ML20206A751
| ML20206A751 | |
| Person / Time | |
|---|---|
| Issue date: | 03/22/1999 |
| From: | Dicus G NRC COMMISSION (OCM) |
| To: | Merrifield J NRC COMMISSION (OCM) |
| References | |
| NUDOCS 9904290016 | |
| Download: ML20206A751 (2) | |
Text
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'ComgEWAoj TO THE PDR CoMM ss oNER March 2,1999 74
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No Objectica.
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- ' ccL3 MEMORANDUM TO
- Chairman Jackson CogissionerAicus 3/ze/99 Commissioner Dieus I
L/J Commissioner Diaz Commissioner McGaffigan CommissionerMerrif%. j///l '
FROM:
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SUBJECT:
SCHEDULE FOR FINAL RULEMAKING CONCERNING 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL By Staff Requirements Memorandum dated November 13,1998, the Commission directed the staff to provide to the Commission by June 28,1999 a final revised rule for 10 CFR Part 35, Medical Use of Byproduct Material. By the normal Commission procedure, the paper would be due to the EDO by June 21,1999. I am also aware of the desire of the Chairman for an earlier decision on this issue and the staff is currently working on a May 22,1999 due date to the EDO and a May 28,1999 due date to the Commission. The staff is under intense pressure to j
achieve these due dates; and I have every confidence that they will attempt to achieve the deadlines with the best product possible. However, I am very concerned that the staff does not have adequate time to evaluate the large number of significant and relevant public comments and provide a thoughtful analysis, complete with an adequate senior management review, within the due date. Therefore i propose that we extend the due date; not for the purpose of obtaining additional public comments, but to allow the staff to do an adequate analysis for the 1
Commission to make an informed decision. Specifically, I propose that the final rulemaking package be due to the Commission on August 30,1999. This package would contain the recommended final rule language and associated OMB package. Once the Commission SRM was issued on the rule language, I propose that the staff be allowed three months from the date of the SRM to provide the supporting Standard Review Plan and a revised Medical Policy Statement for Commission consideration. In addition, I propose that the staff (in concert with the ACMUI) provide the Commission briefing tentatively scheduled for March 26,1999. The o
9 I,oh purpose of this meeting is to summarize the staff's efforts to date, provide the initial staff position conceming the finalization of the rule language, summarize important disagreements either between the staff and industry or among the industry, and to seek specific Commission guidance in areas where policy decisions need to be made.
1 know that this is a complex, controversial issue that has been in progress for over two years. I am sensitive to the fact that the Commission, as a regulatory body, needs to take timely action in revising regulations and cannot allow decisions on complex issues to be unnecessarily delayed. But in an issue of this magnitude, I would prefer that the staff have adequate time to conduct an analysis of both the public comments and of reasonable alternatives so that the
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. Commission can make an informed decision. A decision on this COMSECY needs to be made
- in relative short order in order for it to have a positive effect on the staff spending more time developing a reasoned approach.
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