[Federal Register Volume 62, Number 195 (Wednesday, October 8, 1997)]
[Proposed Rules]
[Page 52513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26641]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / 
Proposed Rules  

[[Page 52513]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35


Medical Use of Byproduct Material; Workshop

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of workshop.

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SUMMARY: The Nuclear Regulatory Commission has initiated a rulemaking 
for a comprehensive revision to its regulations governing the medical 
use of byproduct material in 10 CFR part 35. As part of this 
rulemaking, the Commission intends to solicit the active input of the 
various interests that may be affected by the rulemaking early in the 
rulemaking process. One of the mechanisms that will be used to obtain 
the comments and recommendations from affected interests will be the 
convening of workshops to discuss the fundamental approaches and issues 
that must be addressed in the revision of 10 CFR part 35. A workshop on 
NRC's medical rulemaking initiative will be held during the 
Organization of Agreement States' All Agreement States Meeting in Los 
Angeles, California.

DATE: The workshop will be held on October 18, 1997, from 8:30 a.m. to 
2:15 p.m.

ADDRESS: The Westin LAX Hotel, 5400 W. Century Blvd., Los Angeles, CA 
90045.

FOR FURTHER INFORMATION CONTACT: Cathy Haney, U.S. Nuclear Regulatory 
Commission, Office of Nuclear Material Safety and Safeguards, telephone 
(301) 415-6825, e-mail [email protected].

SUPPLEMENTARY INFORMATION: The NRC has examined the issues 
surrounding its medical use program in great detail during the last 
four years. This process started with NRC's 1993 internal senior 
management review report; continued with the 1996 independent 
external review report by the National Academy of Sciences, 
Institute of Medicine; and culminated in NRC's Strategic Assessment 
and Rebaselining Project (SA). In particular, medical oversight was 
addressed in the SA Direction-Setting Issue Paper Number 7 (DSI 7) 
(released September 16, 1996). In its ``Staff Requirements 
Memorandum (SRM)--COMSECY-96-057, Materials/Medical Oversight (DSI 
7),'' dated March 20, 1997, the Commission directed the NRC staff 
to revise Part 35, associated guidance documents, and, if 
necessary, the Commission's 1979 ``Medical Policy Statement.'' The 
Commission SRM specifically directed the restructuring of part 35 
into a risk-informed, more performance-based regulation.

    A June 30, 1997, SRM informed the NRC staff of the Commission's 
approval, with comments, of the NRC staff's proposed program in SECY-
97-131, Supplemental Information on SECY-97-115, Program for Revision 
of 10 CFR part 35, ``Medical Uses of Byproduct Material,'' and 
Associated Federal Register Notice,'' dated June 20, 1997.
    After Commission approval of the NRC staff's program to revise 10 
CFR part 35 and associated guidance documents, the NRC staff initiated 
the rulemaking process, as announced in 62 FR 42219 (August 6, 1997). 
The rulemaking is being conducted using a group approach. A Working 
Group and Steering Group consisting of representatives of NRC, 
Organization of Agreement States(OAS), and Conference of Radiation 
Control Program Directors have been established to develop rule text 
alternatives, rule language, and associated guidance documents. State 
participation in the process is intended to enhance development of 
corresponding rules in State regulations, to provide an opportunity for 
early State input, and to allow State staff to assess potential impacts 
of NRC draft language on the regulation of non-Atomic Energy Act 
materials used in medical diagnosis, treatment, or research, in the 
States.
    As directed by the Commission, the NRC staff has developed 
alternatives, with draft regulatory text, for the more significant 
issues associated with the regulation of the medical use of byproduct 
material. These alternatives to regulation in specific areas are 
intended to help focus the discussion during workshops and meetings 
during the Fall of 1997 and to assist the NRC staff in developing the 
text of the proposed rule. Alternative regulatory text has been 
developed for: (a) The quality management program; (b) training and 
experience for authorized users, radiation safety officers, and medical 
physicists; (c) radiation safety committee; (d) patient notification of 
reportable events; and (e) the threshold for reportable events. The 
alternatives represent a broad range of possibilities and are being 
provided to stimulate input from members of the public in an effort to 
encourage all interested parties to provide input into the development 
of the revised regulation. The staff has not selected any alternatives 
at this time and is open to additional alternatives that might be 
proposed, which are consistent with the guidance provided by the 
Commission.
    The OAS workshop will be open to the public, on a space available 
basis. The agenda for the workshop will focus on discussion of the 
above regulatory issues, but will also provide enough flexibility for 
the public to have an opportunity to comment on related rulemaking 
issues. Members of the public who are unable to attend the workshop can 
obtain copies of the papers developed by the staff through NRC's Public 
Document Room (U.S. Nuclear Regulatory Commission, Attention: NRC 
Public Document Room, Washington, DC 20555-0001) or on the Internet via 
NRC's Technical Conference Forum (http://techconf.llnl.gov/
noframe.html).

    Dated at Rockville, Maryland this 2nd day of October, 1997.

    For the Nuclear Regulatory Commission.
Donald A. Cool,
Director, Division of Industrial and Medical Nuclear Safety, Office of 
Nuclear Material Safety and Safeguards.
[FR Doc. 97-26641 Filed 10-7-97; 8:45 am]
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