ML20147H412

Application for Amend to License SNM-1735,authorizing Implantation of Six Coratomic C-101 Isotopic Pacemakers Annually During Study.Listed Doctors Will Be Participating in Study

ML20147H412
Person / Time
Site:	07002580
Issue date:	05/19/1978
From:	Claypool W, Schreiber J, Sutorius D VETERANS ADMIN. MEDICAL CENTER, CINCINNATI, OH
To:	Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20147H261	List: ML20147H258 ML20147H269 ML20147H279 ML20147H316 ML20147H390 ML20147H398 ML20147H412 ML20147H435
References
09441, 9441, NUDOCS 8803080475
Download: ML20147H412 (1)

Text

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7 M rF4 VETERANS ADMINISTRATION HOSPITAL 3200 vmc sTsccT h

CINCINNATI. OHIO 45220 May 19, 1978 m Rc m.y R E P'ER TO: 539-112 Ms. Patricla C. Vacca

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Materials Branch Division of Fuel Cycle and s

Materials Safety U. S. Nuclear Regulatory Commission We sh in g t on, D.

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20555

Dear Ms. Vacca,

N, ( t t RE: App lic at ion for license amendment to participate in a research study involving the implantation of Coratamic C-101 Isotopic 0{

Powered Pacemakers, each containing 250 milligrams of Pu-238 b

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((4. 3 curies).

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Die Veterans Administration Hospital hereby requests an amendment

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to its Special Nuclear Materials License No. SNM-1735 to implant a

)}. 6,M maximum of six Coratomic C-101 Isotopic Pacemakers annually during the study.

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Die Veterans Administration Hospital agrees to follow the Protocol l

2.on file at the Division of Fuel Cycle and Materials Safety entitled, 1, t >'

"Human Clinical Protocol for the Coratomic C-101 Radioisotope Powered y3t' Cardiac Pacers", dated November 1, 1975.

Copies of this Protocol have

/ g been provided to the above institutions and are on file at that yj l,l.

f institution.

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Doctors Darryl J.

Sutorius, James A. Helmsworth, J. Tracy Schreiber, and o Harold Settle will be participating in this study.

These physicians being included in the Veterans Administration Hospital Special Nuclear Materials

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License No. SNM-1735 presently in effect.

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WILLIAM E. CLAYPOOL M, I. $

Hospital Director C9441 hysici na Respo sible for Selidy :

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TRACY SCRREIBER, M.D.

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