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Program - Specific Guidance About Medical Use Licenses (NUREG-1556, Vol. 9, Rev. 2) Final Report

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• Publication Information
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NUREG-1556, Vol. 9, Rev. 2

• Abstract - License Fees (PDF - 2.25 MB)
• Contents of an Application (PDF - 5.87 MB)
• Appendices A-H (PDF - 5.54 MB)
• Appendices I-W (PDF - 5.62 MB)
• Appendices X-Z (PDF - 2.66 MB)

Table of Contents

• PUBLICATION INFORMATION
• ABSTRACT
• FOREWORD
• ACKNOWLEDGMENTS
• ABBREVIATIONS
• 1 OVERVIEW
  • 1.1 PURPOSE OF REPORT
  • 1.2 TYPES OF LICENSES
    • 1.2.1 SPECIFIC LICENSE OF LIMITED SCOPE
    • 1.2.2 SPECIFIC LICENSE OF BROAD SCOPE
    • 1.2.3 RESEARCH INVOLVING HUMAN SUBJECTS
    • 1.2.4 GENERAL IN VITRO LICENSE
  • 1.3 OTHER REQUIREMENTS
    • 1.3.1 THE “AS-LOW-AS-REASONABLY-ACHIEVABLE (ALARA)” CONCEPT
    • 1.3.2 WRITTEN DIRECTIVE PROCEDURES
    • 1.3.3 TIMELY NOTIFICATION OF TRANSFER OF CONTROL
    • 1.3.4 TIMELY NOTIFICATION OF BANKRUPTCY PROCEEDINGS
  • 1.4 OFFICE OF MANAGEMENT AND BUDGET CLEARANCES
• 2 AGREEMENT STATES
• 3 MANAGEMENT RESPONSIBILITY
• 4 APPLICABLE REGULATIONS
• 5 HOW TO FILE
  • 5.1 PREPARING AN APPLICATION
  • 5.2 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION
  • 5.3 PAPER FORMAT AND ELECTRONIC FORMAT
• 6 WHERE TO FILE
• 7 LICENSE FEES
• 8 CONTENTS OF AN APPLICATION
  ITEMS FOR WHICH A RESPONSE FROM MEDICAL USE APPLICANT IS REQUIRED ON NRC FORM 313
  • 8.1 ITEM 1: LICENSE ACTION TYPE
  • 8.2 ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS
  • 8.3 ITEM 3: ADDRESS(ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED
  • 8.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION
  • 8.5 ITEM 5: RADIOACTIVE MATERIAL
  • 8.6 ITEM 5: SEALED SOURCES AND DEVICES (including Ra-226 sealed sources and devices)
  • 8.7 ITEM 5: DISCRETE SOURCE OF Ra-226 (OTHER THAN SEALED SOURCES)
  • 8.8 ITEM 5: RECORDKEEPING FOR DECOMMISSIONING AND FINANCIAL ASSURANCE
  • 8.9 ITEM 6: PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
  • 8.10 ITEM 7: INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE
  • 8.11 ITEM 7: RADIATION SAFETY OFFICER (RSO)
  • 8.12 ITEM 7: AUTHORIZED USERS (AUs)
  • 8.13 ITEM 7: AUTHORIZED NUCLEAR PHARMACIST (ANP)
  • 8.14 ITEM 7: AUTHORIZED MEDICAL PHYSICIST (AMP)
  • 8.15 ITEM 9: FACILITIES AND EQUIPMENT
  • 8.16 ITEM 9: FACILITY DIAGRAM
  • 8.17 ITEM 9: RADIATION MONITORING INSTRUMENTS
  • 8.18 ITEM 9: DOSE CALIBRATOR AND OTHER EQUIPMENT USED TO MEASURE DOSAGES OF UNSEALED BYPRODUCT MATERIAL
  • 8.19 ITEM 9: THERAPY UNIT -- CALIBRATION AND USE
  • 8.20 ITEM 9: OTHER EQUIPMENT AND FACILITIES
  • 8.21 ITEM 10: RADIATION PROTECTION PROGRAM
  • 8.22 ITEM 10: SAFETY PROCEDURES AND INSTRUCTIONS
  • 8.23 ITEM 10: OCCUPATIONAL DOSE
  • 8.24 ITEM 10: AREA SURVEYS
  • 8.25 ITEM 10: SAFE USE OF UNSEALED LICENSED MATERIAL
  • 8.26 ITEM 10: SPILL/CONTAMINATION PROCEDURES
  • 8.27 ITEM 10: INSTALLATION, MAINTENANCE, ADJUSTMENT, REPAIR, AND INSPECTION OF THERAPY DEVICES CONTAINING SEALED SOURCES
  • 8.28 ITEM 10: MINIMIZATION OF CONTAMINATION
  • 8.29 ITEM 11: WASTE MANAGEMENT
  • 8.30 ITEM 12: FEES
  • 8.31 ITEM 13: CERTIFICATION
    PROGRAM-RELATED GUIDANCE - NO RESPONSE REQUIRED FROM APPLICANTS ON NRC FORM 313
  • 8.32 ITEM 8: SAFETY INSTRUCTION FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
  • 8.33 PUBLIC DOSE
  • 8.34 OPENING PACKAGES
  • 8.35 PROCEDURES FOR ADMINISTRATIONS WHEN A WRITTEN DIRECTIVE IS REQUIRED
  • 8.36 RELEASE OF PATIENTS OR HUMAN RESEARCH SUBJECTS
  • 8.37 MOBILE MEDICAL SERVICE
  • 8.38 AUDIT PROGRAM
  • 8.39 OPERATING AND EMERGENCY PROCEDURES
  • 8.40 MATERIAL RECEIPT AND ACCOUNTABILITY
  • 8.41 ORDERING AND RECEIVING
  • 8.42 SEALED SOURCE INVENTORY
  • 8.43 RECORDS OF DOSAGES AND USE OF BRACHYTHERAPY SOURCE
  • 8.44 RECORDKEEPING
  • 8.45 REPORTING
  • 8.46 LEAK TESTS
  • 8.47 SAFETY PROCEDURES FOR TREATMENTS WHEN PATIENTS ARE HOSPITALIZED
  • 8.48 TRANSPORTATION
• 9 AMENDMENTS AND RENEWALS TO A LICENSE
• 10 APPLICATIONS FOR EXEMPTIONS
• 11 TERMINATION OF ACTIVITIES

APPENDIX

APPENDICES A-H FORMS AND SAMPLES

• Appendix A: NRC Form 313"Application for Materials License"
• Appendix B: NRC Form 313A Series "Medical Use Training and Experience and Preceptor Attestation"
• Appendix C: License Application Checklists
• Appendix D: Documentation of Training and Experience To Identify Individuals on a License as Authorized User, Radiation Safety Officer, Authorized Medical Physicist, or Authorized Nuclear Pharmacist
• Appendix E: Sample License Application
• Appendix F: Sample Licenses
• Appendix G: Information Needed for Transfer of Control
• Appendix H: NRC Form 314 "Certificate of Disposition of Materials"

APPENDICES I-W MODEL PROCEDURES FOR INFORMATION PURPOSES ONLY

• Appendix I: Typical Duties and Responsibilities of the Radiation Safety Officer and Sample Delegation of Authority
• Appendix J: Model Training Program
• Appendix K: General Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program
• Appendix L: Model Medical Licensee Audit
• Appendix M: Model Procedures for an Occupational Dose Program
• Appendix N: Model Emergency Procedures
• Appendix O: Model Procedures for Ordering and Receiving Packages
• Appendix P: Model Procedure for Safely Opening Packages Containing Radioactive Material
• Appendix Q: Model Leak Test Program
• Appendix R: Model Procedure for Area Surveys
• Appendix S: Model Procedures for Developing, Maintaining, and Implementing Written Directives
• Appendix T: Model Procedures for Safe Use of Unsealed Licensed Material
• Appendix U: Model Procedure for Release of Patients or Human Research Subjects Administered Radioactive Materials
• Appendix V: Guidance for Mobile Medical Services
• Appendix W: Model Procedure for Waste Disposal by Decay-In-Storage, Generator Return, and Licensed Material Return

APPENDICES X-Z RECORDKEEPING AND REPORTING REQUIREMENTS AND DOT RULES FOR SHIPPING

• Appendix X: Recordkeeping Requirements
• Appendix Y: Reporting Requirements
• Appendix Z: Summary of DOT Requirements for Transportation of Type A or Type B Quantities of Licensed Material
• Appendix AA: Production and Noncommercial Distribution by the Medical Facility of PET Radioactive Drugs to Consortium Members under Authorization of 10 CFR 30.32(j)
• Appendix BB: January 2003 Summary of Public Comments on the August 1998 and March 2002 Drafts and NRC Responses
• Appendix CC: List of Documents Considered in the Development of this NUREG
• Appendix DD: Summary of Comments Received on Draft Revision 2 of NUREG-1556, Volume 9

Publication Information

Date 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

[ Top of file ]

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.

Paperwork Reduction Act Statement

This NUREG contains information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget (OMB), approval numbers 3150-0044; 3150-0014; 3150-0035; 3150-0017; 3150-0016; 3150-0001; 3150-0015; 3150-0010; 3150-0009; 3150-0008; 3150-0120; and 3150-0028.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

Foreword

This report, NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses,” is one of twenty-one volumes in NRC’s NUREG-1556 series addressing its materials licensing process. This report is intended for use by applicants, licensees, NRC license reviewers, and other NRC license personnel addressing the medical use of byproduct material. Below is a list of volumes currently included in the NUREG-1556 series:

Questions and Answers on the implementation of Part 35 of Title 10 of the Code of Federal Regulations (CFR) are posted on the NRC’s Web site on the Medical Uses Licensee Toolkit http://www.nrc.gov/materials/miau/med-use-toolkit.html, serving as another source of guidance about implementation of revised 10 CFR Part 35.

After the October 2002 publication of NUREG-1556, Volume 9, the NRC amended 10 CFR Part 35, “Medical Use of Byproduct Material” (March 30, 2005; 70 FR 16335). The licensing guidance contained in NUREG-1556, Volume 9, Revision 1, included updated guidance on requirements for training and experience appearing in the amended rule. The guidance also reflected the extension of the effective date of Subpart J to October 24, 2005 (69 FR 55736).

Following the May 2005 publication of NUREG-1556, Volume 9, Revision 1, the NRC developed six new 313A Forms to record the training and experience of six different groups of individuals seeking recognition as authorized users, radiation safety officers, authorized nuclear pharmacists, and authorized medical physicists. On March 27, 2006, the NRC published a final rule to correct several minor errors in the CFR, update the address for Region III, and remove all references to Subpart J in 10 CFR Parts 32 and 35. Revision 2 of NUREG-1556, Volume 9, includes the new NRC Form 313A series of forms, provides guidance on how to fill them out, and removes references to 10 CFR Part 35, Subpart J.

On November 30, 2007, the NRC amended its regulations to include jurisdiction over certain radium sources, accelerator-produced radioactive materials, and certain naturally occurring radioactive material, as required by the Energy Policy Act of 2005 (EPAct), which was signed into law on August 8, 2005. The EPAct expanded the Atomic Energy Act of 1954 definition of byproduct material to include:

• any discrete source of radium-226 (Ra-226),

• any material made radioactive by use of a particle accelerator, and

• any discrete source of naturally occurring radioactive material, other than source material, that the Commission, in consultation with other Federal officials described in the EPAct, determines would pose a similar threat to the public health and safety or the common defense and security as a discrete source of radium-226

that are extracted or converted after extraction for use for a commercial, medical, or research activity.

In so doing, these materials were placed under the NRC’s regulatory authority. Also as authorized by the EPAct, the NRC issued a waiver on August 31, 2005, to allow continued use and possession of naturally-occurring and accelerator-produced radioactive materials (NARM) while the NRC developed a regulatory framework for regulation of the new byproduct material. The NRC will terminate the waiver in phases, beginning November 30, 2007, and ending on August 7, 2009. On November 30, 2007, the NRC terminated the waiver for Federal Government agencies, Federally recognized Indian tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana. Waiver terminations for Connecticut, New Jersey, Pennsylvania, Vermont, Virginia, West Virginia, Michigan, Missouri, Alaska, Hawaii, Idaho, Pacific Trust Territories, and South Dakota will be executed for groups of States and U.S. Territories in phases between November 30, 2007 and August 7, 2009.

Upon waiver termination, all persons who possess the new byproduct materials in these States, U.S. Territories, or areas of exclusive Federal jurisdiction must be in compliance with NRC regulations. Being in compliance with the NRC regulations means that such persons are responsible for the proper handling, transfer, and disposal of these new byproduct materials as specified in the NRC’s regulations. Some radioactive materials that fall under the newly expanded definition of byproduct materials may already be authorized on an existing NRC license, since the term “byproduct materials” will include the new NARM material. For those radioactive materials and uses of the new byproduct material that are not already on an NRC license, the person will either be required to: (1) apply for license amendments for the new byproduct material within 6 months from the date the waiver is terminated, or (2) submit a new license application for the new byproduct material within 12 months from the date the waiver is terminated. The person may continue to use the materials until NRC takes final licensing action, provided the amendment or new license request was made during the required time periods.

This report follows the risk-informed, performance-based approach adopted for revisions to 10 CFR Part 35. It reduces the amount of information submitted by an applicant seeking to possess and use certain quantities of byproduct material for medical use. In a number of instances, the regulations found in 10 CFR Part 35 and reflected in this report do not require the submission of detailed procedures. Instead, applicants are requested to confirm that they have developed and will implement and maintain procedures required by Part 35, but they are not required to submit those procedures as part of their license application. This report contains appendices containing suggested procedures that applicants may consider. The risk-informed, performance-based approach to the regulation of NRC-licensed materials is also being emphasized in the inspection and enforcement arena.

Revision 2 of NUREG-1556, Volume 9, includes updated guidance on requirements for licensing the accelerator-produced radioactive materials and discrete sources of radium-226 now included in the expanded definition of byproduct material.

In addition to combining and updating the guidance for applicants and licensees previously found in numerous Regulatory Guides, Policy and Guidance Directives, draft Regulatory Guides, Standard Review Plans, and Information Notices, this guidance incorporates input from stakeholders received in public workshops and written comments.

This report follows the risk-informed, performance-based approach adopted for revisions to 10 CFR Part 35. It reduces the amount of information submitted by an applicant seeking to possess and use certain quantities of byproduct material for medical use. In a number of instances, the regulations found in 10 CFR Part 35 and reflected in this report do not require the submission of detailed procedures. Instead, applicants are requested to confirm that they have developed and will implement and maintain procedures required by Part 35, but they are not required to submit those procedures as part of their license application. This report contains appendices containing suggested procedures that applicants may consider. The risk-informed, performance-based approach to the regulation of NRC-licensed materials is also being emphasized in the inspection and enforcement arena.

This document addresses those topics that an applicant must provide in preparing a license application on NRC Form 313. The report also includes descriptions of certain key elements of a medical use program that do not require a response on Form 313. This material is presented for clarification only.

Revision 2 of NUREG-1556, Volume 9, is not a substitute for NRC regulations. The approaches and methods described in this report are provided for information only. Guidance in this document represents one means acceptable to the staff of complying with NRC regulations and is not intended to be the only means of satisfying the requirements for licensing.

The NRC’s “Procedures for Recognizing Certification Processes of Specialty Boards” may be found on NRC’s Web site on the Medical Uses Licensee Toolkit http://www.nrc.gov/materials/miau/med-use-toolkit.html.

Complementary guidance on Inspection Procedures for inspections of medical use licensees is contained in the following documents available at NRC’s Web site on the Medical Uses Licensee Toolkit http://www.nrc.gov/materials/miau/med-use-toolkit.html.

Inspection Procedures in the 87100 series:

• “Nuclear Medicine Programs — Written Directive Not Required,”
• “Nuclear Medicine Programs — Written Directive Required,”
• “Brachytherapy Programs,”
• “Medical Gamma Stereotactic Radiosurgery and Teletherapy Programs,” and
• “Medical Broad-Scope Programs.”

_________________________________
Charles L. Miller, Director
Office of Federal and State Materials and
Environmental Management Programs

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