97-20644. Medical Use of Byproduct Material: Issues and Request for Public Input

[Federal Register Volume 62, Number 151 (Wednesday, August 6, 1997)]
[Proposed Rules]
[Pages 42219-42220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20644]


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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. 62, No. 151 / Wednesday, August 6, 1997 / 
Proposed Rules

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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.

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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 [phone]; Email [e-mail].

FOR FURTHER INFORMATION CONTACT: Catherine Haney, Diane Flack, or 
Susanne Woods; Telephone [phone], or (301) 415-
7267; Email [email protected], [email protected], or [email protected]; 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 performance-based 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;

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    (4) Teletherapy;
    (5) High-dose rate remote afterloaders;
    (6) Gamma stereotactic surgery; and
    (7) Emerging technologies.
    This list is not viewed as all-inclusive. 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: [phone]; fax: [phone].)
    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: [phone]; fax: [phone].)
    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: [phone]; fax: [phone].)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: [phone]; 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]
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