ML20137R609
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% , , ,', / MG 3 0 SS4 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
C0hTROL OF NRC RULEMAKING: RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING, SPONSORED BY NMSS Eased on our independent review of the ongoing rulemaking, " Human Uses of Byproduct haterial--Revisions to 10 CFR Part 35," sponsored by NMSS, RES agrees with the recorrendation of the Director, NMSS, that this rulemaking effort should continue.
The basis for our recomendation is as follows:
This specific ongoing rulemaking would consolidate requirements dispersed in 10 CFR Part 35, standard conditions for specific licenses authorizing human use of byproduct material, branch positions, and certain regulatory guides that apply to institutions and physicians licensed for the internal or external administration of byproduct material, or the radiation therefrom, to human beings. The consolidation of widely dispersed requirements would:
o Result in a greater degree of safety along with cost savings by not requiring a license amendment every time a procedure is changed, o Reduce confusion on the part of the licensee by codifying all the requirements in one place.
o Promote uniformity among regional offices in issuing licensing documents and inspecting licensees for compliance with regulatory requirements and license conditions.
o Eliminate the practice that the license require, as a condition, that the licensee follow the statements and representations (including those not related to health and safety) set forth in the application for license and any supplement to it.
The complete RES independent review package has been sent to OEDO (Attention:
DEDROGR) and to the Director, NMSS. This package includes some suggested wording changes in the rulemaking package which we believe will improve the quality of the supporting documentation for the proposal.
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Robert B. Minogue Director Office of Nuclear Regulatory Research
Enclosure:
As stated fj$92pg59 85o906 35 50FR30616 PDR w--_-___-_______-____ _ - _ _ - - _ - _ - _ _ _ _ _ - - _ _ _ _ _ _ _ _ _ - _ - _ _ _ _ _ - _ - - _ _ _ -