ML20148D302

Amend 14 to License SNM-1345 for Dept of Health & Human Svcs,Nih,Amending License in Entirety

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: ML20148D302 ML20148D309 ML20148D316 ML20148D320
References
NUDOCS 8803240001
Download: ML20148D302 (2)

Text

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1 NRC Fctr=,374* (} ( j g ,0l 8 41, ( J.S. NUCLE AR REGULATORY COMMIS$10N ( ,/ PAGE } OF 2 PAGES 1

1 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. g 1

Licensee I

) In accordance with letter dated bruar l

1 I' 3. [jena nuyb1 r 1988, !p l 1 Department of Health and Human Services SNM-13^5 is amended in l 1 National Institutes of Health its entirety to read as follows: W i

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Building 21, Room 110 Bethesda, Maryland 20205 _\,M j, 'Ehtr$i @e t _ _ 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 f l

                                             @                               \ '                                                                   /~/           'under this license                   l l A. Plutonium (principalQi                                                                                DN                                  Q2Y
                                             ,                                                              A.' S,ealed sources,                             A. 0(75 grams (3 individual 1             radionuclide Pu-238)

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                                                                                                                                                     ,           sourges not to exceed 250milligramseach)
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1 i_ A. /- - , s l 9. Authorized use g em w ll ;hf

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t j A. As a component of Coratomic'Model s -101 nuclear-1 clinical evaluatiorLpurposeQin acc&da"ndN~ith) "Human'powered; Clinic'ai cardiac Protocol pacemakers for the for 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 */ CONDITIONS \~ l

10. Licensed material shall be used nip'atdheiati " n 1 Institutes of Health, 1 1 Bethesda, Maryland.

1  !)b 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 5 of any nuclear pacemaker patient, and any adverse reaction and/or malfunction . 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,                                                                                                         !

j King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a nuclear pacemaker patient.  ; 8803240001 880311 'e g g* ' ' w _; g g a.m o W 7mmx=r-- -er -e-dr.- A E,-m @w .-- - j

7 N R GU A O 2 License number > MATERIALS LICENSE S -1345 h 1 g ,g, SUPPL,EMENTARY SHEET g, g i Amendment No. 14 i ) h CONDITIONS k (Continued) 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 followed upon the death of the patient. i 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

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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.:' ,

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A. Letter dated February 15, 1973 * (,

8. Letter dated September 10, 1975._,_ u , L C. Letter datdd - August '17,1976 J.i [* /, c, ' &

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Letter dated ' March:29; 1978  : N-QF h)nyg[' k f E. LetterreceivedMayi28;1982hl cf F. Letterdated(q Februarft l,;1988% 6 t j fMh %w 'WljaD -' y y O. s< '

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W 6 6 V V \ $ I For the U.S. Nuclear Regulatory Commission original Signed Byf p 1 11 MAR 1988 ey 3 - e 3onaasen g oate Nuclear Materials Safety and g Safeguards Branch, Region I g King of Prussia, Pennsylvania 19406 F( 1 __

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