ML20199K596

Matls Licensing Package for Amend 9 to License SNM-1377 for Univ of Michigan,Radiation Safety Svc.Control:302968

ML20199K596
Person / Time
Site:	07001418
Issue date:	11/07/1997
From:	Patricia Pelke NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
References
302968, NUDOCS 9712010160
Download: ML20199K596 (6)

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. U.S. NUCLEAR, REQUtbTORY COMMISSlo d

MATERIALS LICENSE Amendment No. 09 G

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A! Purswant to the Atomic Energy Act of 195L as amended. the Energy Reorganization Act of 1974 (Pubhc Law 93 438L ai.J Title 10, Code of

,2 jl federal Regulations. Chapter 1. Parts 30. 31,32,33,34 35,36,39. 40, and 70. and in reliance on statements and representations heretofore mad by the licensee, a license is hereby issued authorizing the licenice to receive, acqube, possess, and transfer byproduct, riource, and special nuclear j 1

malerial designated belowito 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 3

specified in section 183 of the Atomic EnerFy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the {

5 Nucleat Regulatory Commission now or hereafter in cf feet and to any conditions specified below.

A-b bb$ Y u ans" In accordance with letter dated 6

$ ' University of Michigan August 12'. 1997

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3.Ucense Number SNM 1377 is amended in Radiation Safety Service its entirety as follows:

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2-1101 N. University Building M

Ann Arbor, MI 48109 1057 A Expintion Date March 31, 2004 6

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5. Docket or Reference No.

070 01418 g

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6. nyproduct. Source, and/or

7. Chemical and/or Physical

8. Maximum Amount that Licensee g

Special Nuclear Material Forrn May Possess at Any One Time g

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Under This License i

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Plutonium (Principal A.

Sealed Sources A.

5 sources not to exceed radionuclide Pu 238) 210 milligrams each B.

Plutonium (Principal 8.

Sealed Source B.

5 sources not to exceed j

radionuclide Pu 238) 250 milligrams each

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Authorized Use:

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As a component of a Medtronic Model 9000 nuclear powered pacimaker for clinical 3;

f evaluation purposes. This license authorizes possession of pacemakers for purposes 3l of explanation, recovery and disposal only, not for implantation, tl f

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As a component of a Coratomic Model C-101 nuclear powered pacemaker for clinical 3l f

evaluation purposes. This license authorizes pcssession of pacemakers for purposes l

3 of explanation, recovery and disposal only, not for implantation.

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CONDITIONS (l

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Licensed material shall be used only at the licensee's facilities located at r y/

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University of Michigan Medical Center, University Hospital, Ann Arbor, MI.

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11. The physicians responsible for implantation, follow up, explanation, and return o'f Ej 3

nuclear powered pacemakers to the manufacturer for proper disposal are Fred Morady, a

3 H.D., S. Adam Strickberger, M.D., Kim Ching Man, 0.0., Rajiva Goyal, M.D., or

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B}j Bradley Knight, M.D.

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4;!+ 12. The specified possession limit includes all licensed material possessed by the licensee under this 1icense whether in storage, implanted in patients or otherwise

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PAGE 2 or 2

UCLEA3 RE!ULATORY COMMISSION PAGES g

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SNM 1377 g

4 MATERIALS LICENSE thlet or f<efnence Numte

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SUPPLEMENTARY SHEET 070 01418 g

Amendment No. 09 l

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13. The licensee shall continue patient follow up and replacement procedures for the E

nuclear pacemaker during the life of the aatient. Procedures for recovery and E

authorized disposal of the nuclear pacema(er by return to the manufacturer shall be g

followed upon the death of the patient.

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[ 14. The licensee shall report to the U. S. m: clear Regulatory commission, Region III.

E ATTN: Chief, Nuclear Materials Safety ocanch, 801 Warrenville Road, Lisle, IL E

60532, 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.

E i,9 and any adverse reaction and/or malfunction involving a pacemaker system, including E

the leads. A written report giving details of the adverse reaction and/or E

malfunction shall be submitted within 30 days.

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4 15. The licensee shall report to the U. S. Nuclear Regulatory Consission, Region III, 5

ATTN: Chief, Nuclear Materials Safety Branch 801 Warrenville Road Lisle, IL E

60532, within 10 dan of loss of contact with a nuclear pacemaker patient.

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4 16.

The licensee shall not receive or transfer in any single transaction, 1 gram or more 9

of plutonium 238 contained in nuclear sowered pacemakers without notifying the j

Division of Safeguards, U. S. Nuclear Regulatory Commission, Washincton. 0.C. 20555, E;

and, in additim, completing and distributing Form NRC 741 as required by Section E

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70.54 of 10 CFR Part 70.

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Except as specifically provided otherwise in this license, the licensee shall E

conduct its program in accordance with the statements, representations, and E

3 3rocedures contained in the documents, including any enclosures, listed below. The E

5 J.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, y

n representations, and procedures in the licensee's application and correspondence are E:

s more restrictive than the regulations.

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Letter received June 22, 1973: and gl 3L B.

Letters dated February 21, 1974. October 17,1975 July 7,1978 July 18,1983 (M

q September 7. 1983 August 25. 1988 and December 15, 1993.

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FOR THE U.S. NUCLEAR REGULATORY COMMISSION

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.1 (FOR L USE) 1 INFORMATION FROM LTS O

EETwEEN License Fee Management Branch, ARM 1

Progran Codel 22160 l

and Status Codel 0 l O Regionat Licensing Sections i

ree Categoru Ex 7C I

Exp. Date 20040331 l

t Fee Comments: PACEMAKER l

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nonnoinonnoninnoninin tlCENSE FEE TRANSMllTAL

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RECiON in 1.

APPLICATION ATTACHED y

Applicant / Licensees MICHICAN UNIVr.RSITY OF da O

Recei<ed D.tei 970sia Docket Not 7001418 77

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Control No.t 302968 License No.I SNM-1377 I3 O

Action Type Amendnent 2.

FEE ATTACHED Anounti

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Fee Catega v and Anountt

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1239 Kiple Drive, Ann Arbor. MI 481091010

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• Fat 313 763-1185 l-llenry D Daier[ Director-August 12, 1997 U.S. Nuclear Regulatory Commission, Region III Nuclear Materials Licensing Section 801'Warrenville Road Lisle, Illinois 60532-4351 RE: ' Amendment:to Special Nuclear Materials License SNM-1377

-Licensina Personnel:

Theli-University ' of Michigan (U-M) is requesting an amendment' to Special Nuclear Mater als License SNM-1377.

Specifically, the U-M would like to amend Condition 11 of SNM-1377 to include the names of the physicians responsible for implantation, follow-up, explanation, and return of nuclear--

powered pacemakers-to the manufacturer for proper disposal.

CONDITION 11-NEW RESPONSIBLE PHYSICIANS Please revise Condition 11 of SNM-1377 to read as follows:

"The ' physicians responsible-for implantation, follow-up, explanation, and return of nuclear-powered pacemakers to the manufacturer for proper disposal are Fred Morady, M -. D., Rajiva Goyal, M.D.,

Bradley Knight, M.D.,

Kim Ching

Man, D.O.,. and S. Adam 5:trickberger, M.D. "

Note that Emile Daond, M.D.

and Mark Niebauer, M.D.

have been removed from Condition 11; Dr. h!ebauer has left the U-M and Dr. Daoud is leaving as of

. September 30, 1997.

Thank you for your time and consideration with respect ta this amendment request.

Please do not hesitate to contact me at Radiation Safety Service /

OSEH [(313) 764-4420] should you have any questions or comments regarding this correspondence.

Sincerely, McJki3nd Mark L. Driscoll-RECEIVED Director / Radiation Safety Officer

= Radiation Safety S'ervice / OSEH AU6181997 MLD/mid' gg REGION III

SNM1377B

,p He h 'Phhs k p h dtaliation Safety Service

.cc:

Ali K. Alkaissi, (SB&EM)

James E. Carey, Chair," 5di~ation Policy Committee

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Fred Morady,'M.D., Director, Clinical Electrophysiology Laboratory g'hh M)G1

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Mark L. Driscoll

- Radiation Safety Officer University of Michigan -

Radiation Safety Service 1_101 N. University Bldg.

- Ann Arbor, M.' 48109-1057

Dear Dr. Driscoll:

- Enclosed is Amendment No. 09.to your NRC Material License No. SNM-1377 in accordance with your request.

10 CFR Part 70, Section 70.38 was amended (Federal Register Notice dated January 16, 1996) to include provisions for a one-time, five year license renewal extension for licensees -

' that satisfied specific criteria. Your institution satified the criteria and item 4 (Expiration Date) of your license has been amended to include the five year extension.

Please review the enclosed document carefully and be sure that you understand all conditions.

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. If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region ill office at (630) 829-9887 so that we can provide ;ppropriate corrections and answers.

Sincerely, i

Original Signed By Patricia J. Pelke b

Nuclear Materials Licensing Branch s License No.: SNM-1377 i

J Docket No.: 070-01418

Enclosure:

Amendment No. 09 i

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801 WARRENVILLE ROAD '

USLE, ILUNOIS 60632-4361 U***

August 25, 1997

~ Mark;L. Oriscoll

- Radiation-Safety Officer'

-Michigan.-University of.

i Radiation Safety Service ~

1101' North University Building

. Ann Arbor, MI 48109 105)

SUBJECT:

2 ACKNOWLEDGEMENT OF CORRESPONDENCE (Letter Dated 08/12/97)

Dear Licensee:

In response to-your request. we have completed the initial-processing, which is an administrative review of your application for a(n):

'New License X: Amendment Renewal Termination Auth User (Amendment not required)

Other No administrative deficiencies were identified during this initial review.

However, it should be noted that a technical review may identify omissions in the 4

submitted information.

It appears that your request is routine (see 1-3 below, as applicable).

1,

'New and imendment actions are normally processed within 90 days, unless we find major deficiencies, or policy issues requiring central program office assistance.

2.

Renewal actions are normally-processed within 180 days, however, under t1mely filing (before expiration), you may continue to operate under your existing license.

3.

TerminatioQ actions are-normally processed within 90 - days, unless confirmatory surveys following decontamination / decommissioning activities i

-are involved.

-A copy of ycur correspondence has been forwarded to our Licensing Fee and Debt Collection Branca (301/415-6097) for approval of the fee category and amount,-if required.

llf you have a compelling safety or business-related reason for requesting expedited review, please contact the Materials ~ Licensing Branch at (630) 829-9867.

We will try to complete your request as soon as practicable.

Any correspondence about' this request shoW1 reference the control number.

Nuclear Materials Support dianch Mail Control No.

302968-

-License No. SNM-1377-1 i

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