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Generally Licensed Products Distribution Licensee Toolkit

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

On this page:

• Regulations
• Guidance
• License Types
• Fees
• Form

See also Frequently Asked Questions.

Note that generally-licensed product distribution licenses for products containing source or special nuclear materials include possession and use as well as manufacture and distribution authorizations. However, these licenses do not cover the possession and use of byproduct material. A separate license is needed for possession and use of byproduct material (see 10 CFR Part 32).

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 generally licensed products distribution licensing and possession.

• Part 32.51 – Byproduct Material Contained in Devices for Use under § 31.5; Requirements for License to Manufacture, or Initially Transfer
• Part 32.53 – Luminous Safety Devices for Use in Aircraft: Requirements for License to Manufacture, Assemble, Repair or Initially Transfer
• Part 32.57 – Calibration or Reference Sources Containing Americium-241: Requirements for License to Manufacture or Initially Transfer
• Part 32.61 – Ice Detection Devices Containing Strontium-90; Requirements for License to Manufacture or Initially Transfer
• Part 32.71 – Manufacture and Distribution of Byproduct Material for Certain in Vitro Clinical or Laboratory Testing under General License
• Part 40.34 – Special Requirements for Issuance of Specific Licenses
• Part 70.39 – Specific Licenses for the Manufacture or Initial Transfer of Calibration or Reference Sources
• Part 31.3 – Certain Devices and Equipment
• Part 31.6 – General License to Install Devices Generally Licensed in § 31.5
• Part 31.7 – Luminous Safety Devices for Use in Aircraft
• Part 31.8 – Americium-241 in the Form of Calibration or Reference Sources
• Part 31.10 – General License for Strontium 90 in Ice Detection Devices
• Part 31.11 – General License for Use of Byproduct Material for Certain in Vitro Clinical or Laboratory Testing
• Part 40.25 - General License for Use of Certain Industrial Products or Devices
• Part 70.19 - General License for Calibration or Reference Sources

Guidance

Consolidated guidance is published in "Consolidated Guidance About Materials Licenses" (NUREG-1556). The volumes most applicable to generally licensed products distribution are—

• Volume 3, Applications for Sealed Source and Device Evaluation and Registration
• Volume 16, Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees

Web (HTML) versions of some NUREG-series publications are available in our NUREG-series document collection. Some are also available in ADAMS.

Regulatory guides (RGs) are issued in 10 divisions and are intended to aid licensees in implementing regulations. The guide most applicable to generally licensed products 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 manufacture or distribute sources or devices to general licensees are identified by the license type G Distribution. The table provides the license title and associated license code for each category under license type.

NRC assigns a five-digit program code number 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.

Program Codes Used in Materials and Fuel Licensing and Inspection Programs

Fees

Generally licensed products 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 generally licensed products distribution licensees.

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Tuesday, February 13, 2007