ML20235B335

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Requests Addl Listed Info Be Added to Application for License to Participate in Research Study Re Implantation of Coratomic C-101 Series Nuclear Powered Pacemaker,Containing 250 Mg Pu-238
ML20235B335
Person / Time
Site: 07002174
Issue date: 01/08/1976
From: Strickler J
SOUTHEAST MISSOURI HOSP., CAPE GIRARDEAU, MO
To:
NRC
Shared Package
ML20235B300 List:
References
NUDOCS 8902130222
Download: ML20235B335 (2)


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SOUTHEAST HOSPITAL

90. p ny 1701 Lacey, Cape Girardeau, Mo. 63701 Phone (314) 334-4822 January 8, 1976 AIR MAIL - SPECIAL DELIVERY

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Chief, Materials Branch

.s Directorate of Licensing and Regulation F C-U. S. Nuclear Regulatory Commission

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  1. 3 U$ M Attention:

Rod Mason and J. Brown s 5O

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Gentlemen:

Re: Docket'#70-2174

k. N Application for License to Participate in the Resear:h Srudy Involving the Implantation of Coratomic C-101 Series Nuclear Powered Pacemaker, Containing 250 Milligrams of Pu-238--4.3 Curres Please add to Item 2 of our application the following information:

Total No. of Total at Years Implants Southeast Hospital a.

C. R. Talbert, Jr., M.D.

7 1000 800 b.

W. K. Bowman,'Jr., M.D.

4 350 250 c.

Jerry L. Kinder, M.D.

6 600 400 Endocardial 100 Myocardial d.

Robert S. Hunt, M.D.

5 300 225 Endocardial 25 Myocardial e.

Charles P.~McGinty, M.D.

5-250 180 Endocardial 20 Myocardial Please add the following at the end of Item 6: This program has been operating about six years and presently serves approximately 250 patients.

Please revise the final paragraph of Item 7 as follows:

Records of monthly pacemaker checks and other information gathered at the clinic will be obtained by and filed at Southeast Hospital.

Duplicates will be kept in the offices of physicians responsible for the individual patient examination, also in the pacemaker clinic files.

These records will also be made available to referring cardiologists.

Very truly yours, 8902130222 880212

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f James R. Stricker Administrator

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PRIVACY ACT STATEMENT Pursuant to 5 U.S.C. 552a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the following.

statement is furnished to individuals who supply information to the Nuclear Regulatory Commission on F orm NRC-313M.

This information is maintained in a system of records designated as NRC 3 and described at 40 Federal Register 45334 (October 1,1975).

1. AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 2201(b)).
2. PRINCIPAL PURPOSE (S) The information is evaluated by the NRC staff pursuant to the criteria set forth in 10 CFR l

Parts 30 36 to determine whether the application meets the requirements of the Atomic Energy Act of 1954,as amended, and the Commission's regulations, for the issuance of a radioactive material license or amendment thereos

' 3. ROUTINE USES The information may be used: (a) to provide records to State health departments for their information and use; and (b) to provide information to Federal, State, and local health officials and other perscos in the event of inci-dent or exposure, for their information, investigation, and protection of the public health and safety. The information j

may also be disclosed to appropriate Federal, State, and local agencies in the event that the informatiors indicates e i

violation or potential violation of law and in the course of an administrative or judicial proceeding. In addition, this in-formation may be transferred to an appropriate Federal, State, or local agency to the extent relevant and necessary for a NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you. A copy of the license issued will routinely be placed in tne NRC's Public Document Room,1717 H Street, N.W.,

Washington, D.C.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECTON INDIVIDUAL OF NOT PROVIDING INFORMATION Disclosure of the requested information is voluntary. If the requested information is not furnished, however, the application for radioactive material license, or amendment thereof, will not be processed.

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, 5. SYSTEM MANAGER (S) AND ADDRESS Director, Division of Fuel Cycle and Material Safety, Office of Nuclear Mate-rial Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

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