ML20247M635
| ML20247M635 | |
| Person / Time | |
|---|---|
| Site: | 07001795 |
| Issue date: | 03/11/1988 |
| From: | Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20247M641 | List: |
| References | |
| NUDOCS 8904060094 | |
| Download: ML20247M635 (2) | |
Text
is.sh 7 ' F ~ ~ W u.S. NUCLEAR REGULATORY COMMISSION PAGE 1 OF 2 PACES MATERIALS LICENSE Amendment No. 05 l Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), arid Title 10, E
i Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, 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 license shall be deemed to contain the conditions specified in Section 183 of the Atomic Ene:gy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any N conditions specified below.
l Ucensee In accordance with application dated i' The George Washington University M87, 3' UEMDinby, SNM-1499 is amended in Medical Center its entirety to read as follows: l 2' "- ~
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- 5. Docket or 7
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- 6. Byptoduct, source, and/or N h Reference No. 0-01795 R
- 7. Chemical and/or physical L6. Maximum amount that licensee 5 special nuclear material form # may possess at any one time 5 hk s / jnder this license N A. Plutonium S e Source m A.0G50 grams (individual princi al radionuc1 e' p } '
, sourpes not to exceed Pu-238 % $. C 4., 25'0milligramseach) e , lu l B. Plutonium 6 y.tSaled'Surce JE3 B.0.Orams(individual l princialradionuelje/
Pu-238 VV
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'l'!'i;%4V QQ / sources not to exceed 25Mmilligramseach)
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- 9. Authorized use L g-M g y A. Follow-up, recovery and' disposal of oratomic.; Mode 1IC-100 ntOlear-powered cardiac pacemakers previously'im" planted in huinahs))F '4 \ l B. Implantation in humans dsVa component of'Coratomic Mo 101 nuclear-powered cardiac pacemakers for clihical evaluation. l R , , , Jr 8904060094 880311
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- 10. Licensed material shall be used only at George Washington University, Medical Center, Washington, D.C.
- 11. The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise in use.
- 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, l ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 475 Allendale Road, 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 any nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. A written report giving P details of the adverse reaction and/or malfunction shall be submitted within j g l 30 days. y i
- 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, p ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 475 Allendale Road, d King of Prussia, Pennsylvania 19406, within 10 days cf loss of corg with a >
nuclear pacemaker patient.
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MATERIALS LICENSE Docket or aererence num SUPPLEMENTARY SHEET ',
070-01795 i
I f l Amendment No. 05 i l l (Continued) CONDITIONS l l l 14. The licensee shall continue patient follow-up and replacement procedures for !
I the nuclear pacemaker during the life of the patient. Procedures for recovery i I and authorized disposal of the nuclear pacemaker by return to the manufacturer l shall be followed upon the death of the patient.
l l l 15. Sealed sources or detector cells containing licensed material shall not be l l Opened or sources removed from source holders or detector cells by the l l licensee. -
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,licen(%Y0 l l I 16. The licensee may transport ? ftsed material in'/ raccdrdance with the i prov of 10 CFR Part 71, "Packagngand Transportation of'Radi ctive Material". l l 17. Except as specifically\provided otherwise in this license l~the licensee shall l l conduct its program"in~ accordance with the statements, representations, and i I procedures contained,in'.the sdocuments including any enclosur~eh, listed below. 1 I
I The Nuclear Regula)ory Co'mmission's regulations sha111 govern 6nless the statements, repre'sentationsihtid)rocedures in theglicinsee's app / lication
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