ML20246M664

Amend 17 to License SNM-1345 for Dept of Health & Human Svcs Nih,Amending License in Entirety

ML20246M664
Person / Time
Site:	07001366
Issue date:	03/14/1989
From:	Jennifer Davis NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20246M671	List: ML20246M664 ML20246M686
References
NUDOCS 8903270221
Download: ML20246M664 (2)

Text

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L ;________________________

N;C Fxrm 374 -

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[V} U.S. NUCLEAR RECULATOT.Y COMMISSION PACE } W p PAGES l l

MATERIALS LICENSE Amendment No 17 l

Pursuant t'o the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations l y

heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and tramfer byproduct, u source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to }

deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This l l license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is I subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any I conditions specified below.

l Licensee I In accordance with letter dated I Department of Health and Human Services February 17, 1989, I l National Institutes of Health 3. License number SNM-1345 is amended in its entirety to read as follows: l y

1

2. Building 21, Room 110 "

l Bethesda, Maryland 20892 4. Expiration date March 31, 1993 1

5. Docket or Reference No. 070-01366 y

6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee I special nuclear material form may possess at any one time I

, under thislicense A. Plutonium (principal A. Sealed source A. 25 grams (1 source) I radionuclidePu-238). .

l 9.. Authorized use -

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A. As a component of Coratomic Model C-101 nuclear-powered cardiac pacemakers for I clinical valuation purposes in accordance with " Human Clinical Protocol for the I Coratonf C-101 Radioisotope Powered Cantiac Pacer," dated November 1,1975.- This license authorizes possession of the pacemaker for purposes of explantation, l g

recovery, storage and disposal.but not;for implantation. _

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I CONDITION 5 REG 1 LIC70 5 i SNM-1345 PNU $ I 10 Licensed material shall be used only at the National Institutes of Health, Bethesda, Maryland. l i g

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11. The Interim Radiation Safety Officer for this license is Ted W. Fowler. I i

12. The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise l in use.

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13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, I ATTN: Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, i 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 I pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker l system, including the leads. A written report giving details of the adverse y reaction and/or malfunction shall be submitted within 30 days. p I

14. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, 1 ATTN: Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, I Pennsylvania 19406, within 10 days of loss of contact with a nuclear pacemaker l patient. l 0FFICIAL. RECORD COPY gjg ( j

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RC Form 374A U.S. N AR REGULATORY COMMISSION p

_ ,,gg 2 g, ,,gg, License number MATERIALS LICENSE cocket or aeterence num SUPPLEMEtlTARY SHEET 070-01366 Amendment Nc. 17 L (Continued) CONDITIONS

15. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker dcring the life of the patient. Procedures for rscovery and L authorized disposal of the nuclear pacemaker by return to the manufacturer shall be . j followed upon the death of the patient.  !

16. Sealed sources or detector cells containing licensed material shall not be opened l i or sources removed from source holders or detector cells by the licensee.

17. The licensee may transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and' Transportation of Radioactive Material".

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18. Except as specifically.provided otherwise in this license, the licensee shall conduct its program 1n accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below.

1 The Nuclear Regulatory Comission's regulations shall govern"unless the statements, representations and procedures in the licensee's' application and correspondence'are more restrictive than the regulations. s t~ 42 ~:~ O

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A. Letter datedeFebruary 15 p1973  ; 1 TIM c ",

8. Letter datediSeptember 10,11975. " (, C 1 1.

C. Letter dated

• August:17, 1976 ,, 4 7 Letter dated farch 29, 1978 9 ,3gg3 g W;2 ,p:

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Letter received May"28, 1982 '

Letter dated February l7,$ 1983 u , a s e 2 4

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Letter Letter dateddated *FebruaryL1Z198851 November'15,1988 7Afh([jAd- j[#

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I. Letter dated February 17, 1989 jfa {x ,j c4f

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1 For the U.S. Nuclear Regulatory Comission Original Signed By:

Date MAR 141989 sy Jack Davis j Nuclear Materials Safety Branch  ;

Region I King of Prussia, Pennsylvania 19406

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