ML20236P568
| ML20236P568 | |
| Person / Time | |
|---|---|
| Site: | 07001331 |
| Issue date: | 07/30/1987 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20236P571 | List: |
| References | |
| NUDOCS 8708120424 | |
| Download: ML20236P568 (2) | |
Text
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g NRC FormM74 :
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.S. NUCLEAR REGULATORY COMMISSION
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MATERIALS LICENSE Amendment No. 09 j,
Pursuant to the Atomic Energy Act of 1954. as ainended, the Energy Iteorganization Act of 1974 (Public I,aw 93-438), a:Id Tit Code of Federal llegulations, Chapter I, Parts 30,31,32,33,34,35; 40 and 70, and in reliance on statements and representations !
heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, !
I
, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to Edehver or transfer such nuteiial to persons authorved to receive it in accordance with the regulations of the appheable Part(s) This !
license shall be decined to contam the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended. and is 9
subject to all' applicable tules, regulatioin and orders of the Nuclear itegulatory Commission now or hereafter in effect and to any ;
conditions specified below; o I__.
Licensee f-in accordance with letter dated I
April 30, 1987, hl1 l
- 3. License numbe' St'M-1305 is amended in 3-Veterans Administration Medical Center
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its entirety to rcad as follows:
h 3495 Bailey Avenue
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d Buffalo, New York 14215
- 4. Expiration date July 31, 1987
- 5. Docket ei 1(eference No.
070-01331 i.
- 6. Ilyproduct, source, and/or
- 7. Chemical and/or physical
- 8. Maximum amount that licensec
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special nuclear material form may possess at any one time j
,d under this license
-A. Plutonium (principal A. Sealed source A. 0.62 grams (3 individual l
radionuclides Pu-238) sources not to exceed j
210 milligrams each)
W B. Plutonium (principal B. Sealed source B. 0.25 grams (1 source l
radionuclides Pu-238) not to exceed 250 i
milligrams) 9 Authorized use l
g A.
Follow-up, recovery and dit.posal of Medtronic 9000 nuclear-powered cardiac k
pacemakers previously implanted in humans.
M, b.
Follow-up, recovery and disposal of Coratomic Model C-101 nuclear-powered cardiac g.
f pacemakers previously implanted in humans.
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CONDITIONS b
- 10. Licensed material shall be used only at Veterans Administration Medical Center, b/ '
li 3495 Bailey Avenue, Buffalo, New York.
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- 11. The specified possession limit includes all licensed material possessed by the j
licensee under this license whether in storage, implanted in patients, or l
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k otherwise in use.
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- 12. The licensee shall repcrt to the U.S. Nuclear Regulatory Commission, Region 1, ATTN:
Chief Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, i
L King of Prussia, Pe;nnsylvania 19406, 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 i*
of any nuclear pacemaker patient, and any adverse reaction and/or malfunction j
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-involving a pacemaker system, including the leads. A written report giving W
details of the adverse reaction and/or malfunction shall be submitted within j
j 30 days.
l 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region 1, i
j ATTN:
Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, e
King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a 1"n" i
ff d Jih G{ ld bla b W r. pg:
f nuclear pacemaker patient.
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b PAGE OF PAGES kl License number
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i MATERIALS LICENSE oocket or nererence numbe h
SUPPLEMENTARY SHEET 070-01331
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Amendment No. 09
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(Continued)
CONDITIONS L
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- 14. The licensee shall continue patient follow-up and replacement procedures f or g
e the nuclear pacemaker during the life of the patient.
Procecures for recovery i
and authorized disposal of the nuclear pacemaker by return to the manufacturer i
shall be followed upon the death of the patient.
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15.
Sealed sources or detector cells containing licensed material shall not be f'
i opened or sources removed from source holders or cetector cells by the j
licensee.
m 16.
The licensee may transport licensed material in accordance with the provisions I*
l of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".
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- 17. Except as specifically provided otherwise in this license, the licensee shall e
conduct its program in accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below.
,i The Nuclear Regulatory Commission's regulations shall govern unless the
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statements, representations and procedures in the licensee's application k
and correspondence are more restrictive than the regulations.
Wi A.
Letter dated August 13, 1971 s
B.
Letter dated March 17, 1972 f
C.
Letter dated May 10, 1972 D.
Letter dated February 28, 1973 l
E.
Two letters dated June 12, 1975 E
i F.
Letter dated September 4,1975 4
G.
Letter dated March 10, 1976 k
H.
Letter dated June 10, 1577 1
1.
Letter dated July 25, 1977 1
9 J.
Letter dated June 2, 1982 l
K.
Letter dated April 30, 1987 h
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For the U.S. Nuclear Regulatory Commission s
Original Signed By:
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JUL 3 01987 3 M Gl*
i Date By I.
9 Nuclear Materials Safety and I
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Safeguards Branch, Region I l
y King of Prussia, Pennsylvania 19406.
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