuclear pacemaker during the life of the patient. Procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the; patient.
- 15. . Sealed sources or detector cells containing licensed material shall not be opened p or sources removed from source holders or detector cells by the licensee. g i
16 The licensee may transport licensedDiiate71a'l(ip; accordance with the provisions i '
of 10 CFR Part 71, " Packaging and Transportations of, Radioactive Material". t m7 %Q ! l 17 Except as specifically provided otherwise in this license, the licensee shall l 6
conduct its program in accordance with the statements, representations, and g procedures contained'in'the documents ' including any enclosures, listed below. p l The Nuclear Regulatory Commission's regulations shal1 govertrunless the state- p ments, representations and procedures in the licensee's application and corre- h spondence are more" restrictive:than the regulations > ^
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A. Letter dated February 15 a1973 .
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B.. Letter dated' September 10; 1975 j i i )' / M
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F[ p i C. Letter dated > August.17, 1976; . rl' : _ N g l C
.0. Letter dated March 29,1978: <
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E. l Letter received May 28,r1982- , ,
q h F.- Letter dated February!7,Il983#l ,(. ! p 2i Eb pW 7 lp G.. Application dated AprilJ1 ,19871 : ., yM Ce" H. Letter dated Sepetember;2,~1987, ^ 92 N, f ,
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s For the U.S. Nuclear Regulatory Commission l i Origirm1 Signed By: >
Date 90 00T 14R7 By 5"Y " 3 ***"" N
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Nuclear Materials Safety and Safeguards Branch, Region I King of Prussia, Pennsylvania 19406 pli r
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