PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

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Sec.

32.1 Purpose and scope.

32.2 Definitions.

32.3 Maintenance of records.

32.8 Information collection requirements: OMB approval.

Subpart A—Exempt Concentrations and Items

32.11 Introduction of byproduct material in exempt concentrations into products or materials, and transfer of ownership or possession: Requirements for license.

32.12 Same: Records and material transfer reports.

32.13 Same: Prohibition of introduction.

32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer.

32.15 Same: Quality assurance, prohibition of transfer, and labeling.

32.16 Certain items containing byproduct material: Records and reports of transfer.

32.17 [Removed].

32.18 Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license.

32.19 Same: Conditions of licenses.

32.20 Same: Records and material transfer reports.

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.

32.21a Same: Conditions of license.

32.22 Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer.

32.23 Same: Safety criteria.

32.24 Same: Table of organ doses.

32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

32.26 Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.

32.27 Same: Safety criteria.

32.28 Same: Table of organ doses.

32.29 Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

32.30 Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.

32.31 Certain industrial devices containing byproduct material: Safety criteria.

32.32 Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer.

32.40 [Removed].

Subpart B—Generally Licensed Items

32.51 Byproduct material contained in devices for use under § 31.5; requirements for license to manufacture or initially transfer.

32.51a Same: Conditions of licenses.

32.52 Same: Material transfer reports and records.

32.53 Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer.

32.54 Same: Labeling of devices.

32.55 Same: Quality assurance; prohibition of transfer.

32.56 Same: Material transfer reports.

32.57 Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.

32.58 Same: Labeling of devices.

32.59 Same: Leak testing of each source.

32.60 [Reserved]

32.61 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.

32.62 Same: Quality assurance; prohibition of transfer.

32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license.

Subpart C—Specifically Licensed Items

32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35.

32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use.

32.201 Serialization of nationally tracked sources.

Subpart D—Sealed Source and Device Registration

32.210 Registration of product information.

32.211 Inactivation of certificates of registration of sealed sources and devices.

Subpart E—Violations

32.301 Violations.

32.303 Criminal penalties.

Authority: Atomic Energy Act of 1954, secs. 81, 161, 170H, 181, 182, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2210h, 2231, 2232, 2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note.

[72 FR 55928, Oct. 1, 2007; 72 FR 58488, Oct. 16, 2007; 77 FR 39905, Jul. 6, 2012; 77 FR 43690, Jul. 25, 2012; 80 FR 54234, Sep. 9, 2015; 80 FR 58574, Sep. 30, 2015]