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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IJ N;;C Form 374
] Wa4 U.S. NUCLEAR REGULATERY COMMISSlHN PAGE 1
OF 2
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 di 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
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g conditions specified below.
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l Licensee I
1 In accordance with application dated E
_ April 1, 1987
(
1-j 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:
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- 2. Building 21, Room 110
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Bethesda, Maryland 20205
- 4. Exp!rstion date March 31, 1988 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
" h may possess at any one time
',ander this license l A. Plutonium (principal A. Sealed sources A. 1.50 grams (6 individual
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sobrces not to exceed j
radionuclide Pu-238)
+
1 250 milligrams each) 1 1 9.
Authorized use 1
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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.,
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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
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licensee under this license whether in storage, implanted in patients, or otherwise in use.
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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 lI l
involving a pacemaker system, including the leads. A written report giving details l
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of the adverse reaction and/or malfunction shall be submitted within 30 days.
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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 l
King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a f
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nuclear pacemaker patient.
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I 8704280299 870415
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SNM-134 PDR b-------5---------------,------------------------ ---- I
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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
(
070-01366 l
l Amendment No. 12 I
I (Continued)
CONDITIONS I
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.
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- 16. The licensee may transport licensed material in accordance with the provisions I
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 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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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
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For the U.S. Nuclear Regulatory Comission 4
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Date By i
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Nuclear Materials Safety and N
I Safeguards Branch, Region I l
l King of Prussia, Pennsylvania 19406 I
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