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Guidance for Inspections of Medical Licensees; Announcement of 10 CFR Part 35 Public Workshop

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Nuclear Regulatory Commission.


Announcements of public workshop.


The Nuclear Regulatory Commission (NRC) is conducting a public meeting on June 6, 2002, to obtain stakeholder comments on draft guidance for inspections of Medical Use licensees. This guidance is being revised in order to facilitate inspections under a recently published, major revision to the regulations governing the medical use of byproduct material (67 FR 20249; April 24, 2002). The final rule becomes effective on October 24, 2002, six months from the date of publication. The meeting on inspection guidance is one of three workshops being conducted on guidance related to the revised rule. The other workshops, related to draft NUREG-1556, Volume 9, “Consolidated Guidance About Materials Licenses; Program-Specific Guidance About Medical Use Licenses,” were held at NRC headquarters in Rockville MD on April 25 and 30, 2002. The NRC is especially interested in stakeholder comments that will improve guidance to make it more risk-informed and performance-based.


Commenters should submit comments on the draft inspection procedures by June 21, 2002. The draft inspection procedures will be made publically available in mid-May, 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 one day public workshop will be held on Thursday, June 6, 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 intent of the open house is to present the opportunity for informal interactions between attendees, both NRC staff and members of the public. To ensure that adequate copies of handouts are available, persons planning to attend the workshop should contact the person designated below by June 4, 2002.


Written comments on the draft inspection guidance may be submitted to the Chief, Rules and Directives Branch, Office of Administration, U.S. Nuclear Regulatory Commission, Mail Stop T6-D59, Washington, DC 20555. The draft inspection guidance will be available for review and comment on the Internet at the NRC's Rulemaking Forum at​cgi-bin/​library?​source=​*&​library=​rg_​lib&​file=​*. A link will be provided at that site to enable submission of public comments. For information about the web site, contact Carol Gallagher via e-mail at

The public workshop 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;​ click on “Public Meeting Schedule.”

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Wade T. Loo, Office of Nuclear Materials Safety and Safeguards, Division of Industrial and Medical Nuclear Safety, Rulemaking and Guidance Branch, Mail Stop T9-C24, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: (404) 562-4727; 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:; telephone: (301) 415-1642. Individuals who need accommodations under the American with Disabilities Act may contact Roberta Gordon in advance at 301-415-7555; from outside of the Washington, DC metropolitan area, call 1-800-368-5642 and ask for extension 7555, e-mail: Persons planning to attend the meeting should contact Ms. Gordon and provide information that will facilitate entrance into the building on the day of the meeting.

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Draft Inspection Guidance for Implementation of Revised Part 35

The NRC is posting draft inspection guidance for public comment on the NRC's Rulemaking Forum web site. In addition to obtaining written comments, the NRC staff will be conducting a public workshop on June 6, 2002, to obtain stakeholder comments on the draft guidance. The workshop will be held in the Auditorium at NRC Headquarters in Rockville, MD.

The NRC staff is seeking input on the draft guidance in order to make it useful for the conduct of inspections for compliance with the revised 10 CFR part 35, “Medical Use of Byproduct Material.” In particular, staff is especially interested in receiving comments on how to make inspection procedures both performance-based and risk-informed.

To facilitate the NRC's handling of comments, we request that commenters relate their comments to specific sections in the draft inspection guidance or in 10 CFR part 35. This will help place the comments in context and aid in understanding how they relate to the guidance.

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For the Nuclear Regulatory Commission.

Dated at Rockville, Maryland, this 10th day of May, 2002.

Patricia K. Holahan,

Chief, Rulemaking and Guidance Branch, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Materials Safety and Safeguards.

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[FR Doc. 02-12418 Filed 5-16-02; 8:45 am]