ML20148D302
| ML20148D302 | |
| Person / Time | |
|---|---|
| Site: | 07001366 |
| Issue date: | 03/11/1988 |
| From: | Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20148D305 | List: |
| References | |
| NUDOCS 8803240001 | |
| Download: ML20148D302 (2) | |
Text
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( J.S. NUCLE AR REGULATORY COMMIS$10N (,/
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MATERIALS LICENSE Amendment No. 14 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, g
4 Code of Federal Regulations / Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations p
1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, y
1 source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to n
1 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This y l
license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is 4
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any q
conditions specified below.
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I Licensee
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In accordance with letter dated l
- 3. [jena nuyb r 1988, bruar 1
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1 Department of Health and Human Services SNM-13^5 is amended in
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1 National Institutes of Health its entirety to read as follows:
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1 j, 'Ehtr$i @e e_M l Building 21, Room 110 t ) Bethesda, Maryland 20205 _\\, _ _ March 31. 1993 Jg j y (f '
- 5. Docket or 7
j s ) Reference No. 070-01366 d
- 6. Byproduct, source, and/or 1
- 7. Chemical and/or physical L8. Maximum amount that licensee special nuclear material form 6may possess at any one time l
f \\ ' /~/ 'under this license l l Qi DN Q2Y A. Plutonium (principal, A.' S,ealed sources, A. 0(75 grams (3 individual hy{ 1 radionuclide Pu-238) + n ) y[ J sourges not to exceed T 1 T .,1 1 250milligramseach) '~~.v /- - s 1 i_ A. l 9. Authorized use . { gy jg,g g w ll t
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) em w e As a component of Coratomic'Model -101 nuclear-clinical evaluatiorLpurposeQin acc&da"ndN~ith) powered; cardiac pacemakers for j A. s "Human' Clinic'ai Protocol for the 1 1 Coratomic C-101 Radi6fsotope PoweFed'CiFdiac Pacer,"; dated foyember 1,1975. This pl 1 license authorizes p'ossessioh of'thefpacemaker for 'purpos bi j recovery, storage and'dijsposal but notgrjimplaritation. qsiof explantation, l
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CONDITIONS \\~ l 10. Licensed material shall be used nip'atdheiati n 1 Institutes of Health, 1 !)b 1 Bethesda, Maryland. 1 j
- 11. The specified possession limit includes all licensed material possessed by the l
3 licensee under this license whether in storage, implanted in patients, or otherwise ] in use. 1 1 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, i 1 ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 475 Allendale Road, l King of Prussia, Pennsylvania 19406, within 24 hours of occurrence, the death of any nuclear pacemaker patient, and any adverse reaction and/or malfunction 5 3 involving a pacemaker system, including the leads. A written report giving details I 1 of the adverse reaction and/or malfunction shall be submitted within 30 days. 1 1
- 13. The licensee shall report to the U.S. Nuclear Regulatory Comission, Region I, k
} ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 475 Allendale Road, King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a j nuclear pacemaker patient. 8803240001 880311 'e g A E m @ w g* ' w _; g g a W 7 o .m mmx=r-- -er -e-dr.-,- j
7 N R GU A O 2 License number S -1345 h MATERIALS LICENSE g ,g, i SUPPL,EMENTARY SHEET g, g Amendment No. 14 i ) h (Continued) CONDITIONS k h
- 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 i followed upon the death of the patient. i 15. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders or detector cells by the licensee, g l ^ ,.s
- 16. The licensee may transport licensed, material sin accordance with the provisions of 10 CFR Part 71, "Packaging and Transportation-of Radioactive Material".
h r ( 17. Except as specifically'provided otherwise in this license, the licensee shall l conduct its program _in accordance with the statements, repr_esentations, and p procedures contained in the documents including any enclosures, listed below. The Nuclear Regulatory Coninission's regulations shall-govern' unless the state-ments, representations an'd procedures in the licensee's application and corre-spondence are more' restrictive than the. regulations.:' x> / -, . i rp,, [ A. Letter dated February 15, 1973 (, 8. Letter dated September 10, 1975._,_ u, L C. Letter datdd - August '17,1976 J.i [* /, c, ' 'T f Letter dated ' March:29; 1978 N h)nyg[' k ,f D. Februarft,;1988% 6 t j f h %w 'Wlj - ' cf -QF LetterreceivedMayi28;1982hl E. l D y Letterdated(q F. ~px c Lt & g'Q M a y O. ,7.y /. a 3>
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'LQlV'$ (' s< ' .n lg m [V 2 ) .- e o W W W = W 6 6 V V \\ I For the U.S. Nuclear Regulatory Commission original Signed Byf p 11 MAR 1988 3 - e 3onaasen ey g 1 oate Nuclear Materials Safety and g Safeguards Branch, Region I g King of Prussia, Pennsylvania 19406 F( 1
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