[Federal Register Volume 67, Number 66 (Friday, April 5, 2002)]
[Notices]
[Pages 16467-16468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8243]


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NUCLEAR REGULATORY COMMISSION


Issuance, Availability of Draft NUREG; Announcements of Public 
Workshops

AGENCY: Nuclear Regulatory Commission.

ACTION: Issuance of draft NUREG for comment and announcements of public 
workshops.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is re-issuing for 
comment a draft of NUREG-1556, Volume 9, ``Consolidated Guidance About 
Materials Licenses; Program-Specific Guidance About Medical Use 
Licenses.'' This licensing guide is a companion to the recently 
published revision to 10 CFR part 35, ``Medical Use of Byproduct 
Material.'' The NRC is also developing additional guidance for medical 
use licensees and will be holding public workshops to obtain 
stakeholder input on content of this guidance. The NRC is especially 
interested in stakeholder comments that will improve the guidance to 
make it useful to applicants for medical use licenses, including 
licensees in Agreement States. The NRC is focusing on making the 
guidance more risk-informed and performance-based.

DATES: Commenters should submit comments on Draft NUREG-1556, Volume 9 
by June 4, 2002. Comments received after this date will be considered 
if it is practical to do so, but the Commission is able to assure 
consideration only for comments received on or before this date. A 1-
day public workshop will be held on Thursday, April 25, 2002, from 9 
a.m. to 5 p.m. at NRC's headquarters; the workshop will be preceded by 
an open house from 8 a.m. to 9 a.m. The emphasis in this workshop will 
be on guidance related to therapeutic applications of byproduct 
materials. To ensure that adequate copies of handouts are available, 
persons planning to attend the workshop should contact the person 
designated below by April 18, 2002. A second 1-day public workshop will 
be held at the same location on April 30, 2002, from 9 a.m. to 5 p.m.; 
the workshop will be preceded by an open house from 8 a.m. to 9 a.m. 
The emphasis of this workshop will be on guidance related to diagnostic 
applications of byproduct material. To ensure that adequate copies of 
handouts are available, persons planning to attend the workshop should 
contact the person designated below by April 23, 2002. The intent of 
the open houses is to present the opportunity for informal interactions 
between attendees, both NRC staff and members of the public. A third 
workshop, relating to guidance for inspection of entities licensed 
under 10 CFR part 35, is planned for late May and will be announced in 
the Federal Register as well as on the NRC's web site (see ADDRESSES, 
below). It is also planned to post draft inspection guidance on the 
NRC's web site for comment.

ADDRESSES: Written comments on NUREG-1556, Volume 9 may be submitted to 
the Chief, Rules and Directives Branch, Division of Administrative 
Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555. You 
may also provide comments through the NRC's rulemaking forum / web site 
at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=MU--PRULE. The NRC 
also plans to post draft inspection guidance at this web site for 
public viewing prior to the public meeting on inspection guidance 
planned for late May. Provisions are available at this site to upload 
comments as files (any format) if your web browser supports that 
function. For information about the web site, contact Carol Gallagher 
via E-mail at [email protected].
    The public workshops will be held at the NRC Auditorium, Two White 
Flint North, 11545 Rockville Pike, Rockville, Maryland. Information 
about the workshops will also be posted at NRC's web site at http://www.nrc.gov; click on ``Public Meeting Schedule.''

FOR FURTHER INFORMATION CONTACT: Roger W. Broseus, Office of Nuclear 
Material Safety and Safeguards, Office of Industrial and Medical 
Nuclear Safety, Rulemaking and Guidance Branch, Mail Stop T9-C24, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 
(301) 415-7608; E-mail: [email protected]. Questions

[[Page 16468]]

about the public meeting process should be directed to Francis Cameron; 
Office of the General Counsel, USNRC, Washington DC 20555-000; E-mail: 
[email protected]; telephone: (301) 415-1642.

SUPPLEMENTARY INFORMATION:

Draft NUREG-1556, Consolidated Guidance About Materials Licenses--
Volume 9, Program--Specific Guidance About Medical Use Licenses

    The NRC is issuing a draft of NUREG-1556, Volume 9, for public 
comment for a 60-day period. In addition to obtaining written comments, 
the staff will be conducting a public workshop on April 25, 2002, to 
obtain stakeholder comments on this Volume, with emphasis on 
therapeutic applications of byproduct materials. A second public 
workshop will be held on April 30, 2002, to receive stakeholder input 
on guidance, with emphasis on diagnostic applications of byproduct 
materials. Both workshops will be held in the Auditorium at NRC 
Headquarters in Rockville, MD.
    The NRC staff is seeking input on the guidance contained in the 
draft NUREG, previously published for public comment in August 1998, in 
order to make the guidance as useful as possible to those who may seek 
NRC licensure under 10 CFR part 35, ``Medical Use of Byproduct 
Material.'' Comments received since publication of the 1998 draft have 
been considered by staff; these comments and NRC's responses appear in 
Appendix Z of the current draft. Comments about any of the guidance in 
Volume 9 are welcome; staff is especially interested in receiving 
comments on the following questions:
    1. Level of Detail and Format: Is the format and level of detail in 
the guidance appropriate for first-time applicants? Should the guidance 
be more general in describing acceptable methods of meeting 10 CFR part 
35 requirements? If so, please provide suggestions for revisions. 
Discussion about the pros and cons of providing extensive detail about 
safety and other procedures would be especially helpful.
    2. Model Procedures: Are the model procedures helpful as written? 
Should they be retained or rewritten? If so, please provide suggestions 
for revisions.
    3. Licensing Guidance Specific to Diagnostic Nuclear Medicine: The 
staff is considering development of a summary of the licensing 
requirements for diagnostic medical use of byproduct materials? Is such 
a document desirable? What should be provided in the guidance? How long 
should it be?
    4. Other Guidance: Are there additional voluntary industry 
consensus standards or other publically available documents that should 
be considered for reference in NUREG-1556, Volume 9?
    To facilitate the NRC's handling of comments, we request that 
commenters relate their comments to specific sections and/or appendices 
in the NUREG. This will help place the comments in context and aid in 
understanding how they relate to the guidance.
    The NRC is placing added emphasis on conducting its regulatory 
activities in a risk-informed and performance-based manner. This 
approach is intended to be less prescriptive and allow for the 
implementation of programs by licensees that may be specific to their 
needs while meeting the regulatory requirements. In the past, 
applicants have requested guidance from the NRC staff on what 
procedures are acceptable, with the expectation that licensing process 
delays would thereby be avoided. Others have expressed the view that 
the provision of specific guidance results in the perception that the 
only way to receive a license is to adhere to the guidance. The NRC 
staff seeks to meet the needs of applicants for licensure, while not 
suggesting that details in the guidance are prescriptive. Comments on 
Volume 9 will help NRC staff to provide guidance that is helpful while 
not providing too much detail.

    Dated at Rockville, Maryland, this 28th day of March, 2002.

For The Nuclear Regulatory Commission
Patricia K. Holahan,
Chief, Rulemaking and Guidance Branch, Division of Industrial and 
Medical Nuclear Safety, Office of Nuclear Materials Safety and 
Safeguards.
[FR Doc. 02-8243 Filed 4-4-02; 8:45 am]
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