section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 10:10:1.0.1.1.22.0.91.1,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,,,,§ 32.1 Purpose and scope.,NRC,,,"[30 FR 8192, June 26, 1965, as amended at 52 FR 27786, July 24, 1987; 63 FR 1896, Jan. 13, 1998; 72 FR 55928, Oct. 1, 2007; 77 FR 43690, July 25, 2012; 78 FR 17006, Mar. 19, 2013; 80 FR 74979, Dec. 1, 2015]","(a)(1) 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: (i) Persons exempted from the licensing requirements of part 30 of this chapter, or equivalent regulations of an Agreement State, or (ii) Persons generally licensed under part 31 of this chapter or equivalent regulations of an Agreement State. (iii) Persons licensed under part 35 of this chapter. (2) 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 a licensee or another, and regulations governing holders of such licenses. (3) This part prescribes certain requirements governing holders of licenses to manufacture or distribute items containing byproduct material. (4) This part describes procedures and prescribes requirements for the issuance of certificates of registration (covering radiation safety information about a product) to manufacturers or initial transferors of sealed sources or devices containing sealed sources. (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, and the provisions of part 37 of this chapter apply to applications and licenses subject to this part. (c)(1) The requirements in this part, including provisions that are specific to licensees, shall apply to Government agencies and Federally recognized Indian Tribes with respect to accelerator-produced radioactive material or discrete sources of radium-226 on November 30, 2007 except that the agency or Tribe may continue to manufacture or initially transfer items containing accelerator-produced radioactive material or discrete sources of radium-226 for sale or distribution to persons exempted from the licensing requirements of part 30 of this chapter, and to persons generally licensed under part 31 of this chapter, and radioactive drugs and sources and devices to medical use licensees, until the date of the NRC's final licensing determination, provided that the agency or Tribe submits a new license application for these activities on or before December 1, 2008 or an amendment application for these activities on or before June 2, 2008. (2) The requirements in this part, including provisions that are specific to licensees, shall apply to all persons other than those included in paragraph (c)(1) of this section with respect to accelerator-produced radioactive material or discrete sources of radium-226 on August 8, 2009, or earlier as noticed by the NRC, except that these persons may continue to manufacture or initially transfer items containing accelerator-produced radioactive material or discrete sources of radium-226 for sale or distribution to persons exempted from the licensing requirements of part 30 of this chapter, and to persons generally licensed under part 31 of this chapter, and to sell or manufacture radioactive drugs and sources and devices to medical use licensees until the date of the NRC's final licensing determination, provided that the person submits a license application within 12 months from the waiver expiration date of August 7, 2009 or within 12 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever is earlier; or that the person submits an amendment request within 6 months from the waiver expiration date of August 7, 2009 or within 6 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier." 10:10:1.0.1.1.22.0.91.2,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,,,,§ 32.2 Definitions.,NRC,,,"[34 FR 6653, Apr. 18, 1969, as amended at 39 FR 22129, June 20, 1974; 71 FR 65708, Nov. 8, 2006; 77 FR 43690, July 25, 2012]","As used in this part: Committed dose for the purposes of this part means the radiation dose that will accumulate over time as a result of retention in the body of radioactive material. Committed dose is a generic term for internal dose and must be calculated by summing the projected dose over the 50 years after intake for all irradiated organs or tissues multiplying the doses to individual organs and tissues by applicable tissue weighting factors. Dose commitment means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years. Lot Tolerance Percent Defective means, expressed in percent defective, the poorest quality in an individual inspection lot that should be accepted. Nationally tracked source is a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix E to part 20 of this Chapter. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold. Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both the NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product." 10:10:1.0.1.1.22.0.91.3,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,,,,§ 32.3 Maintenance of records.,NRC,,,"[53 FR 19246, May 27, 1988, as amended at 90 FR 55629, Dec. 3, 2025]","Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy of a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly." 10:10:1.0.1.1.22.0.91.4,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,,,,§ 32.8 Information collection requirements: OMB approval.,NRC,,,"[49 FR 19625, May 9, 1984, as amended at 59 FR 61780, Dec. 2, 1994; 62 FR 52186, Oct. 6, 1997; 62 FR 63640, Dec. 2, 1997; 71 FR 65708, Nov. 8, 2006; 72 FR 58486, Oct. 16, 2007; 77 FR 43691, July 25, 2012]","(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0001. (b) The approved information collection requirements contained in this part appear in §§ 32.11, 32.12, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.30, 32.31, 32.32, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, 32.201, 32.210, and 32.211. (c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows: (1) In § 32.11, NRC Form 313 is approved under control number 3150-0120. (2) [Reserved]" 10:10:1.0.1.1.22.1.91.1,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,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.",NRC,,,"[30 FR 8192, June 26, 1965, as amended at 49 FR 19625, May 9, 1984; 72 FR 58487, Oct. 16, 2007]","An application for a specific license on Form NRC-313 authorizing the introduction of byproduct material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the byproduct material will be approved if the applicant: (a) Satisfies the general requirements specified in § 30.33 of this chapter; provided, however, that the requirements of § 30.33(a)(2) and (3) do not apply to an application for a license to introduce byproduct material into a product or material owned by or in the possession of the licensee or another and the transfer of ownership or possession of the product or material containing the byproduct material, if the possession and use of the byproduct material to be introduced is authorized by a license issued by an Agreement State; (b) Provides a description of the product or material into which the byproduct material will be introduced, intended use of the byproduct material and the product or material into which it is introduced, method of introduction, initial concentration of the byproduct material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioisotopes in the product or material at the time of transfer; and (c) Provides reasonable assurance that the concentrations of byproduct material at the time of transfer will not exceed the concentrations in § 30.70 of this chapter, that reconcentration of the byproduct material in concentrations exceeding those in § 30.70 is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being." 10:10:1.0.1.1.22.1.91.10,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 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.",NRC,,,"[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]","(a) An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for “in vivo” diagnostic use, to persons exempt from licensing under § 30.21 of this chapter or the equivalent regulations of an Agreement State will be approved if: (1) The applicant satisfies the general requirements specified in § 30.33 of this chapter, provided that the requirements of § 30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, prepared, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State; (2) The applicant meets the requirements under § 32.72(a)(2) of this part; (3) The applicant provides evidence that each capsule contains 37 kBq (1 µCi) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process); (4) The carbon-14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being; (5) The carbon-14 urea is in the form of a capsule, identified as radioactive, and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and (6) The applicant submits copies of prototype labels and brochures and the NRC approves these labels and brochures. (b) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing drugs." 10:10:1.0.1.1.22.1.91.11,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.21a Same: Conditions of license.,NRC,,,"[62 FR 63640, Dec. 2, 1997]","Each license issued under § 32.21 of this part is subject to the following conditions: (a) The immediate container of the capsule(s) must bear a durable, legible label which: (1) Identifies the radioisotope, the physical and chemical form, the quantity of radioactivity of each capsule at a specific date; and (2) Bears the words “Radioactive Material.” (b) In addition to the labeling information required by paragraph (a) of this section, the label affixed to the immediate container, or an accompanying brochure also must: (1) State that the contents are exempt from NRC or Agreement State licensing requirements; and (2) Bears the words “Radioactive Material. For “In Vivo” Diagnostic Use Only. This Material Is Not To Be Used for Research Involving Human Subjects and Must Not Be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products Manufactured for Commercial Distribution. This Material May Be Disposed of in Ordinary Trash.”" 10:10:1.0.1.1.22.1.91.12,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.22 Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer.",NRC,,,"[34 FR 9026, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 77 FR 43691, July 25, 2012]","(a) An application for a specific license to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to initially transfer such products for use pursuant to § 30.19 of this chapter or equivalent regulations of an Agreement State, will be approved if: (1) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, That the requirements of § 30.33(a) (2) and (3) do not apply to an application for a license to transfer tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, or produced pursuant to a license issued by an Agreement State. (2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the self-luminous product to demonstrate that the product will meet the safety criteria set forth in § 32.23. The information should include: (i) A description of the product and its intended use or uses. (ii) The type and quantity of byproduct material in each unit. (iii) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product. (iv) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (a)(2) (iii) and (xii) of this section. (v) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product. (vi) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement. (vii) Degree of access of human beings to the product during normal handling and use. (viii) Total quantity of byproduct material expected to be distributed in the product annually. (ix) The expected useful life of the product. (x) The proposed method of labeling or marking each unit with identification of the manufacturer or initial transferor of the product and the byproduct material in the product. (xi) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product. (xii) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features. (xiii) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.23 and the basis for such estimates. (xiv) A determination that the probabilities with respect to the doses referred to in § 32.23(d) meet the criteria of that paragraph. (xv) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet. (xvi) Any additional information, including experimental studies and tests, required by the Commission. (3)(i) The Commission determines that the product meets the safety criteria in § 32.23; and (ii) The product has been evaluated by the NRC and registered in the Sealed Source and Device Registry. (b) Notwithstanding the provisions of paragraph (a) of this section, the Commission may deny an application for a specific license under this section if the end uses of the product cannot be reasonably foreseen." 10:10:1.0.1.1.22.1.91.13,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.23 Same: Safety criteria.,NRC,,,"[34 FR 9027, June 6, 1969]","An applicant for a license under § 32.22 shall demonstrate that the product is designed and will be manufactured so that: (a) In normal use and disposal of a single exempt unit, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.24 of this part. (b) In normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column II of the table in § 32.24. (c) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life. (d) 1 In use and disposal of a single exempt unit, or in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in § 32.24, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in § 32.24. 1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria: Low—not more than one such failure per year for each 10,000 exempt units distributed. Negligible—not more than one such failure per year for each 1 million exempt units distributed." 10:10:1.0.1.1.22.1.91.14,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.24 Same: Table of organ doses.,NRC,,,"[34 FR 9329, June 13, 1969]", 10:10:1.0.1.1.22.1.91.15,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.",NRC,,,"[34 FR 9027, June 6, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 48 FR 12334, Mar. 24, 1983; 68 FR 58804, Oct. 10, 2003; 72 FR 58488, Oct. 16, 2007; 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]","Each person licensed under § 32.22 shall: (a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission; (b) Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the product and the byproduct material in the product can be identified; and (c) Maintain records of all transfers and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution. (1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (2) The report must indicate that the products are transferred for use under § 30.19 of this chapter or equivalent regulations of an Agreement State. (3) The report must include the following information on products transferred to other persons for use under § 30.19 or equivalent regulations of an Agreement State: (i) A description or identification of the type of each product and the model number(s); (ii) For each radionuclide in each type of product and each model number, the total quantity of the radionuclide; (iii) The number of units of each type of product transferred during the reporting period by model number. (4)(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission. (ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.22 shall file a report for the current calendar year within 30 days after ceasing distribution. (5) If no transfers of byproduct material have been made under § 32.22 during the reporting period, the report must so indicate. (6) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission." 10:10:1.0.1.1.22.1.91.16,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.26 Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.",NRC,,,"[34 FR 6653, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9, 1980; 77 FR 43691, July 25, 2012]","An application for a specific license to manufacture, process, or produce gas and aerosol detectors containing byproduct material and designed to protect health, safety, or property, or to initially transfer such products for use under § 30.20 of this chapter or equivalent regulations of an Agreement State, will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, That the requirements of § 30.33(a) (2) and (3) do not apply to an application for a license to transfer byproduct material in gas and aerosol detectors manufactured, processed or produced pursuant to a license issued by an Agreement State. (b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the gas and aerosol detector to demonstrate that the product will meet the safety criteria set forth in § 32.27. The information should include: (1) A description of the product and its intended use or uses; (2) The type and quantity of byproduct material in each unit; (3) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product; (4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b) (3) and (12) of this section; (5) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product; (6) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement; (7) Degree of access of human beings to the product during normal handling and use; (8) Total quantity of byproduct material expected to be distributed in the product annually; (9) The expected useful life of the product; (10) The proposed methods of labeling or marking the detector and its point-of-sale package to satisfy the requirements of § 32.29(b); (11) Procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the product; (12) Results of the prototype testing of the product, including any change in the form of the byproduct material contained in the product, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features; (13) The estimated external radiation doses and dose commitments relevant to the safety criteria in § 32.27 and the basis for such estimates; (14) A determination that the probabilities with respect to the doses referred to in § 32.27(c) meet the criteria of that paragraph; (15) Quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet; and (16) Any additional information, including experimental studies and tests, required by the Commission. (c)(1) The Commission determines that the product meets the safety criteria in § 32.27; and (2) The product has been evaluated by the NRC and registered in the Sealed Source and Device Registry." 10:10:1.0.1.1.22.1.91.17,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.27 Same: Safety criteria.,NRC,,,"[34 FR 6654, Apr. 18, 1969]","An applicant for a license under § 32.26 shall demonstrate that the product is designed and will be manufactured so that: (a) In normal use and disposal of a single exempt unit, and in normal handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the dose to the appropriate organ as specified in Column I of the table in § 32.28. (b) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life. (c) In use and disposal of a single exempt unit and in handling and storage of the quantities of exempt units likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column II of the table in § 32.28, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column III of the table in § 32.28. 1 1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates which are to be made. The following values may be used as guides in estimating compliance with the criteria: Low—not more than one such failure per year for each 10,000 exempt units distributed. Negligible—not more than one such failure per year for each one million exempt units distributed." 10:10:1.0.1.1.22.1.91.18,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.28 Same: Table of organ doses.,NRC,,,"[34 FR 6654, Apr. 18, 1969]", 10:10:1.0.1.1.22.1.91.19,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.29 Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.",NRC,,,"[34 FR 6654, Apr. 18, 1969, as amended at 43 FR 6923, Feb. 17, 1978; 45 FR 38342, June 9, 1980; 48 FR 12334, Mar. 24, 1983; 72 FR 58488, Oct. 16, 2007; 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]","Each person licensed under § 32.26 shall: (a) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name of the radionuclide and quantity of activity; and (iii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State. (2) The labeling or marking specified in paragraph (b)(1) of this section is located where its will be readily visible when the detector is removed from its mounting. (3) The external surface of the point-of-sale package has a legible, readily visible label or marking containing: (i) The name of the radionuclide and quantity of activity; (ii) An identification of the person licensed under § 32.26 to transfer the detector for use pursuant to § 30.20 of this chapter or equivalent regulations of an Agreement State; and (iii) The following or a substantially similar statement: THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS. THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS. (4) Each detector and point-of-sale package is provided with such other information as may be required by the Commission; and (c) Maintain records of all transfers and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution. (1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (2) The report must indicate that the products are transferred for use under § 30.20 of this chapter or equivalent regulations of an Agreement State. (3) The report must include the following information on products transferred to other persons for use under § 30.20 or equivalent regulations of an Agreement State: (i) A description or identification of the type of each product and the model number(s); (ii) For each radionuclide in each type of product and each model number, the total quantity of the radionuclide; (iii) The number of units of each type of product transferred during the reporting period by model number. (4)(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission. (ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.26 shall file a report for the current calendar year within 30 days after ceasing distribution. (5) If no transfers of byproduct material have been made under § 32.26 during the reporting period, the report must so indicate. (6) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission." 10:10:1.0.1.1.22.1.91.2,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.12 Same: Records and material transfer reports.,NRC,,,"[72 FR 58487, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]","(a) Each person licensed under § 32.11 shall maintain records of transfer of byproduct material and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution. (1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (2) The report must indicate that the byproduct material is transferred for use under § 30.14 of this chapter or equivalent regulations of an Agreement State. (b) The report must identify the: (1) Type and quantity of each product or material into which byproduct material has been introduced during the reporting period; (2) Name and address of the person who owned or possessed the product or material, into which byproduct material has been introduced, at the time of introduction; (3) The type and quantity of radionuclide introduced into each product or material; and (4) The initial concentrations of the radionuclide in the product or material at time of transfer of the byproduct material by the licensee. (c)(1) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission or to an Agreement State. (2) Licensees who permanently discontinue activities authorized by the license issued under § 32.11 shall file a report for the current calendar year within 30 days after ceasing distribution. (d) If no transfers of byproduct material have been made under § 32.11 during the reporting period, the report must so indicate. (e) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission." 10:10:1.0.1.1.22.1.91.20,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.30 Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.",NRC,,,"[77 FR 43691, July 25, 2012]","An application for a specific license to manufacture, process, produce, or initially transfer for sale or distribution devices containing byproduct material for use under § 30.22 of this chapter or equivalent regulations of an Agreement State will be approved if: (a) The applicant satisfies the general requirements of § 30.33 of this chapter: However, the requirements of § 30.33(a)(2) and (3) do not apply to an application for a license to transfer byproduct material in such industrial devices manufactured, processed, or produced under a license issued by an Agreement State; (b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the industrial devices to demonstrate that the device will meet the safety criteria set forth in § 32.31. The information should include: (1) A description of the device and its intended use or uses; (2) The type and quantity of byproduct material in each unit; (3) Chemical and physical form of the byproduct material in the device and changes in chemical and physical form that may occur during the useful life of the device; (4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b)(3) and (b)(12) of this section; (5) Details of construction and design of the device as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the device; (6) Maximum external radiation levels at 5 and 30 centimeters from any external surface of the device, averaged over an area not to exceed 10 square centimeters, and the method of measurement; (7) Degree of access of human beings to the device during normal handling and use; (8) Total quantity of byproduct material expected to be distributed in the devices annually; (9) The expected useful life of the device; (10) The proposed methods of labeling or marking the device and its point-of-sale package to satisfy the requirements of § 32.32(b); (11) Procedures for prototype testing of the device to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, and disposal of the device; (12) Results of the prototype testing of the device, including any change in the form of the byproduct material contained in the device, the extent to which the byproduct material may be released to the environment, any increase in external radiation levels, and any other changes in safety features; (13) The estimated external radiation doses and committed doses resulting from the intake of byproduct material in any one year relevant to the safety criteria in § 32.31 and the basis for these estimates; (14) A determination that the probabilities with respect to the doses referred to in § 32.31(a)(4) meet the criteria of that paragraph; (15) Quality control procedures to be followed in the fabrication of production lots of the devices and the quality control standards the devices will be required to meet; and (16) Any additional information, including experimental studies and tests, required by the Commission. (c)(1) The Commission determines that the device meets the safety criteria in § 32.31. (2) The device is unlikely to be routinely used by members of the general public in a non-occupational environment. (3) The device has been registered in the Sealed Source and Device Registry." 10:10:1.0.1.1.22.1.91.21,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.31 Certain industrial devices containing byproduct material: Safety criteria.,NRC,,,"[77 FR 43692, July 25, 2012]","(a) An applicant for a license under § 32.30 shall demonstrate that the device is designed and will be manufactured so that: (1) In normal use, handling, and storage of the quantities of exempt units likely to accumulate in one location, including during marketing, distribution, installation, and servicing of the device, it is unlikely that the external radiation dose in any one year, or the committed dose resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the device will exceed 200 µSv (20 mrem). (2) It is unlikely that the external radiation dose in any one year, or the committed dose resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from disposal of the quantities of units likely to accumulate in the same disposal site will exceed 10 µSv (1 mrem). (3) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the device from wear and abuse likely to occur in normal handling and use of the device during its useful life. (4) In use, handling, storage, and disposal of the quantities of exempt units likely to accumulate in one location, including during marketing, distribution, installation, and servicing of the device, the probability is low that the containment, shielding, or other safety features of the device would fail under such circumstances that a person would receive an external radiation dose or committed dose in excess of 5 mSv (500 mrem), and the probability is negligible that a person would receive an external radiation dose or committed dose of 100 mSv (10 rem) or greater. 1 1 It is the intent of this paragraph that as the magnitude of the potential dose increases above that permitted under normal conditions, the probability that any individual will receive such a dose must decrease. The probabilities have been expressed in general terms to emphasize the approximate nature of the estimates that are to be made. The following values may be used as guides in estimating compliance with the criteria: Low—not more than one such failure/incident per year for each 10,000 exempt units distributed. Negligible—not more than one such failure/incident per year for each one million exempt units distributed. (b) An applicant for a license under § 32.30 shall demonstrate that, even in unlikely scenarios of misuse, including those resulting in direct exposure to the unshielded source removed from the device for 1,000 hours at an average distance of 1 meter and those resulting in dispersal and subsequent intake of 10 −4 of the quantity of byproduct material (or in the case of tritium, an intake of 10 percent), a person will not receive an external radiation dose or committed dose in excess of 100 mSv (10 rem), and, if the unshielded source is small enough to fit in a pocket, that the dose to localized areas of skin averaged over areas no larger than 1 square centimeter from carrying the unshielded source in a pocket for 80 hours will not exceed 2 Sv (200 rem)." 10:10:1.0.1.1.22.1.91.22,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.32 Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer.",NRC,,,"[77 FR 43692, July 25, 2012]","Each person licensed under § 32.30 shall: (a) Carry out adequate control procedures in the manufacture of the device to ensure that each production lot meets the quality control standards approved by the Commission; (b) Label or mark each device and its point-of-sale package so that: (1) Each item has a durable, legible, readily visible label or marking on the external surface of the device containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name of the radionuclide(s) and quantity(ies) of activity; (iii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and (iv) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information). (2) The external surface of the point-of-sale package has a legible, readily visible label or marking containing: (i) The name of the radionuclide and quantity of activity; (ii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and (iii) The following or a substantially similar statement: “THIS DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 10 CFR 32.31. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.” (3) Each device and point-of-sale package contains such other information as may be required by the Commission; and (c) Maintain records of all transfers and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution. (1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (2) The report must indicate that the devices are transferred for use under § 30.22 of this chapter or equivalent regulations of an Agreement State. (3) The report must include the following information on devices transferred to other persons for use under § 30.22 or equivalent regulations of an Agreement State: (i) A description or identification of the type of each device and the model number(s); (ii) For each radionuclide in each type of device and each model number, the total quantity of the radionuclide; and (iii) The number of units of each type of device transferred during the reporting period by model number. (4)(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. (ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.30 shall file a report for the current calendar year within 30 days after ceasing distribution. (5) If no transfers of byproduct material have been made under § 32.30 during the reporting period, the report must so indicate. (6) The licensee shall maintain the record of a transfer for a period of one year after the transfer is included in a report to the Commission." 10:10:1.0.1.1.22.1.91.3,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.13 Same: Prohibition of introduction.,NRC,,,"[72 FR 58487, Oct. 16, 2007]","No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under § 30.14 of this chapter or equivalent regulations of an Agreement State, except in accordance with a license issued under § 32.11." 10:10:1.0.1.1.22.1.91.4,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer.,NRC,,,"[31 FR 5316, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 43 FR 6922, Feb. 17, 1978; 63 FR 32971, June 17, 1998; 72 FR 58487, Oct. 16, 2007; 77 FR 43691, July 25, 2012]","An application for a specific license to apply byproduct material to, or to incorporate byproduct material into, the products specified in § 30.15 of this chapter or to initially transfer for sale or distribution such products containing byproduct material for use pursuant to § 30.15 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; (b) The applicant submits sufficient information regarding the product pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of byproduct material in each product; (2) Details of construction and design of each product; (3) The method of containment or binding of the byproduct material in the product; (4) Except for electron tubes and ionization chamber smoke detectors and timepieces containing promethium-147 or tritium in the form of gaseous tritium light sources, procedures for and results of prototype testing to demonstrate that the byproduct material will not become detached from the product and that the byproduct material will not be released to the environment under the most severe conditions likely to be encountered in normal use of the product; (5) In the case of ionizing radiation measuring instruments and timepieces containing tritium in the form of paint, quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet; (6) The proposed method of labeling or marking each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container with the identification of the manufacturer or initial transferor of the product and the byproduct material in the product; (7) For products for which limits on levels of radiation are specified in § 30.15 of this chapter, the radiation level and the method of measurement; (8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the product. (c) Each product will contain no more than the quantity of byproduct material specified for that product in § 30.15 of this chapter. The levels of radiation from each product containing byproduct material will not exceed the limits specified for that product in § 30.15 of this chapter. (d) The Commission determines that the byproduct material is properly contained in the product under the most severe conditions that are likely to be encountered in normal use and handling." 10:10:1.0.1.1.22.1.91.5,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.15 Same: Quality assurance, prohibition of transfer, and labeling.",NRC,,,"[31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 FR 22129, June 20, 1974; 43 FR 6922, Feb. 17, 1978; 72 FR 58487, Oct. 16, 2007; 73 FR 42673, July 23, 2008; 77 FR 43691, July 25, 2012; 86 FR 43402, Aug. 9, 2021]","(a) Each person licensed under § 32.14 for products for which quality control procedures are required shall: (1) Maintain quality assurance systems in the manufacture of the part or product, or the installation of the part into the product, in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed products are capable of performing their intended functions; (2) Subject inspection lots to acceptance sampling procedures, by procedures specified in the license issued under § 32.14, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded; and (3) Visually inspect each unit in inspection lots. Any unit which has an observable physical defect that could adversely affect containment of the byproduct material must be considered a defective unit. (b) No person licensed under § 32.14 shall transfer to other persons for use under § 30.15 of this chapter or equivalent regulations of an Agreement State: (1) Any part or product tested and found defective under the criteria and procedures specified in the license issued under § 32.14, unless the defective part or product has been repaired or reworked, retested, and found by an independent inspector to meet the applicable acceptance criteria; or (2) Any part or product contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (a)(2) of this section, unless: (i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.14; and (ii) Each individual sub-lot is sampled, tested, and accepted in accordance with the procedures specified in paragraphs (a)(2) and (b)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.14. (c) [Reserved] (d) Each person licensed under § 32.14 for products for which quality control procedures are required shall: (1) Label or mark each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container so that the manufacturer or initial transferor of the product and the byproduct material in the product can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (B) The name of the radionuclide (“americium-241” or “Am-241”) and the quantity of activity; and (C) An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) of this chapter or equivalent regulations of an Agreement State. (ii) The labeling or marking specified in paragraph (d)(2)(i) of this section is located where it will be readily visible when the detector is removed from its mounting. (iii) The external surface of the point-of-sale package has a legible, readily visible label or marking containing: (A) The name of the radionuclide and quantity of activity; (B) An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) or equivalent regulations of an Agreement State; and (C) The following or a substantially similar statement: “THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.” (iv) Each detector and point-of-sale package is provided with such other information as may be required by the Commission." 10:10:1.0.1.1.22.1.91.6,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.16 Certain items containing byproduct material: Records and reports of transfer.,NRC,,,"[72 FR 58487, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]","(a) Each person licensed under § 32.14 shall maintain records of all transfers of byproduct material and file a report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution. (1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (2) The report must indicate that the products are transferred for use under § 30.15 of this chapter, giving the specific paragraph designation, or equivalent regulations of an Agreement State. (b) The report must include the following information on products transferred to other persons for use under § 30.15 or equivalent regulations of an Agreement State: (1) A description or identification of the type of each product and the model number(s), if applicable; (2) For each radionuclide in each type of product and each model number, if applicable, the total quantity of the radionuclide; and (3) The number of units of each type of product transferred during the reporting period by model number, if applicable. (c)(1) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include data for transfers in prior years not previously reported to the Commission. (2) Licensees who permanently discontinue activities authorized by the license issued under § 32.14 shall file a report for the current calendar year within 30 days after ceasing distribution. (d) If no transfers of byproduct material have been made under § 32.14 during the reporting period, the report must so indicate. (e) The licensee shall maintain the record of a transfer for one year after the transfer is included in a report to the Commission." 10:10:1.0.1.1.22.1.91.7,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,"§ 32.18 Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license.",NRC,,,"[35 FR 6428, Apr. 22, 1970, as amended at 43 FR 6922, Feb. 17, 1978]","An application for a specific license to manufacture, process, produce, package, repackage, or transfer quantities of byproduct material for commercial distribution to persons exempt pursuant to § 30.18 of this chapter or the equivalent regulations of an Agreement State will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, That the requirements of § 30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State; (b) The byproduct material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being; (c) The byproduct material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and (d) The applicant submits copies of prototype labels and brochures and the Commission approves such labels and brochures." 10:10:1.0.1.1.22.1.91.8,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.19 Same: Conditions of licenses.,NRC,,,"[35 FR 6428, Apr. 22, 1970]","Each license issued under § 32.18 is subject to the following conditions: (a) No more than 10 exempt quantities set forth in § 30.71, Schedule B of this chapter shall be sold or transferred in any single transaction. For purposes of this requirement, an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in § 30.71, Schedule B of this chapter, provided that the sum of such fractions shall not exceed unity. (b) Each quantity of byproduct material set forth in § 30.71, Schedule B of this chapter shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to § 30.18 of this chapter. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour. (c) The immediate container of each quantity or separately packaged fractional quantity of byproduct material shall bear a durable, legible label which (1) identifies the radioisotope and the quantity of radioactivity, and (2) bears the words “Radioactive Material.” (d) In addition to the labeling information required by paragraph (c) of this section, the label affixed to the immediate container, or an accompanying brochure, shall also (1) state that the contents are exempt from NRC or Agreement State licensing requirements; (2) bear the words “Radioactive Material—Not for Human Use—Introduction Into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or Into Products Manufactured for Commercial Distribution is Prohibited—Exempt Quantities Should Not be Combined”; and (3) set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material." 10:10:1.0.1.1.22.1.91.9,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,A,Subpart A—Exempt Concentrations and Items,,§ 32.20 Same: Records and material transfer reports.,NRC,,,"[72 FR 58488, Oct. 16, 2007, as amended at 73 FR 5719, Jan. 31, 2008; 73 FR 42673, July 23, 2008]","(a) Each person licensed under § 32.18 shall maintain records of transfer of material identifying, by name and address, each person to whom byproduct material is transferred for use under § 30.18 of this chapter or the equivalent regulations of an Agreement State and stating the kinds, quantities, and physical form of byproduct material transferred. (b) The licensee shall file a summary report with the Director of the Office of Nuclear Material Safety and Safeguards by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution. (1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (2) The report must indicate that the materials are transferred for use under § 30.18 or equivalent regulations of an Agreement State. (c) For each radionuclide in each physical form, the report shall indicate the total quantity of each radionuclide and the physical form, transferred under the specific license. (d)(1) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year. In its first report after December 17, 2007, the licensee shall separately include the total quantity of each radionuclide transferred for transfers in prior years not previously reported to the Commission. (2) Licensees who permanently discontinue activities authorized by the license issued under § 32.18 shall file a report for the current calendar year within 30 days after ceasing distribution. (e) If no transfers of byproduct material have been made under § 32.18 during the reporting period, the report must so indicate. (f) The licensee shall maintain the record of a transfer for one year after the transfer is included in a summary report to the Commission." 10:10:1.0.1.1.22.2.91.1,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,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.",NRC,,,"[39 FR 43533, Dec. 16, 1974, as amended at 40 FR 8785, Mar. 3, 1975; 42 FR 25721, May 19, 1977; 43 FR 6923, Feb. 17, 1978; 58 FR 67660, Dec. 22, 1993; 59 FR 5520, Feb. 7, 1994; 65 FR 79189, Dec. 18, 2000; 77 FR 43693, July 25, 2012]","(a) An application for a specific license to manufacture, or initially transfer devices containing byproduct material to persons generally licensed under § 31.5 of this chapter or equivalent regulations of an Agreement State will be approved if: (1) The applicant satisfies the general requirements of § 30.33 of this chapter; (2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that: (i) The device can be safely operated by persons not having training in radiological protection; (ii) Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in 1 year a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter; and (iii) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in § 32.24. (3) Each device bears a durable, legible, clearly visible label or labels approved by the Commission which contain in a clearly identified and separate statement: (i) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information); (ii) The requirements, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and (iii) The information called for in the following statement in the same or substantially similar form: 1 1 Devices licensed under § 32.51 prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975. The receipt, possession, use, and transfer of this device Model ____ 2 , Serial No.___ 2 , are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. 2 The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device. CAUTION—RADIOACTIVE MATERIAL (Name of manufacturer, or initial transferor) 2 The receipt, possession, use, and transfer of this device Model ____ 2 , Serial No.___ 2 , are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. 2 The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device. (Name of manufacturer, or initial transferor) 2 (4) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, “Caution-Radioactive Material,” the radiation symbol described in § 20.1901 of this chapter, and the name of the manufacturer or initial distributor. (5) Each device meeting the criteria of § 31.5(c)(13)(i) of this chapter, bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, “Caution-Radioactive Material,” and, if practicable, the radiation symbol described in § 20.1901 of this chapter. (6) The device has been registered in the Sealed Source and Device Registry. (b) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, he shall include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Commission will consider information which includes, but is not limited to: (1) Primary containment (source capsule); (2) Protection of primary containment; (3) Method of sealing containment; (4) Containment construction materials; (5) Form of contained radioactive material; (6) Maximum temperature withstood during prototype tests; (7) Maximum pressure withstood during prototype tests; (8) Maximum quantity of contained radioactive material; (9) Radiotoxicity of contained radioactive material; and (10) Operating experience with identical devices or similarly designed and constructed devices. (c) In the event the applicant desires that the general licensee under § 31.5 of this chapter, or under equivalent regulations of an Agreement State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the bases for these estimates. The submitted information must demonstrate that performance of this activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter." 10:10:1.0.1.1.22.2.91.10,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.59 Same: Leak testing of each source.,NRC,,,"[77 FR 43694, July 25, 2012]","Each person licensed under § 32.57 shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or radium-226 before transferring the source to a general licensee under § 31.8 of this chapter or under equivalent regulations of an Agreement State. This test must be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper must be measured using methods capable of detecting 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in this section, the source must be rejected and must not be transferred to a general licensee under § 31.8 of this chapter, or equivalent regulations of an Agreement State." 10:10:1.0.1.1.22.2.91.11,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.60 [Reserved],NRC,,,, 10:10:1.0.1.1.22.2.91.12,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.61 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.,NRC,,,"[30 FR 9905, Aug. 10, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 77 FR 43694, July 25, 2012]","An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under § 31.10 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; (b) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of strontium-90 in the device; (2) Details of construction and design of the source of radiation and its shielding; (3) Radiation profile of a prototype device; (4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use; (5) Details of quality control procedures to be followed in manufacture of the device; (6) Description of labeling to be affixed to the device; (7) Instructions for handling and installation of the device; (8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device; (c) Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form; (d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.1901(a) of this chapter, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices; (e) The Commission determines that: (1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device; (2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use; (3) The device is so designed that it cannot be easily disassembled; (4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (f) of this section. (5) Quality control procedures have been established to satisfy the requirements of § 32.62. (f) The applicant shall subject at least five prototypes of the device to tests as follows: (1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering. (2) The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (f)(3) of this section. (3) Device designs are rejected for which the following has been detected for any unit: (i) A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device; or (ii) Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or (iii) Any other evidence of physical damage. (g) The device has been registered in the Sealed Source and Device Registry." 10:10:1.0.1.1.22.2.91.13,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.62 Same: Quality assurance; prohibition of transfer.,NRC,,,"[30 FR 9905, Aug. 10, 1965, as amended at 39 FR 22130, June 20, 1974; 39 FR 26397, July 19, 1974; 43 FR 6923, Feb. 17, 1978; 77 FR 43694, July 25, 2012]","(a) Each person licensed under § 32.61 shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90. (b) Each person licensed under § 32.61 shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device. (c) Each person licensed under § 32.61 shall: (1) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and (2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (d) of this section and in the license issued under § 32.61, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded. (d) Each person licensed under § 32.61 shall subject each inspection lot to: (1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion. (2) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria for defective: A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device and any other criteria specified in the license issued under § 32.61. (e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter, or under an equivalent general license of an Agreement State: (1) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under § 32.61, unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or (2) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (c)(2) of this section, unless: (i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.61; and (ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (c)(2) and (e)(2)(i) of this section and any other criteria as may be required as a condition of the license issued under § 32.61." 10:10:1.0.1.1.22.2.91.14,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license.,NRC,,,"[33 FR 16553, Nov. 14, 1968, as amended at 38 FR 34110, Dec. 11, 1973; 39 FR 26148, July 17, 1974; 40 FR 8786, Mar. 3, 1975; 42 FR 21604, Apr. 28, 1977; 42 FR 26987, May 26, 1977; 44 FR 50325, Aug. 28, 1979; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 72 FR 55929, Oct. 1, 2007]","An application for a specific license to manufacturer or distribute byproduct material for use under the general license of § 31.11 of this chapter will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter. (b) The byproduct material is to be prepared for distribution in prepackaged units of: (1) Iodine-125 in units not exceeding 10 microcuries each. (2) Iodine-131 in units not exceeding 10 microcuries each. (3) Carbon-14 in units not exceeding 10 microcuries each. (4) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each. (5) Iron-59 in units not exceeding 20 microcuries each. (6) Selenium-75 in units not exceeding 10 microcuries each. (7) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each. (8) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) each. (c) Each prepackaged unit bears a durable, clearly visible label: (1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 0.37 megabecquerel (10 microcuries) of iodine-131, iodine-125, selenium-75, or carbon-14; 1.85 megabecquerels (50 microcuries) of hydrogen-3 (tritium); or 0.74 megabecquerel (20 microcuries) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each; or cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries); and (2) Displaying the radiation caution symbol described in § 20.1901(a) of this chapter and the words, “Caution, Radioactive Material”, and “Not for Internal or External Use in Humans or Animals.” (d) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: 1 1 Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979. The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. (Name of Manufacturer) The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. (Name of Manufacturer) (e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such byproduct material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in § 20.2001." 10:10:1.0.1.1.22.2.91.2,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.51a Same: Conditions of licenses.,NRC,,,"[65 FR 79189, Dec. 18, 2000; 65 FR 80991, Dec. 22, 2000]","(a) If a device containing byproduct material is to be transferred for use under the general license contained in § 31.5 of this chapter, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes— (1) A copy of the general license contained in § 31.5 of this chapter; if paragraphs (c)(2) through (4) or (c)(13) of § 31.5 do not apply to the particular device, those paragraphs may be omitted. (2) A copy of §§ 31.2, 30.51, 20.2201, and 20.2202 of this chapter; (3) A list of the services that can only be performed by a specific licensee; (4) Information on acceptable disposal options including estimated costs of disposal; and (5) An indication that NRC's policy is to issue high civil penalties for improper disposal. (b) If byproduct material is to be transferred in a device for use under an equivalent general license of an Agreement State, each person that is licensed under § 32.51 shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes— (1) A copy of the Agreement State's regulations equivalent to §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a copy of §§ 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter. If a copy of the NRC regulations is provided to a prospective general licensee in lieu of the Agreement State's regulations, it shall be accompanied by a note explaining that use of the device is regulated by the Agreement State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted. (2) A list of the services that can only be performed by a specific licensee; (3) Information on acceptable disposal options including estimated costs of disposal; and (4) The name or title, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained. (c) An alternative approach to informing customers may be proposed by the licensee for approval by the Commission. (d) Each device that is transferred after February 19, 2002 must meet the labeling requirements in § 32.51(a)(3) through (5). (e) If a notification of bankruptcy has been made under § 30.34(h) or the license is to be terminated, each person licensed under § 32.51 shall provide, upon request, to the NRC and to any appropriate Agreement State, records of final disposition required under § 32.52(c)." 10:10:1.0.1.1.22.2.91.3,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.52 Same: material transfer reports and records.,NRC,,,"[65 FR 79189, Dec. 18, 2000, as amended at 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008]","Each person licensed under § 32.51 to initially transfer devices to generally licensed persons shall comply with the requirements of this section. (a) The person shall report to the Director, Office of Nuclear Material Safety and Safeguards , ATTN: GLTS, by an appropriate method listed in § 30.6(a) of this chapter, all transfers of such devices to persons for use under the general license in § 31.5 of this chapter and all receipts of devices from persons licensed under § 31.5 of this chapter. The report must be submitted on a quarterly basis on NRC Form 653—“Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form. (1) The required information for transfers to general licensees includes— (i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use. (ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (iii) The date of transfer; (iv) The type, model number, and serial number of the device transferred; and (v) The quantity and type of byproduct material contained in the device. (2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). (3) For devices received from a § 31.5 general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. (4) If the licensee makes changes to a device possessed by a § 31.5 general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label. (5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. (6) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (7) If no transfers have been made to or from persons generally licensed under § 31.5 of this chapter during the reporting period, the report must so indicate. (b) The person shall report all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.5 of this chapter and all receipts of devices from general licensees in the Agreement State's jurisdiction to the responsible Agreement State agency. The report must be submitted on Form 653—“Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form. (1) The required information for transfers to general licensees includes— (i) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use. (ii) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (iii) The date of transfer; (iv) The type, model number, and serial number of the device transferred; and (v) The quantity and type of byproduct material contained in the device. (2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). (3) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. (4) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label. (5) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. (6) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee. (7) If no transfers have been made to or from a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon request of the agency. (c) The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this paragraph must be maintained for a period of 3 years following the date of the recorded event." 10:10:1.0.1.1.22.2.91.4,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,"§ 32.53 Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer.",NRC,,,"[30 FR 8192, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 43 FR 6923, Feb. 17, 1978; 77 FR 43693, July 25, 2012]","An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under § 31.7 of this chapter, will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter; (b) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3) Details of the method of binding or containing the tritium or promethium-147; (4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use; (5) Quality assurance procedures to be followed that are sufficient to ensure compliance with § 32.55; (6) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device. (c) Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber. (d) The Commission determines that: (1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device; (2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it; (3) The device is so designed that it cannot easily be disassembled; and (4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (e) of this section. (e) The applicant shall subject at least five prototypes of the device to tests as follows: (1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering. (2) The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (e)(3) of this section. (3) Device designs are rejected for which the following has been detected for any unit: (i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device; or (ii) Surface contamination of tritium or promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or (iii) Any other evidence of physical damage. (f) The device has been registered in the Sealed Source and Device Registry." 10:10:1.0.1.1.22.2.91.5,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.54 Same: Labeling of devices.,NRC,,,"[33 FR 16331, Nov. 7, 1968, as amended at 40 FR 8785, Mar. 3, 1975; 43 FR 6923, Feb. 17, 1978; 63 FR 39483, July 23, 1998]","(a) A person licensed under § 32.53 to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under § 31.7 of this chapter shall, except as provided in paragraph (b) of this section, affix to each device a label containing the radiation symbol prescribed by § 20.1901 of this chapter, such other information as may be required by the Commission including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement: 1 1 Devices licensed under § 32.53 prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975. The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing ______ (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label. CAUTION—RADIOACTIVE MATERIAL (Name of manufacturer, assembler, or initial transferor.)* *The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device. The receipt, possession, use, and transfer of this device, Model* _______, Serial No.* ___, containing ______ (Identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. Do not remove this label. (Name of manufacturer, assembler, or initial transferor.)* *The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device. (b) If the Commission determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (a) of this section, it may waive the requirements of that paragraph and require in lieu thereof that: (1) A label be affixed to the device identifying: (i) The manufacturer, assembler, or initial transferor; and (ii) The type of radioactive material; and (2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped: (i) The name of the manufacturer, assembler, or initial transferor, (ii) The type and quantity of radioactive material, (iii) The model number, (iv) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the U.S. NRC or of an Agreement State, and (v) Such other information as may be required by the Commission, including disposal instructions when appropriate." 10:10:1.0.1.1.22.2.91.6,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,"§ 32.55 Same: Quality assurance, prohibition of transfer.",NRC,,,"[77 FR 43693, July 25, 2012]","(a) Each person licensed under § 32.53 shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147. (b) Each person licensed under § 32.53 shall: (1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and (2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (c) of this section and in the license issued under § 32.53, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded. (c) The licensee shall subject each inspection lot to: (1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion. (2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective: (i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device; (ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and (iii) Any other criteria specified in the license issued under § 32.53. (d) No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter, or under an equivalent general license of an Agreement State: (1) Any luminous safety device tested and found defective under any condition of a license issued under § 32.53, or paragraph (b) of this section, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or (2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (b)(2) of this section, unless: (i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.53; and (ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.53." 10:10:1.0.1.1.22.2.91.7,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.56 Same: Material transfer reports.,NRC,,,"[77 FR 43694, July 25, 2012]","(a) Each person licensed under § 32.53 shall file an annual report with the Director, Office of Nuclear Material Safety and Safeguards , ATTN: Document Control Desk/GLTS, by an appropriate method listed in § 30.6(a) of this chapter, which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under § 31.7 of this chapter. The report must identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report must cover the year ending June 30 and must be filed within thirty (30) days thereafter. If no transfers have been made to persons generally licensed under § 31.7 of this chapter during the reporting period, the report must so indicate. (b) Each person licensed under § 32.53 shall report annually all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to § 31.7 of this chapter to the responsible Agreement State agency. The report must state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made to a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State agency upon request of the agency." 10:10:1.0.1.1.22.2.91.8,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.57 Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.,NRC,,,"[30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 72 FR 55928, Oct. 1, 2007; 73 FR 42674, July 23, 2008; 77 FR 43694, July 25, 2012]","An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under § 31.8 of this chapter, will be approved if: (a) The applicant satisfies the general requirements of § 30.33 of this chapter; (b) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source; (2) Details of construction and design; (3) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source; (4) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use; (5) Details of quality control procedures to be followed in manufacture of the source; (6) Description of labeling to be affixed to the source or the storage container for the source; (7) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source. (c) Each source will contain no more than 5 microcuries of americium-241 or radium-226. (d) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that: (1) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and (2) The source has been subjected to and has satisfactorily passed appropriate tests required by paragraph (e) of this section. (e) The applicant shall subject at least five prototypes of each source that is designed to contain more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to tests as follows: (1) The initial quantity of radioactive material deposited on each source is measured by direct counting of the source. (2) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion. (3) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (e)(4) of this section. (4) Source designs are rejected for which the following has been detected for any unit: Removal of more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage." 10:10:1.0.1.1.22.2.91.9,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,B,Subpart B—Generally Licensed Items,,§ 32.58 Same: Labeling of devices.,NRC,,,"[72 FR 55929, Oct. 1, 2007]","Each person licensed under § 32.57 shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement: 1 1 Sources licensed under § 32.57 before January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975. The receipt, possession, use, and transfer of this source, Model, Serial No., are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label. CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE (Name of manufacturer or initial transferor) CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (or RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE (Name of manufacturer or initial transferor)" 10:10:1.0.1.1.22.3.91.1,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,C,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.",NRC,,,"[59 FR 61780, Dec. 2, 1994; 59 FR 65244, Dec. 19, 1994, as amended at 60 FR 324, Jan. 4, 1995; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 67 FR 77652, Dec. 19, 2002; 71 FR 15007, Mar. 27, 2006; 72 FR 45150, Aug. 13, 2007; 72 FR 55929, Oct. 1, 2007; 83 FR 33101, July 16, 2018; 88 FR 57878, Aug. 24, 2023]","(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized pursuant to part 35 of this chapter will be approved if: (1) The applicant satisfies the general requirements specified in 10 CFR 30.33; (2) The applicant submits evidence that the applicant is at least one of the following: (i) Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.17(a); (ii) Registered or licensed with a state agency as a drug manufacturer; (iii) Licensed as a pharmacy by a State Board of Pharmacy; (iv) Operating as a nuclear pharmacy within a Federal medical institution; or (v) A Positron Emission Tomography (PET) drug production facility registered with a State agency. (3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and (4) The applicant commits to the following labeling requirements: (i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL”; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted. (ii) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words “CAUTION, RADIOACTIVE MATERIAL” or “DANGER, RADIOACTIVE MATERIAL” and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. (b) A licensee described by paragraph (a)(2)(iii) or (iv) of this section: (1) May prepare radioactive drugs for medical use, as defined in 10 CFR 35.2, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraphs (b)(2) and (b)(4) of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in 10 CFR 35.27. (2) May allow a pharmacist to work as an authorized nuclear pharmacist if: (i) This individual qualifies as an authorized nuclear pharmacist as defined in 10 CFR 35.2, (ii) This individual meets the requirements specified in § 35.55(b) and 35.59 of this chapter, and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or (iii) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (b)(4) of this section. (3) The actions authorized in paragraphs (b)(1) and (b)(2) of this section are permitted in spite of more restrictive language in license conditions. (4) May designate a pharmacist (as defined in § 35.2 of this chapter) as an authorized nuclear pharmacist if: (i) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and (ii) The individual practiced at a pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC. (5) Shall provide to the Commission: (i) A copy of each individual's certification by a specialty board whose certification process has been recognized by the Commission or an Agreement State as specified in § 35.55(a) of this chapter; or (ii) The Commission or Agreement State license, or (iii) Commission master materials licensee permit, or (iv) The permit issued by a licensee or Commission master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist, or (v) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and (vi) A copy of the State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, under paragraphs (b)(2)(i) and (b)(2)(iii) of this section, the individual to work as an authorized nuclear pharmacist. (c) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall: (1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and (2) Check each instrument for constancy and proper operation at the beginning of each day of use. (d) A licensee shall satisfy the labeling requirements in paragraph (a)(4) of this section. (e) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs." 10:10:1.0.1.1.22.3.91.2,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,C,Subpart C—Specifically Licensed Items,,§ 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use.,NRC,,,"[39 FR 26149, July 17, 1974, as amended at 51 FR 36967, Oct. 16, 1986; 62 FR 59276, Nov. 3, 1997; 67 FR 20370, Apr. 24, 2002; 71 FR 15008, Mar. 27, 2006; 72 FR 45150, Aug. 13, 2007; 77 FR 43695, July 25, 2012]","(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed under part 35 of this chapter for use as a calibration, transmission, or reference source or for the uses listed in §§ 35.400, 35.500, 35.600, and 35.1000 of this chapter will be approved if: (1) The applicant satisfies the general requirements in § 30.33 of this chapter; (2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: (i) The byproduct material contained, its chemical and physical form, and amount; (ii) Details of design and construction of the source or device; (iii) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; (vi) Procedures and standards for calibrating sources and devices; (vii) Legend and methods for labeling sources and devices as to their radioactive content; (viii) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: Provided, That instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label; (3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the U.S. Nuclear Regulatory Commission has approved distribution of the (name of source or device) to persons licensed to use byproduct material identified in §§ 35.65, 35.400, 35.500, and 35.600 as appropriate, and to persons who hold an equivalent license issued by an Agreement State. However, labels worded in accordance with requirements that were in place on March 30, 1987 may be used until March 30, 1989. (4) The source or device has been registered in the Sealed Source and Device Registry. (b)(1) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source. (2) In determining the acceptable interval for test of leakage of radioactive material, the Commission will consider information that includes, but is not limited to: (i) Primary containment (source capsule); (ii) Protection of primary containment; (iii) Method of sealing containment; (iv) Containment construction materials; (v) Form of contained radioactive material; (vi) Maximum temperature withstood during prototype tests; (vii) Maximum pressure withstood during prototype tests; (viii) Maximum quantity of contained radioactive material; (ix) Radiotoxicity of contained radioactive material; (x) Operating experience with identical sources or devices or similarly designed and constructed sources or devices. (c) If an application is filed pursuant to paragraph (a) of this section on or before October 15, 1974, for a license to manufacture and distribute a source or device that was distributed commercially on or before August 16, 1974, the applicant may continue the distribution of such source or device to group licensees until the Commission issues the license or notifies the applicant otherwise." 10:10:1.0.1.1.22.3.91.3,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,C,Subpart C—Specifically Licensed Items,,§ 32.201 Serialization of nationally tracked sources.,NRC,,,"[71 FR 65709, Nov. 8, 2006]","Each licensee who manufactures a nationally tracked source after February 6, 2007 shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters." 10:10:1.0.1.1.22.4.91.1,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,D,Subpart D—Sealed Source and Device Registration,,§ 32.210 Registration of product information.,NRC,,,"[52 FR 27786, July 24, 1987, as amended at 60 FR 24551, May 9, 1995; 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008; 77 FR 43695, July 25, 2012]","(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the NRC for evaluation of radiation safety information about its product and for its registration. (b) The request for review must be sent to the NRC's Office of Nuclear Material Safety and Safeguards, ATTN: SSDR by an appropriate method listed in § 30.6(a) of this chapter. (c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. (d) The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria with the help of the manufacturer or distributor. The NRC shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Subpart A of this part includes specific criteria that apply to certain exempt products and subpart B includes specific criteria applicable to certain generally licensed devices. Subpart C includes specific provisions that apply to certain specifically licensed items. (e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate. (f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with— (1) The statements and representations, including quality control program, contained in the request; and (2) The provisions of the registration certificate. (g) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases: (1) Calibration and reference sources containing no more than: (i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or (ii) 0.37 MBq (10 µCi), for alpha emitting radionuclides; or (2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and (i) The intended recipients are licensed under part 33 of this chapter or comparable provisions of an Agreement State; or (ii) The recipients are authorized for research and development; or (iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide. (h) After the certificate is issued, the Commission may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Commission will complete its evaluation in accordance with criteria specified in this section. The Commission may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested." 10:10:1.0.1.1.22.4.91.2,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,D,Subpart D—Sealed Source and Device Registration,,§ 32.211 Inactivation of certificates of registration of sealed sources and devices.,NRC,,,"[77 FR 43695, July 25, 2012]","(a) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Commission shall request inactivation of the registration certificate. Such a request must be made to the NRC's Office of Nuclear Material Safety and Safeguards, ATTN: SSDR by an appropriate method listed in § 30.6(a) of this chapter and must normally be made no later than two years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within 90 days of this determination and briefly describe the circumstances of the delay. (b) If a distribution license is to be terminated in accordance with § 30.36 of this chapter, the licensee shall request inactivation of its registration certificates associated with that distribution license before the Commission will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number. (c) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate." 10:10:1.0.1.1.22.5.91.1,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,E,Subpart E—Violations,,§ 32.301 Violations.,NRC,,,"[57 FR 55073, Nov. 24, 1992]","(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of— (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of— (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended." 10:10:1.0.1.1.22.5.91.2,10,Energy,I,,32,PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL,E,Subpart E—Violations,,§ 32.303 Criminal penalties.,NRC,,,"[57 FR 55073, Nov. 24, 1992, as amended at 59 FR 61781, Dec. 2, 1994; 73 FR 42674, July 23, 2008; 77 FR 43696, July 25, 2012]","(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 32 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 32 that are not issued under subsections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 32.1, 32.2, 32.8, 32.11, 32.14, 32.18, 32.21, 32.22, 32.23, 32.24, 32.26, 32.27, 32.28, 32.30, 32.31, 32.51, 32.53, 32.57, 32.61, 32.71, 32.72, 32.74, 32.301, and 32.303." 17:17:1.0.1.1.25.0.7.1,17,Commodity and Securities Exchanges,I,,32,PART 32—REGULATION OF COMMODITY OPTION TRANSACTIONS,,,,§ 32.1 Scope.,CFTC,,,,"The provisions of this part shall apply to all commodity option transactions, except for commodity option transactions on a contract of sale of a commodity for future delivery conducted or executed on or subject to the rules of either a designated contract market or a foreign board of trade." 17:17:1.0.1.1.25.0.7.2,17,Commodity and Securities Exchanges,I,,32,PART 32—REGULATION OF COMMODITY OPTION TRANSACTIONS,,,,§ 32.2 Commodity option transactions; general authorization.,CFTC,,,,"Subject to §§ 32.1, 32.4, and 32.5, which shall in any event apply to all commodity option transactions, it shall be unlawful for any person or group of persons to offer to enter into, enter into, confirm the execution of, maintain a position in, or otherwise conduct activity related to any transaction in interstate commerce that is a commodity option transaction, unless: (a) Such transaction is conducted in compliance with and subject to the provisions of the Act, including any Commission rule, regulation, or order thereunder, otherwise applicable to any other swap, or (b) Such transaction is conducted pursuant to § 32.3." 17:17:1.0.1.1.25.0.7.3,17,Commodity and Securities Exchanges,I,,32,PART 32—REGULATION OF COMMODITY OPTION TRANSACTIONS,,,,§ 32.3 Trade options.,CFTC,,,"[81 FR 14974, Mar. 21, 2016]","(a) Subject to paragraphs (b), (c), and (d) of this section, the provisions of the Act, including any Commission rule, regulation, or order thereunder, otherwise applicable to any other swap shall not apply to, and any person or group of persons may offer to enter into, enter into, confirm the execution of, maintain a position in, or otherwise conduct activity related to, any transaction in interstate commerce that is a commodity option transaction, provided that: (1) Such commodity option transaction must be offered by a person that has a reasonable basis to believe that the transaction is offered to an offeree as described in paragraph (a)(2) of this section. In addition, the offeror must be either: (i) An eligible contract participant, as defined in section 1a(18) of the Act, as further jointly defined or interpreted by the Commission and the Securities and Exchange Commission or expanded by the Commission pursuant to section 1a(18)(C) of the Act; or (ii) A producer, processor, or commercial user of, or a merchant handling the commodity that is the subject of the commodity option transaction, or the products or by-products thereof, and such offeror is offering or entering into the commodity option transaction solely for purposes related to its business as such; (2) The offeree must be a producer, processor, or commercial user of, or a merchant handling the commodity that is the subject of the commodity option transaction, or the products or by-products thereof, and such offeree is offered or entering into the commodity option transaction solely for purposes related to its business as such; and (3) The commodity option must be intended to be physically settled, so that, if exercised, the option would result in the sale of an exempt or agricultural commodity for immediate or deferred shipment or delivery. (b) In connection with any commodity option transaction entered into pursuant to paragraph (a) of this section, every counterparty that is not a swap dealer or major swap participant shall obtain a legal entity identifier pursuant to § 45.6 of this chapter if the counterparty to the transaction involved is a swap dealer or major swap participant, and provide such legal entity identifier to the swap dealer or major swap participant counterparty. (c) In connection with any commodity option transaction entered into pursuant to paragraph (a) of this section, the following provisions shall apply to every trade option counterparty to the same extent that such provisions would apply to such person in connection with any other swap: (1) Part 20 (Swaps Large Trader Reporting) of this chapter; (2) Subpart J of part 23 (Duties of Swap Dealers and Major Swap Participants) of this chapter; (3) Sections 23.200, 23.201, 23.203, and 23.204 of subpart F of part 23 (Reporting and Recordkeeping Requirements for Swap Dealers and Major Swap Participants) of this chapter; and (4) Section 4s(e) of the Act (Capital and Margin Requirements for Swap Dealers and Major Swap Participants). (d) Any person or group of persons offering to enter into, entering into, confirming the execution of, maintaining a position in, or otherwise conducting activity related to a commodity option transaction in interstate commerce pursuant to paragraph (a) of this section shall remain subject to part 180 (Prohibition Against Manipulation) and § 23.410 (Prohibition on Fraud, Manipulation, and other Abusive Practices) of this chapter and the antifraud, anti-manipulation, and enforcement provisions of sections 2, 4b, 4c, 4o, 4s(h)(1)(A), 4s(h)(4)(A), 6, 6c, 6d, 9, and 13 of the Act. (e) The Commission may, by order, upon written request or upon its own motion, exempt any person, either unconditionally or on a temporary or other conditional basis, from any provisions of this part, and the provisions of the Act, including any Commission rule, regulation, or order thereunder, otherwise applicable to any other swap, other than § 32.4, part 180 (Prohibition Against Manipulation), and § 23.410 (Prohibition on Fraud, Manipulation, and other Abusive Practices) of this chapter, and the antifraud, anti-manipulation, and enforcement provisions of sections 2, 4b, 4c, 4o, 4s(h)(1)(A), 4s(h)(4)(A), 6, 6c, 6d, 9, and 13 of the Act, if it finds, in its discretion, that it would not be contrary to the public interest to grant such exemption." 17:17:1.0.1.1.25.0.7.4,17,Commodity and Securities Exchanges,I,,32,PART 32—REGULATION OF COMMODITY OPTION TRANSACTIONS,,,,§ 32.4 Fraud in connection with commodity option transactions.,CFTC,,,,"In or in connection with an offer to enter into, the entry into, or the confirmation of the execution of, any commodity option transaction, it shall be unlawful for any person directly or indirectly: (a) To cheat or defraud or attempt to cheat or defraud any other person; (b) To make or cause to be made to any other person any false report or statement thereof or cause to be entered for any person any false record thereof; or (c) To deceive or attempt to deceive any other person by any means whatsoever." 17:17:1.0.1.1.25.0.7.5,17,Commodity and Securities Exchanges,I,,32,PART 32—REGULATION OF COMMODITY OPTION TRANSACTIONS,,,,§ 32.5 Option transactions entered into prior to the effective date of this part.,CFTC,,,,Nothing contained in this part shall be construed to affect any lawful activities that occurred prior to the effective date of this part. 28:28:1.0.1.1.33.0.14.1,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",,,,§ 32.0 Scope of part.,DOJ,,,"[73 FR 76528, Dec. 17, 2008]","This part implements the Act, which, as a general matter, authorizes the payment of three different legal gratuities: (a) Death benefits; (b) Disability benefits; and (c) Educational assistance benefits." 28:28:1.0.1.1.33.1.14.1,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,§ 32.1 Scope of subpart.,DOJ,,,,This subpart contains provisions generally applicable to this part. 28:28:1.0.1.1.33.1.14.2,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,§ 32.2 Computation of time; filing.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22378, May 15, 2018]","(a) In computing any period of time prescribed or allowed, the day of the act, event, or default from which the designated period of time begins to run shall not be included. The last day of the period so computed shall be included, unless it is a Saturday, a Sunday, or a federal legal holiday, or, when the act to be done is a filing with the PSOB Office, a day on which weather or other conditions have caused that Office to be closed or inaccessible, in which event the period runs until the end of the next day that is not one of the aforedescribed days. (b) Except as provided in paragraph (g) of this section, a filing is deemed filed with the PSOB Office, a Hearing Officer, the Director, or any other OJP office, -officer, -employee, or -agent, only on the day that it actually is received at the office of the same. When a filing is prescribed to be filed with more than one of the foregoing, it shall be deemed filed as of the day the last such one so receives it. (c) Except as provided in paragraph (g) of this section, notice is served by the PSOB Office upon an individual on the day that it is— (1) Mailed, by U.S. mail, addressed to the individual (or to his representative) at his (or his representative's) last address known to such Office; or (2) Delivered to a courier or other delivery service, addressed to the individual (or to his representative) at his (or his representative's) last address known to such Office. (d) In the event of withdrawal or abandonment of a filing, the time periods prescribed for the filing thereof shall not be tolled, unless, for good cause shown, the Director grants a waiver. (e) No claim may be filed (or approved) under the Act, at 34 U.S.C. 10281(a) or (b), with respect to an injury, if a claim under the Act, at 34 U.S.C. 10286 or Public Law 107-37, has been approved, with respect to the same injury. (f) No claim may be filed (or approved) under the Act, at 34 U.S.C. 10286 or Public Law 107-37, with respect to an injury, if a claim under the Act, at 34 U.S.C. 10281(a) or (b), has been approved, with respect to the same injury. (g) The Director may prescribe that— (1) Any filing be filed using electronic means, in which case it shall be deemed filed when it is submitted electronically; and (2) Any notice, within the meaning of paragraph (c) of this section, be served by the PSOB Office upon an individual by electronic means (such as by telefacsimile or electronic mail addressed to the individual (or to his representative) at his (or his representative's) last address known to such Office), in which case it shall be deemed served on the day that such notice is sent." 28:28:1.0.1.1.33.1.14.3,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,§ 32.3 Definitions.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 73 FR 76528, Dec. 17, 2008; 78 FR 29234, May 20, 2013; 79 FR 35492, June 23, 2014; 83 FR 22378, May 15, 2018]","Act means the Public Safety Officers' Benefits Act of 1976 (generally codified at 34 U.S.C. 10281, et seq.; part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968) (including (uncodified) sections 4 through 6 thereof (payment in advance of appropriations, rule of construction and severability, and effective date and applicability)), as applicable (cf. § 32.4(d)) according to its effective date and those of its various amendments ( e.g., Sep. 29, 1976 (deaths of State and local law enforcement officers and firefighters); Oct 3, 1996 (educational assistance (federal law enforcement officer disabled)); Nov. 14, 1998 (educational assistance (officer (other than federal law enforcement officer) disabled)); Oct. 30, 2000 (disaster relief workers); Sep. 11, 2001 (chaplains and insurance beneficiaries); Dec. 15, 2003 (certain heart attacks and strokes); Apr. 5, 2006 (designated beneficiaries); June 1, 2009 (certain members of rescue squads or ambulance crews); Jan. 2, 2013 (designated beneficiaries; vascular ruptures); and June 2, 2017 (certain administrative changes)); and also includes Public Law 107-37 and section 611 of the USA PATRIOT Act (both of which relate to payment of benefits, described under subpart 1 of such part L, in connection, respectively, with the terrorist attacks of Sept. 11, 2001, or with such terrorist attacks as may occur after Oct. 26, 2001), as well as the proviso under the Public Safety Officers Benefits heading in title II of division B of section 6 of Public Law 110-161. Adopted child —An individual is an adopted child of a public safety officer only if— (1) The individual is legally adopted by the officer; or (2) As of the injury date, and not being a stepchild, the individual was— (i) Known by the officer not to be his biological first-generation offspring; and (ii) After the officer obtained such knowledge, in a parent-child relationship with him. Authorized commuting means travel (not being described in the Act, at 34 U.S.C. 10282, and not being a frolic or detour) by a public safety officer to and from work (at a situs (for the performance of line of duty activity or action) authorized or required by his public safety agency)— (1) In the course of actually responding (as authorized)— (i) Directly to a fire, rescue, or police emergency; or (ii) To a particular and extraordinary request (by such public safety agency) for that specific officer to perform public safety activity (including emergency response activity the agency is authorized to perform), within his line of duty; or (2) Under circumstances not described in paragraph (1) of this definition— (i) While using a vehicle provided by such agency, pursuant to a requirement or authorization by such agency that he use the same for travel to and from work; or (ii) While using a vehicle not provided by such agency, pursuant to a requirement by such agency that he use the same for work. Biological means genetic, but does not include circumstances where the genetic donation (under the laws of the jurisdiction where the offspring is conceived) does not (as of the time of such conception) legally confer parental rights and obligations. BJA means the Bureau of Justice Assistance, OJP. Candidate-officer means an individual who is officially enrolled or -admitted, as a cadet or trainee, in candidate-officer training. Candidate-officer training means a formal and officially recognized program of instruction or of training ( e.g., a police or fire academy) that is specifically intended to result, directly or immediately upon completion, in— (1) Commissioning of such individual as a law enforcement officer; (2) Conferral upon such individual of official authority to engage in fire suppression (as an officer or employee of a public fire department or as an officially recognized or -designated member of a legally organized volunteer fire department); or (3) The granting to such individual of official authorization or -license to engage in rescue activity, or in the provision of emergency medical services, as a member of a rescue squad or ambulance crew that is (or is part of) the agency or entity sponsoring the individual's enrollment or admission Cause —A death, injury, or disability is caused by intentional misconduct if— (1) The misconduct is a substantial factor in bringing it about; and (2) It is a reasonably foreseeable result of the misconduct. Certification means a formal assertion of a fact (or facts), in a writing that is— (1) Expressly intended to be relied upon by the PSOB determining official in connection with the determination of a claim specifically identified therein; (2) Expressly directed to the PSOB determining official; (3) Legally subject to the provisions of 18 U.S.C. 1001 (false statements) and 1621 (perjury), and 28 U.S.C. 1746 (declarations under penalty of perjury), and expressly declares the same to be so; (4) Executed by a natural person with knowledge of the fact (or facts) asserted and with legal authority to execute the writing (such as to make the assertion legally that of the certifying party), and expressly declares the same (as to knowledge and authority) to be so; (5) In such form as the Director may prescribe from time to time; (6) True, complete, and accurate (or, at a minimum, not known or believed by the PSOB determining official to contain any material falsehood, incompleteness, or inaccuracy); and (7) Unambiguous, precise, and unequivocal, in the judgment of the PSOB determining official, as to any fact asserted, any matter otherwise certified, acknowledged, indicated, or declared, and any provision of this definition. Certification described in the Act, at 34 U.S.C. 10286 or Public Law 107-37 means a certification, acknowledging all the matter specified in § 32.5(f)(1) and (2)— (1) In which the fact (or facts) asserted is the matter specified in § 32.5(f)(3); (2) That expressly indicates that all of the terms used in making the assertion described in paragraph (1) of this definition (or used in connection with such assertion) are within the meaning of the Act, at 34 U.S.C. 10286 or Public Law 107-37, and of this part; and (3) That otherwise satisfies the provisions of the Act, at 34 U.S.C. 10286 or Public Law 107-37, and of this part. Chaplain means a clergyman, or other individual trained in pastoral counseling, who meets the definition provided in the Act, at 34 U.S.C. 10284(2). Child of a public safety officer means an individual— (1) Who meets the definition provided in the Act, at 34 U.S.C. 10284(3); and (2) With respect to whom the public safety officer's parental rights have not been terminated, as of the injury date. Claim means a request (in such form, and containing such information, as the Director may require from time to time) for payment of benefits under this part, where the individual seeking payment has affirmatively requested that the PSOB Office proceed to determination on the basis of the supporting evidence filed by or on behalf of the individual (and any associated legal arguments so filed) at or before the time of that affirmative request: Provided, That nothing in this definition shall be understood to preclude any PSOB determining official from (at any time) obtaining or considering other evidence in connection with a determination of the claim. Claimant means an individual who has filed a claim on his own behalf or on whose behalf a claim has been filed. Commonly accepted means generally agreed upon within the medical profession. Convincing evidence means clear and convincing evidence. Crime means an act or omission punishable as a criminal misdemeanor or felony. Criminal laws means that body of law that declares what acts or omissions are crimes and prescribes the punishment that may be imposed for the same. Department or agency —An entity is a department or agency within the meaning of the Act, at 34 U.S.C. 10284(8), and this part, only if the entity is— (1) A court; (2) An agency described in the Act, at 34 U.S.C. 10284(9)(B) or (C); or (3) Otherwise a public entity— (i) That is legally an express part of the internal organizational structure of the relevant government; (ii) That has no legal existence independent of such government; and (iii) Whose obligations, acts, omissions, officers, and employees are legally those of such government. Determination means the approval or denial of a claim (including an affirmance or reversal pursuant to a motion for reconsideration under § 32.27). Director means the Director of BJA. Direct and proximate cause —Except as may be provided in the Act, at 34 U.S.C. 10281(k), something directly and proximately causes a wound, condition, or cardiac-event, if it is a substantial factor in bringing the wound, condition, or cardiac-event about. Direct and proximate result of an injury —Except as may be provided in the Act, at 34 U.S.C. 10281(k), a death or disability results directly and proximately from an injury if the injury is a substantial factor in bringing it about. Disaster relief activity means activity or an action encompassed within the duties described in the Act, at 34 U.S.C. 10284(9)(B) or (C). Disaster relief worker means any individual who meets the definition provided in the Act, at 34 U.S.C. 10284(9)(B) or (C). Disturbance includes any significant and negative alteration, any significant negative deviation from the objectively normal, or any significant deterioration. Divorce means a legally-valid (for civil purposes) dissolution of the bond of wedlock (i.e., the bond of marriage), except that, otherwise, and notwithstanding any other provision of law, a spouse (or purported spouse) of an individual shall be considered to be divorced from that individual within the meaning of this definition if, subsequent to his marriage (or purported marriage) to that individual (and while that individual is living), the spouse (or purported spouse)— (1) Holds himself out as being divorced from, or not being married to, the individual; (2) Holds himself out as being married to another individual; or (3) Was a party to a ceremony purported by the parties thereto to be a marriage between the spouse (or purported spouse) and another individual. Drugs or other substances means— (1) Controlled substances within the meaning of the drug control and enforcement laws, at 21 U.S.C. 802(6), including any active metabolite ( i.e., any metabolite whose introduction into (or presence otherwise in) the human body, ordinarily or objectively can result in a disturbance of mental or physical faculties) of any such controlled substance; or (2) Any physical matter (other than alcohol, or anything described in paragraph (1) of this definition) whose introduction into (or presence otherwise in) the human body, ordinarily or objectively can result in a disturbance of mental or physical faculties. Educational/academic institution means an institution whose primary purpose is educational or academic learning. Eligible payee means— (1) An individual (other than the officer) described in the Act, at 34 U.S.C. 10281(a), with respect to a claim under subpart B of this part; or (2) An individual described in the Act, at 34 U.S.C. 10281(b), with respect to a claim under subpart C of this part. Emergency medical services means— (1) First-response emergency medical care (other than in a permanent medical-care facility); or (2) Transportation of persons in medical distress (or under emergency conditions) to medical-care facilities. Emergency response activity means response to a fire-, rescue-, or police emergency. Employed by a public agency —A public safety officer is employed, within the meaning of the Act, at 34 U.S.C. 10286 or Public Law 107-37, by a public agency, when he— (1) Is employed by the agency in a civilian capacity; and (2) Is— (i) Serving the agency in an official capacity (with respect to officers described in the Act, at 34 U.S.C. 10284(9)(A)); (ii) Performing official duties as described in the Act, at 34 U.S.C. 10284(9)(B) or (C) (with respect to disaster relief workers). (iii) Engaging in activity (or in the provision of services) described in the Act, at 34 U.S.C. 10284(9)(D), under the authority (or by the license) of a public agency (with respect to rescue squad or ambulance crew members). Employee does not include— (1) Any independent contractor; or (2) Any individual who is not eligible to receive death or disability benefits from the purported employer on the same basis as a regular employee of such employer would. Employment in a civilian capacity refers to status as a civilian, rather than to the performance of civilian functions. Filing means any claim, request, motion, election, petition, or appeal, and any item or matter ( e.g. , evidence, certifications, authorizations, waivers, legal arguments, or lists) that is, or may be, filed with the PSOB Office. Fire protection means— (1) Suppression of fire; (2) Hazardous-material response; or (3) Emergency medical services or rescue activity of the kind performed by firefighters. Fire-, rescue-, or police emergency includes disaster-relief emergency. Firefighter means an individual who— (1) Is trained (or is receiving candidate-officer training) in— (i) Suppression of fire; or (ii) Hazardous-material response; and (2) Has the legal authority or responsibility to engage in the suppression of fire, as— (i) An employee (or candidate-officer) of the public agency he serves, which legally recognizes him to have such (or, at a minimum, does not deny (or has not denied) him to have such); or (ii) An individual otherwise included within the definition provided in the Act, at 34 U.S.C. 10284(4). Foundational evidence as to status and injury means supporting evidence (filed by a claimant at or before the time his claim is filed) that constitutes the basis for his belief or assertion that— (1) The individual upon whose injury the claim is predicated— (i) Was a public safety officer as of the injury date; and (ii) As the direct and proximate result of a personal injury sustained in the line of duty, either— (A) Died (with respect to a claim under subpart B of this part); or (B) Became permanently and totally disabled (with respect to a claim under subpart C of this part); and (2) With respect to a claim under subpart B of this part, the claimant is an eligible payee. Functionally within or -part of —No individual shall be understood to be functionally within or -part of a public agency solely by virtue of an independent contractor relationship. Gross negligence means great, heedless, wanton, indifferent, or reckless departure from ordinary care, prudence, diligence, or safe practice (which departure is without reasonable excuse and is objectively unjustified)— (1) In the presence of serious risks that are known or obvious; (2) Under circumstances where it is highly likely that serious harm will follow; or (3) In situations where a high degree of danger is apparent. Hazardous-material response means emergency response to the threatened or actual release of hazardous materials, where life, property, or the environment is at significant risk. Heart attack means— (1) A myocardial infarction; or (2) A cardiac-event (i.e., cessation, interruption, arrest, or other similar disturbance of heart function), not included in paragraph (1) of this definition, that is— (i) Acute; and (ii) Directly and proximately caused by a pathology (or pathological condition) of the heart or of the coronary arteries. Illegitimate child —An individual is an illegitimate child of a public safety officer only if he is a natural child of the officer, and the officer is not married to the other biological parent at (or at any time after) the time of his conception. Incapable of self-support because of physical or mental disability —An individual is incapable of self-support because of physical or mental disability if he is under a disability within the meaning of the Social Security Act, at 42 U.S.C. 423(d)(1)(A), applicable mutatis mutandis. Independent contractor includes any volunteer, servant, employee, contractor, or agent, of an independent contractor. Injury means a traumatic physical wound (or a traumatized physical condition of the body) directly and proximately caused by external force (such as bullets, explosives, sharp instruments, blunt objects, or physical blows), chemicals, electricity, climatic conditions, infectious disease, radiation, virus, or bacteria, and includes (with respect to a WTC responder) a WTC-related health condition, but does not include— (1) Any occupational disease; or (2) Any condition of the body caused or occasioned by stress or strain. Injury date —Except with respect to claims under the Act, at 34 U.S.C. 10281(k) (where, for purposes of determining beneficiaries under the Act, at 34 U.S.C. 10281(a), it generally means the time of the engagement or participation referred to in the Act, at 34 U.S.C. 10281(k)(1)), injury date means the time of the line of duty injury that— (1) Directly and proximately results in the public safety officer's death, with respect to a claim under— (i) Subpart B of this part; or (ii) Subpart D of this part, by virtue of his death; or (2) Directly (or directly and proximately) results in the public safety officer's total and permanent disability, with respect to a claim under— (i) Subpart C of this part; or (ii) Subpart D of this part, by virtue of his disability. Instrumentality means entity, and does not include any individual, except that, subject to § 32.5(m), no entity shall be considered an instrumentality within the meaning of the Act, at 34 U.S.C. 10284(8), or this part, unless, as of the injury date, (1) The entity— (i) Is legally established, -recognized, or -organized, such that it has legal existence; and (ii) Is so organized and controlled, and its affairs so conducted, that it operates and acts solely and exclusively as a functional part of the relevant government, which legally recognizes it as such (or, at a minimum, does not deny (or has not denied) it to be such); and (2) The entity's— (i) Functions and duties are solely and exclusively of a public character; (ii) Services are provided generally to the public as such government would provide if acting directly through its public employees ( i.e. , they are provided without regard to any particular relationship (such as a subscription) a member of the public may have with such entity); and (iii) Acts and omissions are, and are recognized by such government as (or, at a minimum, not denied by such government to be), legally— (A) Those of such government, for purposes of sovereign immunity; or (B) The responsibility of such government, for purposes of tort liability. Intention —A death, injury, or disability is brought about by a public safety officer's intention if— (1) An intentional action or activity of his is a substantial factor in bringing it about; and (2) It is a reasonably foreseeable result of the intentional action or activity. Intention-notice filer means an individual— (1) Who believes that he may be an eligible payee; (2) Who has filed a notice of intention to file a claim; and (3) Who has no claim pending. Intentional action or activity means activity or action (other than line of duty activity or action), including behavior, that is— (1) A result of conscious volition, or otherwise voluntary; (2) Not a result of legal insanity or of impulse that is legally and objectively uncontrollable; and (3) Not performed under legal duress or legal coercion of the will. Intentional misconduct —A public safety officer's action or activity is intentional misconduct if— (1) As of the date it is performed, (i) Such action or activity— (A) Is in violation of, or otherwise prohibited by, any statute, rule, regulation, condition of employment or service, official mutual-aid agreement, or other law; or (B) Is contrary to the ordinary, usual, or customary practice of similarly-situated officers within his public safety agency; and (ii) He knows, or reasonably should know, that it is so in violation, prohibited, or contrary; and (2) Such action or activity— (i) Is intentional; and (ii) Is— (A) Performed without reasonable excuse; and (B) Objectively unjustified. Involvement —An individual is involved in crime and juvenile delinquency control or reduction, or enforcement of the criminal laws (including juvenile delinquency), only if he is an officer (including a candidate-officer) of a public agency and, in that capacity, has legal authority or -responsibility to arrest, apprehend, prosecute, adjudicate, correct or detain (in a prison or other detention or confinement facility), or supervise (as a parole or probation officer), persons who are alleged or found to have violated the criminal laws, and is recognized by such agency, or the relevant government (or, at a minimum, not denied by such agency, or the relevant government), to have such authority and responsibility. Itemized description of representative services provided —A description of representative services provided is itemized only when it includes— (1) The beginning and end dates of the provision of the services; (2) An itemization of the services provided and the amount of time spent in providing them; and (3) An itemization of the expenses incurred in connection with the services provided for which reimbursement is sought. Kinds of public safety officers —The following are the different kinds of public safety officers: (1) Law enforcement officers; (2) Firefighters; (3) Chaplains; (4) Members of rescue squads or ambulance crews; and (5) Disaster relief workers. Law enforcement means enforcement of the criminal laws, including— (1) Control or reduction of crime or of juvenile delinquency; (2) Prosecution or adjudication of individuals who are alleged or found to have violated such laws; (3) Prison security activity; and (4) Supervision of individuals on parole or probation for having violated such laws. Line of duty activity or action —Subject to § 32.5(j) and (k), activity or an action is performed in the line of duty, in the case of a public safety officer who is (as of the injury date)— (1) A law enforcement officer or a firefighter— (i) Whose primary function (as applicable) is public safety activity, only if, not being described in the Act, at 34 U.S.C. 10282(a), and not being commuting or a frolic or detour— (A) It is activity or an action that he is obligated or authorized by statute, rule, regulation, condition of employment or service, official mutual-aid agreement, or other law, to perform (including any social, ceremonial, or athletic functions (or any official training programs of his public agency) to which he is assigned, or for which he is compensated), under the auspices of the public agency he serves; and (B) Such agency (or the relevant government) legally recognizes that activity or action to have been so obligated or authorized at the time performed (or, at a minimum, does not deny (or has not denied) it to have been such); or (ii) Whose primary function is not public safety activity, only if, not being described in the Act, at 34 U.S.C. 10282(a), and not being commuting or a frolic or detour— (A) It is activity or an action that he is obligated or authorized by statute, rule, regulation, condition of employment or service, official mutual-aid agreement, or other law, to perform (including any social, ceremonial, or athletic functions (or any official training programs of his public agency) to which he is assigned, or for which he is compensated), under the auspices of the public agency he serves; (B) It is performed (as applicable) in the course of public safety activity (including emergency response activity the agency is authorized to perform), or taking part (as a trainer or trainee) in an official training program of his public agency for such activity, and such agency (or the relevant government) legally recognizes it to have been such at the time performed (or, at a minimum, does not deny (or has not denied) it to have been such); and (C) Such agency (or the relevant government) legally recognizes (or, at a minimum, does not deny (or has not denied) that activity or action to have been— ( 1 ) Obligated or authorized (as described in paragraph (1)(ii)(A) of this definition) at the time performed; and ( 2 ) Performed as described in paragraph (1)(ii)(B) of this definition; (2) A disaster relief worker, only if, not being described in the Act, at 34 U.S.C. 10282(a), and not being commuting or a frolic or detour, it is disaster relief activity, and the public agency in which he is an employee (or the relevant government), being described in the Act, at 34 U.S.C. 10284(9)(B) or (C), legally recognizes it to have been such at the time performed (or, at a minimum, does not deny (or has not denied) it to have been such); or (3) A chaplain, only if, not being described in the Act, at 34 U.S.C. 10282(a), and not being commuting or a frolic or detour— (i) It is activity or an action that he is obligated or authorized by statute, rule, regulation, condition of employment or service, official mutual-aid agreement, or other law, to perform, under the auspices of the public agency he serves, and such agency (or the relevant government) legally recognizes it to have been such at the time performed (or, at a minimum, does not deny (or has not denied) it to have been such); and (ii) It is performed in the course of responding to a fire-, rescue-, or police emergency, and such agency (or the relevant government) legally recognizes it to have been such at the time performed (or, at a minimum, does not deny (or has not denied) it to have been such). (4) A member of a rescue squad or ambulance crew, only if, not being described in the Act, at 34 U.S.C. 10282(a), and not being commuting or a frolic or detour, it is performed in the course of rescue activity (or of the provision of emergency medical services) that he is authorized or licensed, by law and by his public safety agency, to engage in (or provide) as described in the Act, at 34 U.S.C. 10284(9)(D), and such agency (and the relevant government) legally recognizes it to have been such at the time performed (or, at a minimum, does not deny (or has not denied) it to have been such). Line of duty injury —An injury is sustained in the line of duty only if— (1) It is sustained in the course of— (i) Performance of line of duty activity or a line of duty action; or (ii) Authorized commuting; or (2) In connection with any claim in which the injury is not sustained as described in paragraph (1) of this definition: (i) The injured party's status as a public safety officer was a substantial contributing factor in the injury; and (ii) Where the injury is brought about by the hostile action of an individual— (A) The individual knew of the injured party's status as a public safety officer; and (B) Nothing else motivated the individual's taking of his hostile action to so great a degree as either of the following did: ( 1 ) The injured party's status as a public safety officer; or ( 2 ) Retaliation for line of duty activity or a line of duty action performed by a public safety officer (including the injured party). Mental faculties means brain function. Natural child —An individual is a natural child of a public safety officer only if he is a biological child of the officer, and the officer is alive at the time of his birth. Notice of intention to file a claim —Nothing shall be understood to be a notice of intention to file a claim unless it names the individual upon whose injury such a claim would be predicated and otherwise is in such form, and contains such other information, as the Director may require from time to time therefor. Occupational disease means a disease (including an ailment or condition of the body) that routinely constitutes a special hazard in, or is commonly regarded as a concomitant of, an individual's occupation. Official capacity —Subject to § 32.5(l), an individual serves a public agency in an official capacity only if— (1) He is officially authorized, -recognized, or -designated (by such agency) as functionally within or -part of it; and (2) His acts and omissions, while so serving, are legally those of such agency, which legally recognizes them as such (or, at a minimum, does not deny (or has not denied) them to be such). Official duties means duties that are officially authorized, -recognized, or -designated by an employing entity, such that the performance of those duties is legally the action of such entity, which legally recognizes it as such (or, at a minimum, does not deny (or has not denied) it to be such). Official training program of a public safety officer's public safety agency means a program— (1) That is officially sponsored, -conducted, or -authorized by his public safety agency; and (2) Whose purpose is to train public safety officers of his kind in (or to improve their skills in), specific activity or actions encompassed within their respective lines of duty. Officially recognized or designated employee member of a rescue squad or ambulance crew means an employee member of a rescue squad or ambulance crew (described in the Act, at 34 U.S.C. 10284(7)) who is officially recognized (or officially designated) as such an employee member, by such squad or crew. Officially recognized or designated member of a department or agency means a member of a department or agency, or of an instrumentality, of a government described in the Act, at 34 U.S.C. 10284(8), who is officially recognized (or officially designated) as such a member by the same. Officially recognized or designated public employee of a department or agency means a public employee of a department or agency who is officially recognized (or officially designated) as a public safety officer, by the same. Officially recognized or designated volunteer member of a rescue squad or ambulance crew means a volunteer member of a rescue squad or ambulance crew (described in the Act, at 34 U.S.C. 10284(7)) who is officially recognized (or officially designated) as such a volunteer member, by such squad or crew. OJP means the Office of Justice Programs, U.S. Department of Justice. Parent means a father or a mother. Parent-child relationship means a relationship between a public safety officer and another individual, in which the officer has the role of parent (other than biological or legally-adoptive), as shown by convincing evidence. Performance of duties in a grossly negligent manner at the time of death or catastrophic injury means gross negligence, as of or near the injury date, in the course of authorized commuting or performance of line of duty activity or a line of duty action, where such negligence is a substantial contributing factor in bringing such death or injury about. Posthumous child —An individual is a posthumous child of a public safety officer only if he is a biological child of the officer, and the officer is— (1) Alive at the time of his conception; and (2) Deceased at or before the time of his birth. Prison security activity means correctional or detention activity (in a prison or other detention or confinement facility) of individuals who are alleged or found to have violated the criminal laws. PSOB determining official means, as applicable, any of the following: (1) The PSOB Office; (2) The Hearing Officer; or (3) The Director. PSOB Office means the unit of BJA that directly administers the Public Safety Officers' Benefits program. Public employee means— (1) An employee of a government described in the Act, at 34 U.S.C. 10284(8) , (or of a department or agency thereof) and whose acts and omissions while so employed are legally those of such government, which legally recognizes them as such (or, at a minimum, does not deny (or has not denied) them to be such); or (2) An employee of an instrumentality of a government described in the Act, at 34 U.S.C. 10284(8), who is eligible to receive disability benefits (or whose survivors are eligible to receive death benefits) from such government on the same basis as an employee of that government (within the meaning of paragraph (1) of this definition), or his survivors, would. Public employee of a department or agency means a public employee whose public agency employer is the department or agency. Public safety activity means any of the following: (1) Law enforcement; (2) Fire protection; (3) Rescue activity; or (4) The provision of emergency medical services. Public safety agency means— (1) A public agency— (i) That an individual described in the Act, at 34 U.S.C. 10284(9)(A), serves in an official capacity; or (ii) For which an employee described in the Act, at 34 U.S.C. 10284(9)(B) or (C) performs official duties; or (2) An agency or entity under whose authority (or by whose license) a member of a rescue squad or ambulance crew engages in activity (or in the provision of services) described in the Act, at 34 U.S.C. 10284(9)(D). Qualified beneficiary —An individual is a qualified beneficiary under the Act, at 34 U.S.C. 10286 or Public Law 107-37, only if he is an eligible payee— (1) Who qualifies as a beneficiary pursuant to a final agency determination that— (i) The requirements of the Act, at 34 U.S.C. 10281(a) or (b) (excluding the limitations relating to appropriations), as applicable, have been met; and (ii) The provisions of this part, as applicable, relating to payees otherwise have been met; and (2) Whose actions were not a substantial contributing factor to the death of the public safety officer (with respect to a claim under subpart B of this part). Representative services include expenses incurred in connection with such services. Rescue activity means search or rescue assistance in locating or extracting from danger persons lost, missing, or in imminent danger of serious bodily harm. Rescue squad or ambulance crew means a squad or crew whose members (including candidate-officers) are rescue workers, ambulance drivers, paramedics, health-care responders, emergency medical technicians, or other similar workers, who— (1) Are trained (or are receiving candidate-officer training) in rescue activity or the provision of emergency medical services; and (2) As such members, have the legal authority and -responsibility to— (i) Engage in rescue activity; or (ii) Provide emergency medical services. September 11, 2001, attacks means September 11, 2001, terrorist attacks, as defined (as of January 17, 2017) at 42 CFR 88.1. Spouse means an individual with whom another individual lawfully entered into marriage under the law of the jurisdiction in which it was entered into, and includes a spouse living apart from the other individual, other than pursuant to divorce, except that— (1) In connection with a claim, the term does not include anyone upon whose injury the claim is predicated; and (2) Notwithstanding any other provision of law— (i) For an individual purporting to be a spouse on the basis of a common-law marriage (or a putative marriage), or on any other basis, to be considered a spouse within the meaning of this definition, it is necessary (but not sufficient) for the jurisdiction of domicile of the parties to recognize such individual as the lawful spouse of the other individual; and (ii) In deciding who may be the spouse of a public safety officer— (A) The relevant jurisdiction of domicile is the officer's (as of the injury date); and (B) With respect to a claim under subpart B of this part, the relevant date is that of the officer's death. Stepchild —An individual is a stepchild of a public safety officer only if the individual is the legally-adoptive or biological first-generation offspring of a public safety officer's current, deceased, or former spouse, which offspring (not having been legally adopted by the officer)— (1) Was conceived before the marriage of the officer and the spouse; and (2) As of the injury date— (i) Was known by the officer not to be his biological first-generation offspring; and (ii) After the officer obtained such knowledge— (A) Received over half of his support from the officer; (B) Had as his principal place of abode the home of the officer and was a member of the officer's household; or (C) Was in a parent-child relationship with the officer. Stress or strain includes physical stress or strain, mental stress or strain, post-traumatic stress disorder, and depression. Stroke means cerebrovascular accident. Student means an individual who meets the definition provided in the Act, at 34 U.S.C. 10284(3)(ii), with respect to an educational/academic institution. Substantial contributing factor —A factor substantially contributes to a death, injury, disability, heart attack, stroke, or vascular rupture, if the factor— (1) Contributed to the death, injury, or disability to a significant degree; or (2) Is a substantial factor in bringing the death, injury, or disability about. Substantial factor —A factor substantially brings about a death, injury, disability, wound, condition, cardiac-event, heart attack, or stroke if— (1) The factor alone was sufficient to have caused the death, injury, disability, wound, condition, cardiac-event, heart attack, or stroke; or (2) No other factor (or combination of factors) contributed to the death, injury, disability, wound, condition, cardiac-event, heart attack, or stroke to so great a degree as it did. Suppression of fire means extinguishment, physical prevention, or containment of fire, including on-site hazard evaluation. Supporting-evidence collection period means the period— (1) That begins upon the filing of a notice of intention to file a claim, and ends upon the earlier of— (i) One year thereafter (unless, for good cause shown, the Director extends the period); or (ii) The date on which such claim is filed; and (2) During which an intention-notice filer may collect and assemble supporting evidence for his intended claim. Terrorist attack —An event or act is a terrorist attack within the meaning of the Act, at 34 U.S.C. 10286(a), only if the Attorney General determines that— (1) There is a reasonable indication that the event or act was (or would be or would have been, with respect to a priori prevention or investigation efforts) an act of domestic or international terrorism within the meaning of the criminal terrorism laws, at 18 U.S.C. 2331; and (2) The event or act (or the circumstances of death or injury) was of such extraordinary or cataclysmic character as to make particularized factual findings impossible, impractical, unnecessary, or unduly burdensome. Voluntary intoxication at the time of fatal or catastrophic injury means the following, as shown by any commonly-accepted tissue, -fluid, or -breath test or by other competent evidence: (1) With respect to alcohol, (i) In any claim arising from a public safety officer's death in which the death was simultaneous (or practically simultaneous) with the injury, it means intoxication as defined in the Act, at 34 U.S.C. 10284(5), unless convincing evidence demonstrates that the officer did not introduce the alcohol into his body intentionally; and (ii) In any claim not described in paragraph (1)(i) of this definition, unless convincing evidence demonstrates that the officer did not introduce the alcohol into his body intentionally, it means intoxication— (A) As defined in the Act, at 34 U.S.C. 10284(5), mutatis mutandis ( i.e., with “post-mortem” (each place it occurs) and “death” being substituted, respectively, by “post-injury” and “injury”); and (B) As of the injury date; and (2) With respect to drugs or other substances, it means intoxication as defined in the Act, at 34 U.S.C. 10284(5), as evidenced by the presence (as of the injury date) in the body of the public safety officer— (i) Of any of the following, unless convincing evidence demonstrates that the introduction of the controlled substance into the body was not a culpable act of the officer's under the criminal laws: (A) Any controlled substance included on Schedule I of the drug control and enforcement laws (see 21 U.S.C. 812(a)); (B) Any controlled substance included on Schedule II, III, IV, or V of the drug control and enforcement laws (see 21 U.S.C. 812(a)) and with respect to which there is no therapeutic range or maximum recommended dosage; (C) Any controlled substance included on Schedule II, III, IV, or V of the drug control and enforcement laws (see 21 U.S.C. 812(a)) and with respect to which there is a therapeutic range or maximum recommended dosage, at levels above or in excess of such range or dosage; or (D) Any active metabolite of any controlled substance within the meaning of the drug control and enforcement laws, at 21 U.S.C. 802(6), which metabolite is not itself such a controlled substance; (ii) Of any drug or other substance (other than one present as described in paragraph (2)(i) of this definition), unless convincing evidence demonstrates that— (A) The introduction of the drug or other substance into the body was not a culpable act of the officer's under the criminal laws; and (B) The officer was not acting in an intoxicated manner immediately prior to the injury date. WTC-related health condition means— (1) A WTC-related physical health condition determined by the September 11th Victim Compensation Fund, for the specific WTC responder, to meet the definition at section 104.2(i) of this title (as in effect on January 17, 2017); (2) A WTC-related health condition (other than a mental health condition) that the WTC Health Program has certified, for the specific WTC responder, under (as applicable) 42 U.S.C. 300mm-22(b)(1)(B)(ii) or 42 U.S.C. 300mm-22(b)(2)(A)(ii); or (3) An illness or health condition, as defined in (and determined pursuant to) 42 U.S.C. 300mm-22(a)(1)(A)(i), that is a WTC-related physical health condition, as defined at section 104.2(i) of this title (as in effect on January 17, 2017). WTC responder means an individual who— (1) Meets the definition at 42 U.S.C. 300mm-21(a)(1)(A) and has been identified as enrolled in the WTC Health Program, under 42 CFR 88.3 (as in effect on January 17, 2017); (2) Meets the definition at 42 U.S.C. 300mm-21(a)(1)(B) and has received an affirmative decision from the WTC Health Program under 42 CFR 88.6(d)(1) (as in effect on January 17, 2017); (3) Meets the definition at 42 U.S.C. 300mm-31(a)(1) and— (i) Has been identified as certified-eligible under 42 CFR 88.7 (as in effect on January 17, 2017); or (ii) Has received the status of a certified-eligible survivor from the WTC Health Program under 42 CFR 88.12 (as in effect on January 17, 2017); (4) Has been determined by the September 11th Victim Compensation Fund to be an eligible claimant under section 104.2(b)(1) of this title (as in effect on January 17, 2017); or (5) Subject to 42 U.S.C. 300mm-21(a)(5), meets the definition at 42 U.S.C. 300mm-21(a)(1)." 28:28:1.0.1.1.33.1.14.4,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,"§ 32.4 Terms; construction, severability; effect.",DOJ,,,"[73 FR 76531, Dec. 17, 2008, as amended at 83 FR 22382, May 15, 2018]","(a) In determining the meaning of any provision of this part, unless the context should indicate otherwise, the first three provisions of 1 U.S.C. 1 (rules of construction) shall apply. (b) If benefits are denied to any individual pursuant to the Act, at 34 U.S.C. 10282(a)(4), or otherwise because his actions were a substantial contributing factor to the death of the public safety officer, such individual shall be presumed irrebuttably, for all purposes, not to have survived the officer. (c) Any provision of this part held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to give it the maximum effect permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event such provision shall be deemed severable herefrom and shall not affect the remainder hereof or the application of such provision to other persons not similarly situated or to other, dissimilar circumstances. (d) Unless the same should expressly provide otherwise (e.g., by use of the word “hereafter” in an appropriations proviso), any amendment to the Act (or any statutory enactment otherwise directly referent or -applicable to the program that is the subject of this part), shall apply only with respect to injuries (or, in connection with claims under the Act, at 34 U.S.C. 10281(k), shall apply only with respect to heart attacks, strokes, or vascular ruptures referred to in the Act, at 34 U.S.C. 10281(k)(2)) occurring on or after the date it takes effect. (e) Unless expressly provided otherwise, any reference in this part to any provision of law not in this part shall be understood to constitute a general reference under the doctrine of incorporation by reference, and thus to include any subsequent amendments to the provision." 28:28:1.0.1.1.33.1.14.5,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,§ 32.5 Evidence.,DOJ,,,"[73 FR 76531, Dec. 17, 2008, as amended at 83 FR 22383, May 15, 2018]","(a) Except as otherwise may be expressly provided in the Act or this part, a claimant has the burden of persuasion as to all material issues of fact, and by the standard of proof of “more likely than not.” (b) Except as otherwise may be expressly provided in the Act or this part, the PSOB determining official may, at his discretion, consider (but shall not be bound by) the factual findings of a public agency (or public safety agency). (c) Rules 301 (presumptions), 401 (relevant evidence), 402 (admissibility), 602 to 604 (witnesses), 701 to 704 (testimony), 901 to 903 (authentication), and 1001 to 1007 (contents of writings, records, and photographs) of the Federal Rules of Evidence shall apply, mutatis mutandis, to all filings, hearings, and other proceedings or matters. No extrinsic evidence of authenticity as a condition precedent to admissibility shall be required with respect to any document purporting to bear the signature of an expert engaged by the BJA. (d) In determining a claim, the PSOB determining official may, at his discretion, draw an adverse inference if, without reasonable justification or excuse— (1) A claimant fails or refuses to file with the PSOB Office— (i) Such material- or relevant evidence or -information within his possession, control, or ken as may reasonably be requested from time to time by such official; or (ii) Such authorizations or waivers as may reasonably be requested from time to time by such official to enable him (or to assist in enabling him) to obtain access to material- or relevant evidence or -information of a medical, personnel, financial, or other confidential nature; (2) A claimant under subpart C of this part fails or refuses to appear in person— (i) At his hearing under subpart E of this part (if there be such a hearing); or (ii) Before such official (or otherwise permit such official personally to observe his condition), at a time and location reasonably convenient to both, as may reasonably be requested by such official; or (3) A claimant under subpart B or C of this part fails or refuses to apply for (or to pursue to completion), in timely fashion, the benefits, if any, described in § 32.15(a)(1)(i) or § 32.25(a)(1)(i), respectively. (e) In determining a claim, the PSOB determining official may, at his discretion, draw an inference of voluntary intoxication at the time of death or catastrophic injury if, without reasonable justification or excuse, appropriate toxicologic analysis (including autopsy, in the event of death) is not performed, and/or the results thereof are not filed with the PSOB Office, where there is credible evidence suggesting that intoxication may have been a factor in the death or injury, or that the public safety officer— (1) As of or near the injury date, was— (i) A consumer of alcohol— (A) In amounts likely to produce a blood-alcohol level of .10 per centum or greater in individuals similar to the officer in weight and sex; or (B) In any amount, after ever having been treated at an inpatient facility for alcoholism; (ii) A consumer of controlled substances included on Schedule I of the drug control and enforcement laws ( see 21 U.S.C. 812(a)); or (iii) An abuser of controlled substances included on Schedule II, III, IV, or V of the drug control and enforcement laws (see 21 U.S.C. 812(a)); or (2) Immediately prior to the injury date, was under the influence of alcohol or drugs or other substances or otherwise acting in an intoxicated manner. (f) In determining a claim under the Act, at 34 U.S.C. 10286 or Public Law 107-37, the certification described therein shall constitute prima facie evidence— (1) Of the public agency's acknowledgment that the public safety officer, as of the injury date, was— (i) A public safety officer of the kind described in the certification; (ii) Employed by the agency and performing official functions for, or on behalf of, the agency; and (iii) One of the following: (A) With respect to a law enforcement officer, an officer of the agency; (B) With respect to a firefighter, ( 1 ) An officially recognized or designated member of the agency (if it is a legally organized volunteer fire department); or ( 2 ) An employee of the agency; (C) With respect to a chaplain, ( 1 ) An officially recognized or designated member of the agency (if it is a legally organized police or volunteer fire department); or ( 2 ) An officially recognized or designated public employee of the agency (if it is a legally organized police or fire department); (D) With respect to a member of a rescue squad or ambulance crew, an officially recognized or designated employee member or volunteer member of a rescue squad or ambulance crew that is (or is a component of) the agency; or (E) With respect to a disaster relief worker, an employee of the agency (if it is described in the Act, at 34 U.S.C. 10284(9)(B) or (C)); (2) Of the public agency's acknowledgment that there are no eligible payees other than those identified in the certification; and (3) That the public safety officer— (i) Sustained a line of duty injury in connection with public safety activity (or, otherwise, with efforts described in the Act, at 34 U.S.C. 10286 or Public Law 107-37) related to a terrorist attack (under the former statute) or to the terrorist attacks of September 11, 2001 (under the latter statute); and (ii) As a direct and proximate result of such injury, was (as applicable)— (A) Killed (with respect to a claim under subpart B of this part); or (B) Totally and permanently disabled (with respect to a claim under subpart C of this part). (g) In determining a claim, the PSOB determining official shall have, in addition to the hearing-examiner powers specified at 34 U.S.C. 10225 (hearings, subpoenas, oaths, witnesses, evidence), and to the authorities specified at 34 U.S.C. 10226(b)-(d) (experts, consultants, government resources) and in the Act and this part, the authority otherwise and in any reasonable manner to conduct his own inquiries, as appropriate. (h) Acceptance of payment (by a payee (or on his behalf)) shall constitute prima facie evidence that the payee (or the pay agent)— (1) Endorses as his own (to the best of his knowledge and belief) the statements and representations made, and the evidence and information provided, pursuant to the claim; and (2) Is aware (in connection with the claim) of no— (i) Fraud; (ii) Concealment or withholding of evidence or information; (iii) False, incomplete, or inaccurate statements or representations; (iv) Mistake, wrongdoing, or deception; or (v) Violation of 18 U.S.C. 287 (false, fictitious, or fraudulent claims), 1001 (false statements), or 1621 (perjury), or 34 U.S.C. 10272 (falsification or concealment of facts). (i) A public safety officer's response to an emergency call from his public safety agency for him to perform public safety activity (including emergency response activity the agency is authorized to perform) shall constitute prima facie evidence of such response's non-routine character. (j) Public safety activity that is performed by a law enforcement officer or a firefighter shall be presumed to satisfy the requirements of paragraph (1)(i)(A) or (1)(ii)(A) (as the case may be) of the definition of Line of duty activity or action in § 32.3 if the public safety activity— (1) Was not forbidden (at the time performed) by any applicable statute, rule, regulation, condition of employment or service, official mutual-aid agreement, or other law; and (2) Occurred— (i) Within a jurisdiction where he is authorized to act, in the ordinary course, in an official capacity as such a law enforcement officer or firefighter; or (ii) Within a jurisdiction (not described in the immediately-preceding paragraph) that, at the time the public safety activity was performed, had a statute, rule, regulation, official mutual-aid agreement, or other law, in effect that authorized law enforcement officers or firefighters from outside such jurisdiction to perform, within the jurisdiction, the activity that occurred. (k) Absent evidence that the public safety activity was forbidden as described in paragraph (j)(1) of this section, the requirements of such paragraph (j) shall be presumed to be satisfied in any case in which full line-of-duty death or disability benefits (as the case may be) have been paid— (1) By (or on behalf of) any jurisdiction described in paragraph (j)(2) of this section; (2) With respect to a law enforcement officer or firefighter; and (3) Upon an administrative or judicial determination in the ordinary course (other than pursuant to a settlement or quasi-settlement) that such law enforcement officer or firefighter sustained an injury in the line of duty that caused his death or disability. (l) In the event that the presumption established by paragraph (j) of this section should arise pursuant to paragraph (j)(2)(ii) thereof, the law enforcement officer or firefighter shall be presumed to have been serving the jurisdiction described in such paragraph (j)(2)(ii) in an official capacity at the time he performed the public safety activity. (m) A volunteer fire department that is legally licensed or-authorized to engage in fire suppression shall be presumed to satisfy the requirements of paragraphs (1)(ii) and (2)(iii) of the definition of Instrumentality." 28:28:1.0.1.1.33.1.14.6,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,§ 32.6 Payment and repayment.,DOJ,,,"[73 FR 76532, Dec. 17, 2008, as amended at 83 FR 22383, May 15, 2018]","(a) No payment shall be made to (or on behalf of) more than one individual, on the basis of being a particular public safety officer's spouse. If more than one should qualify, payment shall be made to the one with whom the officer considered himself, as of the injury date, to have the closest relationship, except that the individual (if any) who was a member of the officer's household (as of such date) shall be presumed rebuttably to be such one, unless legal proceedings (by the officer against such member, or vice versa) shall have been pending then in any court. (b) No payment shall be made, save pursuant to a claim, filed by (or on behalf of) the payee, that (except as provided in the Act, at 34 U.S.C. 10281(c)) has been approved in a final agency determination. (c) Any amounts that would be paid but for the provisions of paragraph (b) of this section shall be retained by the United States and not paid. (d) With respect to the amount paid to a payee (or on his behalf) pursuant to a claim, the payee shall repay the following, unless, for good cause shown, the Director grants a full or partial waiver pursuant to the Act, at 34 U.S.C. 10281(m): (1) The entire amount, if approval of the claim was based, in whole or in material part, on the payee's (or any other person's or entity's) fraud, concealment or withholding of evidence or information, false, incomplete, or inaccurate statements or representations, mistake, wrongdoing, or deception; or (2) The entire amount subject to divestment, if the payee's entitlement to such payment is divested, in whole or in part, such as by the subsequent discovery of individuals entitled to make equal or superior claims. (e) At the discretion of the Director, repayment of amounts owing or collectible under the Act or this part may, as applicable, be executed through setoffs against future payments on financial claims under subpart D of this part. (f)(1) If the actual net payment of the Victim Compensation Fund after subtraction of any offset required by law (compensation) made under the September 11th Victim Compensation Fund of 2001 (49 U.S.C. 40101 note) has been paid with respect to an injury, the total amount payable under subpart B or C of this part, with respect to the same injury, shall be reduced by the amount of such payment of compensation. (2) Nothing in paragraph (f)(1) of this section, or in the Act, at 34 U.S.C. 10281(f)(3), shall be understood to preclude payment under this part before the final payment of compensation under such Fund. (3) Nothing in the Act, at 34 U.S.C. 10281(f)(3), shall be understood to require reduction of any amount payable under subpart D of this part." 28:28:1.0.1.1.33.1.14.7,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,§ 32.7 Fees for representative services.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22383, May 15, 2018]","(a) A person seeking to receive any amount from (or with respect to) a claimant for representative services provided in connection with any matter under this part may petition the PSOB Office for authorization under this section. Such petition shall include— (1) An itemized description of the services; (2) The total amount sought to be received, from any source, as consideration for the services; (3) An itemized description of any representative or other services provided to (or on behalf of) the claimant in connection with other claims or causes of action, unrelated to the Act, before any public agency or non-public entity (including any insurer), arising from the public safety officer's death, disability, or injury; (4) The total amount requested, charged, received, or sought to be received, from any source, as consideration for the services described in paragraph (a)(3) of this section; (5) A statement of whether the petitioner has legal training or is licensed to practice law, and a description of any special qualifications possessed by the petitioner (other than legal training or a license to practice law) that increased the value of his services to (or on behalf of) the claimant; (6) A certification that the claimant was provided, simultaneously with the filing of the petition, with— (i) A copy of the petition; and (ii) A letter advising the claimant that he could file his comments on the petition, if any, with the PSOB Office, within thirty-three days of the date of that letter; and (7) A copy of the letter described in paragraph (a)(6)(ii) of this section. (b) Unless, for good cause shown, the Director extends the time for filing, no petition under paragraph (a) of this section shall be considered if the petition is filed with the PSOB Office later than one year after the date of the final agency determination of the claim. (c) Unless the petition is approved pursuant to paragraph (h)(1) of this section (without regard to the exception thereto), consideration of a petition under paragraph (a) of this section shall be subject to paragraph (d) of this section and shall be based on the following factors: (1) The nature of the services provided by the petitioner; (2) The complexity of the claim; (3) The level of skill and competence required to provide the petitioner's services; (4) The amount of time spent on the claim by the petitioner; (5) The results achieved as a function of the petitioner's services; (6) The level of administrative or judicial review to which the claim was pursued and the point at which the petitioner entered the proceedings; (7) The ordinary, usual, or customary fee charged by other persons (and by the petitioner) for services of a similar nature; and (8) The amount authorized by the PSOB Office in similar cases. (d) Unless the petition is approved pursuant to paragraph (h)(1) of this section (without regard to the exception thereto), no amount in a petition under paragraph (a) of this section shall be approved for— (1) Any stipulated-, percentage-, or contingency fee; (2) Services at a rate in excess of that specified in 5 U.S.C. 504(b)(1)(A)(ii) (Equal Access to Justice Act); or (3) Services provided in connection with— (i) Obtaining or providing evidence or information previously obtained by the PSOB determining official; (ii) Preparing the petition; or (iii) Explaining or delivering an approved claim to the claimant. (e) Upon a petitioner's failure (without reasonable justification or excuse) to pursue in timely fashion his filed petition under paragraph (a) of this section, the Director may, at his discretion, deem the same to be abandoned, as though never filed. Not less than thirty-three days prior thereto, the PSOB Office shall serve the petitioner and the claimant with notice of the Director's intention to exercise such discretion. (f) Upon its approving (in whole or in part), or denying, a petition under paragraph (a) of this section, the PSOB Office shall serve notice of the same upon the claimant and the petitioner. Such notice shall specify the amount, if any, the petitioner is authorized to charge the claimant and the basis of the approval or denial. (g) No agreement for representative services in connection with a claim shall be valid if the agreement provides for any consideration other than under this section. A person's receipt of consideration for such services other than under this section may, among other things, be the subject of referral by BJA to appropriate professional, administrative, disciplinary, or other legal authorities. (h)(1) Except as provided in paragraph (h)(2) of this section, the PSOB Office shall approve any petition under paragraph (a) of this section for authorization to receive an amount that is not greater than the following, for representative services provided by an individual who was duly licensed to practice law in the jurisdiction in any State: (i) In connection with a claim that is approved under subpart B or C, an amount equal to three percent of the benefit paid to (or with respect to) the claimant on whose behalf the representative services were provided; (ii) In connection with a claim approved under subpart E that is subsequently approved under subpart F, an amount equal to six percent of the benefit paid to (or with respect to) the claimant on whose behalf the representative services were provided; and (iii) In connection with a claim denied under subpart E that is subsequently approved under subpart F, an amount equal to nine percent of the benefit paid to (or with respect to) the claimant on whose behalf the representative services were provided. (2) In the event that it decides that the amount set forth in paragraph (h)(1) of this section would be excessive (or otherwise inappropriate) for the representative services that form the substance of a particular petition under paragraph (a) of this section, the PSOB Office shall consider the petition pursuant to paragraph (c) of this section." 28:28:1.0.1.1.33.1.14.8,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",A,Subpart A—General Provisions,,§ 32.8 Exhaustion of administrative remedies.,DOJ,,,,"No determination or negative disability finding that, at the time made, may be subject to a request for a Hearing Officer determination, a motion for reconsideration, or a Director appeal, shall be considered a final agency determination for purposes of judicial review, unless all administrative remedies have been exhausted." 28:28:1.0.1.1.33.2.14.1,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",B,Subpart B—Death Benefit Claims,,§ 32.11 Scope of subpart.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22383, May 15, 2018]","Consistent with § 32.1, this subpart contains provisions applicable to claims made under the Act— (a) At 34 U.S.C. 10281(a); or (b) At 34 U.S.C. 10286 or Public Law 107-37, with respect to a public safety officer's death." 28:28:1.0.1.1.33.2.14.2,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",B,Subpart B—Death Benefit Claims,,§ 32.12 Time for filing claim.,DOJ,,,"[83 FR 22384, May 15, 2018]","(a) Unless, for good cause shown, the Director extends the time for filing, no claim shall be considered if it is filed with the PSOB Office after whichever of the following is latest: (1) Three years after the public safety officer's death; or (2) One year after the later of— (i) A final determination of entitlement to receive, or of denial of, the benefits, if any, described in § 32.15(a)(1)(i); or (ii) The receipt of the certification described in § 32.15(a)(1)(ii); or (3) The end of the supporting-evidence collection period. (b) Unless, for good cause shown, the Director extends the time for filing, no individual may file a notice of intention to file a claim after the later of— (1) The period described in paragraph (a)(1) of this section; or (2) The period described in paragraph (a)(2) of this section. (c) In the event that a claim is filed that fails to identify and provide foundational evidence as to status and injury, the Director shall deny the claim for lack of that foundational evidence. Not less than thirty-three days prior to such denial, the PSOB Office shall serve the claimant with notice of the date on which the Director will deny for that lack of evidence. Upon the claimant's request, filed prior to the date specified for the denial, the Director shall, in lieu of the denial— (1) Allow the claimant to withdraw his claim; and (2) Deem (as of the date of the request to withdraw) the claimant to have filed a notice of intention to file a claim, if a notice of intention otherwise filed by the claimant on that date would be timely under paragraph (b) of this section. (d) Notwithstanding paragraph (a) of this section, unless, for good cause shown, the Director extends the time for filing, no claim based on an injury sustained by a WTC responder and resulting from the September 11, 2001, attacks shall be considered if it is filed with the PSOB Office after the later of— (1) The time provided in paragraph (a) of this section; or (2) Two years after the earlier of— (i) The date on which the WTC-related physical health condition, if any, is determined by the September 11th Victim Compensation Fund, for the WTC responder, to meet the definition at section 104.2(i) of this title (as in effect on January 17, 2017); or (ii) The date on which the WTC-related health condition, if any, is certified, for the WTC responder, under (as applicable) 42 U.S.C. 300mm-22(b)(1)(B)(ii) or 42 U.S.C. 300mm-22(b)(2)(A)(ii)." 28:28:1.0.1.1.33.2.14.3,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",B,Subpart B—Death Benefit Claims,,§ 32.13 Definitions.,DOJ,,,"[61 FR 50213, Sept. 24, 1996, as amended at 73 FR 76832, Dec. 17, 2008; 83 FR 22384, May 15, 2018]","Adoptive parent of a public safety officer means any individual who (not being a step-parent), as of the injury date, was the legally-adoptive parent of the public safety officer, or otherwise was in a child-parent relationship with him. Beneficiary of a life insurance policy of a public safety officer —An individual (living or deceased on the date of death of the public safety officer) is designated as beneficiary of a life insurance policy of such officer as of such date, only if the designation is, as of such date, legal and valid (as a designation of beneficiary of a life insurance policy) and unrevoked (by such officer or by operation of law) or otherwise unterminated, except that— (1) Any designation of an individual (including any designation of the biological or adoptive offspring of such individual) made in contemplation of such individual's marriage (or purported marriage) to such officer shall be considered to be revoked by such officer as of such date of death if the marriage (or purported marriage) did not take place, unless preponderant evidence demonstrates that— (i) It did not take place for reasons other than personal differences between the officer and the individual; or (ii) No such revocation was intended by the officer; and (2) Any designation of a spouse (or purported spouse) made in contemplation of or during such spouse's (or purported spouse's) marriage (or purported marriage) to such officer (including any designation of the biological or adoptive offspring of such spouse (or purported spouse)) shall be considered to be revoked by such officer as of such date of death if the spouse (or purported spouse) is divorced from such officer after the date of designation and before such date of death, unless preponderant evidence demonstrates that no such revocation was intended by the officer. Beneficiary under the Act, at 34 U.S.C. 10281(a)(4)(A) —An individual (living or deceased on the date of death of the public safety officer) is designated, by such officer (and as of such date), as beneficiary under the Act, at 34 U.S.C. 10281(a)(4)(A), only if the designation is, as of such date, legal and valid and unrevoked (by such officer or by operation of law) or otherwise unterminated, except that— (1) Any designation of an individual (including any designation of the biological or adoptive offspring of such individual) made in contemplation of such individual's marriage (or purported marriage) to such officer shall be considered to be revoked by such officer as of such date of death if the marriage (or purported marriage) did not take place, unless preponderant evidence demonstrates that— (i) It did not take place for reasons other than personal differences between the officer and the individual; or (ii) No such revocation was intended by the officer; and (2) Any designation of a spouse (or purported spouse) made in contemplation of or during such spouse's (or purported spouse's) marriage (or purported marriage) to such officer (including any designation of the biological or adoptive offspring of such spouse (or purported spouse)) shall be considered to be revoked by such officer as of such date of death if the spouse (or purported spouse) is divorced from such officer subsequent to the date of designation and before such date of death, unless preponderant evidence demonstrates that no such revocation was intended by the officer. Cardiovascular disease includes heart attack and stroke. Child-parent relationship means a relationship between a public safety officer and another individual, in which the individual (other than the officer's biological or legally-adoptive parent) has the role of parent, as shown by convincing evidence. Competent medical evidence means evidence that indicates a fact to a degree of medical probability. Designation on file —A designation of beneficiary under the Act, at 34 U.S.C. 10281(a)(4)(A), is on file with a public safety agency, -organization, or -unit, only if it is deposited with the same by the public safety officer making the designation, for it to maintain with its personnel or similar records pertaining to him. Direct and proximate result of a heart attack or stroke —A death results directly and proximately from a heart attack or stroke if the heart attack or stroke is a substantial factor in bringing it about. Engagement in a situation involving law enforcement, fire suppression, rescue, hazardous material response, emergency medical services, prison security, disaster relief, or other emergency response activity —A public safety officer is so engaged only when, within his line of duty— (1) He is in the course of actually— (i) Engaging in law enforcement; (ii) Suppressing fire; (iii) Responding to a hazardous-material emergency; (iv) Performing rescue activity; (v) Providing emergency medical services; (vi) Performing disaster relief activity; or (vii) Otherwise engaging in emergency response activity; and (2) His public safety agency (or the relevant government) legally recognizes him to have been in such course at the time of such engagement (or, at a minimum, does not deny (or has not denied) him so to have been). Event includes occurrence, but does not include any engagement or participation described in the Act, at 34 U.S.C. 10281(k)(1). Execution of a designation of beneficiary under the Act, at 34 U.S.C. 10281(a)(4)(A) means the legal and valid execution, by the public safety officer, of a writing that, designating a beneficiary, expressly, specifically, or unmistakably refers to— (1) The Act (or the program it creates); or (2) All the death benefits with respect to which such officer lawfully could designate a beneficiary (if there be no writing that satisfies paragraph (1) of this definition). Execution of a life insurance policy means, with respect to a life insurance policy, the legal and valid execution, by the individual whose life is insured thereunder, of— (1) The approved application for coverage; (2) A designation of beneficiary; or (3) A designation of the mode of benefit. Life insurance policy on file —A life insurance policy is on file with a public safety agency, -organization, or -unit, only if— (1) It is issued through (or on behalf of) the same; or (2) The original (or a copy) of one of the following is deposited with the same by the public safety officer whose life is insured under the policy, for it to maintain with its personnel or similar records pertaining to him: (i) The policy (itself); (ii) The declarations page or -statement from the policy's issuer; (iii) A certificate of insurance (for group policies); (iv) Any instrument whose execution constitutes the execution of a life insurance policy; or (v) The substantial equivalent of any of the foregoing. Medical probability —A fact is indicated to a degree of medical probability, when, pursuant to a medical assessment, the fact is indicated by a preponderance of such evidence as may be available. Most recently executed designation of beneficiary under the Act, at 34 U.S.C. 10281(a)(4)(A) means the most recently executed such designation that, as of the date of death of the public safety officer, designates a beneficiary. Most recently executed life insurance policy of a public safety officer means the most recently executed policy insuring the life of a public safety officer that, being legal and valid (as a life insurance policy) upon its execution, as of the date of death of such officer— (1) Designates a beneficiary; and (2) Remains legally unrevoked (by such officer or by operation of law) or otherwise unterminated. Nonroutine strenuous physical activity means line of duty activity that— (1) Is not excluded by the Act, at 34 U.S.C. 10281( l ); (2) Is not performed as a matter of routine; and (3) Entails an unusually-high level of physical exertion. Nonroutine stressful or strenuous physical activity means nonroutine stressful physical activity or nonroutine strenuous physical activity. Nonroutine stressful physical activity means line of duty activity that— (1) Is not excluded by the Act, at 34 U.S.C. 10281( l ); (2) Is not performed as a matter of routine; (3) Entails non-negligible physical exertion; and (4) Occurs— (i) With respect to a situation in which a public safety officer is engaged, under circumstances that objectively and reasonably— (A) Pose (or appear to pose) significant dangers, threats, or hazards (or reasonably-foreseeable risks thereof), not faced by similarly-situated members of the public in the ordinary course; and (B) Provoke, cause, or occasion an unusually-high level of alarm, fear, or anxiety; or (ii) With respect to a training exercise in which a public safety officer participates, under circumstances that objectively and reasonably— (A) Simulate in realistic fashion situations that pose significant dangers, threats, or hazards; and (B) Provoke, cause, or occasion an unusually-high level of alarm, fear, or anxiety. Parent of a public safety officer means a public safety officer's surviving— (1) Biological or adoptive parent whose parental rights have not been terminated, as of the injury date; or (2) Step-parent. Participation in a training exercise —A public safety officer participates (as a trainer or trainee) in a training exercise only when actually taking formal part in a structured activity that itself is— (1) Within an official training (or -fitness) program of his public safety agency; and (2) Mandatory, rated (i.e., officially tested, -graded, -judged, -timed, etc.), or directly supervised, -proctored, or -monitored. Public safety organization or unit means— (1) The component of a public agency, in which component— (i) An individual described in the Act, at 34 U.S.C. 10284(9)(A), serves in an official capacity; or (ii) An employee described in the Act, at 34 U.S.C. 10284(9)(B) or (C) performs official duties; or (2) The component of an agency or entity, under the authority (or by the license) of which component a member of a rescue squad or ambulance crew engages in activity (or in the provision of services) described in the Act, at 34 U.S.C. 10284(9)(D). Routine —Neither of the following shall be dispositive in determining whether an activity or action shall be understood to have been performed as a matter of routine: (1) Being generally described by the public safety agency as routine or ordinary; or (2) The frequency with which it may be performed. Something other than the mere presence of cardiovascular disease risk factors means— (1) Ingestion of controlled substances included on Schedule I of the drug control and enforcement laws (see 21 U.S.C. 812(a)); or (2) Abuse of controlled substances included on Schedule II, III, IV, or V of the drug control and enforcement laws (see 21 U.S.C. 812(a)). Step-parent of a public safety officer means a current or former spouse of the legally-adoptive or biological parent (living or deceased) of a public safety officer conceived (or legally adopted) by that parent before the marriage of the spouse and the parent, which spouse (not being a legally-adoptive parent of the officer), as of the injury date, (1) Received over half of his support from the officer; (2) Had as his principal place of abode the home of the officer and was a member of the officer's household; or (3) Was in a child-parent relationship with the officer. Unrelated — A public safety officer's heart attack, stroke, or vascular rupture is unrelated to the officer's engagement in a situation or participation in a training exercise, when an independent event or occurrence is a substantial contributing factor in bringing the officer's heart attack, stroke, or vascular rupture about." 28:28:1.0.1.1.33.2.14.4,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",B,Subpart B—Death Benefit Claims,,§ 32.14 PSOB Office determination.,DOJ,,,"[73 FR 76534, Dec. 17, 2008, as amended at 83 FR 22385, May 15, 2018]","(a) Upon its approving or denying a claim, the PSOB Office shall serve notice of the same upon the claimant (and upon any other claimant who may have filed a claim with respect to the same public safety officer). Such notice shall — (1) Specify the factual findings and legal conclusions that support it; and (2) In the event of a denial, provide information as to requesting a Hearing Officer determination. (b) Upon a claimant's failure (without reasonable justification or excuse) to pursue in timely fashion the determination, by the PSOB Office, of his filed claim, the Director may, at his discretion, deem the same to be abandoned, as though never filed. Not less than thirty-three days prior thereto, the PSOB Office shall serve the claimant with notice of the Director's intention to exercise such discretion." 28:28:1.0.1.1.33.2.14.5,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",B,Subpart B—Death Benefit Claims,,§ 32.15 Prerequisite certification.,DOJ,,,"[73 FR 76534, Dec. 17, 2008, as amended at 83 FR 22385, May 15, 2018]","(a) Except as provided in the Act, at 34 U.S.C. 10286 or Public Law 107-37, and unless, for good cause shown, the Director grants a waiver, no claim shall be approved unless the following (which shall be necessary, but not sufficient, for such approval) are filed with the PSOB Office: (1) Subject to paragraphs (b) and (d) of this section, a certification from the public safety officer's public safety agency (as of the injury date) that he died as a direct and proximate result of a line of duty injury, and either— (i) That his survivors (listed by name, address, relationship to him, and amount received) have received (or legally are entitled to receive) the maximum death benefits legally payable by the agency with respect to deaths of public safety officers of his kind, rank, and tenure; or (ii) Subject to paragraph (c) of this section, that the agency is not legally authorized to pay— (A) Any benefits described in paragraph (a)(1)(i) of this section, to any person; or (B) Any benefits described in paragraph (a)(1)(i) of this section, to public safety officers of the kind, rank, and tenure described in such paragraph; (2) A copy of any findings or rulings made by any public agency (or public safety agency) that relate to the officer's death; and (3) A certification from the claimant listing every individual known to him who is or might be the officer's child, spouse, or parent. (b) The provisions of paragraphs (a)(1) and (d) of this section shall also apply with respect to every public agency (or public safety agency) that legally is authorized to pay death benefits with respect to the agency described in such paragraph (a)(1). (c) No certification described in paragraph (a)(1)(ii) of this section shall be deemed complete for purposes of this section unless it— (1) Lists every public agency (other than BJA), and every public safety agency, that legally is authorized to pay death benefits with respect to the certifying agency; or (2) States that no public agency (other than BJA), or public safety agency, legally is authorized to pay death benefits with respect to the certifying agency. (d) Subject to paragraphs (b) and (c) of this section, if the Director finds that the conditions specified in the Act, at 34 U.S.C. 10281(k), are satisfied with respect to a particular public safety officer's death, and that no circumstance specified in the Act, at 34 U.S.C. 10282(a)(1), (2), or (3), applies with respect thereto— (1) The certification as to death, described in paragraph (a)(1) of this section, shall not be required; and (2) The certification as to benefits, described in paragraph (a)(1)(ii) of this section, shall be deemed complete for purposes of this section if it— (i) Describes the public agency's (or public safety agency's) understanding of the circumstances (including such causes of which it may be aware) of the officer's death; and (ii) States that, in connection with deaths occurring under the circumstances described in paragraph (d)(2)(i) of this section, the public agency (or public safety agency's) is not legally authorized to pay any benefits described in paragraph (a)(1)(i) of this section." 28:28:1.0.1.1.33.2.14.6,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",B,Subpart B—Death Benefit Claims,,§ 32.16 Payment.,DOJ,,,"[73 FR 76535, Dec. 17, 2008, as amended at 83 FR 22385, May 15, 2018]","(a) No payment shall be made to (or on behalf of) more than one individual, on the basis of being a public safety officer's parent as his mother, or on that basis as his father. If more than one parent qualifies as the officer's mother, or as his father, payment shall be made to the one with whom the officer considered himself, as of the injury date, to have the closest relationship, except that any biological or legally adoptive parent whose parental rights have not been terminated as of the injury date shall be presumed rebuttably to be such one. (b) Any amount payable with respect to a minor or incompetent shall be paid to his legal guardian, to be expended solely for the benefit of such minor or incompetent." 28:28:1.0.1.1.33.2.14.7,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",B,Subpart B—Death Benefit Claims,,§ 32.17 Request for Hearing Officer determination.,DOJ,,,,"In order to exhaust his administrative remedies, a claimant seeking relief from the denial of his claim shall request a Hearing Officer determination under subpart E of this part. Consistent with § 32.8, any denial that is not the subject of such a request shall constitute the final agency determination." 28:28:1.0.1.1.33.3.14.1,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.21 Scope of subpart.,DOJ,,,"[71 FR 46037, Aug. 10, 2016, as amended at 83 FR 22385, May 15, 2018]","Consistent with § 32.1, this subpart contains provisions applicable to claims made under the Act— (a) At 34 U.S.C. 10281(b); or (b) At 34 U.S.C. 10286 or Public Law 107-37, with respect to a public safety officer's disability." 28:28:1.0.1.1.33.3.14.2,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.22 Time for filing claim.,DOJ,,,"[83 FR 22386, May 15, 2018]","(a) Unless, for good cause shown, the Director extends the time for filing, no claim shall be considered if it is filed with the PSOB Office after the later of— (1) Three years after the injury date; or (2) One year after the later of— (i) A final determination of entitlement to receive, or of denial of, the benefits, if any, described in § 32.25(a)(1)(i); or (ii) The receipt of the certification described in § 32.25(a)(1)(ii); or (3) The end of the supporting-evidence collection period. (b) Unless, for good cause shown, the Director extends the time for filing, no individual may file a notice of intention to file a claim after the later of— (1) The period described in paragraph (a)(1) of this section; or (2) The period described in paragraph (a)(2) of this section. (c) In the event that a claim is filed that fails to identify and provide foundational evidence as to status and injury, the Director shall deny the claim for lack of that foundational evidence. Not less than thirty-three days prior to such denial, the PSOB Office shall serve the claimant with notice of the date on which the Director will deny for that lack of evidence. Upon the claimant's request, filed prior to the date specified for the denial, the Director shall, in lieu of the denial— (1) Allow the claimant to withdraw his claim; and (2) Deem (as of the date of the request to withdraw) the claimant to have filed a notice of intention to file a claim, if a notice of intention otherwise filed by the claimant on that date would be timely under paragraph (b) of this section. (d) Notwithstanding paragraph (a) of this section, unless, for good cause shown, the Director extends the time for filing, no claim based on an injury sustained by a WTC responder and resulting from the September 11, 2001, attacks shall be considered if it is filed with the PSOB Office after the later of— (1) The time provided in paragraph (a) of this section; or (2) Two years after the earlier of— (i) The date on which the WTC-related physical health condition, if any, is determined by the September 11th Victim Compensation Fund, for the WTC responder, to meet the definition at section 104.2(i) of this title (as in effect on January 17, 2017); or (ii) The date on which the WTC-related health condition, if any, is certified, for the WTC responder, under (as applicable) 42 U.S.C. 300mm-22(b)(1)(B)(ii) or 42 U.S.C. 300mm-22(b)(2)(A)(ii)." 28:28:1.0.1.1.33.3.14.3,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.23 Definitions.,DOJ,,,,"Direct result of an injury —A disability results directly from an injury if the injury is a substantial factor in bringing the disability about. Gainful work means full-or part-time activity that actually is compensated or commonly is compensated. Medical certainty —A fact exists to a degree of medical certainty, when, pursuant to a medical assessment, the fact is demonstrated by convincing evidence. Permanently disabled —An individual is permanently disabled only if there is a degree of medical certainty (given the current state of medicine in the United States) that his disabled condition— (1) Will progressively deteriorate or remain constant, over his expected lifetime; or (2) Otherwise has reached maximum medical improvement. Product of an injury —Permanent and total disability is produced by a catastrophic injury suffered as a direct and proximate result of a personal injury if the disability is a direct result of the personal injury. Residual functional capacity means that which an individual still is capable of doing, as shown by medical (and, as appropriate, vocational) assessment, despite a disability. Totally disabled —An individual is totally disabled only if there is a degree of medical certainty (given the current state of medicine in the United States) that his residual functional capacity is such that he cannot perform any gainful work." 28:28:1.0.1.1.33.3.14.4,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.24 PSOB Office determination.,DOJ,,,"[71 FR 46037, Aug. 10, 2018, as amended at 83 FR 22386, May 15, 2018]","(a) Upon its approving or denying a claim, the PSOB Office shall serve notice of the same upon the claimant (and upon any other claimant who may have filed a claim with respect to the same public safety officer). Such notice shall— (1) Specify the factual findings and legal conclusions that support it; and (2) In the event of a denial, provide information as to— (i) Requesting a Hearing Officer determination; or (ii) As applicable, moving to reconsider a negative disability finding. (b) Upon a claimant's failure (without reasonable justification or excuse) to pursue in timely fashion the determination of his filed claim, the Director may, at his discretion, deem the same to be abandoned, as though never filed. Not less than thirty-three days prior thereto, the PSOB Office shall serve the claimant with notice of the Director's intention to exercise such discretion." 28:28:1.0.1.1.33.3.14.5,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.25 Prerequisite certification.,DOJ,,,"[71 FR 46037, Aug. 10, 2018, as amended at 83 FR 22386, May 15, 2018]","(a) Except as provided in the Act, at 34 U.S.C. 10286 or Public Law 107-37, and unless, for good cause shown, the Director grants a waiver, no claim shall be approved unless the following (which shall be necessary, but not sufficient, for such approval) are filed with the PSOB Office: (1) Subject to paragraph (b) of this section, a certification from the public safety officer's public safety agency (as of the injury date) that he was permanently and totally disabled as a direct result of a line of duty injury, and either— (i) That he has received (or legally is entitled to receive) the maximum disability benefits (including workers' compensation) legally payable by the agency with respect to disabled public safety officers of his kind, rank, and tenure; or (ii) Subject to paragraph (c) of this section, that the agency is not legally authorized to pay— (A) Any benefits described in paragraph (a)(1)(i) of this section, to any person; or (B) Any benefits described in paragraph (a)(1)(i) of this section, to public safety officers of the kind, rank, and tenure described in such paragraph; and (2) A copy of— (i) Each State, local, and federal income tax return filed by or on behalf of the public safety officer from the year before the injury date to the date of determination by the PSOB determining official; and (ii) Any rulings or findings made by any public agency (or public safety agency) that relate to the claimed disability. (b) The provisions of paragraph (a)(1) of this section shall also apply with respect to every public agency (or public safety agency) that legally is authorized to pay disability benefits with respect to the agency described in that paragraph. (c) No certification described in paragraph (a)(1)(ii) of this section shall be deemed complete unless it— (1) Lists every public agency (other than BJA), and every public safety agency, that legally is authorized to pay disability benefits with respect to the certifying agency; or (2) States that no public agency (other than BJA), or public safety agency, legally is authorized to pay disability benefits with respect to the certifying agency." 28:28:1.0.1.1.33.3.14.6,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.26 [Reserved],DOJ,,,, 28:28:1.0.1.1.33.3.14.7,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.27 Motion for reconsideration of negative disability finding.,DOJ,,,,"A claimant whose claim is denied in whole or in part on the ground that he has not shown that his claimed disability is total and permanent may move for reconsideration, under § 32.28, of the specific finding as to the total and permanent character of the claimed disability (in lieu of his requesting a Hearing Officer determination with respect to the same)." 28:28:1.0.1.1.33.3.14.8,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.28 Reconsideration of negative disability finding.,DOJ,,,,"(a) Unless, for good cause shown, the Director extends the time for filing, no negative disability finding described in § 32.27 shall be reconsidered if the motion under that section is filed with the PSOB Office later than thirty-three days after the service of notice of the denial. (b) Notwithstanding any other provision of this section, no negative disability finding described in § 32.27 shall be reconsidered— (1) If or after such reconsideration is rendered moot ( e.g. , by the final denial of the claim on other grounds, without possibility of further administrative or judicial recourse); or (2) If a request for a Hearing Officer determination has been filed in timely fashion with respect to such finding. (c) Unless, for good cause shown, the Director grants a waiver, upon the making of a motion under § 32.27, reconsideration of the negative disability finding described in that section shall be stayed for three years. Upon the conclusion of the stay, the claimant shall have not more than six years to file evidence with the PSOB Office in support of his claimed disability. (d) Upon a claimant's failure (without reasonable justification or excuse) to file in timely fashion evidence pursuant to paragraph (c) of this section, the Director may, at his discretion, deem the motion for reconsideration to be abandoned, as though never filed. Not less than thirty-three days prior thereto, the PSOB Office shall serve the claimant with notice of the Director's intention to exercise such discretion. (e) No negative disability finding described in § 32.27 shall be reversed unless a copy (which shall be necessary, but not sufficient, for such reversal) of each federal, State, and local income tax return filed by or on behalf of the claimant from the year before the date of the motion for reconsideration under that section to the date of reversal is filed with the PSOB Office. (f) Upon its affirming or reversing a negative disability finding described in § 32.27, the PSOB Office shall serve notice of the same upon the claimant. In the event of an affirmance, such notice shall— (1) Specify the factual findings and legal conclusions that support it; and (2) Provide information as to requesting a Hearing Officer determination of the disability finding." 28:28:1.0.1.1.33.3.14.9,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",C,Subpart C—Disability Benefit Claims,,§ 32.29 Request for Hearing Officer determination.,DOJ,,,"[73 FR 76535, Dec. 17, 2008]","(a) In order to exhaust his administrative remedies, a claimant seeking relief from the denial of his claim shall request a Hearing Officer determination under subpart E of this part— (1) Of— (i) His entire claim, if he has not moved for reconsideration of a negative disability finding under § 32.27; or (ii) Consistent with § 32.42(c), the grounds (if any) of the denial that are not the subject of such motion, if he has moved for reconsideration of a negative disability finding under § 32.27; and (2) Of a negative disability finding that is affirmed pursuant to his motion for reconsideration under § 32.27. (b) Consistent with § 32.8, the following shall constitute the final agency determination: (1) Any denial not described in § 32.27 that is not the subject of a request for a Hearing Officer determination under paragraph (a)(1)(i) of this section; (2) Any denial described in § 32.27 that is not the subject of a request for a Hearing Officer determination under paragraph (a)(1)(ii) of this section, unless the negative disability finding is the subject of a motion for reconsideration; and (3) Any affirmance that is not the subject of a request for a Hearing Officer determination under paragraph (a)(2) of this section." 28:28:1.0.1.1.33.4.14.1,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",D,Subpart D—Educational Assistance Benefit Claims,,§ 32.31 Scope of subpart.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22386, May 15, 2018]","Consistent with § 32.1, this subpart contains provisions applicable to claims ( i.e. , threshold claims and financial claims) made under the Act, at 34 U.S.C. 10302." 28:28:1.0.1.1.33.4.14.2,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",D,Subpart D—Educational Assistance Benefit Claims,,§ 32.32 Time for filing claim.,DOJ,,,"[73 FR 76535, Dec. 17, 2008, as amended at 83 FR 22386, May 15, 2018]","(a) Subject to the Act, at 34 U.S.C. 10302(c), and to paragraph (b) of this section, a claim may be filed with the PSOB Office at any time after the injury date. (b) Unless, for good cause shown, the Director grants a waiver, no financial claim may be filed with the PSOB Office, with respect to a grading period that commences more than six months after the date of filing. (c) A claimant may file with his claim such supporting documentary, electronic, video, or other non-physical evidence and legal arguments as he may wish to provide." 28:28:1.0.1.1.33.4.14.3,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",D,Subpart D—Educational Assistance Benefit Claims,,§ 32.33 Definitions.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22386, May 15, 2018]","Application means claim ( i.e. , a threshold claim or a financial claim). Assistance means financial assistance. Child of an eligible public safety officer means the child of a public safety officer, which officer is an eligible public safety officer. Educational assistance benefits means benefits specifically to assist in paying educational expenses. Educational expenses means such of the following as may be in furtherance of the educational, professional, or vocational objective of the program of education that forms the basis of a financial claim: (1) Tuition and fees, as described in 20 U.S.C. 1087 ll (1) (higher education assistance); (2) Reasonable expenses for— (i) Room and board (if incurred for attendance on at least a half-time basis); (ii) Books; (iii) Computer equipment; (iv) Supplies; (v) Transportation; and (3) For attendance on at least a three-quarter-time basis, a standard allowance for miscellaneous personal expenses that is the greater of— (i) The allowance for such expenses, as established by the eligible educational institution for purposes of financial aid; or (ii) $200.00 per month. Eligible educational expenses means a claimant's educational expenses, reduced by the amount of educational assistance benefits from non-governmental organizations that the claimant has received or will receive. Eligible public safety officer means a public safety officer— (1) With respect to whose death, benefits under subpart B of this part properly— (i) Have been paid; or (ii) Would have been paid but for operation of the Act, at 34 U.S.C. 10281(f); or (2) With respect to whose disability, benefits under subpart C of this part properly— (i) Have been paid; or (ii) Would have been paid, but for operation of— (A) Paragraph (b) of § 32.6; or (B) The Act, at 34 U.S.C. 10281(f). Financial assistance means financial assistance, as described in the Act, at 34 U.S.C. 10302. Financial claim means a request for financial assistance, with respect to attendance at a program of education, for a particular grading period. Financial need —An individual is in financial need for a particular grading period to the extent that the amount of his eligible educational expenses for that period exceed the sum of— (1) The amount of his educational assistance benefits as described in the Act, at 34 U.S.C. 10302(a)(3); and (2) His expected family contribution calculated pursuant to 20 U.S.C. 1087nn (higher education assistance). Funds means financial assistance. Grading period means the period of attendance ( e.g. , a semester, a trimester, a quarter) in a program of education, after (or with respect to) which period grades are assigned, units of credit are awarded, or courses are considered completed, as determined by the eligible educational institution. Prospective financial claim means a financial claim with respect to a grading period that ends after the claim is filed. Retroactive financial claim means a financial claim with respect to a grading period that ends before the claim is filed. Spouse of an eligible public safety officer at the time of the officer's death or on the date of a totally and permanently disabling injury means the spouse of a public safety officer (which officer is an eligible public safety officer) as of— (1) The date of the officer's death (with respect to a claim by virtue of such death); or (2) The injury date (with respect to a claim by virtue of the officer's disability). Threshold claim means a request for determination of general eligibility to receive financial assistance." 28:28:1.0.1.1.33.4.14.4,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",D,Subpart D—Educational Assistance Benefit Claims,,§ 32.34 PSOB Office determination.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22387, May 15, 2018]","(a) In the event of the PSOB Office's denying a claim, the notice it serves upon the claimant shall— (1) Specify the factual findings and legal conclusions that support the denial; and (2) Provide information as to requesting a Hearing Officer determination. (b) No financial claim shall be approved, unless the claimant's threshold claim has been approved. (c) Upon a claimant's failure (without reasonable justification or excuse) to pursue in timely fashion the determination of his filed claim, the Director may, at his discretion, deem the same to be abandoned, as though never filed. Not less than thirty-three days prior thereto, the PSOB Office shall serve the claimant with notice of the Director's intention to exercise such discretion." 28:28:1.0.1.1.33.4.14.5,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",D,Subpart D—Educational Assistance Benefit Claims,,§ 32.35 Disqualification.,DOJ,,,,"No claim shall be approved if the claimant is— (a) In default on any student loan obtained under 20 U.S.C. 1091 (higher education assistance), unless, for good cause shown, the Director grants a waiver; or (b) Subject to a denial of federal benefits under 21 U.S.C. 862 (drug traffickers and possessors)." 28:28:1.0.1.1.33.4.14.6,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",D,Subpart D—Educational Assistance Benefit Claims,,§ 32.36 Payment and repayment.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22387, May 15, 2018]","(a) The computation described in the Act, at 34 U.S.C. 10302(a)(2), shall be based on a certification from the eligible educational institution as to the claimant's full-, three-quarter-, half-, or less-than-half-time student status, according to such institution's own academic standards and practices. (b) No payment shall be made with respect to any grading period that ended before the injury date. (c) With respect to any financial claim, no amount shall be payable that exceeds the amount of the eligible educational expenses that form the basis of the claim. (d) In the event that appropriations for a fiscal year are insufficient for full payment of all approved or anticipated financial claims, the following payments shall be made— (1) The amounts payable on approved prospective financial claims from claimants in financial need, to the extent of such need (if sufficient funds be available therefor), in the order the claims are approved; (2) All other amounts payable on approved prospective financial claims (in the order the claims are approved), if sufficient funds be available therefor— (i) After payment of all amounts payable pursuant to paragraph (d)(1) of this section; and (ii) After making allowance for anticipated amounts payable in the fiscal year pursuant to paragraph (d)(1) of this section; and (3) The amounts payable on approved retroactive financial claims (in the order the claims are approved), if sufficient funds be available therefor— (i) After payment of all amounts payable pursuant to paragraphs (d)(1) and (2) of this section; and (ii) After making allowance for anticipated amounts payable in the fiscal year, pursuant to paragraphs (d)(1) and (2) of this section. (e) In the event that, at the conclusion of a fiscal year, any amounts remain payable on an approved financial claim, such amounts shall remain payable thereafter until paid (when appropriations be sufficient therefor). (f) In the event that any amounts remain payable on an approved prospective financial claim after the end of the grading period that forms its basis, such claim shall be deemed an approved retroactive financial claim for purposes of paragraph (d) of this section. (g) No payment shall be made to (or on behalf of) any individual, on the basis of being a particular living public safety officer's spouse, unless the individual is the officer's spouse on the date of payment. (h) Unless, for good cause shown, the Director grants a full or partial waiver, a payee shall repay the amount paid to him (or on his behalf) pursuant to a prospective financial claim if, during the grading period that forms its basis— (1) He fails to maintain satisfactory progress under 20 U.S.C. 1091(c) (higher education assistance); (2) He fails to maintain the enrollment status described in his claim; or (3) By his acts or omissions, he is or becomes ineligible for financial assistance." 28:28:1.0.1.1.33.4.14.7,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",D,Subpart D—Educational Assistance Benefit Claims,,§ 32.37 Request for Hearing Officer determination.,DOJ,,,,"In order to exhaust his administrative remedies, a claimant seeking relief from the denial of his claim shall request a Hearing Officer determination under subpart E of this part. Consistent with § 32.8, any denial that is not the subject of such a request shall constitute the final agency determination." 28:28:1.0.1.1.33.5.14.1,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",E,Subpart E—Hearing Officer Determinations,,§ 32.41 Scope of subpart.,DOJ,,,"[73 FR 76535, Dec. 17, 2008]","Consistent with § 32.1, this subpart contains provisions applicable to requests for Hearing Officer determination of claims denied under subpart B, C (including affirmances of negative disability findings described in § 32.27), or D of this part, and of claims remanded (or matters referred) under § 32.54(c)." 28:28:1.0.1.1.33.5.14.2,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",E,Subpart E—Hearing Officer Determinations,,§ 32.42 Time for filing request for determination.,DOJ,,,"[73 FR 76535, Dec. 17, 2008]","(a) Subject to paragraph (c) of this section, and unless, for good cause shown, the Director extends the time for filing, no claim shall be determined if the request therefor is filed with the PSOB Office later than thirty-three days after the service of notice of— (1) The denial (under subpart B, C (except as may be provided in paragraph (a)(2) of this section), or D of this part) of a claim; or (2) The affirmance (under subpart C of this part) of a negative disability finding described in § 32.27. (b) A claimant may file with his request for a Hearing Officer determination such supporting documentary, electronic, video, or other non-physical evidence and legal arguments as he may wish to provide. (c) The timely filing of a motion for reconsideration under § 32.28(a) shall be deemed to constitute a timely filing, under paragraph (a) of this section, of a request for determination with respect to any grounds described in § 32.29(a)(1)(ii) that may be applicable." 28:28:1.0.1.1.33.5.14.3,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",E,Subpart E—Hearing Officer Determinations,,§ 32.43 Appointment and assignment of Hearing Officers.,DOJ,,,"[73 FR 76535, Dec. 17, 2008, as amended at 78 FR 29234, May 20, 2013; 83 FR 22387, May 15, 2018]","(a) Pursuant to 34 U.S.C. 10225 (employment and authority of hearing officers), Hearing Officers may be appointed from time to time by the Director, to remain on the roster of such Officers at his pleasure. (b) Upon the filing of a request for a Hearing Officer determination (or upon remand or referral), the PSOB Office shall assign the claim to a Hearing Officer on the roster; the PSOB Office may assign a particular claim to a specific Hearing Officer if it judges, in its discretion, that his experience or expertise suit him especially for it. (c) Upon its making the assignment described in paragraph (b) of this section, the PSOB Office shall serve notice of the same upon the claimant, with an indication that any evidence or legal argument he wishes to provide is to be filed simultaneously with the PSOB Office and the Hearing Officer. (d) With respect to an assignment described in paragraph (b) of this section, the Hearing Officer's consideration shall be— (1) De novo (unless the Director should expressly prescribe otherwise, with respect to a particular remand or referral), rather than in review of the findings, determinations, affirmances, reversals, assignments, authorizations, decisions, judgments, rulings, or other actions of the PSOB Office; and (2) Consistent with subpart B, C, or D of this part, as applicable." 28:28:1.0.1.1.33.5.14.4,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",E,Subpart E—Hearing Officer Determinations,,§ 32.44 Hearing Officer determination.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 78 FR 29234, May 20, 2013; 83 FR 22387, May 15, 2018]","(a) Upon his determining a claim, the Hearing Officer shall file a notice of the same simultaneously with the Director (for his review under subpart F of this part in the event of approval) and the PSOB Office, which notice shall specify the factual findings and legal conclusions that support it. (b) Upon a Hearing Officer's approving or denying a claim, the PSOB Office shall serve notice of the same simultaneously upon the claimant (and upon any other claimant who may have filed a claim with respect to the same public safety officer). Such notice shall— (1) Specify the Hearing Officer's factual findings and legal conclusions that support it; and (2) In the event of a denial, provide information as to Director appeals. (c) Upon a claimant's failure (without reasonable justification or excuse) to pursue in timely fashion the determination of his claim pursuant to his filed request therefor, the Director may, at his discretion, deem the request to be abandoned, as though never filed. Not less than thirty-three days prior thereto, the PSOB Office shall serve the claimant with notice of the Director's intention to exercise such discretion." 28:28:1.0.1.1.33.5.14.5,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",E,Subpart E—Hearing Officer Determinations,,§ 32.45 Hearings.,DOJ,,,"[73 FR 76536, Dec. 17, 2008, as amended at 83 FR 22387, May 15, 2018]","(a) Except with respect to a remand or referral, at the election of a claimant under subpart B or C of this part, the Hearing Officer shall hold a hearing, at a location agreeable to the claimant and the Officer (or, otherwise, at a location ruled by the Hearing Officer to be suitable), for the sole purposes of obtaining, consistent with § 32.5(c), (1) Evidence from the claimant and his fact or expert witnesses; and (2) Such other evidence as the Hearing Officer, at his discretion, may rule to be necessary or useful. (b) Unless, for good cause shown, the Director extends the time for filing, no election under paragraph (a) of this section shall be honored if it is filed with the PSOB Office later than ninety days after service of the notice described in § 32.43(c). (c) Not less than seven days prior to any hearing, the claimant shall file simultaneously with the PSOB Office and the Hearing Officer a list of all expected fact or expert witnesses and a brief summary of the evidence each witness is expected to provide. (d) At any hearing, the Hearing Officer— (1) May exclude any evidence whose probative value is substantially outweighed by considerations of undue delay, waste of time, or needless presentation of cumulative evidence (2) Shall exclude witnesses (other than the claimant, or any person whose presence is shown by the claimant to be essential to the presentation of his claim), so that they cannot hear the testimony of other witnesses; and (3) Shall (unless the Director should direct or allow otherwise) be the only individual (other than the claimant's representative, if any) who may examine the claimant. (e) Each hearing shall be recorded, and the original of the complete record or transcript thereof shall be made a part of the claim file. (f) Unless, for good cause shown, the Director grants a waiver, a claimant's failure to appear at a hearing (in person or through a representative) shall constitute a withdrawal of his election under paragraph (a) of this section. (g) Upon a claimant's failure to pursue in timely fashion his filed election under paragraph (a) of this section, the Director may, at his discretion, deem the same to be abandoned. Not less than thirty-three days prior thereto, the PSOB Office shall serve the claimant with notice of the Director's intention to exercise such discretion." 28:28:1.0.1.1.33.5.14.6,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",E,Subpart E—Hearing Officer Determinations,,§ 32.46 Director appeal.,DOJ,,,,"(a) In order to exhaust his administrative remedies, a claimant seeking relief from the denial of his claim shall appeal to the Director under subpart F of this part. (b) Consistent with § 32.8, any claim denial that is not appealed to the Director under paragraph (a) of this section shall constitute the final agency determination, unless the denial is reviewed otherwise under subpart F of this part." 28:28:1.0.1.1.33.6.14.1,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",F,Subpart F—Director Appeals and Reviews,,§ 32.51 Scope of subpart.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22387, May 15, 2018]","Consistent with § 32.1, this subpart contains provisions applicable to Director appeals and reviews of claim approvals and denials made under subpart E of this part, and reviews of claim approvals under the Act, at 34 U.S.C. 10286 or Public Law 107-37." 28:28:1.0.1.1.33.6.14.2,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",F,Subpart F—Director Appeals and Reviews,,§ 32.52 Time for filing Director appeal.,DOJ,,,"[73 FR 76536, Dec. 17, 2008, as amended at 83 FR 22387, May 15, 2018]","(a) Unless, for good cause shown, the Director extends the time for filing, no Director appeal shall be considered if it is filed with the PSOB Office later than thirty-three days after the service of notice of the denial (under subpart E of this part) of a claim. (b) A claimant may file with his Director appeal such supporting documentary, electronic, video, or other non-physical evidence and legal arguments as he may wish to provide." 28:28:1.0.1.1.33.6.14.3,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",F,Subpart F—Director Appeals and Reviews,,§ 32.53 Review.,DOJ,,,"[71 FR 46037, Aug. 10, 2006, as amended at 83 FR 22387, May 15, 2018]","(a) Upon the filing of the approval (under subpart E of this part) of a claim, the Director shall review the same. (b) The Director may review— (1) Any claim denial made under subpart E of this part; and (2) Any claim approval made under the Act, at 34 U.S.C. 10286 or Public Law 107-37. (c) Unless the Director judges that it would be unnecessary, the PSOB Office shall serve notice upon the claimant (and upon any other claimant who may have filed a claim with respect to the same public safety officer) of the initiation of a review under paragraph (a) or (b) of this section. Unless the Director judges that it would be unnecessary, such notice shall— (1) Indicate the principal factual findings or legal conclusions at issue; and (2) Offer a reasonable opportunity for filing of evidence or legal arguments. (d) The Director may reconsider a claim under subparts B or C of this part that has been denied in a final agency determination if— (1) The public safety officer was a WTC responder; (2) The claim was based on the allegation that— (i) The WTC responder sustained an injury that was the direct and proximate cause of his death or of his permanent and total disability; and (ii) The WTC responder's injury was sustained in the course of performance of line of duty activity or a line of duty action that exposed him to airborne toxins, other hazards, or other adverse conditions resulting from the September 11, 2001, attacks; (3) The sole ground of the denial was that the claim did not establish that— (i) The WTC responder sustained an injury in the course of performance of line of duty activity or a line of duty action; or (ii) The injury allegedly sustained by the WTC responder was the direct and proximate cause of his death or permanent and total disability; (4) The alleged injury on which the claim was based is a WTC-related health condition; and (5) The claimant files with the PSOB Office a motion for such reconsideration before the earlier of two year— (i) The date on which the WTC-related physical health condition, if any, is determined by the September 11th Victim Compensation Fund, for the WTC responder, to meet the definition at section 104.2(i) of this title (as in effect on January 17, 2017); or (ii) The date on which the WTC-related health condition, if any, is certified, for the WTC responder, (as applicable) 42 U.S.C. 300mm-22(b)(1)(B)(ii) or 42 U.S.C. 300mm-22(b)(2)(A)(ii)." 28:28:1.0.1.1.33.6.14.4,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",F,Subpart F—Director Appeals and Reviews,,§ 32.54 Director determination.,DOJ,,,"[73 FR 76536, Dec. 17, 2008, as amended at 83 FR 22387, May 15, 2018]","(a) Upon the Director's approving or denying a claim, the PSOB Office shall serve notice of the same simultaneously upon the claimant (and upon any other claimant who may have filed a claim with respect to the same public safety officer), and upon any Hearing Officer who made a determination with respect to the claim. Such notice shall— (1) Specify the factual findings and legal conclusions that support it; and (2) In the event of a denial, provide information as to judicial appeals. (b) Upon a claimant's failure (without reasonable justification or excuse) to pursue in timely fashion the determination of his claim pursuant to his filed Director appeal, the Director may, at his discretion, deem the same to be abandoned, as though never filed. Not less than thirty-three days prior thereto, the PSOB Office shall serve the claimant with notice of the Director's intention to exercise such discretion. (c) With respect to any claim before him, the Director, as appropriate, may (among other things)— (1) Remand the same to the PSOB Office, or to a Hearing Officer; (2) Vacate any related determination under this part; or (3) Refer any related matters to a Hearing Officer (as a special master), to recommend factual findings and dispositions in connection therewith." 28:28:1.0.1.1.33.6.14.5,28,Judicial Administration,I,,32,"PART 32—PUBLIC SAFETY OFFICERS' DEATH, DISABILITY, AND EDUCATIONAL ASSISTANCE BENEFIT CLAIMS",F,Subpart F—Director Appeals and Reviews,,§ 32.55 Judicial appeal.,DOJ,,,"[83 FR 22387, May 15, 2018]","Consistent with § 32.8, no administrative action other than an approval or denial described in § 32.54(a) shall constitute a final agency determination for purposes of the Act, at 34 U.S.C. 10287." 29:29:1.1.1.1.31.1.66.1,29,Labor,,,32,PART 32—NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—General Provisions,,§ 32.1 Purpose.,DOL,,,"[45 FR 66709, Oct. 7, 1980, as amended at 68 FR 51368, Aug. 26, 2003]",Section 504 of the Rehabilitation Act of 1973 prohibits discrimination on the basis of handicap in any program or activity receiving Federal financial assistance. The purpose of this part is to implement section 504 with respect to receiving Federal financial assistance from the Department of Labor. 29:29:1.1.1.1.31.1.66.10,29,Labor,,,32,PART 32—NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—General Provisions,,§ 32.10 Effect of State or local law or other requirements and effect of employment opportunities.,DOL,,,"[45 FR 66709, Oct. 7, 1980, as amended at 68 FR 51368, Aug. 26, 2003]","(a) The obligation to comply with this part is not obviated or alleviated by the existence of any state or local law or other requirement that, on the basis of handicap, imposes prohibitions or limits upon the eligibility of qualified handicapped individuals to receive services, participate in programs or activities or practice any occupation or profession. (b) The obligation to comply with this part is not obviated or alleviated because employment opportunities in any occupation or profession are or may be more limited for handicapped individuals than for nonhandicapped persons." 29:29:1.1.1.1.31.1.66.2,29,Labor,,,32,PART 32—NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—General Provisions,,§ 32.2 Application.,DOL,,,"[45 FR 66709, Oct. 7, 1980, as amended at 68 FR 51367, Aug. 26, 2003]","(a) This part applies to each recipient of Federal financial assistance from the Department of Labor, and to every program or activity that receives such assistance. (b) A government contractor covered by the provisions of section 503 of the Act shall be deemed in compliance with the employment provisions of these regulations if it is in compliance with 41 CFR part 60-741 (as amended after publication of these regulations) with respect to Federal financial assistance from the Department of Labor." 29:29:1.1.1.1.31.1.66.3,29,Labor,,,32,PART 32—NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—General Provisions,,§ 32.3 Definitions.,DOL,,,"[45 FR 66709, Oct. 7, 1980, as amended at 61 FR 19985, May 3, 1996; 68 FR 51367, 51368, Aug. 26, 2003]","As used in this part, the term: The Act means the Rehabilitation Act of 1973, Public Law 93-112, as amended by the Rehabilitation Act Amendments of 1974, Public Law 93-516, and by the Rehabilitation, Comprehensive Services, and Developmental Disabilities Amendments of 1978, Public Law 95-602. Assistant Secretary means the Assistant Secretary for Employment and Training Administration or his or her designee. Applicant for assistance means one who submits an application, request, or plan required to be approved by a Department official or by a recipient as a condition to becoming a recipient. Department means the Department of Labor. Facility means all or any portion of the buildings, structures, equipment, roads, walks, parking lots or other real or personal property or interest in such property which are utilized in the execution of the program or activity for which Federal financial assistance is received. Federal financial assistance means any grant, loan, contract (other than a procurement contract or a contract of insurance or guarantee), or any other arrangement by which the Department provides or otherwise makes available assistance in the form of: (a) Funds; (b) Services of Federal personnel; or (c) Real and personal property or any interest in or use of such property, including: (1) Transfers or leases of such property for less than fair market value or for reduced consideration; and (2) Proceeds from a subsequent transfer or lease of such property if the Federal share of its fair market value is not returned to the Federal Government. Government means the Government of the United States of America. Handicap means any condition or characteristic that renders a person a handicapped individual as defined in this section. Handicapped individual (a) Handicapped individual means any person who— (1) Has a physical or mental impairment which substantially limits one or more major life activities; (2) Has a record of such an impairment; or (3) Is regarded as having such an impairment. (b) As used in the proceeding paragraph of this section, the phrase: (1) Physical or mental impairment means— (i) Any physiological disorder or condition, cosmetic disfigurement, or anatomical loss affecting one or more of the following body systems: neurological; musculoskeletal; special sense organs; respiratory, including speech organs; cardiovascular; reproductive; digestive; genito-urinary; hemic and lymphatic; skin; and endocrine; (ii) Any mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities. (iii) The term physical or mental impairment includes but is not limited to such diseases and conditions as orthopedic, visual, speech and hearing impairments, cerebral palsy, epilepsy, muscular distrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation, emotional illness, and drug addiction and alcoholism. (2) Substantially limits means the degree that the impairment affects an individual becoming a beneficiary of a program or activity receiving Federal financial assistance or affects an individual's employability. A handicapped individual who is likely to experience difficulty in securing or retaining benefits or in securing, or retaining, or advancing in employment would be considered substantially limited. (3) Major life activities means functions such as caring for one's self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, working, and receiving education or vocational training. (4) Has a record of such an impairment means that the individual has a history of, or has been misclassified as having, a mental or physical impairment that substantially limits one or more life activity. (5) Is regarded as having such an impairment means that the individual— (i) Has a physical or mental impairment that does not substantially limit major life activities but that is treated by a recipient as constituting such a limitation; (ii) Has a physical or mental impairment that substantially limits major life activities only as a result of the attitudes of others toward such impairment; or (iii) Has none of the impairments defined in paragraph (b)(1) of this section but is treated by a recipient as having such an impairment. Program or activity means all of the operations of any entity described in paragraphs (1) through (4) of this definition, any part of which is extended Federal financial assistance: (1)(i) A department, agency, special purpose district, or other instrumentality of a State or of a local government; or (ii) The entity of such State or local government that distributes such assistance and each such department or agency (and each other State or local government entity) to which the assistance is extended, in the case of assistance to a State or local government; (2)(i) A college, university, or other postsecondary institution, or a public system of higher education; or (ii) A local educational agency (as defined in 20 U.S.C. 7801), system of vocational education, or other school system; (3)(i) An entire corporation, partnership, or other private organization, or an entire sole proprietorship— (A) If assistance is extended to such corporation, partnership, private organization, or sole proprietorship as a whole; or (B) Which is principally engaged in the business of providing education, health care, housing, social services, or parks and recreation; or (ii) The entire plant or other comparable, geographically separate facility to which Federal financial assistance is extended, in the case of any other corporation, partnership, private organization, or sole proprietorship; or (4) Any other entity which is established by two or more of the entities described in paragraph (1), (2), or (3) of this definition. Qualified handicapped individual means: (a) With respect to employment, an individual with a handicap who is capable of performing the essential functions of the job or jobs for which he or she is being considered with reasonable accommodation to his or her handicap; (b) With respect to services, a handicapped individual who meets eligibility requirements relevant to the receipt of services provided in the program or activity; (c) With respect to employment and to employment related training, a handicapped individual who meets both the eligibility requirements for participation in the program or activity and valid job or training qualifications with reasonable accommodation. Reasonable accommodation means the changes and modifications which can be made in the structure of a job or employment and training, or in the manner in which a job is performed or employment and training is conducted, unless it would impose an undue hardship on the operation of the recipient's program or activity. Reasonable accommodation may include: (a) Making the facilities used by the employees or participants in the area where the program or activity is conducted, including common areas used by all employees or participants such as hallways, restrooms, cafeterias and lounges, readily accessible to and usable by handicapped persons, and (b) Job restructuring, part-time or modified work schedules, acquisition or modification of equipment or devices, the provision of readers or interpreters, and other similar actions. Recipient means any state or its political subdivisions, any instrumentality of a State or its political subdivisions, any public or private agency, institution, organization, or other entity, or any person to which Federal financial assistance is extended directly or through another recipient, including any successor, assignee, or transferee of a recipient, but excluding the ultimate beneficiary of the assistance. Secretary means the Secretary of Labor, U.S. Department of Labor, or his or her designee. Section 504 means section 504 of the Act. Small recipient means a recipient who serves fewer than 15 beneficiaries, and employs fewer than 15 employees at all times during a grant year. United States means the several states, the District of Columbia, the Virgin Islands, the Commonwealth of Puerto Rico, Guam, American Samoa and the Trust Territory of the Pacific Islands." 29:29:1.1.1.1.31.1.66.4,29,Labor,,,32,PART 32—NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—General Provisions,,§ 32.4 Discrimination prohibited.,DOL,,,"[45 FR 66709, Oct. 7, 1980, as amended at 68 FR 51367, 51368, Aug. 26, 2003]","(a) General. No qualified handicapped individual shall, on the basis of handicap, be excluded from participation in, be denied the benefits of, or otherwise be subjected to discrimination under any program or activity which receives Federal financial assistance. (b) Discriminatory actions prohibited. (1) A recipient, in providing any aid, benefit, service or training, may not, directly or through contractual, licensing, or other arrangments, on the basis of handicap: (i) Deny a qualified handicapped individual the opportunity to participate in or benefit from the aid, benefit, service or training; (ii) Afford a qualified handicapped individual an opportunity to participate in or benefit from the aid, benefit, service or training that is not equal to that afforded others; (iii) Provide a qualified handicapped individual with any aid, benefit, service or training that is not as effective as that provided to others; (iv) Provide different or separate aid, benefits, or services to handicapped individuals or to any class of handicapped individuals unless such action is necessary to provide qualified handicapped individuals with aid, benefits, services or training that are as effective as those provided to others; (v) Aid or perpetuate discrimination against a qualified handicapped individual by providing significant assistance to an agency, organization, or person that discriminates on the basis of handicap in providing any aid, benefit, service or training to beneficiaries of the recipient's program or activity; (vi) Deny a qualified handicapped individual the opportunity to participate as a member of planning or advisory boards; or (vii) Otherwise limit a qualified handicapped individual in enjoyment of any right, privilege, advantage, or opportunity enjoyed by others receiving any aid, benefit, service or training. (2) For purposes of this part, aid, benefits, services or training, to be equally effective, are not required to produce the identical result or level of achievement for handicapped and nonhandicapped individuals, but must afford handicapped individuals equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement, in the most integrated setting appropriate to the person's needs. (3) A recipient may not deny a qualified handicapped individual the opportunity to participate in its regular aid, benefits, services, or training, despite the existence of separate or different aid, benefits, services, or training for the handicapped which are established in accordance with this part. (4) A recipient may not, directly or through contractual or other arrangements, utilize criteria or methods of administration: (i) That have the effect of subjecting qualified handicapped individuals to discrimination on the basis of handicap; (ii) That have the purpose or effect of defeating or substantially impairing accomplishment of the objectives of the recipient's program or activity with respect to handicapped individuals; or (iii) That perpetuate the discrimination of another recipient if both recipients are subject to common administrative control or are agencies of the same state. (5) In determining the site or location of a facility, an applicant for assistance or a recipient may not make selections. (i) That have the effect of excluding handicapped individuals from, denying them the benefits of, or otherwise subjecting them to discrimination under any program or activity that receives Federal financial assistance; or (ii) That have the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the program or activity with respect to handicapped individuals. (6) As used in this section, the aid, benefit, service or training provided under a program or activity receiving Federal financial assistance includes any aid, benefit, service or training provided in or through a facility that has been constructed, expanded, altered, leased, rented, or otherwise acquired, in whole or in part, with Federal financial assistance. (7)(i) In providing services receiving Federal financial assistance, except for employment-related training, a recipient to which this subpart applies, except small recipients, shall ensure that no handicapped participant is denied the benefits of, excluded from participation in, or otherwise subjected to discrimination under the program or activity operated by the recipient because of the absence of auxiliary aids for participants with impaired sensory, manual or speaking skills. In employment and employment-related training, this paragraph shall apply only to the intake, assessment and referral services. A recipient shall operate each program or activity to which this subpart applies so that, when viewed in its entirety, auxiliary aids are readily available. (ii) Auxiliary aids may include brailled and taped written materials, interpreters or other effective methods of making orally delivered information available to persons with hearing impairments, readers for persons with visual impairments, equipment adapted for use by persons with manual impairments, and other similar services and actions. Recipients need not provide attendants, individually prescribed devices, readers for personal use or study, or other devices or services of a personal nature. (c) Aid, benefits, services, or training limited by Federal law. The exclusion of nonhandicapped persons from aid, benefits, program services, or training limited by Federal statute on Executive order to handicapped individuals or the exclusion of a specific class of handicapped individuals from aid, benefits, services, or training limited by Federal statute or Executive order to a different class of handicapped individuals is not prohibited by this part. (d) Integrated setting. Recipients shall administer programs or activities in the most integrated setting appropriate to the needs of qualified handicapped individuals. (e) Communications with individuals with impaired vision and hearing. Recipients shall take appropriate steps to ensure that communications with their applicants, employees, and beneficiaries are available to persons with impaired vision and hearing."