[Federal Register Volume 62, Number 198 (Tuesday, October 14, 1997)]
[Proposed Rules]
[Pages 53249-53250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27084]


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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. 198 / Tuesday, October 14, 1997 / 
Proposed Rules

[[Page 53249]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35


Medical Use of Byproduct Material; Workshops

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Notice of workshops.

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SUMMARY: The Nuclear Regulatory Commission has initiated a rulemaking 
for a comprehensive revision of 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 part 35. The first NRC public 
workshop will be held in Philadelphia, Pennsylvania on October 28, 29, 
and 30, 1997. The second NRC public workshop will be held in Chicago, 
Illinois on November 12, 13, and 14, 1997. Both workshops will be open 
to the public. 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 first workshop will be in Philadelphia on October 28, 1997, 
from 9 a.m. to 5 p.m.; October 29, 1997, from 8:30 a.m. to 5 p.m.; and 
October 30, 1997, from 8:30 a.m. to noon. The second workshop will be 
in Chicago on November 12, 1997, from 9 a.m. to 5 p.m.; November 13, 
1997, from 8:30 a.m. to 5 p.m.; and November 14, 1997, from 8:30 a.m. 
to noon.

ADDRESSES: The Philadelphia workshop will be held at the Korman Suites 
Hotel, 2001 Hamilton Street, Philadelphia, PA 19130, 215-569-7000. The 
Chicago workshop will be held at the Ramada Congress Hotel, 520 South 
Michigan Avenue, Chicago, IL 60605, 312-427-3800.

FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel 
for Public Liaison, Office of the General Counsel, Nuclear Regulatory 
Commission, Washington D.C. 20555, Telephone: 301-415-1642.

SUPPLEMENTARY INFORMATION:

Background

    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 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 staff of the Commission's 
approval, with comments, of the 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 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 rulemaking 
is being conducted using a group approach. A Working Group and Steering 
Group, consisting of representatives of NRC, the Organization of 
Agreement States, and the 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 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 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. In 
addition, alternative recommendations for revision of NRC's 1979 
Medical Policy Statement have been developed. 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 contribute to 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.

Workshops

    The Commission believes that it is important for interests affected 
by the medical use rulemaking to not only have an early opportunity to 
comment on the rulemaking issues, but also to have an opportunity to 
discuss the rulemaking issues with one another and the Agency. 
Accordingly, the Commission is convening two public workshops where the 
representatives of the interests that may be affected by the rulemaking 
will have an opportunity to discuss the rulemaking issues. Although the 
workshops are intended to foster a clearer understanding of the 
positions and concerns of the affected interests, as

[[Page 53250]]

well as to identify areas of agreement or disagreement, it is not the 
intent of the workshop process to develop a consensus agreement of the 
participants on the rulemaking issues.
    To have a manageable discussion, the number of participants in each 
workshop will be limited. The Commission, through the facilitator for 
the workshop, will attempt to ensure participation by the broad 
spectrum of interests that may be affected by the rulemaking. These 
interests include: Nuclear medicine physicians; physician specialists, 
such as cardiologists and radiologists; medical physicists; medical 
technologists; nurses; medical education and certification 
organizations; radiopharmaceutical interests; hospital administrators; 
patients rights advocates; Agreement States; Federal agencies; and 
experts in risk analysis. Other members of the public are welcome to 
attend, and the public will have the opportunity to comment on the 
rulemaking issues and the workshop discussions at periodic intervals 
during the workshops. Questions about participation may be directed to 
the facilitator, Francis X. Cameron.
    To ensure that each workshop addresses the issues in a consistent 
manner, the workshops will have a common pre-defined scope and agenda 
focused primarily on the alternatives, with draft regulatory text, 
developed by the Part 35 Working and Steering Groups. However, the 
workshop format will be sufficiently flexible to allow for the 
introduction of additional related issues that the participants may 
want to raise. The workshop commentary will be transcribed and made 
available to the participants and the public.
    Copies of the issue papers developed by the staff will be provided 
to the workshop participants. Also, copies will be available for 
members of the public in attendance at the workshops, as well as 
available through NRC's Public Document Room (U.S. Nuclear Regulatory 
Commission, Attention: NRC Public Document Room, Washington, DC 20555-
0001) and on the Internet via NRC's Technical Conference Forum (<a href="http://
techconf.llnl.gov/noframe.html">http://
techconf.llnl.gov/noframe.html</a>).
    Public input is solicited during the development of the proposed 
rule but, to be most helpful, should be received by March 1, 1998. 
Comments received after this date will be considered if it is practical 
to do so, but the Commission only is able to ensure consideration of 
comments received on or before this date. Written input and suggestions 
can be sent to Secretary, Nuclear Regulatory Commission, Washington, DC 
20555-0001, Attention: Rulemakings and Adjudications Staff. Hand-
deliver comments to 11555 Rockville Pike, Rockville, MD, between 7:30 
a.m. and 4:15 p.m. on Federal workdays.

    Dated at Rockville, Md., this 6th 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. 97-27084 Filed 10-10-97; 8:45 am]
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