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Medical Uses Licensee Toolkit

This toolkit is designed to help licensees find key information easily. Submit medical-related inquiries to MedicalQuestions@nrc.gov.

On this page:

• Recent Activities
• Regulations and Medical Policy Statement
• Medical List Server
• Guidance
• Other Guidance
• Inspection Procedures
• License Types
• Fees
• Forms

Recent Activities

NRC has created a Recent Activities listing medical-related items of interest.

Regulations and Medical Policy Statement

The NRC's regulations are found in Chapter I of Title 10, "Energy," of the Code of Federal Regulations (CFR). Chapter I is divided into Parts 1 through 199. The following parts contain the requirements most relevant to medical use of nuclear materials:

• Part 35 – "Medical Use of Byproduct Material"
• Final Rule, 10 CFR Parts 20, 32, and 35; Medical Use of Byproduct Material
  • Part I, 67 FR 20249
  • Part II, 67 FR 20299
  • Part III, 67 FR 20349
• Direct Final Rule, Clarifying and Minor Amendments, 68 FR 19321
• Final Rule, Extending Expiration Date for 10 CFR Part 35 Subpart J, 69 FR 55736
• Final Rule, Medical Use or Byproduct Material – Recognition of Specialty Boards, 70 FR 16336
• Red-Line/Strike-out Part 35 – Training and Experience text including final Rule of March 30, 2005
• Correcting Amendment, Medical Use of Byproduct Material—Recognition of Specialty Boards; Correction, 71 FR 1926
• Final Rule, 10 CFR Parts 1, 13, 20, 30, 32, 35, 40, 55, 70, 73, 110, and 140, 71 FR 15005
• Direct Final Rule, Medical Use of Byproduct Material - Minor Corrections and Clarifications, 72 FR 45147
• NARM Rule, "Requirements for Expanded Definition of byproduct Material (NARM)" - 72 FR 55864  - final rule
• NARM, "Notification of the Plan for the Transition of Regulatory Authority Resulting From the Expanded Definition of Byproduct Material" 72 FR 59157
• Medical Policy Statement
• Part 40 – "Domestic Licensing of Source Material"
• Part 70 – "Domestic Licensing of Special Nuclear Material"
• Petitions for Rulemaking
• Peter G. Crane
           Petition 70 FR 75752
           Resolution 73 FR 29445
• William Stein, III, M.D.
           Petition 71 FR 34285
           Resolution 72 FR 60285
• E. Russell Rittenour, PhD
           Petition 71 FR 64168
           Resolution 73 FR 27773

See also:

• NARM Toolbox – Requirement for Expanded Definition of byproduct material (NARM)
• Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications page for other regulations, guidance documents, and generic communications that are applicable to all licensees including medical use licensees. The following provide quick links to the NMSS Newsletters and revised lists of Regulatory Issues Summaries and Information Notices that are of specific Interest to Medical Use Licensees:
  • NMSS Newsletters
  • Regulatory Issue Summaries of Interest to Medical Use Licensees from 1999 to February 2008
  • Information Notices of Interest to Medical Use Licensees from January 2000 to December, 2007
    For an archive of INs see NRC Information Notices.
• The Part 35 regulatory initiatives page for rulemaking information on changes to Part 35.

Medical List Server

NRC has created a medical list server for automatic e-mail notifications of medical-related generic communications, NMSS/FSME Newsletters, and Federal Register Notices.

Guidance

Consolidated materials guidance is published in "Consolidated Guidance About Materials Licenses" (NUREG-1556).

• Volume 9, Rev. 2, Program-Specific Guidance About Medical Use Licenses
• Volume 11, Program-Specific Guidance About Licenses of Broad Scope
• Volume 13, Revision 1, Program-Specific Guidance About Commercial Radiopharmacy Licenses
• Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator

Other Guidance

• Guide for Diagnostic Nuclear Medicine - The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM), in 2002, published a "Guide for Diagnostic Nuclear Medicine." This guide provides information that was current on October 24, 2002 and maybe useful to nuclear medicine professionals in understanding the applicability of NRC requirements at that time for the medical use of byproduct material in diagnostic settings and provides measures that practitioners may use to facilitate implementation of the October 2002 revised 10 CFR Part 35. Note: This document has not been updated to included changes to the training and experience requirements issued in March 30, 2005 in the "Final Rule, Medical Use of Byproduct Material - Recognition of Specialty Boards."
• Erratum for SNM "Guide for Diagnostic Nuclear Medicine" (December 20, 2002)
• Questions and Answers About Licensing Medical Uses of Byproduct Material Under Revised 10 CFR Part 35
• Radiation Dose Estimates for Radiopharmaceuticals (NUREG/CR-6345), April 1996
• Part 35 Stakeholder Workshop Slide Presentations
• Procedures for Recognizing Certification Process of Specialty Boards
• Specialty Boards Certification Recognized by NRC in accordance with 10 CFR Part 35 Subparts B, D, E, F, G, and H
• Complying with 10 CFR 35.400(a), 35.500(a), and 35.600(a) requirements for licensees to only use sources and devices "as approved in the Sealed Sources and Devices Registry" and "Sealed Source and Device Registry: Supplement for 10 CFR Part 35 Uses."
• Licensing Guidance for 10 CFR 35.1000 sealed sources and devices (New entries will be added as additional 35.1000 sealed sources and devices are identified. Licensing guidance will be updated when necessary to address comments from stakeholders. Comments should be sent to NRC Headquarters, Materials Safety and Inspection Branch.)
• TheraSphere and SIRSpheres Yttrium-90 Microspheres
• I-125 Iotrex Liquid Brachytherapy Source in Cytyc GliaSite Radiation Therapy System
• Best Vascular, Inc. Beta-Cath Intravascular Brachytherapy (IVB) System
• Nucletron seedSelectron® System, Isotron Brachytherapy Sources and Nucletron FIRST™ System
• Iodine-125 and Palladium-103 Low Dose Rate Brachytherapy Seeds Used for Localization of Non-Palpable Lesions
• Leksell Gamma Knife Perfexion ^TM
• Table of Authorizations - for unsealed byproduct material requiring a written directive. This table contains sample language for licensing actions completed after the revised 10 CFR 35 for the "authorized use" (item 9) and "user authorization" sections of a U.S. NRC medical use license.

Regulatory guides are issued in 10 divisions and are intended to aid licensees in implementing regulations. The guides most applicable to medical use are in Division 8, Occupational Health. (See the detailed list of Division 8 regulatory guides in Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications for guides with general applicability to medical uses.)

Web (HTML) versions of some regulatory guides are available for viewing or downloading at this site. In the index for each division of guides, the number of each guide available at this site is underscored. All active final and draft guides are also available in NRC’s Agencywide Documents Access and Management System (ADAMS).

Inspection Procedures

NRC’s regional offices (Region I - East, Region III - Midwest, and Region IV - West/Southwest) conduct typically unannounced, periodic inspection of licensed activities using guidance from NRC's Inspection Manual, Chapter 2800. The frequency of inspection is based on the hazard of materials used. The following address inspections directly related to medical use.

• IP 87130 – Nuclear Medicine Programs, Written Directive Not Required
• IP 87131 – Nuclear Medicine Programs, Written Directive Required
• IP 87132 – Brachytherapy Programs
• IP 87133 – Medical Gamma Sterotactic Radiosurgery and Teletherapy Programs
• IP 87134 – Medical Broad-Scope Programs

License Types

NRC assigns a five-digit code to each license to designate the major activity or principal use authorized in the license. These codes may be used to identify the appropriate NUREG-1556 guidance documents and secondary activities or uses authorized in the license. NRC uses approximately 100 program codes to classify the primary and secondary activities of thousands of active licenses. Additional information provided in the description of each license type may be used to identify the fee categories information in the schedules in 10 CFR Part 170 and 10 CFR Part 171. To learn more about the license category and the associated fee and inspection categories, see "Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures" (NUREG-1556, Vol. 20, Appendix G: LTS Program Code Descriptions).

License Types (Program Codes) for Medical Facilities, Practices, Laboratories
The code used depends upon whether licensee is a medical facility, private practice, mobile service, or laboratory.

Additional License Types (Program Codes) Associated with Medical Use
The code used depends upon the medical device used.

Additional License Types (Program Codes) Associated with Medical Use
The code used depends upon radiation program authorizations.

Fees

Medical use licensees are required to pay an annual license fee to the NRC. These fees are explained in our Materials Fee Billing Handbook. Refer to the schedule of materials fees for the fees required for each category of license and each type of fee.

Forms

The following forms are to be used by medical use licensees.

• Reciprocity Form 214
• Training and Experience NRC Form 313A Series of Forms and Guidance
  • NRC Form 313A(RSO) - Radiation Safety Officer
  • NRC Form 313A(AMP) - Authorized Medical Physicist
  • NRC Form 313A(ANP) - Authorized Nuclear Pharmacist
  • NRC Form 313A(AUD) - Authorized User 35.100, 35.200, 35.500 uses
  • NRC Form 313A(AUT) - Authorized User 35.300 uses
  • NRC Form 313A(AUS) - Authorized User 35.400, 35.600 uses
  • Guidance for the NRC 313A Forms
• License Application Form 313
• Disposition of Materials Form 314
• NRC Form 3
• NRC Form 4
• NRC Form 5

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Wednesday, June 11, 2008