ML20246C523
| ML20246C523 | |
| Person / Time | |
|---|---|
| Site: | 07002730 |
| Issue date: | 08/12/1988 |
| From: | Kinneman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20246C525 | List: |
| References | |
| 108725, NUDOCS 8907110049 | |
| Download: ML20246C523 (5) | |
Text
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l MATEdIALS LICENSE Amendment No. 02 1,
l Pursuant to the Atomic Energy Act of 1954. as amended, the Energy Reorgani/ation Act of 1974 (Public Law 93 - 438), and Title 10.
Code of Federal Regulations, Chapter 1. Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y 6
- 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; deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This lF l
5 license shall be deemed to cor.tain 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 j
4 conditions specified below.
!p Licensee N
In accordance with letter dated 8
l g*ril12"5' ""*6"19 88, j!p I-(
Community Memorial Hospital SNM-1814 is amended in N
its entirety to read as follows:
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2.
k Highway 37 West U
-Expiration date August 31, 1993 l
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e Toms River, New Jersey 08753 t
- 5. Docket or g
g Reference No.
070-02730 g.
- 6. Byproduct, source, and/or
- 7. Chemica' and/or physical
- 8. Maximum amount that licensee R:
special nuclear material form imay possess at any one time f
l
, under this license k A. Plutonium (Principal A. Sealed source (s)
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A. 4.5. grams (20 individual f;
g radionuclides Pu-238) sources not to exceed g
R 225 milligrams each) lr 0
9.
Authorized use 1
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l A.
Implantation in humans as a component of Cordis Nuc; ear Omni-Stanicor Model 184A f
g nuclear-powered cardiac pacemakers for clinical evaluation purposes.
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CONDITIONS E
d lE:
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- 10. Licensed material shall be used only at Comunity Memorial Hospital, Highway 37 E
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l West, Toms River, New Jersey.
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- 11. The specified possession limit includes all licensed material possessed by the p
I licensee under this license whether in storage, implanted in patients, or E
otherwise in use.
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- 12. The licensee shall not receive or transfer in any single transaction, 1 gram or fl i
more of plutonium 238 contained in nuclear-powered pacemakers without notifying the
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Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555,
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and, in addition, completing and distributing Form NRC-741 as required by Section L
70.54 of 10 CFR Part 70.
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- 13. The licensee shall report to the U.S. Nuclear Regulatory Comission, Region I, k
fl ATTN: Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, Pennsylvania 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 of any I
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nuclear pacemaker patient, and any adverse reaction and/or malfunction p;
N involving a pacemaker system, including the leads. A written report giving E
I details of the adverse reaction and/or malfunction shall be submitted within F
30 days.
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Ri 8907110049 880812 REG 1 LIC70 E
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P P G l
8"I License number I
I SNM-1814 i
q M ATERIALS LICENSE f
pocket or Reference number 4
SUPPLEMENTARY SHEET 070-02730 g
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Amendment No. 02 g
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I (Continued)
CONDITIONS P
N 14 The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, l
ATTN: Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of y
Prussia, Pennsylvania 19406, within 10 days of loss of contact with a nuclear p
pacemaker patient.
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- 15. The licensee shall continue patient follow-up and replacement procedures for l
the nuclear pacemaker during the life of the patient.
Procedures for recovery g
and authorized disposal of the nuclear pacemaker by return to the manufacturer y
i shall be followed upon the death of the patient.
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- 16. Except as specifically provided otherwise in this' license, the licensee shall i
conduct its program in accordance with the statements, representations, and l
n procedures contained in the documents including any enclosures, listed below.
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3 1
The Nuclear Regulatory Commission':; regulations shall govern unless the W
statements, representations and procedures in the licensee's application p
and correspondence are more restrictive than the regulations.
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A.
Application dated June 1, 1977 j
B.
Letter dated December 19, 1977 y
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C.
Letter dated February 17, 1978 p'
D.
Letter dated March 17, 1983 3
E.
Letter dated April 12, 1988 i
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P For the U.S. Nuclear Regulatory Commission F
M h Date By man Nuclear Materials Safety Branch p
Region I p
King of Prussia, Pennsylvania 19406 h
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12 AUS 388 License No. SNM-1814 Docket No.
070-02730 Contre' No. 108725 Community Memorial Hospital ATTN: Charles Fortunato, M.D.
l Highway 37 West Toms River, New Jersey 08753 Gentlemen:
Please find enclosed the renewal of your NRC Material License.
Please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or questions, please notify the Region I Material Licensing Section, (215) 337-5239, so that we can provide appropriate corrections and answers.
Please be advised that you must conduct your program involving licensed radioactive materials in accordance with the conditions of your NRC license, representations made in your license application, and NRC regulations.
In particular, please note the items in the enclosed, " Requirements for Materials Licensees "
l l
Since serious consequences to employees and the public can result from failure to comply with NRC requirements, the NRC expects licensees to pay meticulous attention to detail and to achieve the high standard of compliance which the-NRC expects of its licensees.
You will be periodically inspected by NRC. A fee may be charged for inspections in accordance with 10 CFR Part 170.
Failure to conduct your l
program safely and in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in prompt and vigorous enforcement action against you.
This could include issuance of a notice of violation, or in case of serious violations, an imposition of a civil penalty or an order suspending, modifying or revoking your license as !pecified in the General Policy and Procedures for NRC Enforcement Actions, 10 CFR Part 2, Appendix C.
i 0FFICIAL RECORD COPY ML SNM-1814/LTR - 0001.0.0 1807/28/88
I 0
0 A.
l 2
q We wish you success in operating a safe and effective licensed program.
Sincerely, Origtuel Signed Rye John D. Kinneman I
John D. Kinneman, Chief Nuclear Materials Safety Section B Division of Radiation Safety I
l and Safeguards
Enclosures:
1.
Amendment No. 02 2.
Requirements for Materials Licensees l
3.
NRC Forms 3 and 313 l
l I
- RI pr s' s' allace/mjh j.y,_s f////88 5'[// //
OFFICIAL RECORD COPY ML SNM-1814/LTR - 0002.0.0 07/28/88 I
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UNITED STATES o
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'q,g VNUCLEAR REGULATORY COMMI N
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REGION l
, [8 KING OF PRUSSIA, PENNSYLVANIA 19406 t
475 ALLENDALE ROAD g
28 APR 1988 Community Memorial. Hospital ATTN:
Charles Fortunato, M.D.
Highway 37 West Toms River, NJ 08753 Docket No.
070-02730 License No.
SNM-1814 Control No.
108725
SUBJECT:
LICENSE RENEWAL APPLICATION Gentlemen:
This is to acknowledge receipt of your application for renewal of the material (s) license identified above.
Your application is deemed timely filed, and accordingly, the license will not expire until final action has been taken by this office.
Any correspondence regarding the renewal application should reference the control number specified and your license number.
Sincerely, Originel Signed By:
Doris J. Foster John E. Glenn, Ph.D., Chief Nuclear Materials Safety Section B Division of Radiation Safety and Safeguards 1
"0FRCIAL RECORD COPY"[jl