02-8243. 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.

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=​MUPRULE. 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 [e-mail].

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: [phone]; E-mail: [e-mail]. Questions about the public meeting process should be directed to Francis Cameron; Office of the General Counsel, USNRC, Washington DC 20555-000; E-mail: [e-mail]; telephone: [phone].

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.