ML20006B571
| ML20006B571 | |
| Person / Time | |
|---|---|
| Issue date: | 01/11/1990 |
| From: | Rathbun D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Clement B HOUSE OF REP. |
| Shared Package | |
| ML20006B572 | List: |
| References | |
| RULE-PRM-35-9 CCS, NUDOCS 9002050087 | |
| Download: ML20006B571 (2) | |
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NUCLEAR RESULATORY COMMi&8 ION n
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January 11, 1990 The Honorable Bob Clement j
Unitec States House of Representatives i
Washington, D. C.
20515
Dear Congressman Clement:
This is to acknowledge receipt of your letter dated December 20, 1989, transmitting correspondence f rom your constituent Dr. M. R. Habibian, in support of a petition for rulemaking to revise 10 CFR 35 Regulations.
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l The petition for rulemaking was submitted to the Nuclear Regulatory l
l Commission (NRC) by the American College of Nuclear Physicians and the i
Society of Nuclear Medicine. The petitioners requested that the NRC l
modify current regulations to allow:
(a) the use of radiopharmaceuticals l
for therapeutic indications not listed in the package insert (diagnostic i
indications are not restricted by current regulations).. (b) deviations j
from the manufacturer's instructions in preparing radiopharmaceuticals, and(c)compoundingradiopharmaceuticalsfromreagentchemicals.
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The NRC published a Federal Register notice (54 FR 38239 September 15, 1989), announcing receipt of the petition and providing a 90-day public comment period. We have received more than 400 consent letters.
In light of the information: submitted by the petitioners and the commenters, the NRC is currently reexamining its regulations governing the i
l use of radiopharmacauticals in nuclear medicine. The issues raised will L
be addressed in a rulemaking 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 i
the i.anufacturer's instructions, and the State Boards;of Pharmacy and.
invite their views regarding the resolution of this petition.
f I want to assure you that the connents of your constituent will be-l 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, M
R/((IE%TAggjjSCN/
Dennis K. Rathbun, Director Congressional Affairs Office of Governnental and Public Affairs 9002050087 900111 p
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I Letter also verbally approved by Jim Blaha and Mike Weter (per Dennis Rathbun/Betsy Keeling) 9/t.> /-//- 94
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