[Federal Register: August 25, 1998 (Volume 63, Number 164)] [Notices] [Page 45270-45271] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25au98-110] ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, Availability of Draft NUREG AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability and request for comments. ----------------------------------------------------------------------- SUMMARY: The Nuclear Regulatory Commission is announcing the availability of and requesting comment on draft NUREG-1556, Volume 9, ``Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Medical Use Licenses,'' dated August 1998. This draft guide has been developed in parallel with the proposed revision of 10 CFR Part 35, ``Medical Use of Byproduct Material.'' Comments received in response to publication of this draft will be considered in developing the final guide. Finalization of the guidance will continue to parallel the rulemaking; resulting in a guidance document that is consistent with the final rule. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. This draft guidance, where applicable, provides a more risk- informed, performance-based approach to medical use licensing consistent with the proposed regulations. It combines and supersedes the guidance previously found in Regulatory Guide (RG) 10.8, Revision 2, ``Guide for the Preparation of Applications for Medical Use Programs''; Appendix X to RG 10.8, Revision 2, ``Guidance on Complying With New Part 20 Requirements''; Draft RG DG-0009, ``Supplement to Regulatory Guide 10.8, Revision 2, Guide for the Preparation of Applications for Medical Use Programs''; Draft RG FC 414-4, ``Guide for the Preparation of Applications for Licenses for Medical Teletherapy Programs''; Policy and Guidance Directive (P&GD) FC 87-2, ``Standard Review Plan for License Applications for the Medical Use of Byproduct Material''; P&GD FC 86-4, Revision 1, ``Information Required for Licensing Remote Afterloading Devices''; Addendum to Revision 1 to P&GD FC 86-4, ``Information Required for Licensing Remote Afterloading Devices-Increased Source Possession Limits''; P&GD 3-15, ``Standard Review Plan for Review of Quality Management Programs''; RG 8.39, ``Release of Patients Administered Radioactive Materials''; RG 8.33, ``Quality Management Program''; P&GD 3-17, ``Review of Training and Experience Documentation Submitted by Proposed Physician User Applicants''; and RG 8.23, ``Radiation Safety Surveys at Medical Institutions, Revision 1''. This draft guide has been distributed for public comment to encourage participation in its development. It is NOT for use in preparing or reviewing applications until it is published in final form. This guidance represents the current position of NRC staff, which is subject to change after the review of public comments. Comments received will be considered in developing the final guide that represents the official NRC staff position. DATES: The comment period ends on November 12, 1998, to be consistent with the rulemaking. Comments received after that time will be considered if practicable. ADDRESSES: Submit written comments to: Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U. S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Hand deliver [[Page 45271]] comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 a.m. and 4:30 p.m. on Federal workdays. Comments may also be submitted through the Internet by addressing electronic mail to DLM1@NRC.GOV. Those considering public comment may request a free single copy of draft NUREG-1556, Volume 9, by writing to the U.S. Nuclear Regulatory Commission, ATTN: Mrs. Sally L. Merchant, Mail Stop TWFN 9-F-31, Washington, DC 20555-0001. Alternatively, submit requests through the Internet by addressing electronic mail to slm2@nrc.gov. A copy of draft NUREG-1556, Volume 9, is also available for inspection and/or copying for a fee in the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC 20555-0001. FOR FURTHER INFORMATION CONTACT: Mrs. Sally L. Merchant, Mail Stop TWFN 9-F-31, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-7874; electronic mail address: slm2@nrc.gov. Electronic Access Draft NUREG-1556, Vol. 9 will be available electronically by visiting NRC's Home Page (http://www.nrc.gov/NRC/nucmat.html) approximately two weeks after the publication date of this notice. Dated at Rockville, Maryland, this 17th day of August, 1998. For the Nuclear Regulatory Commission. Donald A. Cool, Director, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards. [FR Doc. 98-22765 Filed 8-24-98; 8:45 am] BILLING CODE 7590-01-P