United States Nuclear Regulatory Commission - Protecting People and the Environment

Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, Draft Report for Comment (NUREG-1556, Volume 9, Revision 3)

This NUREG-series publication was issued for public comment. The comment period is now closed.

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Publication Information

Manuscript Completed: November 2016
Date Published:
November 2016

Prepared by:
M. Burkhart
A. Cockerham
J. Cook
S. Daibes
S. Gabriel
D. B. Howe
P. Lanzisera
T. Simmons
K. Tapp
R. Zelac

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

Abstract

This technical report contains information intended to provide program-specific guidance and assist applicants and licensees in preparing applications for materials licenses for the medical use of byproduct material. In particular, it describes the types of information needed to complete U.S. Nuclear Regulatory Commission (NRC) Form 313, "Application for Materials License," and the NRC Form 313A series for authorized users (AU), authorized medical physicists (AMP), authorized nuclear pharmacists (ANP), and Radiation Safety Officers (RSO). This document describes both the methods acceptable to the NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating the application to determine if the proposed activities are acceptable for licensing purposes.

The document contains appendices that include (i) copies of necessary forms; (ii) a sample license application for different types of medical uses of byproduct materials; and (iii) examples of the types of supporting documents, such as procedures, that may need to be prepared by applicants. Guidance in this document represents one means acceptable to NRC staff of complying with NRC regulations and is not intended to be the only means of satisfying requirements for a license.

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