ML20204F215

Amend 4 to License SNM-1525 for General Hosp Ctr at Passaic,Amending License in Entirety

ML20204F215
Person / Time
Site:	07001941
Issue date:	06/16/1986
From:	Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML19292G993	List: ML20204F215 ML20204F322 ML20204F360 ML20204F517
References
NUDOCS 8703260154
Download: ML20204F215 (2)

Text

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gi.40C Form 373 I

g (S-64 f S. NUCLEAR RE!ULATARY COMMISSION h PAGE OF PAGES g

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7 MATERIALS LICENSE Amendment No. 04 l

Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations Pursua{.t, to,theytomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 10, I gj N' heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g

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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 g

I deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This I

license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is I l g

rubject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any E

conditions vecified below.

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In accordance with application dated I

g November 25 1985 l l 1

The General Hospital Center at Passaic

3. License number, SNM-1525 is amended in

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I-l its entirety to read as follows:

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350 Boulevard

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l Passaic, New Jersey 07055 b '~

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June 30, 1991 l

5. Docket or l

Reference No.

070-01941 gg l' 6. Byproduct, source,and/or

7. Chemical and/or physical V 8. Maximum amount that licensee I

special nuclear material form

< may possess at any one time I

,under this license g

l A. Plutonium A. Sealed Source 4

A. 0.5 grams (1 source i l (Princi f.

not'to exceed

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Pu-238) pal radionuclide

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500, mil 11 grams) nl g

i B. Plutonium B. Sealed Source j-B. 0.5; grams (2 individual b

I (Princi PU-238) pal radionuclide sources not to exceed i

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I 250 milligrams each)

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Authorized use R

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A.

Implantation in humans as a component of ~ ARC 0 Nuclear Model. NU-5 nuclear-powered g

cardiac pacemakers for clinical evaluation.

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B.

Implantation in humans as a component of Coratomic Model C-101 nuclear-powered l

l cardiac pacemakers for clinical evaluation.

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CONDITIONS.

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l d'10. Licensed material shall be used only at The General Hospital Center at Passaic, y

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350 Boulevard, Passaic, New Jersey.

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11. The specified possession limit includes all licensed material possessed by the Il licensee under thh license whether in storage, implanted in patients, or oth-

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erwise in use.

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12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, g

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ATTH: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, l

l 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 ll g

of any nuclear pacemaker patient, and any adverse reaction and/or malfunction I

involving a pacemaker system, including the leads. A written report giving I

details of the adverse reaction and/or malfunction shall be submitted within 1

30 days.

I lj 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, g g

ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue,

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gi King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a

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l{I nuclear pacemaker patient.

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8703260154 860616 LIC70

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= = = = = F w = w w s m wr.arw w w3 SNM-1525

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'NYC Nm 374A U.S. NUCLf-] R E!ULATCRY COMMISSION

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AGE OF PAGES h

License number NM-5 MATERIALS LICENSE SUPPLEMENTARY SHEET f

070-01941 Amendment No. 04

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(continued)

CONDITIONS

14. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient. Procedures for recovery L

and authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient.

15. Sealed sources containing licensed material shall not be opened.

16. The licensee may transport licensed material in accordance with the provisions 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 conduct its program in accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below.

The Nuclear Regulatory Commission's regulations shall govern unless the statements, representations and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A.

Application dated February 19, 1975 B.

Letter dated March 27, 1975 C.

Application dated November 26, 1975

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D.

Letter dated June 16, 1977 E.

Letter dated April 17, 1980 F.

Letter dated November 25, 1985 For the U.S. Nuclear Regulatory Commission Or1 1nal Signed By:

6 JUN is 1986 sennyu. so w en Dan Nuclear Materials Safety and Safeguards Branch, Region I King of Prussia, Pennsylvania 19406

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