ML20195D165
| ML20195D165 | |
| Person / Time | |
|---|---|
| Issue date: | 11/10/1998 |
| From: | Dicus G NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20195D146 | List: |
| References | |
| REF-10CFR9.7 SECY-98-263-C, NUDOCS 9811170307 | |
| Download: ML20195D165 (2) | |
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- l. NOTATION VOTE i
RESPONSE SHEET I
TO: John C. Hoyle, Secretary l
FROM: COMMISSIONER DICUS
SUBJECT:
SECY-98-263 - PROPOSED RULE: REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL Approved I Disapproved Abstain Not Participating COMMENTS: Please see attached comments.
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$$11C @ s gjji3 DATE CORRESPONDENCE PDR Entered on "AS" Yes M No i
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4 Commissioner Dicus' comments on SECY-98-268:
I reluctantly approve option 28, namely providing 30 day extensions of the comment period for the proposed revision to Part 35 and the final rule date.
The 30 day extension of the comment period is not unreasonable because it will permit stakeholders to fully develop their comments on the proposed rule especially in light of the most recent public workshop discussions. My approval of the recommendation to extend the final rule date is based on the importance of enabling staff to hold meaningful discussions with ACMUI before submitting the proposed final rule to the Commission.
Given the enhanced particpatory process that was utilized for this proposed rule and the long time that this matter has been under review, I find the request from stakeholders for a risk assessment at this late stage to be a disappointing development. That said, I am willing to consider such a request but I am not willing to delay further the rulemaking process on that account at this time. When staff submits the propose final rule to the Commission, staff should include discussion of the risk assessment as an option and provide the pros and cons for this option.
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