ML20034C608
| ML20034C608 | |
| Person / Time | |
|---|---|
| Issue date: | 03/07/1990 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Duncan J HOUSE OF REP. |
| Shared Package | |
| ML20034C609 | List: |
| References | |
| FRN-55FR1439, RULE-PR-35 NUDOCS 9005040205 | |
| Download: ML20034C608 (1) | |
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n NUCLEAR REGULATORY COMMISSION WA$HING ton, D. C. 20666 k....+ /
March 7, 1990
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m e Honorable John Duncan, Jr.
United States House of Representatives l
Washington, D. C.
20515 Dear Congressman Duncan l
m is is in response to your letter of January 30, 1990 to Chsirman Carr requesting the status of the rulemaking process on the 10 cm 35 regulations, j
Currently, we have two major rulemaking prWings involving Part 35. Se status of each rulemaking is as follows, Prmnami hiemakina on Basic Ouality Assurance Prouram
%e NRC published.a proposed ameMment to 10 cm 35 it the Eghgal Register on-January 16,1990 (55 m 1439) for a 90-day public otrasant period. Se proposed ameMment would require medical use licensees to have a basic quality assurance program to prevent, detect, and correct the cause of errors in the medical use of byproduct material.. W e proposed amendment would also modify related recordkeeping and reporting requirements.
Petition for hiemakina Subnitted bv the American Colleoe of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) he NRC received a petition for rulemaking subnitted by the ACNP and SNM in June 1989. We petitioners requested that the NRC amend its regulations to allow, among other things, (1) the use of radiopharmaceuticals for therapy applications not included in instructions approved by the Food and Drug Administration (diagnostic applications are not restricted by current regulations), (2) deviations from the ITR approved manufacturer's instructions in preparing radiopharmaceuticals, and (3) winding radiopharmaceuticals frcan reagent chemicals. We NRC is actively pursuing the issues in the-petition.
A notice announcing receipt of the petition was published in the Federal Reaister on September 15,1989 (54 m 38239) for a 90-day public coment period. We received 466 ocument letters and are currently analyzing these coments.
In light of the information subnitted by the petitioners and the ccamenters, the staff is currently reexamining the regulations governing the t
use of byproduct material in radiopharmaceuticals. W e issues raised in the petition will be addressed in a rulemaking pre ing specifically designed to resolve the petition. We are placing a high priority on an expeditious-i resolution of these issues. During the rulemaking process, the staff will.
1 consult with ITA and the State Boards of Pharmacy to assess the effects on public health and safety of adopting the petitioners' requests.
1 I trust this information is responsive to your request.
sincerely, FULL TEXT ASCll S
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