ML20246B886
| ML20246B886 | |
| Person / Time | |
|---|---|
| Site: | 07001453 |
| Issue date: | 01/09/1989 |
| From: | Vacherlon P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20246B890 | List: |
| References | |
| 385741, NUDOCS 8903150075 | |
| Download: ML20246B886 (3) | |
Text
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M 5SSYWM M, $$M Mk {l${ )S{ )M{ M{' M 1M]}MjMfM }Q' qf g q]q[ gj l NRC Fum 374 PAGE l OF 2 g g (M84 , , U.S. NUCLEAft REGULATORY COMMISSION PAGES l . MATERIALS LICENSE Amendment No. 16 l
' Pursuant to th'e Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, g Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations fy g heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, y
( source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to E N deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This N license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any I conditions specified below. f g
k""5" In accordance with letter dated !
N July 11, 1988 E N 1. Wright State University 3. License number SNM-1419 is amended in l Department of Environmental Health its entirety to read as follows: i' g and Safety g 2. ATTN: Radiation Safety Officer e .
H 337L Allyn Hall 4. Expiration date January 31, 1994
! Dayton, OH 45435 l
- 5. Docket or lq ,
070-1453 Reference No. l s 6. Byproduct, source, and/or 7. Chemical and/or physical <
- 8. Maximum amount that licensee h special nuclear material form , . may possess at any one time
' under this license ;
A. Plutonium (Principal, '
LA. Sealed Sources A.'One source not !
radionuclides PU-238)' 'to exceed 210 l P milligrams l ,
N B. Plutonium (Principal k y A)SealedSources. A. One source not g 1 radionuclides PU-238) _to exceed 250 ( i ff - milligrams 4 t i
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- 9. Authorized Use g! A. As a component of a Medtronic Model,9000' nuclear-powered pacemaker for clinical i evaluation purposes. This license ' authorized possession of pacemakers for purposes 4 of explantation, recovery and disposal only, not for implantation.
E i N B. As a component of a Coratomic Model C-101 nuclear-powered pacemaker for clinical l evaluation purposes. This license authorized possession of pacemakers for purposes g of explantation, recovery and disposal ~ only, not^ for implantation. f g
W E 4 CONDITIONS E
- 10. Licensed material shall be used only at the licensee's facilities located at Wright State University, Cox Heart Institute, 3525 Southern Blvd. , Kettering, II Ohio.
i 11. The specified possession limit includes all licensed material possessed by the I licensee under this license whether in storage, implanted in patients, or otherwise in use.
l, i f NI lg 8903150075 890109 E l
g REG 3 LIC70 SNM-1419 PNV g
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pmamm9m-mmmmmm-mm mammm9 l NRC Form 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 OF 2 P AGES I l
- Licznse number l l ,
MATERIALS LICENSE oocket or Reference number i SUPPLEMENTARY SHEET l 070-1453 l l l Amendment No. 16 i
! 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, h i ATTN: Chief Nuclear Materials Safety Branch, 799 Roosevelt Road, Glen Ellyn, N I Illinois 60137, 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 E I
pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker l l system, including the leads. A written report giving details of the adverse reaction y and/or malfunction shall be submitted within 30 days, j l
- 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, N ATTN: Chief, Nuclear Material Safety Branch, 799 Roosevelt Road, Glen Ellyn, E Illinois 60137, within 10 days of loss of contact with a nuclear pacemaker patient. l 4 O PCn 'p q 14. The licensee shall continue patiente follow-up? arid' replacement procedures for the N 1 i nuclear pacemaker during,the life of the patient".'{ Procedures for recovery and N 1 l authorized ' disposal of thelnuclear pacemaker by retueri to the manufacturer shall be i 1 followed upon the deathfof the patient. f/,
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i 15. The licensee shall,qot receive or transfer in any sino' tra'nsaction,1 gram or more y y of plutonium-238 c'ontain'ediin nuclear-powered pacemah with'out notifying the p 4 Division of Safegbhrds, U.1S'.4 Nuclear Regulatory; Commission, Washington, D.C. 20555, N I and, in additionbcompleting and 'd. distributing /ForniLNRC-741 as hequired by Section l
70.54 of 10 CFR yPart 70.
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l 16. Radiation SafetkOfficer[:d Ei.T.\,gaFd A T Ph!D.7 -
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p i fp d jj M Jy g r E f JjH W I 17. Except as specifichily provideditherwish nsthis license, thYlicensee shall I conduct its program,in sdcor' dance with ith s'tatementsprepresentations, and i procedures contained,in therdocumsntilin'c) dinh anyfsnclosures, listed below.
! The Nuclear Regulatop y Commiis' s ion's regulaiti6ns7shall govefri/unless the statements, p-i representations andsprocedures in theilicens~ee!siapplicati6n and correspondence are p more restrictive than(the, regulations!)N N i
! % .pl3 (f E g A. Letters dated August el,1.973, September 5,,1973) May 6,1974, August 28, 1975, g October 13, 1975, August,29, ,1978 (with enclosures), October 12, 1982, g April 22, 1983, August 31,'1983, Oct'ob'er 7,' 1983, March 14,1986, September 18, p i 1986, February 13, 1987, and March 25, 1987 (with attachment). F 4 li 4 W H
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% H 4 W 4 B; I le 4 For the U.S. Nuclear Regulatory Commission p i
5 d E 9 Y N
l Original Signed i Date: January 9, 198_9 By Patricia M. Vacherlon h '
( Materials Licensing Section, Region III i
i COPY
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L) 1 (FOR LFMS'USE)
() BETWEEN:
1 INFORMATION FROM LTS
,' 'i LICENSE FEE MANAGEMENT BRANCH, ARM PROGRAM CODE: 22160 AND I STATUS CCOE: 2 REGIONAL LICENSING SECTIONS. I FEE. CATEGORY: EX 7C
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- EXP. DATE:: 19880930 s FEE; COMMENTS: 170 11 ( A) (9)
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LICENSE FEE TRANSMITTAL:
(~) A. REGION 4
- 1. APPLICATION ATTACHED: l
() APPLICANT / LICENSEE:
RECEIVED DATE:
WRIGHT STATE UNIVERSITY 880714 l
l OOCKET NO: 7001453 )
() CONTROL NO. 385741 (
LICENSE NO. SNM-1419 1 ACTION TYPE: RENEWAL l')
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- 2. FEE ATTACHED AMOUNT: -
d CHECK NO,8
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- 3. COMMENTS SIGNED !
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DATE / N WP<f' B. LICENSE FEE MANAGEMENT BRANCH (CHECK WHEN MILESTONE 03 IS ENTERE06 /_[7) i
() 1 FEE CATEGORY AND AMOUNT: wirt"t Er y< ef a
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- 2. CORRECT FEE PAIO. APP ATION MAY BE PROCESSED FOR:
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(} AMENOMENT RENEWAL
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- 3. OTHER SIGNE0 m /M/e DATE
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