ML20199C628

Matls Licensing Package for Amend 10 to License SNM-1377 for Univ of Michigan.Control:303456

ML20199C628
Person / Time
Site:	07001418
Issue date:	01/13/1998
From:	Mullauer J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
References
303456, NUDOCS 9801300059
Download: ML20199C628 (8)

Text

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U.s. NucLF.AR RE uLAToRY CoMhassioN Amendmen No.10 MATERIALS LICENSE Pursuant to the Atomic Energy Ad of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10 Code of Federal Regulations Chapter 1. Parts 30,31,32,33,34,3$, 36,39,40, and 70, ard in reliance on statements and representations heretofore made by the loensee, a konse is hereby issued authorizing the lcens00 to receive Dcquire, 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; in delNier or transfer sudi rnatertal to persons authortred to reoeh's t in accordance wtth the regulations of the applicable Part(s). This license shal be deemed to contain the conditions specifed in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all app 6aabne rules, regulatons, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specifed below.

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. &OY in accordance with letter dated December 24,1997, l

1. University of Michigan 3. License number SNM 1377 . is amended in Occupational Ssfety & Environmental Health its entirety as follows:

Radiation Safety Service 2.1239 Kipke Drive g R 28 feptetion date March 31,2004 Ann Art >or, MI 48109 1010 G[ 5. DocFet1(o.j70-01418 Referonce No A

6. Byproduct, source, and/or special [ 7. Chemicaland/or physicalform ximum amount that licensee may maclear material as at any one time under this C2 se A Plutonium (Principal S ?o s A. S sources not to exceed 210 radionuclide Pu 238)k /i' Qillligrams each B. Plutonium (Principal p .,

, B. hsources not to exceed 250 radionuclide Pu-238) g Ellligrams each A -

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9. Authorized Use: -

7 A. As a component of a Medrpic Model Sar-powei ed phaker for clinical evaluation purposes. This license authorbs ssession of pacem kers for purposes of explanation, reco ery and disposal only, not for implant .

B. As a component-of a Coratomic Model C 101 nuclear-powered pacemaker for clinical evaluati n purposes. This license authorizes possessictl of pacemakers for purposes of explanation, recovery and disposal only, not for implantation.

CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at University of Michigan Medical Center, University Hospital, Ann Arbor, MI.

11. The physicians responsible for implantation, follow-up, explanation, and retum of nuclear-powered pacemakers to the manufacturer for proper disposal are Fred Morady, M.D., S. Adam Strickberger, M.D.

Kim Ching Man, D.O., Rajiva Goyal, M.D., or Bradley Knight, M.D.

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' 12. The speelfied possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise in use.

13. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during l' the life of the patient. Procedures for recovery and authorized disposal of the nuclear pacemaker by retum to the manufacturer shall be followed upon the death of the patient.

14. The licensee shall report to the U. 8. Nuclear Regulatory commission, Region ill, ATTN: Chief, Nucioar '

Materials safety Brenoh,801 Warrenville Road, Lisle, IL 80532, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of ooourtence, the death of any nuclear pacemaker patient, and any adverse reaction and/or malfundion involving a pacemaker system, including the leads. A written pivirgdgsigof the adverse reaction and/or malfunction shall be submitted within 30 days. S.

' 15. The licensee shall report to V

. 8. Nuclear Regulatory Ccss'r':-I U(4 lon lil, ATTN: Chief Nuclear Materials Safety Branch, arrenville Road, Lisle, IL 80532, within ys ofloss of contact with a nuclear pacemaker pat ,A i

16. The licenses shall not th or ,

gram oOnore of plutonium-238 contained in nuoloor pdwered of Wuards, U. 8. Nuclear '

Regulatory Commissiof$ , completitynd distributing Form NRC-741 as required by Seqion 70. , /,

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17. Except as specifically pb 4 /'s hall conduct its program in accordance with the statagpents inoc0ln the documents, including any encloswes, listed t@ "

lon's 4gulations shall govem unless the statements, representations, u .%',vs application and correspondence are -

more restrictive than the regu . 0 4 _+ -

A. Letter received June 22,1973; a% y B. Letters dated February 21,1974, October 17,1 75, July 7,1978, July 18,1983, September 7,1983, August 25,1988 and December 15,1993. '

FOR THE U.S. NUCLEAR REGUL.ATORY COMMISSION l

Dati By =-1 4 bu >"s Jany R. Mullauer,(.H.S.

Nucioar Materials Lloonslag Branch

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Q DETWEfN I INFORMATION FROM LTS License Fee Management Branch, ARM Prcoran Code 22160 O and a status Code: 0 l

Fiegional Licensing Sections EX 7C

Fee Exp.Category:040331 Dates c0

Fee Comments: PACEMAKER

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• l'at 313 763-1185 llent) D. llater, Director December 24, 1997 i

Materials Licensing Section U.S. Nuclear Regulatory Commission, Region III 801 Warrenville Road Lisle, Illinois 60532-4351 1 RE: Amendment to Materials License [SNM-1377]

Licensing Personnel:

The University of Michigan (U-M) is requesting amendments to Materials License is detailed below, SNM-1377 (238-Pu Nuclear-Powered Pacemaker Sources) . The amendment t

1.0 LICENSEE LOCATION (SECTIONS 1.0 and 2.0)

The licensee mailing address noted in Sections 1.0 & 2.0 of Materials License SNM-1377 should read a.: follows:

University of Michigan Occupational Safety & Environmental Health Radiation Safety Service 1239 Kipke Drive Ann Arbor, Michigan 48109-1010 Thank you for your time, effort, and consideration with respect to this amendment request. Please do not hesitate to contact me at Radiation Safety Service / OSEH [(313) 764-4420) should you have any questions, comments, or concerns regarding this correspondence.

Sincerely, 1 i

1) e b Ma'rk L. Driscoll Director / Radiation Safety Officer Radiation Safety Service MLD/mld NRCl297A cc: Henry D. Baier, Director, Occupational Safety & Environmental RECEIVED Health James E. Carey, Chair, Radiation Policy Committee )

DEC 2 91997 dc #,

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ph JAN .131998 Mark L Driscoll Director / Radiation Safety Officer Radiation Safety Service University of Michigan Occupational Safety & Environmental Health Radiation Safety Servloe 1239 Kipke Drive Ann Arbor, MI 481091010 2

Dear Mr. Driscoll:

Enclosed are Amendment Nos. 10,06,08, and 37 to your NRC Material License Nos.

SNM-1377, SNM 1529, SNM 1835, and 210021505 in accordance with your request.

Please review the enclosed document carefully and be sure that you understand all conditions. If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region lil office at (630) 829-9887 so that we can provide appropriate corrections and answers.

Please note the following, in accordance with 10 CFR 30.36, effective February 15,1996, the expiration date of license Nos. SNM 1529, SNM-1835 and 2100215 05 have been extended by a period of five years and are stated in item 4 of each license. Also please note that for license No. 21-00215 05, Timothy Konsors and James Schewe, Ph.D. were not added as authorized users at this time because no information regarding their training and experience with radioactive materials were included in the amendment request. If you wish to add these individuals to this license, please provide their training and experience with radioactive materials as additional information to mall control No. 303461.

Please be advised that your license expires at the end of the day, in the month, and year stated in the license. Unless your license has been terminated, you must conduct your program involving byproduct materials in accordance with the conditions of your NRC license, r6 presentations made in your license application, and NRC regulations, in particular, note that you must:

1. Operate in accordance with NRC regulations 10 CFR Part 19, " Notices, instructions and Reports to Workers; inspections," 10 CFR Part 20, " Standards for Protection Against Radiation," and other applicable regulations.

2. Notify NRC, in writing, within 30 days:

a. When the Radiation Safety Officer permanently discontinues performance of duties under the license or has a name change; or

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1 MDriscoll 2 ,

i- b, When the mailing address listed on the license changes. (No fee is required if the location of byproduct material remains the same.)

i 3. In accordance with 10 CFR 30.36(b) and/or license condition, notify NRC, promptly, in writing, and request termination of the license whr:n a decision is made to terminate all

. activities involving materials authorized under the license.

I

4. Request and obtain a license amendment before you: ,

l a. Change Radiation Safety Offiorers;

b. Order byproduct mato ial in excess of the amount, or radionuclide, or form

! different than authorized on the license;

c. Add or change the areas of use or address or addresses of use identified in the

license application or on the license; or

, d. Change ownership of your organization.

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5. Submit a complete renewal application with proper fee or termination request at least 30 ,

days before the expiration date of your license. You will reoelve a reminder notice

! approximately 90 days before the expiration date. Possession of byproduct material after your license expires is a violation of NRC regulations. A license vAll not reormally be

! renewed, except on a case-by-case basis, in int.tances where licensed material has never been possessed or used.

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in addition, please note that NRC Form 313 requires the applicant, by nis/her sigrmture, to verify that the applicant understands that all statements contained in the application are true and

correct to the best of the applicant's knowledge. The signatory for the application should be the licensee or certifying official rather than a consultant.

! You will be periodically inspected by NRC. Failure to conduct your program in socordance with NRC regulations, license conditions, and representations made in your license application and

- supplemental correspondence with NRC will result in enforcement action against you. This could include issuanoe of a notice of violation, or imposition of a civil penalty, or an order suspending, modifying or revoking your license as specified in the General Statement of Policy and Procedure for NRC Enforcement Actions, Since serious consequences to employees and the public can

! result from failure to comply wid NRC requirements, prot < pt and vigorous enforcement action will F ' be taken when dealing with licensees who do not achieve the necessary meticulous attention to

- detail and the high standard of compliance which NRC expects of its licensees.

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Sincerely, Original Signed by .

James R. Mullauer, M.H.S.

Health Physicist Nuclear Materials Lloonsing Branch Lloense Nos.: SNM-1377, SNM-1529, SNM-1835, and 2100215-05 Docket Nos.: 070-01418, 070-01856, 070 02864, and 030-00251

Enclosure:

Amendment No. 10,08,08, and 37 f

To toestve e copy of tNo document,Indosto in the box: "C"

• Copy without ettechmenVenclosure "E" a Copy with ettechmenvenoksure "W" n No copy _

OFFICE DN(I W w DNMS/ Rill ] l l I4AME JMu%ir/ /

DATE i ihA/%F OFFICIAL RECORD COPY t

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e UNITED STATES y*i

1. • %,h,, NUCliAR REEULATORY CEMMISSION e

'j RLiOloN lli 601 WARRENVILLE ROAD USLE, ILUNotS 60532-4351

• • • • • January 5,1998 Mark L. Driscoll, RSO l University of Michigan Occupational Safety &

Environmental Health 1239 Kipke Drive Ann Arbor, MI 48109-1010

SUBJECT:

ACKNOWLEDGMENT OF CORRESPONDENCE -

(Letter Dated December 24,1997)

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 .K. 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 submitted information, it appears that your request is routine (see 13 below, as applicable).

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

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

3. Termination actions are normally processed within 90 days, unless confirmatory surveys following decontamination / decommissioning activities are involved.

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

if you have a compelling safety or business-related reason for requesting expedited review, please contact th 'Aaterials L! censing Branch at (630) 829 9887. We will try to complete your request as con as practicable. Any correspondence about this request should reference the contrs number. __

Nuclear Materials Support Branch

Mail Control No. 303456 License No. SNM 1377