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Home > Electronic Reading Room > Document Collections > NUREG-Series Publications > Staff Reports > NUREG-1556 > Vol. 9, Rev. 1

Program-Specific Guidance About Medical Use Licenses - Final Report (NUREG-1556, Vol. 9, Rev. 1)

A revised NRC Form 313A was developed to replace the previous version.

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Publication Information

Manuscript Completed: May 2005
Date Published: May 2005

Prepared by
R. W. Broseus, N. Bhalla, P. A. Lanzisera,
A. R. Jones, R. G. Gattone, R. D. Reid

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

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 the 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. 9, Rev. 1 "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Medical Use Licenses," dated May 2005, is the ninth program-specific guidance document 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 contains information that is intended to assist applicants for licenses for the medical use of byproduct material in preparing their license applications. In particular, it describes the types of information needed to complete NRC Form 313, "Application for Material License" and NRC Form 313A, "Training and Experience and Preceptor Statement." The document provides an overview of the types of licenses issued by the NRC; the commitments and responsibilities that must be undertaken by a licensee; applicable regulations; the process for filing a license application; and the contents of applications for different types of medical uses of byproduct material. In particular, this document provides a description, on an item-by-item basis, of the information to be provided by an applicant on NRC Form 313. Because of the wide variety in the types of medical uses of byproduct material, indicators have been placed in the document to alert applicants for particular types of medical uses to material that pertains to those types of uses.

The document also contains appendices that include (1) copies of necessary forms; (2) a sample license application and completed licenses for different types of medical uses of byproduct materials; and (3) examples of the types of supporting documents, such as implementing procedures, that may need to be prepared by applicants. NRC is placing added emphasis on conducting its regulatory activities in a risk-informed and performance-based manner. This approach is intended to be less prescriptive and to allow for the implementation by licensees that may be specific to their needs while meeting the regulatory requirements. By supplying examples, NRC seeks to provide information to meet the needs of applicants for licensure, without being prescriptive. 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.

Volume 9 of NUREG-1556, Rev. 1 provides guidance for licensure under revised Title 10, Part 35, "Medical Use of Byproduct Material." It is also available for use by Agreement States and combines and supersedes guidance found in the documents listed below:

  • 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;"
  • RG 8.23, "Radiation Safety Surveys at Medical Institutions, Revision 1;"
  • RG 8.33, "Quality Management Program;"
  • RG 8.39, "Release of Patients Administered Radioactive Materials;"
  • Policy and Guidance Directive (P&GD) 03-02, "Licensing Lixiscope and BMA;"
  • Policy and Guidance Directive (P&GD) 03-08, "Standard Review Plan for Teletherapy;"
  • Policy and Guidance Directive (P&GD) 3-17, "Review of Training and Experience Documentation Submitted by Proposed Physician User Applicants;"
  • Policy and Guidance Directive (P&GD) FC 87-2, "Standard Review Plan for License Applications for the Medical Use of Byproduct Material;"
  • Policy and Guidance Directive (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;"
  • Policy and Guidance Directive (P&GD) FC 92-01 "Information Required for Licensing Mobile Nuclear Medicine Services," and
  • Policy and Guidance Directive (P&GD) 3-15, "Standard Review Plan for Review of Quality Management Programs."


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