ML20216D620
| ML20216D620 | |
| Person / Time | |
|---|---|
| Site: | 07002304 |
| Issue date: | 02/05/1987 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20216D625 | List: |
| References | |
| NUDOCS 8706300562 | |
| Download: ML20216D620 (2) | |
Text
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p PAGE OF PAGES (5. s4 U.S. NUCLEAR REGULATORY COMMISSION Amendment No. 04 MATERIALS LICENSg Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations
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. heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, scquire, possess, and transfer byproduct, l
source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to l
deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This L
license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is L l subject to all applicable rules, regulations and orders of the Nuclear Regg
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conditions specified below.
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a Licensee I
In accordance with letter dated i
I July 28, 1986, The Medical College of Pennsylvania
- 3. License number SNM-1656 is amended in h
l-its entirety to read as follows:
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3300 Henry Avenue s
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P rati February 29, 1992 fj Philadelphia, Pennsylvania 19129
- 5. Docket or n
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Reference No.
070-02304 L
- 6. Byproduct, source, and/or
- 7. Chemical and/or physical 8.. Maximum amount that licensee L
special nuclear material form may possess at any one time L
under this license
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A. Plutonium (Principal A. Sealed Source (s)
A. 0.75 grams (3. individual radionuclide Pu-238) sources not to exceed t
,;n 250.m1111gramseach)
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Authorized use L !
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Follow-up, recovery and disposal of Coratomic Model C-101 nuclear-powered f
cardiac pacemakers previously implanted in humans..
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CONDITIONS,
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- 10. Licensed material shall-be used only at The Medical' College of Pennsylvania, 3300 f
HenryAvenue, Philadelphia (Pennsylvania.
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- 11. Thespecifiedpossessionlimitincludes,all-y'ednedmaterialpossessedbythe-f;!
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licensee under this license whetherlin storage, implanted in, patients or otherwise
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in use.
- 12. Sealed sources or detector cells containing licensed material shall not be I
opened or sources removed from detector cells by the-licensee.
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- 13. The licensee shall report to the Material Licensing Branch, U.' S. Huclear
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Regulatory Commission, Region I, 631 Park Avenue, King of Prussia, Pennsylvania
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19406, within 24~ hours of occurrence, the death of any nuclear-pacemaker patient, I
and any adverse. reaction and/or malfunction _ involving a pecemaker system. including 1
the leads'. -A written report giving details of_the adverse reaction and/or
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malfunction shall-be submitted within 30 days.
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- 14. The licensee'shall report to, the Material Licensing Branch, U.S. Nuclear Regulatory.
L Commission, Region I, 631 Park Avenue, King of Prussia Pennsylvania 19406, within lj 1
-10 days, loss of contact with'a_ nuclear pacemaker patient.
l B706300562 870205
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REG 1 LIC70 I
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m____________________________________________,,,,,9 km 374A U.S. N.""3AR REGULATORY COMMISSION
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PAGE5
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License numW l
MATERIALS LICENSE 37,,,,,, g,f,,,,,,,,,Q,4 E S
SUPPLEMENTARY SHEET 070-02304 i
p Amendment No. 04 i
(Continued)
CONDITIONS
- 15. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient; and procedures for reccvery and W
authorized disposal of the nuclear pacemaker by return to the manufacturer shall be I
followed upon the death of the patient.
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- -16.
The licensee may transport licensed material in accordance with the provisions y
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 I
conduct its program in accordance with the statements, representations, and l
procedures contained in the documents including any enclosures, listed below.
l The Nuclear Regulatory Commission's regulations shall govern unless the state-l ments, representations and procedures in the licensee's application and corre-I spondence are more restrictive than the regulations.
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A.
Letter (with application) dated March 31, 1976 B.
Letter dated August 17, 1976 C.
Letter dated September 7, 1976 D.
Letter dated December 17, 1976 4
E.
Letter dated June 8, 1981 F.
Letter dated July 28, 1986 l
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For the U.S. Nuclear Regulatory Commission Original Signed Bys -
f John E. Glenn Date FEB 0 51987 By l
Nuclear Materials Safety and q
Safeguards Branch, Region I l
King of Prussia, Pennsylvania 19406 I
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