ML20196F277

Responds to ,jointly Signed by Organizations Re Extension of Comment Period for Proposed Rule,Which Would Amend Regulations in 10CFR35, Medical Use of Byproduct Matl

ML20196F277
Person / Time
Issue date:	11/24/1998
From:	Hoyle J NRC OFFICE OF THE SECRETARY (SECY)
To:	Nichols D AMERICAN COLLEGE OF NUCLEAR PHYSICIANS
Shared Package
ML20196F283	List: ML20196F277
References
FRN-63FR43516, RULE-PR-35 NUDOCS 9812070001
Download: ML20196F277 (1)

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Mr. David Nichols Director of Government Relations American College of Nuclear Physicians / l Society of Nuclear Medicine i 1850 Samuel Morse Drive j Reston, VA 20190 i

Dear Mr. Nichols:

I am responding to a letter dated October 30,1998, that was jointly signed by: the American College of Nuclear Physicians; Society of Nuclear Medicine; American College of Radiology; Council on Radionuclides and Radiopharmaceuticals; Nuclear Energy Institute; National l Electrical Manufacturers Association; American College of Nuclear Medicine; and American i Association of Physicists in Medicine. These aforementioned organizations requested: 1) an immediate extension of the comment period for the proposed rule, which would amend the regulations in 10 CFR Part 35, " Medical Use of Byproduct Material," to allow for the development of the risk analysis and the rule, and 2) an extension of the implementation date for the final rule.

i On November 13,1998, via a Staff Requirements Memorandum (enclosed), the Commission approved a 30-day extension of the public comment period and the final rule date. On November 23,1998, the Commission announced in the Egderal Recister (63 FR 64829) that the comment period has been reopened until Wednesday, December 16,1998. In addition, the staff will provide a discussion on the need for future risk assessment in this area, when the final rule is forwarded to the Commission for approval.

Sincerely, j j

John C. oyle

Enclosure:

11/13/98 Staff Requirements

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Memorandum S

9812070001 981124 PDR PR PDR 9k0 35 63FR43516

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%, November 13, 1998

. . . . . ,o OFFICE OF THE SECRETARY l l MEMORANDUM TO

William D. Travers Ex. ti Di ctor for Operations

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SUBJECT:

- AFF REQUIREMENTS - SECY-98-263 - PROPOSED RULE:

REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL The Commission has approved Option 2B to allow for a 30 day extension of the public comment period and the final rule date. While the extension of the final rule date is to ensure meaningful 4 discussion with the ACMUI can be accomplished, the staff should seek to complete as much l

work as possible in parallelin order to attempt to meet the original due date. In addition, when j the proposed final rule is submitted to the Commission, the staff should include a discussion of i the risk assessment as an option and provide the pros and cons for this option.

The Commissioners' offices have designated the following points of contact for work related to l the Part 35 revision:

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Chairman Jackson's office: James Smith Commissioner Dieus's office: JoelLubenau Commissioner Diaz's office: Patrick Castleman Commissioner McGaffigan's office: Janet Schlueter l Commissioner Merrifield's office: Lynne Stauss The staff should continue to follow established procedures for developing and promulgating l rulemakings.

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cc: Chairman Jackson Commissioner Dieus Commissioner Diaz -

Commissioner McGaffigan i Commissioner Merrifield i OGC CIO CFO OCA OlG  ;

OPA l Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail) l PDR DCS- ,

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