ML20235E043
| ML20235E043 | |
| Person / Time | |
|---|---|
| Site: | 07002032 |
| Issue date: | 02/17/1988 |
| From: | Vacherlon P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20235E046 | List: |
| References | |
| 25918, NUDOCS 8902210187 | |
| Download: ML20235E043 (3) | |
Text
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y NRC Form 374 1
2 PAGE OF PAGES j D 84)
U.S. NUCLEAR REGULATORY COMMISSION MATERIAf,S LIClNSE Amendment No. 03 l
l 1
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, j
i Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations 1
heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, j
hl source, and special nuclear material designated below; to 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 N
license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is 5
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any 1
conditions specified below, p
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In accordance with letter dated October 15, 1985 g
1.
Welborn Memorial Baptist Hospital
- 3. Ucense number SNM-1557 is amended in iH its entirety to read as follows:
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401 S. E. Sixth Street
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- 4. Eipiration date February 28, 1993 il Evansville, IN 47713 c()3, C s
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- 5. Docket or
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- 7. Chemical and/or physical L 8. Maximum amount that licensee 3
- 6. Byproduct, source, and/or
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special nuclear material form jmay possess at any one time
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s A. Plutonium (Principal
' YA. Sealed Sources' [,
A.wl0 grams (20 l!!
radionuclides Pu-238)'
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( not to exceed 500
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B.s4.5 grams (20 j
k radionuclides Pu-238) 5individualsources 1
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9 cA, en milligrams each) i yy
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- 9. Authorized Use gJ 3m
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As a component of ARC 0 Nuclear Model NU-5 nuclear-powered cardiac pacemakers for clinical evaluation purposes.
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V pacemakers for clinical evaluation purposes.
This license authorizes possession of these pacemakers for purposes of explantation, ja l
recovery and disposal, but not for implantation or reimplantation.
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CONDITIONS p
!.1 10.
Licensed material shall be used only at the licensee's facilities located
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j-at Welborn Memorial Baptist Hospital, 401 S. E. Sixth Street, Evansville, Indiana.
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.
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License number E
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SNM-1557 M ATERI ALS' LICENSE F
4 SUPPLEMENTARY SHEET 070-02032 g
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- 12. The licensee shall not receive or transfer in any single transaction,1 gram or more e
of plutonium-238 contained in nuclear-powered pacemakers without notifying the i
Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Nl and, in addition, completing and distributing Form NRC-741 as required by Section
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70.54 of 10 CFR Part 70.
P The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory I>
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13.
4 Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of 4
occurrence, the death of any nuclear pacemaker patient, and any adverse reaction i
and/or malfunction involving a pacemaker system, including the leads. A written N
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report giving details of the adverse reaction and/or malfunction shall be submitted l
h within 30 days.
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- 14. The licensee shall reportLto"the Material Licensing Se'ction, U.S. Nuclear Regulatory p
8 Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of N
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contact with a nuclear > pacemaker patient.
The licensee shal[during the life of the patient;/and'the procedures for recovery f
continue'patientfollow-upand, replacement 1proceduresforthe l
15.
E nuclear pacemaker-s d
4 and authorized disposal of the " nuclear. pacemaksr/byg return to' the manufacturer shall E
be followed uponlthe death of the[ patient.l !
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16.
Except as specifically provided otherwise ~ f n'this~ license, theLlicensee shall y
a conduct its program in 'a'ccordance 41th the-s'tatements', representations, and g-
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W procedures contained in:the' documents iinbluding' anyfenclosures, listed below.
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The Nuclear Regulatory Commission!sireg'uliti.ons shall: govern-bnless the statements, k!
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representations and proceaures'in theflicensee's application"and correspondence are
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more restrictive than,the regulations.
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Application dated; June, 1975; and.
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Letters dated July 3,~1975, May 7, 1976, July 257 1980, October 1, 1980 and k'
October 15, 1985.
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For the U.S. Nuclear Regulatory Commission f
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9 Original Signed F:
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l Date: February 17, 1988 By Patricia M. Vacherlon q
Materials Licensing Section, Region III
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UNITED STATES f
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BETWEEN: William 0. Miller, Chief License Fee Management. P. ranch Office of Administration Regional License Section Material Licensing Branch FCMS, Office of Nuclear Material Safety & Safeguards LICENSE FEE TRANSMITTAL I
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REGI 1.
APPLICATION ATTACHED 94h
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App 11' ant / Licensee:
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Application Dated:
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Control No.:
S 77/7 License No.:
NM ~ /dT7 2.
FEEAiTACHED Amount:
A/4 check No.:
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COMMENTS h
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Date
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LICENSE FEE MANAGEMENT BRANCH d'Op
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Fee Category and Amount:
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Correct Fee Paid.
Application may be processed for:
4 Amendment
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Renewal License
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