01-3136. Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution

AGENCY:

Nuclear Regulatory Commission (NRC).

ACTION:

Notice of Availability of final NUREG.

SUMMARY:

The NRC is announcing the availability of the final NUREG-1556, Volume 12, “Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution,” dated December 2000.

The NRC is using Business Process Redesign techniques to redesign its materials licensing process, as described in NUREG-1539, “Methodology and Findings of the NRC's Materials Licensing Process Redesign.” A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG-series of reports. This final NUREG report is the 12th program-specific guidance developed to support an improved materials licensing process.

This guidance is intended for use by applicants, licensees, and the NRC staff, and will also be available to Agreement States. This document combines and updates the guidance found in Regulatory Guide 10.7, “Guide for the Preparation of Applications for Licenses for Laboratory and Industrial Use of Small Quantities of Byproduct Material,” dated August 1979; Nuclear Material Safety and Safeguards (NMSS) Policy and Guidance Directive FC 84-1, “Review Responsibility—Manufacturing and Distribution of Products to Persons Exempt Pursuant to 10 CFR 32.11 through 32.26,” dated April 1984; NMSS Policy and Guidance Directive FC 85-6, “Standard Review Plan for Applications for Licenses and Approvals to Authorize Distribution of Various Items to Group Medical Licensees,” dated February 1985; and Draft Regulatory Guide DG-0007, “Guide for the Preparation of Applications for Licenses to Authorize Distribution of Various Items to Commercial Nuclear Pharmacies and Medical Use Licensees,” dated March 1997. This final report takes a more risk-informed, performance-based approach to licensing possession for manufacturing and distribution, and reduces the amount of detailed information needed to support an application.

A free single copy of final NUREG-1556, Volume 12, may be requested by writing to the U.S. Nuclear Regulatory Commission, ATTN: Mrs. Carrie Brown, Mail Stop TWFN 9-F-31, Washington, DC 20555-0001. Alternatively, submit requests through the Internet by addressing electronic mail to [e-mail]. A copy of final NUREG-1556, Volume 12, is also available for inspection and/or copying for a fee in the NRC Public Document Room, 11555 Rockville Pike, Room 01-F21, Rockville, Maryland 20852.

FOR FURTHER INFORMATION, CONTACT:

Mrs. Carrie Brown, Mail Stop TWFN 9-F-31, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone [phone]; electronic mail address: [e-mail].

Electronic Access

Final NUREG-1556, Vol. 12 is available electronically by visiting the NRC's Home Page (http://www.nrc.gov/​nrc/​nucmat.html).

Dated at Rockville, Maryland, this 31st day of January, 2001.

For the Nuclear Regulatory Commission.

Patricia K. Holahan,

Chief, Rulemaking and Guidance Branch, Division of Industrial and Medical Nuclear Safety, NMSS.