[Federal Register Volume 64, Number 24 (Friday, February 5, 1999)]
[Proposed Rules]
[Page 5721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2749]


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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. 64, No. 24 / Friday, February 5, 1999 / 
Proposed Rules  

[[Page 5721]]


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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 U.S. Nuclear Regulatory Commission (NRC) is continuing the 
process of developing a proposed revision of its regulations governing 
the medical use of byproduct material in 10 CFR part 35, ``Medical Use 
of Byproduct Material.'' Throughout the development of the proposed 
rule the Commission solicited input from the various interests that may 
be affected by these proposed revisions. The proposed rule was 
published in the Federal Register on August 13, 1998 (63 FR 43516), for 
a 90-day comment period, which was later reopened to December 16, 1998. 
During the public comment period, several public meetings were held to 
discuss major issues, such as training and experience requirements, 
that are being addressed during the rulemaking. The Commission is now 
soliciting specific information on the implementation issues associated 
with the proposed revisions to the training and experience 
requirements. To that end, a public workshop is being convened to 
obtain comments and recommendations on implementation issues from 
affected parties. Francis X. Cameron, Special Counsel for Public 
Liaison, in the Commission's Office of the General Counsel, will be the 
convener and facilitator for the workshops.

DATES: The workshop will be held on February 17, 1999, from 9 a.m. to 
4:30 p.m. and on February 18, 1999, from 9 a.m. to 12 noon.

ADDRESSES: This workshop will be held at the NRC Headquarters Office, 
11555 Rockville Pike, Rockville, Maryland
    Members of the public who are unable to attend the workshop can 
send comments to Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, Attention: Rulemakings and Adjudications 
Staff.

FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel 
for Public Liaison, Office of the General Counsel, U. S. Nuclear 
Regulatory Commission, Washington DC 20555, Telephone: 301-415-1642, e-
mail [email protected].

SUPPLEMENTARY INFORMATION: After a comprehensive review of its medical 
use program, the Commission directed the staff to revise 10 CFR part 
35, associated guidance documents, and, if necessary, the Commission's 
1979 Medical Policy Statement (Staff Requirements Memorandum (SRM)--
COMSECY-96-057, ``Materials/Medical Oversight'' (DSI-7), dated March 
20, 1997). The Commission specifically directed the restructuring of 
Part 35 into a risk-informed, more performance-based regulation by June 
1999. The revision is intended to:
    (1) Focus the regulations on those medical procedures that pose the 
highest risk, from a radiation safety aspect, with a subsequent 
decrease in the oversight of low-risk activities;
    (2) Focus on those requirements that are essential for patient 
safety;
    (3) Initiate improvements in NRC's medical program, by implementing 
recommendations from internal staff audits, other rulemaking 
activities, and results of analyses in medical issues papers;
    (4) Incorporate regulatory requirements for new treatment 
modalities; and
    (5) Reference, as appropriate, available industry guidance and 
standards.
    The program for revising part 35, associated guidance documents, 
and the Medical Policy Statement has provided more opportunity for 
input from potentially affected parties (the medical community and the 
public) than is provided by the typical notice and comment rulemaking 
process. Based on the worthwhile public input received earlier in the 
rulemaking process, the Commission is now soliciting additional 
comments on implementation issues associated with the proposed 
revisions to the training and experience requirements. The proposed 
training and experience requirements appear in subparts B, D-F, and H, 
and Appendix A of the proposed rulemaking (63 FR 43516; August 13, 
1998). The Commission is specifically interested in information on the 
process and criteria for approving boards and examining organizations 
or entities. Such information includes how the boards would implement 
the training and experience requirements; how the boards would 
implement the requirements in Appendix A for examining organizations 
and entities; and what are the resource implications of these proposed 
actions? Accordingly, the Commission is convening a public workshop 
where representatives of the interests that may be affected by the 
proposed changes in the training and experience requirements will have 
an opportunity to discuss implementation of these requirements. 
Although the meeting is intended to foster a clearer understanding of 
the positions and concerns of the affected interests, as well as to 
identify areas of agreement or disagreement, it is not the intent of 
the meeting to develop a consensus agreement of the participants on the 
rulemaking issues.
    To have a manageable discussion, the number of participants at the 
workshop will be limited. The Commission, through the facilitator for 
the meeting, will attempt to ensure participation by the broad spectrum 
of interests that may be affected by the rulemaking. Other members of 
the public are welcome to attend, and the public will have the 
opportunity to comment on the issues and the meeting discussions at 
periodic intervals during the workshop. Questions about participation 
may be directed to the facilitator, Francis X. Cameron. The agenda for 
the workshop will focus on:
    (1) The impact, on the medical community, of the proposed revisions 
to the training and experience criteria; and
    (2) The process and criteria used by NRC to approve certifying 
boards and examining organizations.

    Dated at Rockville, Maryland this 28th day of January, 1999.

    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. 99-2749 Filed 2-4-99; 8:45 am]
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