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

42219

Vol. 62, No. 151

Wednesday, August 6, 1997

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

RIN 3150–AF74

Medical Use of Byproduct Material:

Issues and Request for Public Input

AGENCY: Nuclear Regulatory

Commission.

ACTION: Request for public input on rule

development.

SUMMARY: The U.S. Nuclear Regulatory

Commission (NRC) has developed a

program for revising the regulations

governing the medical use of byproduct

material. The decision to revise this

regulation resulted from the NRC

Strategic Assessment and Rebaselining

Initiative (SA), a process involving

identification of the direction-setting

issues and associated options for the

future of NRC activities. This notice

describes the NRC’s program for

revising the medical use regulation;

notifies the public of the availability of

documents associated with this action

on the NRC Technical Conference

Forum and through the NRC Public

Document Room; and solicits informal

public input on development of

proposed rule language and associated

documents. The Commission plans to

formally propose specific rulemaking

text for public comment during the

summer of 1998.

DATES: Public input is solicited during

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.

ADDRESSES: Send written input and

suggestions 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.

Public input may also be submitted

electronically on the Internet via NRC’s

Technical Conference Forum (http://

techconf.llnl.gov/noframe.html). This

site provides the ability to post your

input as a message. For information

about the Technical Conference Forum

contact Mary L. Thomas at (301) 415–

6230; Email MLT1@nrc.gov.

FOR FURTHER INFORMATION CONTACT:

Catherine Haney, Diane Flack, or

Susanne Woods; Telephone (301) 415–

6825, (301) 415–5681, or (301) 415–

7267; Email CXH@NRC.GOV,

DSF1@NRC.GOV, or SRW@NRC.GOV;

Office of Nuclear Material Safety and

Safeguards, Nuclear Regulatory

Commission, Washington, DC 20555–

0001.

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 SA process. 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 NRC staff to

revise part 35, associated guidance

documents, and, if necessary, the

Commission’s 1979 Medical Policy

Statement. Further, the SRM stated:

With respect to the medical program, the

Commission was not persuaded by the

National Academy of Sciences, Institute of

Medicine (IOM) report that recommends that

NRC should not be the Federal agency

involved in the regulation of ionizing

radiation in medicine. The Commission

continues to believe that the conclusions in

the report were not substantiated and that the

recommendations should not be pursued.

The Commission SRM specifically

directed the restructuring of part 35 into

a risk-informed, more performancebased regulation. Further, during

development of the rule and associated

guidance, as well as during review of

the Medical Policy Statement, the NRC

staff was directed to consider the

following issues:

1. Focusing part 35 on those

procedures that pose the highest risk.

2. Regulatory oversight alternatives,

for diagnostic procedures, that are

consistent with the lower overall risk of

these procedures.

3. The best way to capture not only

relevant safety-significant events, but

also precursor events.

4. The need to change from the term

‘‘misadministration’’ to ‘‘medical event’’

or other comparable terminology.

5. Redesigning part 35 so that

regulatory requirements for new

treatment modalities can be

incorporated in a timely manner.

6. Revising the requirement for a

quality management program (10 CFR

35.32) to focus on those requirements

that are essential for patient safety.

7. The viability of using or referencing

available industry guidance and

standards, within part 35 and related

guidance, to the extent that they meet

NRC needs.

Program for Revision of Part 35

The 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. With this approval, the NRC staff

initiated development of draft language

using an entirely modality-based

approach. The modality approach

places all requirements for a given type

of treatment into a single section of the

regulation, including: Who or what

organization is licensed; what type of

license is issued; the necessary

technical requirements, such as surveys

and calibration; the training and

experience requirements; the event

recording and reporting requirements;

and the quality improvement and

management objectives. The NRC staff

anticipates that the following modalities

would be addressed:

(1) Low-dose unsealed materials

(diagnostic nuclear medicine);

(2) High-dose unsealed materials

(nuclear medicine therapy);

(3) Low-dose sealed source

applications;
42220 Federal Register / Vol. 62, No. 151 / Wednesday, August 6, 1997 / Proposed Rules

(4) Teletherapy;

(5) High-dose rate remote afterloaders;

(6) Gamma stereotactic surgery; and

(7) Emerging technologies.

This list is not viewed as allinclusive. Additional categories may be

developed, depending on the breadth of

the areas to be covered, and the

similarity of requirements in a given

area.

Development of rule text alternatives,

including draft guidance documents,

would be done using a governmental

working group (or groups) and steering

group approach. State participants have

been identified for both the working and

steering groups and will enhance State

participation in this process.

The NRC staff plans to solicit public

input on the revision to part 35,

associated guidance, and the 1979

Medical Policy Statement on an

informal and formal basis during the

rulemaking process. It is expected that

the first version of the draft rule

language will be available to the public

on the NRC Technical Conference

Forum and through the NRC Public

Document Room, in August 1997.

During the development process, the

NRC staff will make drafts publicly

available, but will need to cut off

consideration of informal public input

at a point approximately two to three

months before providing the draft

proposed rule language and associated

draft documents to the Commission for

approval. (Currently the draft proposed

rule and associated draft documents are

scheduled to be provided to the

Commission in May 1998.) Public input

received after that time would be

considered as part of the ongoing

interaction process, and as part of the

comments received during the formal

public comment period on the proposed

rule after Commission approval. The

NRC staff plans to interact with

professional societies on an ongoing

basis to solicit input. The NRC staff will

conduct facilitated public meetings in

the Fall of 1997. These meetings will be

used to focus discussion on specific rule

text proposals. Discussions would also

be held in meetings with the Advisory

Committee on the Medical Uses of

Isotopes (ACMUI) and the Organization

of Agreement States in the Fall of 1997.

After Commission approval of the

proposed rule language and associated

documents, the proposed rule and

associated draft documents will be

published in the Federal Register for

public comment for 75 days. The NRC

staff will also make these documents

available on the NRC rulemaking

website. The NRC staff plans to hold

two public meetings during the formal

comment period to facilitate comment

submittal.

Development of the final rule,

associated documents, and final

guidance will be done using a

governmental working group and

steering group. The NRC staff will

continue to make draft documents

available on the NRC Technical

Conference Forum, but will not be able

to consider further public input on these

documents, beginning approximately

four months before the submission of

the draft documents for Commission

approval (currently scheduled for May

1999). The NRC staff plans to discuss

the draft final documents with the

ACMUI and the Agreement States before

submitting them to the Commission.

Reference Information

1. Strategic Assessment Direction-Setting

Issues Paper Number 7 is available by writing

to the U.S. Nuclear Regulatory Commission,

Attention: NRC Public Document Room,

Washington, DC 20555–0001. (Telephone:

(202) 634–3273; fax: (202) 634–3343.)

2. The memorandum ‘‘Management Review

of Existing Medical Use Regulatory Program

(COMIS–92–026)’’ (dated June 16, 1993) is

available by writing to the U.S. Nuclear

Regulatory Commission, Attention: NRC

Public Document Room, Washington, DC

20555–0001. (Telephone: (202) 634–3273;

fax: (202) 634–3343.)

3. ‘‘Radiation in Medicine: A Need for

Regulatory Reform’’ (1996) is available from

the National Academy Press at 2101

Constitution Avenue, NW, Box 285,

Washington, DC 20055.

4. Summary minutes and transcripts of the

ACMUI April 1997 meeting or transcripts of

the May 8, 1997, Commission briefing are

available by writing to the U.S. Nuclear

Regulatory Commission, Attention: NRC

Public Document Room, Washington, DC

20555–0001. (Telephone: (202) 634–3273;

fax: (202) 634–3343.)Transcripts of the May

8, 1997, briefing are also available by Internet

at http://www.nrc.gov.

5. The NRC Medical Policy Act Statement

of 1979 was published in the Federal

Register, Volume 44, page 8242, on February

9, 1979.

6. SECY–97–115, Program for Revision of

10 CFR part 35, ‘‘Medical Uses of Byproduct

Material’’ and Associated Federal Register

Notice; SECY–97–131, Supplemental

Information on 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; and the associated SRM

(dated June 30, 1997) are available by writing

to the U.S. Nuclear Regulatory Commission,

Attention: NRC Public Document Room,

Washington, DC 20555–0001. (Telephone:

(202) 634–3273; fax: (202) 634–3343.)

Copies are also available on the NRC

Technical Conference Forum at http://

techconf.llnl.gov/noframe.html.

Dated at Rockville, MD., this 31st day of

July, 1997.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 97–20644 Filed 8–5–97; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF THE TREASURY

31 CFR Part 27

Departmental Offices; Civil Penalty

Assessment for Misuse of Department

of the Treasury Names, Symbols, Etc.

AGENCY: Departmental Offices, Treasury.

ACTION: Notice of proposed rulemaking

by cross-reference to interim

regulations.

SUMMARY: In the rules and regulations

portion of this Federal Register, the

Department of the Treasury is issuing

interim regulations setting forth the

procedures by which civil penalties will

be imposed for violations of the

statutory prohibition against misuse of

Department of the Treasury names,

symbols, titles, abbreviations, initials,

seals, or badges. Section 333(c) of title

31, United States Code authorizes the

Secretary of the Treasury to impose

these civil penalties. The regulations are

being promulgated to ensure that

persons assessed with a civil penalty

under 31 U.S.C. 333(c) are accorded due

process. The interim regulations also

serve as the text of this notice of

proposed rulemaking for final

regulations.

DATES: Written comments must be

received on or before October 6, 1997.

ADDRESSES: Send written comments to:

Karen Wehner, Senior Advisor, Office of

Enforcement, Room 4414, Department of

the Treasury, 1500 Pennsylvania

Avenue, N.W., Washington, D.C. 20220.

FOR FURTHER INFORMATION CONTACT:

Karen Wehner, Senior Advisor, Office of

Enforcement, 202–622–0300 (not a tollfree call).

SUPPLEMENTARY INFORMATION: The

interim regulations in this issue of the

Federal Register establish 31 CFR part

27. For the text of the interim

regulations, see Civil Penalty

Assessment for Misuse of Department of

the Treasury Names, Symbols, etc.,

Interim rule, published in the rules and

regulations section of this issue of the

Federal Register.

Executive Order 12866

It has been determined that this

proposed rule is not a significant

regulatory action as defined in E.O.

12866. Therefore, a regulatory

assessment is not required.