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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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, f g
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 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, y
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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 I
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any f conditions specified below.
g In accordance with letter dated k""5" 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:
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and Safety g
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ATTN:
Radiation Safety Officer e
H 337L Allyn Hall
- 4. Expiration date January 31, 1994 Dayton, OH 45435 l
- 5. Docket or l
Reference No.
070-1453 l
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- 6. Byproduct, source, and/or
- 7. Chemical and/or physical
- 8. Maximum amount that licensee h
,. 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
l milligrams P
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y B. Plutonium (Principal A)SealedSources.
A. One source not g
1 radionuclides PU-238)
_to exceed 250
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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.
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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 f
g of explantation, recovery and disposal ~ only, not^ for implantation.
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CONDITIONS E
I 10.
Licensed material shall be used only at the licensee's facilities located at Wright State University, Cox Heart Institute, 3525 Southern Blvd., Kettering, Ohio.
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- 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 l
in use.
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REG 3 LIC70 SNM-1419 PNV g
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NRC Form 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 OF 2 P AGES I
Licznse number l
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MATERIALS LICENSE oocket or Reference number i
SUPPLEMENTARY SHEET l
070-1453 l
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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
pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker l I
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
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- 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.
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q 14.
The licensee shall continue patiente follow-up? arid' replacement procedures for the N
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nuclear pacemaker during,the life of the patient".'{ Procedures for recovery and N
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authorized ' disposal of thelnuclear pacemaker by retueri to the manufacturer shall be i
1 followed upon the deathfof the patient.
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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 70.54 of 10 CFR Part 70.
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Radiation SafetkOfficer[:d
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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 Commiis' ion's regulaiti6ns7shall govefri/unless the statements, p-y s
i representations andsprocedures in theilicens~ee!siapplicati6n and correspondence are p
i more restrictive than(the, regulations!)N N (f
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Letters dated August el,1.973, September 5,,1973) May 6,1974, August 28, 1975, October 13, 1975, August,29,,1978 (with enclosures), October 12, 1982, g
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).
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For the U.S. Nuclear Regulatory Commission p
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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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INFORMATION FROM LTS BETWEEN:
1 LICENSE FEE MANAGEMENT BRANCH, ARM PROGRAM CODE: 22160
, 'i 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:
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REGION 4
1.
APPLICATION ATTACHED:
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APPLICANT / LICENSEE:
WRIGHT STATE UNIVERSITY l
RECEIVED DATE:
880714 l
OOCKET NO:
7001453
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CONTROL NO.
385741
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LICENSE NO.
SNM-1419 1
ACTION TYPE:
RENEWAL l')
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2.
FEE ATTACHED AMOUNT:
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CHECK NO,8
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- 3. COMMENTS D'#'
SIGNED DATE
/ N WP<f' B. LICENSE FEE MANAGEMENT BRANCH (CHECK WHEN MILESTONE 03 IS ENTERE06 /_[7) i wirt"t Er
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1 FEE CATEGORY AND AMOUNT:
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2.
CORRECT FEE PAIO.
APP ATION MAY BE PROCESSED FOR:
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OTHER SIGNE0
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