ConsolidatedGuidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, Final Report (NUREG-1556, Volume 9, Revision 3)

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Publication Information

Manuscript Completed: September 2019
Date Published: September 2019

Prepared by:
M. Burkhart
A. Cockerham
J. Cook
S. Daibes
S. Forster
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

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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) and Ophthalmic Physicist, authorized nuclear pharmacists (ANP), and Radiation Safety Officers (RSO) and associate 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 checklist for preparing an application; (iii) step-by-step instructions for adding authorized individuals; and (iv) 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.