ML20006B589
| ML20006B589 | |
| Person / Time | |
|---|---|
| Issue date: | 01/26/1990 |
| From: | Rathbun D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Deconcini D SENATE |
| Shared Package | |
| ML20006B590 | List: |
| References | |
| RULE-PRM-35-9 CCS, NUDOCS 9002050108 | |
| Download: ML20006B589 (2) | |
Text
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. Caggk UNITED STATES J
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3 NUCLEAR REGULATORY COMMISSION 5
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WASHINGTON, D, C. 20006 January 26, 1990 The Honorable Dennis DeConcini United States Senate
. Washington, D. C.
20510-
Dear Senator DeConcini:
This is.to acknowledge receipt of your letter dated January 22, 1990, transmitting correspondence from your constituent, Dr. Marshall Brucer, in support of a petition for rulemaking to revise 10 CFR 35 Regulations.
The petition for rulemaking was submitted to the Nuclear Regulatory Comission (NRC) by the American College of Nuclear Physicians and>the Society of Nuclear Medicine. The petitioners requested that the NRC modify current regulations to allow: :(a) the use of radiopharmaceuticalsL for therapeutic indications not listed in the package insert-(diagnostic indications are not restricted by current' regulations), (b) deviations from the manufacturer's instructions in preparing radiopharmaceuticals..
and(c)compoundingradiopharmaceuticalsfromreagentchemicals.
TheNRCpublisitadaFederal-Registernotice.(54-FR38239, September 15,
~
1989)', announcing receipt of the petition _ and providing a 90-day. public coment period. We have received more than 400 conenent letters.
In light of the information submitted by the petitioners and the commenters, the NRC is currently reexamining its-regulations governing the.
l use of radiopharmaceuticals in nuclear medicine. The' issues raised will be addressed in a ruleliiaking proceeding specifically designed to resolve -
the petition.
During this rulemaking process, the NRC will consult with the Food and Drug Administration, which approves the package: inserts 'and the manufacturer's instructions, and the State Boards.ofLPharmacy and-invite their views regarding the resolution of this petition.
I want to assure you that the comments 'of your constituent will be considered along with the others in reexamining our regulations. However, it would be premature-to predict the outcome of the reexamination-before completion of the rulemaking proceeding..
I trust this information is responsive to your request.
Sincerely,
.s -
Dennis K. Rathbun, Director Congressional-Affairs Fl)M~ g U SONSCAN Office of Governmental and
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Letter also verbally approved by Jim Blaha and Mike-Weber 96..
(per Dennis Rathbun/Betsy Keeling) pyt.,
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