ML20195D191

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Notation Vote,Disapproving with Comments,On SECY-98-263 Re Rev of 10CFR35 on Medical Use of Byproduct Matl
ML20195D191
Person / Time
Issue date: 11/12/1998
From: Diaz N
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 9811170314
Download: ML20195D191 (2)


Text

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s, NOTATION VOTE RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER DIAZ l

SUBJECT:

SECY-98-263 - PROPOSED RULE: REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL l

l Approved Disapproved X Abstain Not Participating COMMENTS:

See attached coments.

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l SIGNATURE

a. a.so '% W DATE i

Entered on "AS" Yes X No 9811170314 981113 PDR COMMS NRCC CORRESPONDENCE PDR

, COMMISSIONER DIAZ'S COMMENTS ON SECY-98 263 - PROPOSED RULE: REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL (Notation Vote)

I disapprove the staff's recommended Option 2B and I approve Option 1. Sufficient time and opportunity has already been provided for stakeholders to weigh in during the enhanced participatory process that is being used for this rulemaking -indeed, many have already provided timely and substantial comments. I am concemed that extending the schedule and attempting to accommodate an as-yet not clearly defined risk assessment will cause this rulemaking to become protracted. We must keep in mind the need to strive for efficiency in all our activities, rulemaking being one of the more visible.

The staff should continue to use risk information to determine appropriate changes to specific provisions of the proposed rule as it analyses the comments submitted. The staff should not

, undertake additional analyses (or other similar activities) in this area beyond those previously approved by the Commission and accounted for in the budget. Should our stakeholders develop new information and recommendations in the future, we can address such fully developed concepts in refinements to 10 CFR Part 35.

The point of contact in my office for 10 CFR Part 35 matters is Patrick Castleman.

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