ML20006B583
| ML20006B583 | |
| Person / Time | |
|---|---|
| Issue date: | 01/17/1990 |
| From: | Rathbun D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Duncan J HOUSE OF REP. |
| Shared Package | |
| ML20006B584 | List: |
| References | |
| RULE-PRM-35-9 CCS, NUDOCS 9002050103 | |
| Download: ML20006B583 (2) | |
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UNITED STATES -
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' NUCLEAR REGULATORY COMMISSION.
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.a January 17, 1990 i
The Honorable John J. Duncan, Jr.
United States House of Representatives Washington, D.
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Dear Congressman Duncan:
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This is to acknowledge receipt of your letter dated January 3,1990, U
transmitting correspondence from your constituent, Shannon Anderson ;
in support of a petition for rulemaking-to revise 10 CFR 35 Regulations.-
The petition for.rulemaking was submitted.to the Nuclear Regulatory l
Consiission (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 radiopharmaceuticals 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, i
and.(c). compounding radiopharmaceuticals from reagent chemicals.-
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The NRC published a Federal Register notice (54 FR 38239.- September 15,
H 1989), announcing receipt of the petition and providing a 90-day public comment period. We have" received more than 400 comment letters..
In light of the information submitted by the. petitioners and-the comenters, the.NRC is currently reexamining its. regulations governing the-use of radiopharmaceuticals intnuclear medicine. The issues raised will-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 q
l the manufacturer's-instructions,.and the' State Boards of Pharmacy:and invite their views regarding the resolution of this' petition U
t' I want to assure you-that the comments of your constituent will;be considered along with the others in reexamining our. regulations. _However,-
y it would be premature to predict the outcome.of the reexamination before' t
completion of the rulemaking proceeding -
i I trust this information 'is responsive to your request..
l Sincerely',
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.l FUtt 7pg7ASCll SCAN Dennis.K. Rathbun D ctor Congressional Aff irs Office of Gover ntal and 1
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4' Letter also verbally approved by. Jim Blaha and Mike Weber (per Dennis Rathbun/Betsy Keeling) p /-//- 90 j
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