ML20148D320

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Application for Renewal of License SNM-1345,authorizing Possession of 0.75 G Pu-238 in Three Coratomic Model C-101 Pacemakers
ML20148D320
Person / Time
Site: 07001366
Issue date: 02/01/1988
From: Augustine R
HEALTH & HUMAN SERVICES, DEPT. OF, U.S. PUBLIC HEALTH
To:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20148D305 List:
References
108376, NUDOCS 8803240007
Download: ML20148D320 (3)


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DEPARTMENT OF HEALTH 8t HUMAN SERVICES.

Public Health Sstvics b

7, National Institutes of Health Bethesda, Maryland 20892 Building : 21 Room

110 (301) 496 2254 February 1, 1988 U.S. Nuclear Regulatory Commission Nuclear Materials Safety Section B Division of Radiation Safety and Safeguards Region 1 475 Allendale Road King of Prussia, PA 19406

Reference:

License No. SNM-1345

Dear Sir or Ms:

This is a request to renew License No. SNM-1345 issued to the National

-Institutes of Health.

The following is the information requested in your instructions:

a. License to be renewed:

SNM-1345

b. Name and address of institution Department of Ilealth and lluman Services National Institutes of Health Building 21. Room 110 Bethesda, MD 20892
c. Number of pacemakers to be authorized Three Coratomic Model C-101 Plutoniuta Pacemakers Possession Limit 0.75 grams Plutonium-238 (three individual sources not to exceed 250 milligrams each)
d. Activities to be conducted To follow patients with implanted pacetakers and to return explanted pacemakers to the manufacturer for proper disposal (but not to implant pacemakers in the future).
e. Nill Physician involved in pacemaker program :

Charles L. McIntosh, M.D.

Surgery Branch g-National lleaf,t.,'L,\\

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cp 6803240007 880311 s

REG 1 LIC70 10b376 SNM-1345 DCD

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"UmclAL RECORD COPY" Ell Jx

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Request to Renew ShM-1345 (Continued)

f. Description of changes k

in commitments No changes. All activities will continue in accordance with the conditions stated in License No. SNM-1345 This completes the informa* ion required for renewal.

Please be advised that as a follow up to our letter to you dated November 17, 1987, regarding the explantation of a pacemaker, the following is the information on the disposition of this pacemaker:

Coratomic Model C-101 Nuclear-Powered Pacemaker, Serial No. 015, was shipped from NIH on November 24, 1987 to Biocontrol Technology (formerly Coratomic, Inc.), 300 Indian Springs Road, Indiana, PA 15701, License No. SNM-1319, and received by them on November 25, 1987.

If you require additional information for the license renewal or regarding the explanted pacemaker returned to the manufacturer, please contact me.

t Sincerely,

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R.J. Augustine, Ph.D.

Radiation Safety-Officer, NIH cc: Director, Procurement Division Department of Energy Richland Operations Section P.O. Box 550 Richland, WA 99352 I

Charles L. McIntosh, M.D.,

NHLBI Jacob Robbins, M.D., Chairman, NIH Radiation Safety Committee License File #SNM-1345 "0FFICIAl. RECORD COPY" g,7g

l (FOR LFMS USE)

INFORMATION FROM LTS 3ETWEEN:

LICENSE FEE MANAGEMENT BRANCH, ARM PROGRAM COGE: 22160 AND STATUS CODE: 2 REGIONAL LICENSIN3 SECTIONS FEE CATEGORY: EX 7C EXP. DATE: 19850331 FEE COMMENTS:

LICENSE FEE TRANSMITTAL 4.

REGION 1.

APPLICATION ATTACHED APOLICANT/ LICENSEE:

HEALTH t HUMAN SERVICES, DEPT. OF RECEIVED DAT2:

330203 DOCKET No:

7031366 CONTROL NO.:

105376 LICENSE No.:

SNM-1345 AC TIO N TYPE:

RENEWAL 2.

.EE ATTACHED A M OU'? T :

CHECK N9.:

3. C04d.FNT5 SIGNED

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0 ATE CA-

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3. LIC 3NSE FEE MANAGENINT 3R ANCH (CHECK WHEN MILESTONE 03 IS ENTERED /__/)

1.

FEt C ATEGORY AND AMOUNT:

2.

CORRiCI FEf PAIO.

APpLIC AT ION M AY SE PROCESSED FOR:

AMENDMENT F. E N E d A L LICENSE 3.

OTdER SIGNED nd7"

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