United States Nuclear Regulatory Commission - Protecting People and the Environment

Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution (NUREG-1556, Volume 12)

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Publication Information

Manuscript Completed: December 2000
Date Published: December 2000

Prepared by:
D.J. Collins, C.F. Gill, A.S. Kirkwood, L. Manning III, E.H. Reber, M.E. Schwartz, R.E. Zelac

Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001

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Abstract

As part of its redesign of the materials licensing process, the United States Nuclear Regulatory Commission (NRC) is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. NUREG-1556, Vol. 12, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution," dated December 2000, is the twelfth program-specific guidance developed for the new process and is intended for use by applicants, licensees, and NRC staff, and will also be available to Agreement States. This document combines and updates the guidance found in: (1) 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; (2) 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; (3) 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 (4) 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 report takes a more risk-informed, performance-based approach to licensing possession and reduces the amount of detailed information needed to support an application. If a license of broad scope is being sought (under 10 CFR 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." When published, this final report should be used in preparing manufacturing and distribution license applications. NRC staff will use this final report in reviewing these applications.

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