[Code of Federal Regulations] [Title 10, Volume 1] [Revised as of January 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 10CFR32.1] [Page 508-509] TITLE 10--ENERGY CHAPTER I--NUCLEAR REGULATORY COMMISSION PART 32_SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL--Table of Contents Sec. 32.1 Purpose and scope. 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 Resins containing scandium-46 and designed for sand-consolidation in oil wells: Requirements for license to manufacture, or initially transfer for sale or distribution. 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 Sec. 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 Sec. 32.26: Quality control, labeling, and reports of transfer. 32.40 Schedule A--Prototype tests for automobile lock illuminators. Subpart B_Generally Licensed Items 32.51 Byproduct material contained in devices for use under Sec. 31.5; requirements for license to manufacture or initially transfer. 32.51a Same: Conditions of licenses. 32.52 Same: Material transfer reports and records. [[Page 509]] 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: 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. 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. 32.101 Schedule B--prototype tests for luminous safety devices for use in aircraft. 32.102 Schedule C--prototype tests for calibration or reference sources containing americium-241. 32.103 Schedule D--prototype tests for ice detection devices containing strontium 90. Subpart C_Quality Control Sampling Procedures 32.110 Acceptance sampling procedures under certain specific licenses. Subpart D_Specifically Licensed Items 32.210 Registration of product information. Subpart E_Violations 32.301 Violations. 32.303 Criminal penalties. Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note). Source: 30 FR 8192, June 26, 1965, unless otherwise noted. (a) This part prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing byproduct material for sale or distribution to: (1) Persons exempted from the licensing requirements of part 30 of this chapter, or (2) Persons generally licensed under part 31 or 35 of this chapter. This part also prescribes certain regulations governing holders of these licenses. In addition, this part prescribes requirements for the issuance of specific licenses to persons who introduce byproduct material into a product or material owned by or in the possession of the licensee or another and regulations governing holders of such licenses. Further, this part describes procedures and prescribes requirements for the issuance of certificates of registration (coverning radiation safety information about a product) to manufacturers or initial transferors of sealed source or devices containing sealed sources which are to be used by persons specifically licensed under part 30 of this chapter or equivalent regulations of an Agreement State. (b) The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of part 30 of this chapter apply to applications, licenses and certificates of registration subject to this part. [30 FR 8192, June 26, 1965, as amended at 52 FR 27786, July 24, 1987; 63 FR 1896, Jan. 13, 1998]