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.

Proposed Rules Federal Register

52513

Vol. 62, No. 195

Wednesday, October 8, 1997

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

Medical Use of Byproduct Material;

Workshop

AGENCY: Nuclear Regulatory

Commission.

ACTION: Notice of workshop.

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 cxh@nrc.gov.

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 DirectionSetting 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 riskinformed, 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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