ML20195K346
| ML20195K346 | |
| Person / Time | |
|---|---|
| Issue date: | 11/24/1998 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Miriam Cohen AMERICAN COLLEGE OF NUCLEAR PHYSICIANS |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 NUDOCS 9811250235 | |
| Download: ML20195K346 (1) | |
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UNITED STATES y
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November 24, 1998 1
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SECRETARY OF,.
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Marvin B. Cohen, M.D.
2CKET NUMBEROD President, Califomia Chapter uROPOSED RUI.E ra A 2a +35 American College of Nuclear Physicians
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Box 31 Los Altos, CA 94023
Dear Dr. Cohen:
I am responding to your letter dated November 9,1998, requesting a 1-year 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 resolve many outstanding problems with the proposed rule.
' 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 Ee._grg] Reaister (63 FR 64829) that d
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.
In addition, your letter will be docketed as a comment on the proposed 10 CFR Part 35.
Sincerely, fn.-
John C.
oyle
Enclosure:
11/13/98 Staff Requirements Memorandum
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November 13, 1998 OFFICE oF THE SECRETARY L
MEMORANDUM TO:
William D. Travers l
Exe ti Dir ctor for Operations
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Jo
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SUBJECT:
AFF REQUIREMENTS - SECY-98-263 - PROPOSED RULE:
REVISION OF 10 CFR PART 35, MEDICAL USE OF i
BYPRODUCT MATER lAL i
s 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 discussion with the ACMUI can be accomplished, the staff should seek to complete as much work as possible in parallelin order to attempt to meet the original due date, in addition, when 4
the proposed final rule is submitted to the Commission, the staff should include a discussion of the risk assessment as an option and provide the pros and cons for this option.
4 The Commissioners' offices have designated the following points of contact for work related to
' the Part 35 revision:
Chairman Jackson's office:
James Smith Commissioner Dicus's office:
Joel Lubenau Commissioner Diaz's office:
Patrick Castleman Commissioner McGaffigan's office: Janet Schlueter Commissioner Merrifield's office:
Lynne Stauss The staff should continue to follow established procedures for developing and promulgating rulemakings.
Enclosure
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o cc:
Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan Commissioner Mernfield OGC CIO CFO OCA OlG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
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..s TD w&L American November 9,1998 College of Nuclear SMans The Honorable Shirley Ann Jackson Chairman, U.S. Nuclear Regulatory Commission California Mail Stop 016G15 "P#
Washington,DC 20555 Dorothy Duffy Pnce Executwe Director
Dear Chairman Jackson:
t,"So.. c4 84on TEL I4151949-1341 Enclosed is the response and comments of the California Chapter rax (4isi s4s.134i of the American College of Nuclear Physicians (ACNP) to the NRC's
. proposed revision of 10 CFR Part 35. This response was developed by our Government Relations Committee and approved by our Executive Committee.
The California Chapter of the ACNP believes that the proposed revision of Part 35 is seriously flawed and that a one year delay is required in order to resolve the many outstanding problems. This could not be accomplished in the public hearings because responses were severely limited by the frame of reference and restricted questions imposed unilaterally by the NRC's " Working Group" and " Steering Group. The California Chapter believes that the restrictive format is a large handicap that prevents us from commenting on each of the proposed new regulations. Our response, therefore, takes the form of an Executive Summary of our comments and concerns followed by a detailed discussion of these matters with suggested language for many revised regulations.
I A one year delay in the revision of Part 35 should give ample time for the success of a good faith effort of the NRC and concerned professional organizations to resolve the many remaining problems.
Sincerely yours,
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Marvin B. Cohen, M.D.
l President, California Chapter American College of Nuclear Physicians i
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