ML20126D133
| ML20126D133 | |
| Person / Time | |
|---|---|
| Issue date: | 02/11/1985 |
| From: | Minogue R NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20126D070 | List: |
| References | |
| FRN-50FR15752, RULE-PR-35 AB72-1, NUDOCS 8506140651 | |
| Download: ML20126D133 (3) | |
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WASHINGTON. D. C. 205,55 bb FE811585 1
MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES INDEPENDENT REVIEW 0F ONGOING RULEMAKING SPONSORED BY NMSS Based on our independent review of the proposed rulemaking, sponsored by NMSS, to modify 935.14(b)(7) of 10 CFR Part 35, " Human Uses of Byproduct Material," to add six new methods of use and the appropriate radiopharma-ceuticals, RES agrees with the recommendation of the Director, NMSS, that this rulemaking effort should continue.
The basis for our recommendation is as follows:
o This is a minor rulemaking implementing a policy, set out in a final rulemaking notice published February 4, 1983 (48 FR 5217) to add a new 10 CFR 35.14(b)(7), that the NRC would amend the specified para-graph to allow NRC-licensed physicians and hospitals to use radiophar-maceuticals for newly developed methods of use (that are not listed on their respective FDA-approved package labels), without applying to the NRC for a license amendment.
, o The proposed rule would modify 10 CFR 35.14(b)(7) to add six new methods of use and the appropriate technetium-99 radiopharmaceuticals for each method of use. With assistance from its Advisory Committee on the Medical Uses of Isotopes, NRC staff has determined that the proposed clinical procedures involving oral administration or injec-tion of the radiopharmaceuticals can be conducted with no unjustified radiation dose to the patient and with a demonstration of adequate occupational radiation protection measures.
The complete RES independent review package has been sent to OEDO (Atten-tion: DEDROGR) and to the Director, NMSS.
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Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
As stated 8506140651 PR 850611 PDR PDR 35
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ROUTING AND TRANSMITTAL SUP JAN 8 1985
. 10 me. emee symn #, reem nummer. mRinas em As ncr/ Pest) g, D. E. Bassett, tiember, RIRB g K. R. Goller, itember, RIRB g G. A. Arlotto, tiember, RIRB Y Action File Note and Retum Approval For Deerence
- Per Coswersation As Requested For Correction Propero Reply .
Dirculete For Your Information See Me b- . _ ^ lrwestigste Signature ooordinetton Justify
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We are at step III.C.2, "RIR3 deliberations " of the RES independent review procedures fo'r the attached specific ongoing rulemaking sponsored by Please evaluate the attached dra'ft independent review package and provide RAliRB with your voting sheet indicating your position on the rulemaking.
Your response by c.o.b. JAN 16 285 will assist in RES' making independent recommendations to the EDO in a timely manner.
DO NOT use this form as a Rtc0RD of approvels. eencurrences. qReponeA clearances. and similar actions FROta: (Name, org. symbol. Agency / Post) ' Room No.--Sids.
RN1RB staff Phone No.
443-7885 sess-see g roRu 41 (new. 7-76)
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