ML20209A866
| ML20209A866 | |
| Person / Time | |
|---|---|
| Site: | 07001366 |
| Issue date: | 04/15/1987 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20209A874 | List: |
| References | |
| NUDOCS 8704280299 | |
| Download: ML20209A866 (2) | |
Text
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J I N;;C Form 374 " -
PAGE 1 OF 2
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- U.S. NUCLEAR REGULATERY COMMISSlHN PACES 1
1 MATERIALS LICENSE Amendment No. 12 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, j! Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in rehance on statements and representations 1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, 1 source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to 1r deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This d
i license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is f subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in g conditions specified below.
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l Licensee I 1
In accordance with application dated E
! _ April 1, 1987 (
j 1-Department of Health and Human Services
- L'c'"S* 'mmb" SNM-1345 is amended in i 1 National Institutes of Health its entirety to read as follows: p.,
1 j
- 2. Building 21, Room 110 '
Bethesda, Maryland 20205 4. Exp!rstion date March 31, 1988
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j 5. Docket or j Reference No. 070-01366 1 6. Byproduct, source, and/or 7. Chemical and/or physical i . 8. Maximum amount that licensee 1 special nuclear material form . " h may possess at any one time
,- ' ,ander this license l A. Plutonium (principal A. Sealed sources , A. 1.50 grams (6 individual j radionuclide Pu-238) +
'[ sobrces not to exceed 1 250 milligrams each) 1 -
1 9. Authorized use 1
]A. As a component of Coratomic Model C-'101 nuclear-powered cardia'c pacemakers for j clinical evaluation' purposes in accordance with " Human Clinical Protocol for the j Coratomic C-101 Radioisotope Powered Cardiac Pacer," dated November 1, 1975. This j license authorizes possession of the pacemaker for purposes of explantation, 1 recovery, storage and disposal but not for implantation.,
a j CONDITIONS N l 10. Licensed material shall be used only at-the Natio al Institutes of Health, 1 Bethesda, Maryland.
1 1 11. The specified possession limit includes all licensed material possessed by the
] licensee under this license whether in storage, implanted in patients, or otherwise ,
j in use.
1 I 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, pl I ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, ll 1 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 Nl I of any nuclear pacemaker patient, and any adverse reaction and/or malfunction l involving a pacemaker system, including the leads. A written report giving details lI l J of the adverse reaction and/or malfunction shall be submitted within 30 days. g l
I I I 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, p 1 ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, 1l King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a l nuclear pacemaker patient. f ,
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8704280299 870415 w, I REG 1 LIC30 Dy" k~ ' I SNM-134 *h'"W 9 Y$' 'AW" J jg l b-------5 PDR
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r----"------------------------------------------"h9 l C Form 374A U.S. N AR REIULATORY COMMISSION w PAGE OF PAGES <
l License sumber I l'
! MATERIALS LICENSE S -1 5
- DockH w Referem SUPPLEMENTARY SHEET l
070-01366 (
l Amendment No. 12 I
I I
(Continued) CONDITIONS l 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 I followed upon the death of the patient.
I l 15. Sealed sources or detector cells containing licensed material shall not be opened i or sources removed from source holders or detector cells by the licensee. '
I 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".
l l 17. Except as specifically provided otherwise in this license, the licensee shall y i conduct its program in accordance with the statements, representations, and I procedures contained in the documents including any enclosures, listed below.
I The Nuclear Regulatory Commission's regulations shall govern unless the state-I ments, representations ar.d procedures in the licensee's application and corre-l spondence are more restrictive than the regulations.
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h i A. Letter dated February 15, 1973 -
i i B. Letter dated September 10, 1975 l l C. Letter dated August 17, 1976 W I D. Letter dated March 29, 1978 t I E. Letter received May 28, 1982 E l F. Letter dated February 7, 1983 j i j t I :
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For the U.S. Nuclear Regulatory Comission ; l l ,, , - . >
, , p I Date By i l
l Nuclear Materials Safety and N I
Safeguards Branch, Region I King of Prussia, Pennsylvania 19406 l l ,
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