[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Proposed Rules]
[Pages 55559-55560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27809]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35


Medical Use of Byproduct Material; Workshop

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Notice of workshop.

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SUMMARY: The Nuclear Regulatory Commission has developed a proposed 
rulemaking for a comprehensive revision of its regulations governing 
the medical use of byproduct material in 10 CFR part 35, ``Medical Use 
of Byproduct Material,'' and a proposed revision of its 1979 Medical 
Use Policy Statement (MPS). Throughout the development of the proposed 
rule and MPS, the Commission solicited input from the various interests 
that may be affected by these proposed revisions. The Commission is now 
soliciting comments on the proposed rule and MPS through

[[Page 55560]]

two mechanisms--publishing the documents in the Federal Register for a 
90-day public comment period (63 FR 43516 and 63 FR 43580, August 13, 
1998); and convening facilitated public meetings and a workshop, during 
the public comment period, to discuss the Commission's proposed 
resolution of the major issues. The workshop on NRC's medical 
rulemaking initiative will be held during the Organization of Agreement 
States' (OAS) 1998 All Agreement States Meeting, in Bedford, New 
Hampshire.

DATES: The workshop will be held on October 31, 1998, from 9 a.m. to 12 
noon.

ADDRESSES: The Wayfarer Inn, 121 South River Road, Bedford, NH 03110, 
telephone 603-622-3766.

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: 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 MPS (Staff Requirements Memorandum (SRM)--COMSECY-96-057, 
``Materials/Medical Oversight'' (DSI 7), dated March 20, 1997). The 
Commission's SRM specifically directed the restructuring of Part 35 
into a risk-informed, more performance-based regulation. In its SRM 
dated June 30, 1997, ``SECY-97-115, Program for Revision of 10 CFR part 
35, `Medical Uses of Byproduct Material' and Associated Federal 
Register Notice,'' the Commission approved the staff's proposed plan 
for the revision of Part 35 and the Commission's 1979 MPS. The schedule 
the Commission approved in SRM-SECY-97-115 provides for the rulemaking 
to be completed by June 1999. After Commission approval of the staff's 
program to revise part 35 and associated guidance documents, the staff 
initiated the rulemaking process, as announced in 62 FR 42219 (August 
6, 1997).
    The proposed rule and MPS were developed using a group approach. A 
Working Group and Steering Group, consisting of representatives from 
NRC, OAS, and the Conference of Radiation Control Program Directors, 
Inc., were established to develop rule text alternatives, rule 
language, and associated guidance documents. State participation in the 
process was 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.
    The proposed revision of part 35 is based on the Commission's 
directions in the SRMs of March 20, 1997, and June 30, 1997. The 
revision is intended to make part 35 a more risk-informed, performance-
based regulation that will: (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; (5) 
reference, as appropriate, available industry guidance and standards; 
and (6) provide for capturing relevant safety-significant events.
    The program for revising part 35, associated guidance document, and 
MPS 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 during the early rulemaking process, the 
Commission believes that it is important for interests affected by the 
proposed revisions not only to have an opportunity to comment on the 
proposed rulemaking and MPS, but also to have an opportunity to discuss 
the proposed revisions with one another and the Commission. 
Accordingly, the Commission is convening three public meetings (63 FR 
39763, July 24, 1998) and a workshop, during the public comment period, 
where representatives of the interests that may be affected by the 
proposed rulemaking and MPS will have an opportunity to discuss the 
proposed revisions.
    The workshop will be open to the public, on a space available 
basis. The agenda for the workshop will focus on discussion of: (1) The 
proposed revision of part 35 and the MPS; (2) proposed changes in 
licensing, inspection and enforcement philosophy; (3) implementation 
costs; (4) resolution of cross-cutting issues; and (5) Agreement State 
issues. However, the workshop 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 
send comments to Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, Attention: Rulemakings and Adjudications 
Staff, or provide comments via NRC's interactive rulemaking website 
through the NRC home page (http://www.nrc.gov). The comment periods for 
the proposed rule and the MPS end on November 12 and November 13 ,1998, 
respectively. Comments received after these dates will be considered if 
it is practical to do so, but the Commission is only able to ensure 
consideration of comments received on or before these dates.

    Dated at Rockville, Maryland this 9th day of October, 1998.

    For the Nuclear Regulatory Commission.
Frederick C. Combs,
Acting Director, Division of Industrial and Medical Nuclear Safety, 
Office of Nuclear Material Safety and Safeguards.
[FR Doc. 98-27809 Filed 10-15-98; 8:45 am]
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