ML20153C435
| ML20153C435 | |
| Person / Time | |
|---|---|
| Site: | 07001366 |
| Issue date: | 04/25/1988 |
| From: | Costello F NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20153C439 | List: |
| References | |
| NUDOCS 8809010147 | |
| Download: ML20153C435 (2) | |
Text
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'@* YMMM MIOEMMMEA_N L _ D M MA*Ef_E j t$aO '
.S. NUCLE A"4 REGULATORY COMMIS$10N - ---
ms l l 4 '. MATERIALS LICENSE Amendment No. 15 !
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] Pursuant to the Atomic Energy Act of 1954,its amended, the Energy Reorganization A et of 1974 (Public Law 93-438), and T 1 Code of Federal Regulations Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations j j heretofore made by the licensee, a license is hereby issued authorizing the licensee to receise, acquire, possess, and transfer byproduct, j
! I source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to !l l 1 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This lt I l license shall be deemed to contain the conditions specined in Section 183 of the Atomic Energy Act of 1954, as amended, and is lI subject to all applicable rules, regulations and onders of the Nuclear Regulatory Commission now or heie fter in effec' and to any j conditions specified belcw. y 1
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j Department of Health and Human Services In accordance with letter dated j' I* 3'{ arch 11""" """E"19 88, g 1 National Institutes of Health SNM-1345 is amended in i l its entirety to read as follows: I 1 I 2.
1 Buil ;ng 21. Room 110 l
- 4. Exphation date March 31,1993 Bethesda, Maryland 20892
.l 1 5. Docket or il'g J Reference No. 070-01366 .>
J 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee l 1 special nuclear material form may possess at any one time lJ
, under this licc. se
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] A. Plutonium (principal A. Sealed sources A. 0.5. grams (2 individual sources not to exceed j
1 radionuclide Pu-238)'
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250 milligrams each) li:I g
j 9. Authorized use -
j . As a component of Coratomic Model C-101 nuclear-powered cardiac pacemakers for },,
) clinical evaluation purposes in accordance with "Human Clinical Protocol for the 1 Coratomic C-101 Radioisotope Powered Cardiac Pacer," dated November 1, 1975. This 5 1 license authorizes possession of the pacemaker for purposes .of explantation, 1
] recovery, storage and disposal but not for implantation.g [
]
J CONDITIONS
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,b 1 10. Licensed material shall be used only at the National Institutes of Health, p 1 Bethesda, Maryland. I-I k 1
- 11. The specified possession limit includes all licensed material possessed by the >
l licensee under this license whether in storage, implanted in patients, or otherwise {
in use, p l
1 k i 12. The licensee shall report to the U.S. Nuclear Regulatory Comission, Region I, I l ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 475 Allendale Road, J lll 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 k l any nuclear pacemaker patient, and any adverse reaction and/or malfunction involving l g a pacemaker system, including the leads. A written report giving details of the i; adverse reaction and/or malfunction shall be submitted within 30 days. )p I )
I 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, t 1 ATTN: Chief. Nuclear Materials Safety anf Safeguards Branch, 475 Allendale Road, >
l King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a (
- nuclear pacemaker patient. ML10 '>
I e809010147 000425
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"" , Licea n:mber I I S 5 ei MATERIALS LICENSE " " " " " l SUPPLEMENTARY SHEET O 0-01366 [
Amendment No. 15 ll1 1 1 (Continued) CONDITIONS
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- 14. The licensee shall continue patient follow-up and replacement procedures for the I nuclear pacemaker during the life of the patient. Procedures for recovery and I authorized disposal of the nuclear pacemaker by return to the manufacturer shall be L followed upon the death of the patient. ll l
- 15. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders or detector cells by the licensee. r L
- 16. The licensee may transport licensed'mateFiil(in accordance with the provisions of L 10 CFR Part 71, "Packaging and Transportation'ofJadioactive Material". jt
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- 17. Exceptasspecifically,prov'idedotherwiseinthislichns'e,thelicenseeshall }
conduct its program infaccordance with the statements, representations, and r procedures containedln the documents including any enclos4res, listed below. t The Nuclear Regulatory Commission's regulations shall govern'unless the ,t statements, representations and. procedures in the-licensee's application and correspondencA*.are more r'estrictive. than the' reyulations.a.-
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B.
Letter dated February 15,;1973 Letter dated September 10, 1975 / - e' (
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C. Letter dated' August!17, 1976 9 D'1 ff ,'. $ L t
D. Letter date( Marcht29', 1978 / F f'.<' .
E. ,f F. LetterreceivedMaf281198204(lliJG.1,119883lll Letter dated , February g .,,.- s 1
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y For the U.S. Nuclear Regulatory Commission
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Date 25 APR 1988 sy rm. m .c - 'tt huclear Materials Safety Branch Region I >
King of Prussia, Pennsylvania 19406 [
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