ML20147H258

Amend 3 to License SNM-1735 for Veterans Admin Medical Ctr, Amending License in Entirety

ML20147H258
Person / Time
Site:	07002580
Issue date:	02/17/1988
From:	Vacherlon P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20147H261	List: ML20147H258 ML20147H269 ML20147H279 ML20147H316 ML20147H390 ML20147H398 ML20147H412 ML20147H435
References
NUDOCS 8803080434
Download: ML20147H258 (4)

Text

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yl===---------------A---------------------------------y l NRc Form 374 l(s84) U.S. NUCLEAR REcULATORY COMMISSION PAGE 1 OF 2 PAGES l Amendment No. 03 MATERIALS LICENSE , (

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorga'nizatio'n Act of 1974 (Public Law 93-438), and Title 10, l Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations j y 1 heretofore made by the licensee, a license is hereby !ssued authorizing the licensee to receive, acquire, possess, and transfer byproduct, t 1 source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to r 1 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This E I license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amanded, and is [

subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any j conditions specified below.

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In accordance with letter received j May 8, 1987 h j

1- Veterans Administration Medical Center 3. Ucense number SNM-1735 is amended in k 1

its entirety to read as follows: if 1

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1 3200 Vine Street -

t, ..f . l l 3 Cincinnati, OH 45220 s yF 4. Expiration date February 28, 1993 l l 1 r -

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5. Docket or Reference No.

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070-02580  !!

i ll1 6. Byproduct, source,and/or/ '

7. Chemical and/or physical V8. Maximum amount that licensee 9 i special nuclear material form , $may possess at any one time d 1 L, \ / dnder this license d

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, g 1 A. Plutonium (Principal '

- A. ' Sealed Sources' r ? A;,.21 grams (1 source j l radionuclide Pu-238) ~( )

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/C \ 'not to exceed 210 Cmilligrams je j

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9. Authorized Use i t;

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f A. As a component of MedtronicModel'9000 nEc1le'arlpowered pacemakers for clinical evaluation purposes. This license ~ authorizes possession of

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j purposes of explantation,~ recovery and disposalc but not for;these pacemakers

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reimplantation. (. '+

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ji CONDITIONS p{ <f<? 7 b 4/ j,i

) 10. Licensed material shall be'ured only at VeteransiAdministration Medical Center, q 1

3200 Vine Street, Cincinnati, Ohio.. v-4*3 1 n r

( The specified possession limit includes all licensed material possessed by the 1j 11. .-

1 licensee under this license whether in storage, implanted in patients or otherwise in use. I

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l 12. The licensee shall not receive or transfer in any single transaction, 1 gram or more 1 1 of plutonium-238 contained in nuclear-powered pacemakers without notifying the 1 1 Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, l l and, in addition, completing and distributing Form NRC-741 as required by Section 70.54 of 10 CFR Part 70. l

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) 13. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory L jl Cormiission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of 4i 1l occurrence, the death of any nuclear pacemaker patient, and any adverse reaction -

l 11 and/or malfunction involving a pacemaker system, including the leads. A written l I report giving details of the adverse reaction and/or malfunction shall be submitted ,

l within 30 days.  ;

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l NRC Form 3MA U.S. NUCLE AT! r.E;ULATcRY COMMISSION ,,oe 2 o, 2 ,,oes l l '

Licen,e number l l MATERIALS LICENSE ,g,,,,, ,'r Reference number CUPPLEMENTARY SHEET 070-02580 l i ,

i Amendment No. 03 p

! 14. The licensee shall report to the Material Licensing Section, U.S. Nuclear "gulatory l l Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of M 4 contact with a nuclear pacemaker patient. E i #

15. The licensee shall continue patient follow-up and replacement procedures for the l nuclear pacemaker during the life of the patient; and the procedures for recovery l q yi g and authorized disposal of the nuclear pacemaker by return to the manufacturer shall 4 be followed upon the death of the patient.

4 1

16. Except as specifically provided otherwise in this license, the licensee shall l conduct its program in accordance with the statements, represent tions, and g procedures contained in the documents including any enclosurcs, listed below, q The Nuclear Regulatory Comission's regulations'shall . govern unless the statements, N representations and procedures in the licensee's application and correspondence are j more restrictive than the regulations.

l A. Letters dated April, 22, 1977, May 19, 1978 and April 14, 1982; and 4 .

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4 B. Letter receiv,ed May 8, 1987.

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4 Original Signed j, Date: February 17, 1988 By Patricia M. Vacherlon 1' l Materials Licensing Section, Region III l

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g NRC Form 374 PAGE } OF 2 PAGES g

y (b84 U.S. NUCLET.R REGULATORY COMMISSION .

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Amendment No. 03 1

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-. MATERIALS LICENSE , l Pursuant 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 I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y g

l heretofore made by the licensee, a license is hereby issued authorizing the licerece to receive, acquire, possess, and transfer byproduct,~ y q source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to l I deliver or transfer such material to persons authorized to receive it in accordance with the regu:ations of the applicable Pargs). This l N license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amedded, and is I subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any l conditions specified below. g y

I Licensee I

N In accordance w.th s letter received i May 8, 1987 il j

N l- Veterans Administration Medical Center 3. Ucense number SNM-1735 is amended in l its entirety to read as follows: y g

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2. 3200 Vine Street Cincinnati, OH 45220 8 2i 'C ^ [n'date

4. Eipkr?ti February 28, 1993 g

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/m A 070-02580 y

R 6. Byproduct, source, and/or 7. Chemical and/or physical L Maximum amount that licensee I special nuclear material 1 form -

,ay possess at any one time I

@) \' - / under this license .I A. Plutonium (Principa.1 Sealed. Sources .21 grams (1 source radionuclide Pu-238)* [ ;p ) /$ not to exceed 210 l q'

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9. Authorized Use i '

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As a component of Medtron E'Hodel 9000 nuc ear-powered pacema,fers for clinical g i I

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evaluation purposeO This}5dov'eFy C a'n'didis'p'osaltb0t. not foikimplantationl!l orlicense purposes reimplantation. of explantation,]V *\\

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10. Licensed material shall be used1only, at Veteranst Admi istration Medical Center,

3200 Vine Street, Cincinnati, aOhio

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g 11. The specified possession limit includes all licensed material possessed by the p

1. licensee under this license whether in storage, implanted in patients or otherwise j

!N in use.

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12. The licensee shall not receive or transfer in any single transaction, 1 gram or more k

! of plutonium-238 contained in nuclear-powered pacemckers without notifying the g .

R Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555,  !

H and, in addition, completing and distributing Form NRC-741 as required by Section l 70.54 of 10 CFR Part 70. l l

l 13. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory q Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of ly g occurrence, the death of any nuclear pacemaker patient, and any adverse reaction p 4 and/or malfunction involving a pacemaker system, including the leads. A written lh

R I report giving details of the adverse reaction and/or malfunction shall be submitted I within 30 days, lli k,

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pm Amm m mmat l NRC Form 374A U.S. NUCLEAR RE1ULATORY COMMISSloN pf,g g 2 g, 2 PAGES I I Lic:nn number )

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SNM-1735 l MATERIALS LICENSE ''"""" l SUPPLEMENTARY SHEET 0 -02580 f 4 >

d Amendment No. 03 p 4 >

q 14. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory p i Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of n 4 contact with a nuclear pacemaker patient. >

d W l 15. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient; and the procedures for recovery l

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h and authorized disposal of the nuclear pacemaker by return to the manufacturer shall )

W be followed upon the death of the patient. p Y >

I 16. Except as specifically provided otherwise in this license, the licensee shall 5 E

l conduct its program in accordance with therstatements, representations, and q procedures contained in the documentis incliding['any enclosures, listed below. lp The Nuclear Regulatory Co,mmissio'n's regulations shall, govern unless the statements,

$q representations and procedures in the licensee's applicat, ion and correspondence are >

5 more restrictive than the regulations. # - N N A (,) E A. Letters dated Pil 22, 1977, May 19, 1978 and Apri,1 'l 1982; and l

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4 For the U.S. Nuclear Regulatory Commission 4 5 4l Original Signed k I

fDate: February 17, 1988 q

By Patricia M. Vacherlon Materials Licensing Section, Region III f

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