ML20134P228

Matls Licensing Package for Amend 22 to License SNM-1419 for Wright State University.Control:301961

ML20134P228
Person / Time
Site:	07001453
Issue date:	10/24/1996
From:	Weber M NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
References
301961, NUDOCS 9611270296
Download: ML20134P228 (9)

Text

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yRG g FORM 374 U.S. NUCLEAR' REGUL TORY COMMISSION PAGE OF PAGES MATERI Al,S 1.lCENSE Amendment No. 22

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! Pursuant to the Atmnic Energy Act of 1954. as amended, the Fuergy Reorganization Act of 1974 (Public Law 93-438), an l federal Regulations Chapter 1, Parts 30,31,32. 33,34,35. 36,39. 40, and 70, and in reliance on statements and re l by the beensee, a license is hereby iwued authorizing the licensee to receive, acquire, possew, and transfer byproduct. source, and special l nuc

! matenal designated below; to use such material for the purpose!.) and at the place 6) designated below; to deliser or tran l l penon authori/ed to receive it in accordance with the regulations of the applicable Part(s). This bcense shall be deemed to contain the conditions pecihed in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicablej ru!

3 . Nuclear Regulatory Commission now or hereafter in ef fect and to an) conditions specified below.

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& l1 l Sol 961 4l Licensee In accordance with the letter dated E i October 10, 1996 l1. Wright State University 3. License Number SNM-1419 is amended in 6

E Radiation Safety Office

its entirety to read as follows

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1 6 I 3640 Colonel Glenn Highway Room 104 Health Sciences Building

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4. Expiration Date August 31, 2004 (

Dayton, OH 45435

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5. Docket or ( l Reference No.

070-01453 e i s O

6. Byproduct, Source, and/or t C 7. Chemical and/or Physical 8. Maximum Amount that Licensee g Special Nuclear Material Form  ?

May Possess at Any One Time Under This License 3 3

2 I

A. Plutonium (Principal A. Sealed Sources radionuclide PU-238)

A. One source not to exceed 250 milligrams l ,

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9. Authorized Use: $

' e 1 A. As a component of a Coratomic Model C-101 nuclear-powered pacemaker for clinical evaluation purposes. This license authorizes possession of pacemakers for purposes $

t of explantation, recovery and disposal only, not for implantation. 6

' 6 CONDITIONS 6

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10. Licensed material shall be used only at the licensee's facilities located at Wright E

[ State University, 141 Biological Sciences Building, 3640 Colonel Glenn Highway, Dayton, Ohio.

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j 11. The specified possession limit includes all licensed material possessed by the e i licensee under this license whether in storage, implanted in patients, or otherwise E j in use.

3 i

• j 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, E ATTN: Chief, Nuclear Materials Safety Branch, 801 Warrenville Road, Lisle, Illinois E f 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 j and any adverse reaction and/or malfunction involving a pacemaker system, including s the leads. A written report giving details of the adverse reaction and/or E malfunction shall be submitted within 30 days.

f j f13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, 5 ATTN: Chief, Nuclear Material Safety Branch, 801 Warrenville Road, Lisle, Illinois E

60532-4351, within 10 days of loss of contact with a nuclear pacemaker patient. i p j i

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License Number gl SNM-1419 MATERIALS LICENSE Dodet or Referenu Numkr El g i j SUPPLEMENTARY SHEET 070-01453 E s

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$ Amendment No. 22 E 3

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y E j 14. The licensee shall continue patient follow-up and replacement procedures for the s

5 g nuclear pacemaker during the life of the patient. Procedures for recovery and s authorized disposal of the nuclear pacemaker by return to the manufacturer shall be s followed upon the death of the patient. i W

j 15. The Radiation Safety Officer for this license is Thomas H. Mohaupt, M.S. E g

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16. E g

n Except as specifically provided otherwise in this license, the licensee shall s f

conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. The j '

g g U.S. NuclEur Regulatory Commission's regulations shall govern unless the statements, g m

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

!s more restrictive than the regulations. g E

5 A. Letters dated August 1, 1973, September 5, 1973, May 6, 1974, August 28, 1975, E d October 13, 1975, August 29, 1978 (with enclosures), Octobe- 12, 1982, 4

5.

April 22, 1983, August 31, 1983, October 7, 1983, March 14, .1986, September 18, 3

1986, February 13, 1987, March 25, 1987 (with attachment), December 7, 1990, E l

December 2, 1993 and October 10, 1996.

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E 5 FOR THE U.S. NUCLEAR REGULATORY COMMISSION g h N 4

• y Date /0/ZMS By "k -

Nuclear' Materials Licensing Branch, Region III ;g

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O BETWEEN: I INFORMATION FROM LTS t

License Fee Management Branch, ARM Program Code: 22160 Q and Regional Licensing Sections Status Code: 0 Fee Category: EX 7C Exp. Date: 20040831

Fee Comments: TAYLOR LTR 5/16/95/PU Q Decom Fin Assur Re

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LICENSE FEE TRANSMITTAL $-

A. REGION g

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1. APPLICATION ATTACHED Applicant / Licensee: WRIGHT STATE UNIVERSITY he Received Date: 961021 00-ket No: 7001453 g Control No.: 301961 O License No. SNM-1419 9 Action Type: Amendment -

2. FEE ATTACHED O Amount: # ~~

Check No. ~~b~_~

3. COMMENTS S;gnee _ 4 , g ________

O s. LICENSE FEE MANAGEMENT BRANCH (Check 1'tn A ered / /)

1. Fee Category and Amounts _ _ _ _ _ _ _ _ _ _ _ _ _ _

] _l_ _______

O 2. Correct Fee Paid. / Application may be processed for:

Amendment Red ~_~~~j(~_~~~~_~_~~~_

3. OTHER __________________________________

O gigned __ g g_g W_

Q RECEIVEO cy gpggg a o Date_h_f }y "o-d_a t By -

O OCT 311996 oa,s,,;2-g ,

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[ .,\g Wright State orpartment of environmentai Health and Safety 1

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University 3640 Colonel Glenn Hwy.

Dayton. Ohio 45435-0001

.,%,*" 513/873 2215 October 10,1996 U.S. Nuclear Regulatory Commission, Region III License No. SNM-1419 Material Licensing Section Expiration Date: 8/31/2004 801 Warrenville Road Lisle, IL 60532-4351 h

Dear Sir / Madam:

We request to amend our U.S. N3C special nuclear material license no. SNM-1419. This license tracks one patient in whom a nuclear-powered pacemaker is implanted. Please remove Dr. Paul Kezdi as the ~p hysician responsible for the patient and add the following physician:

Milton Nathan , M.D.

Ohio License No. 40194 Board Certified in Internal Medicine (1975) and Cardiovascular Diseases (1977)

Address: 3533 Southern Blvd., Suite 355, Kettering, OH 45429 Phone No. (937) 643-9941 Curriculum vitae attached.

Please change Condition 10 of the license to read:

Licensed material shall be used only at the licensee's facilities located at Wright State University,141 Biological Sciences Building, 3640 Colonel Glenn Highway, Dayton, Ohio.

This is where we plan to store the pacemaker pending return to the manufacturer.

The payment of fees for this license has been waived due to the humanitarian nature of our commitment (reference NRC letter of 5/16/95).

Thank-you for prompt consideration of this matter. If you have any questions, please call me at (973) 873-2169 [before 12/13/96] or (973) 775-2169 [after 12/13/96].

Sincerely,

_/-

Thomas Mohaupt, M.S., CHP University Radiation Safety Officer g er e RECEIVED d C b N_f OCT 21896 REGION III frn 10 - l b- % 00T 21 FA

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0Q OFFICE-OF FACULTY AFFAIRS /SOM CURRICULUM VITAE i t)3FEB 10 PM 2 1+ 1 i Milton F. Nathan, M.D.

j Suite 906

111 W. First St.

._ Dayton,0hio 45402 l Born 9-9-47 Cincinnati, Ohio '

, Undergraduate School: University of Cincinnati-BS, Cum Laude 1965-1968

Pht-Beta-Kappa -

l Medical School: University of Cincinnati College of Medicine 1968-1972 4

Alpha-Omega-Alpha (medical honorary society) i Phi-Delta-Alpha (medical fraternity)  ;

Stella-Hoffheimer Award (number i for all .4 years of medical sch) j{ National Boards Part I & ll -

Internship: Emory University Affiliated Hospitals (Atlanta,Ga) 1972-73 l Straight Medicine i National Boards Part ill

! Georgia License l Residency: Emory U Affiliated Hosp.-Internal Medicine Atlanta,Ga 73-75 '

l Board Certification Internal Medicine .

1 Fellowship: Emory U Affil, Hosp. Atlanta,Ga. Cardiology 1975-77 i Board Certification Cardiovascular Diseases l Ohio License i Private' Practice Cardiovascular Diseases 1977-Active Staff: Kettering and Sycamore Medical Centers l l Consulting Staff: Greene Memorial Hosp and Clinton Mem, Hosp.

l l Courtesy Staff: St. Elizabeth Hosp & Miami Valley Hosp.

j. Pubitcations:

L EurJ of Nuclear Medicine:The clinical utility of provacative I - radionuclide oesophageal transitnin the evaluation of non-cardiac chest j pain, Elloway, Jacobs, Nathan and Mantti , 1992,113.-  ;

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NOV 011996  ;

i Thomas H. Mohaupt, CHP Radiation Safety Officer - l Wright State University.

Radiation Safety Office 1 3640 Colonel Glenn Highway.

~ Room 104 Health Sciences Building ,

~ Dayton, OH ~ 45435  :

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Dear Mr. Mohaupt:

' Enclosed is Amendment No. 22 to your NRC Material License No. SNM-1419 in

accordance with your request.  ;

I Please review the enclosed document carefully and be sure that you understand all- -

4 conditions. If there are any errors'or questions, please notify the U.S. Nuclear Regulatory  ;

' Commission, Region 111 office at (630) 829-9887 so that we can provide appropriate j corrections and answers.

i'i- . -

i 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, representations made in your license application, and NRC regulations. _in i particular, note that you must:

l . .

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

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

a. When an authorized user or Radiation Safety Officer permanently

discontinues performance of duties under the license or has a name change;

.or

b. When the licensee's mailing address changes (no fee is required if the

location of byproduct material remains the same).

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' T. Mohaupt .

- 3. - In accordance with 10 CFR 30.36(b) and/or license condition, notify NRC, promptly, in writing, and request termination of the license when you decide to terminate all activities involving materials authorized under the license.

' 4. Request and obtain a license amendment before you;

a. Receive er use byproduct material for a clinical procedure permitted under Part 35 but not permitted by your license issued pursuant to this Part;

b. Permit anyone, except individuals described in 10 CFR 35.13(b), to work as an authorized user under the license;

c. Change Radiation Safety Officers; j 1

d. Order byproduct materialin excess of the amount, or radionuclide, or form. .)

different than authorized on the license;

e. Add or change'the areas of use or address or addresses of use identified in the license application or on the license; or

f. Change ownership of your organization.

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 receive 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 will not normally be renewed, except on a case-by-case basis, in instances where licensed material has never been possessed or used.

In addition, please note that NRC Form 313 requires the applicant, by his/her signature, 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 accordance 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 issuance 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 Policy and Procedures for NRC Enforcement Actions. Since serious consequences

. to employees and the public can result from failure to comply with NRC requirements,

- , . . _ .. ... - - . - - . = . _. - . - ._ _ . -

O -

O T. Mohaupt - I prompt and vigorous enforcement action will 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.

Sincerely, l

Original Signed By Michael F. Weber Nuclear Materials Licensing Branch License No.: SNM-1419 Docket No.: 070-01453

Enclosure:

Amendment No. 22 DOCUMENT NAME: M:\07001453.CL6 Ts receive a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE DNMS/ Rill c l NAME MWEBER:jawC DATE 10/2f96 OFFICIAL RECORD COPY

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[gu%k UNITED STATES NUCLEAR REOULATORY COMMISSION y S REGION lli D j 801 WARRENVILLE ROAD

• g***** / uste. itunOis eos32-43si October 22. 1996  ;

l Thomas H. Mohaupt. M.S..'CHP d Radiation Safety Officer Wright State University Radiation Safety Office Room 104 Health Science Building

-3640-Colonel Glenn Highway Dayton OH 45435-

~

SUBJECT:

ACKNOWLEDGEMENT OF CORRESPONDENCE (Letter Dated 10/10/96)

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 deficiencier cere identified during this initial review.

However, it should be noted that a technical review may identify omissions in the i submitted information.

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

1. :New and amendment actions are normally processed within 90 days unless we l find 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.

i

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

A copy of your corres30ndence has been forwarded to our Licensing Fee and Debt Collection Branc1 (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 the Materials Licensing Branch at (630)

'829-9887. We will try to complete your request as soon as practicable.

Any correspondence about this request should reference the control number.

Nuclear Materials . Support Branch Mail. Control No. 301961 License No. SNM-1419