[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
________________________________________________________________________
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 fxc@nrc.gov.
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]
BILLING CODE 7590-01-P
