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Exempt Distribution Licensee Toolkit

This toolkit has been designed to help licensees find key information easily.

On this page:

• Regulations
• Guidance
• License Types
• Fees
• Form

Regulations

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 set forth additional provisions regarding exempt distribution licensing and possession.

• Part 32.11 – Introduction of Byproduct Material in Exempt Concentrations into Products or Materials, and Transfer of Ownership or Possession: Requirements for License
• Part 32.14 – Certain Items Containing Byproduct Material; Requirements for License to Apply or Initially Transfer
• Part 32.17 – Resins Containing Scandium-46 and Designed for Sand-Consolidation in Oil Wells: Requirements for License to Manufacture, or Initially Transfer for Sale or Distribution
• Part 32.18 – Manufacture, Distribution and Transfer of Exempt Quantities of Byproduct Material: Requirements for License
• Part 32.21 – Radioactive Drug: Manufacture, Preparation, or Transfer for Commercial Distribution of Capsules Containing Carbon-14 Urea Each for "in Vivo" Diagnostic Use for Humans to Persons Exempt from Licensing; Requirements for a License
• Part 32.22 – Self-Luminous Products Containing Tritium, Krypton-85 or Promethium-147: Requirements for License to Manufacture, Process, Produce, or Initially Transfer
• Part 32.26 – Gas and Aerosol Detectors Containing Byproduct Material: Requirements for License to Manufacture, Process, Produce, or Initially Transfer
• Part 30.14 – Exempt Concentrations
• Part 30.15 – Certain Items Containing Byproduct Material
• Part 30.16 – Resins Containing Scandium-46 and Designed for Sand-Consolidation in Oil Wells
• Part 30.18 – Exempt Quantities
• Part 30.19 – Self-luminous Products Containing Tritium, Krypton-85, or Promethium-147
• Part 30.20 – Gas and Aerosol Detectors Containing Byproduct Material
• Part 30.21 – Radioactive Drug: Capsules Containing Carbon-14 Urea for "in Vivo" Diagnostic Use for Humans

Guidance

Consolidated guidance is published in "Consolidated Guidance About Materials Licenses," NUREG-1556. The volumes most applicable to exempt distribution of nuclear material are—

• Volume 8, Program-Specific Guidance About Exempt Distribution Licenses
• Volume 12, Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution

Web (HTML) versions of some NUREG-series publications are available in our NUREG-Series Document Collection. Some are also available in ADAMS (see our table listing their availability).

Regulatory guides (RGs) are issued in 10 divisions and are intended to aid licensees in implementing regulations. The guide most applicable to exempt distribution is RG 6.9 – Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material.

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).

License Types

Licensees who distributed sealed sources or devices to individuals exempt from licensing are identified by the license type E distribution.

NRC assigns a five-digit program code to each license to designate the major activity or principal use authorized in the license. NRC uses approximately 100 program codes to classify the thousands of active licenses. To learn more about this 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. Use this information to find the fee you will pay in the schedules in 10 CFR Part 170 and 10 CFR Part 171.

Program Codes Used in Materials and Fuel Licensing and Inspection Programs

Fees

Exempt distribution 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.

Form

The Application for Material License Form 313 is to be used by all exempt distribution licensees.

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Tuesday, February 13, 2007