United States Nuclear Regulatory Commission - Protecting People and the Environment

Consolidated Guidance About Materials Licenses: Program - Specific Guidance About Medical Use Licenses (NUREG-1556, Volume 9, Revision 2)

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Publication Information

Manuscript Completed: January 2008
Date Published:
January 2008

Prepared by:
D.B. Howe, M. Beardsley, S.R. Bakhsh

Office of Federal and State Materials and Environmental Management Programs
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) consolidated and updated 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, Volume 9, Revision 2, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Medical Use Licenses," is the third version of the ninth program-specific guidance document developed for the new process; it 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 those preparing applications for licenses for the medical use of byproduct material. In particular, it describes the types of information needed to complete NRC Form 313, "Application for Materials License," and the NRC Form 313A series of forms: NRC Form 313A (RSO), "Radiation Safety Officer Training and Experience and Preceptor Attestation [10 CFR 35.50]"; NRC Form 313A (AMP), "Authorized Medical Physicist Training and Experience and Preceptor Attestation [10 CFR 35.51]"; NRC Form 313A (ANP), "Authorized Nuclear Pharmacist Training and Experience and Preceptor Attestation [10 CFR 35.55]"; NRC Form 313A (AUD), "Authorized User Training and Experience and Preceptor Attestation (for uses defined under 10 CFR 35.100, 35.200, and 35.500) [10 CFR 35.190, 35.290, and 35.590]"; NRC Form 313A (AUT), "Authorized User Training and Experience and Preceptor Attestation (for uses defined under 10 CFR 35.300) [10 CFR 35.390, 35.392, 35.394, and 35.396]"; and NRC Form 313A (AUS), "Authorized User Training and Experience and Preceptor Attestation (for uses defined under 10 CFR 35.400 and 35.600) [10 CFR 35.490, 35.491, and 35.690]."

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 sample licenses for different types of medical uses of byproduct materials; (3) examples of the types of supporting documents, such as implementing procedures, that may need to be prepared by applicants; and (4) information required by regulation for requesting authorization for preparation of Positron Emission Tomography (PET) radioactive drugs for noncommercial distribution to other members of a consortium. The 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 implementation by licensees that may be specific to their needs while meeting the regulatory requirements. By supplying examples, the 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.

The original Volume 9 of NUREG-1556 provided guidance for licensure under revised Title 10, Part 35, "Medical Use of Byproduct Material." It combined and superseded 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."

Revision 1 of NUREG-1556, Volume 9, revised Volume 9 to reflect the March 30, 2005, Final Rule, Medical Use or Byproduct Material Recognition of Specialty Boards (70 FR 16336), that revised the training and experience requirements for recognition of specialty boards. Revision 2 of NUREG-1556, Volume 9, revises Volume 9 to provide additional guidance to reflect regulatory changes made by the Naturally Occurring and Accelerator-Produced Material (NARM) Rule, "Requirements for Expanded Definition of Byproduct Material" (72 FR 55864), replaces NRC Form 313A with six new NRC Form 313A forms, makes additional changes to enhance clarification of the training and experience requirements, and removes all references to, and information contained in, 10 CFR Part 35, Subpart J, which expired on October 25, 2005.

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