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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[V U.S. NUCLEAR RECULATOT.Y COMMISSION N;C Fxrm 374 -

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l MATERIALS LICENSE Amendment No 17 Pursuant t'o the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, l Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations 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

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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 l

its entirety to read as follows:

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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).

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Authorized use p

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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 l

license authorizes possession of the pacemaker for purposes of explantation, g

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

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CONDITION 5 REG 1 LIC70 5

i SNM-1345 PNU $

I 10 Licensed material shall be used only at the National Institutes of Health, l

Bethesda, Maryland.

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

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12. 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.

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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.

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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 (

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l RC Form 374A U.S. N AR REGULATORY COMMISSION 2

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,,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.

The Nuclear Regulatory Comission's regulations shall govern"unless the 1

statements, representations and procedures in the licensee's' application and correspondence'are more restrictive than the regulations.

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Letter datedeFebruary 15 p1973 1

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Letter datediSeptember 10,11975.

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Letter dated

• August:17, 1976,,

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Letter dated farch 29, 1978 9,3gg3 g W;2

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Letter received May"28, 1982

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Letter dated *FebruaryL1Z198851 Afh([jAd-j[#

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

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Letter dated November'15,1988

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Letter dated February 17, 1989 jf {x,j c4f a

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

Jack Davis Date MAR 141989 sy j

Nuclear Materials Safety Branch Region I King of Prussia, Pennsylvania 19406

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