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| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 15:15:4.1.1.1.2.0.1.1 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.1 Purpose. | DOC | [91 FR 1691, Jan. 15, 2026] | The purpose of this part is to provide general information on international trade in services and direct investment data collection programs and analyses under the International Investment and Trade in Services Survey Act (22 U.S.C. 3101 to 3108, as amended) (the Act). | ||||||
| 15:15:4.1.1.1.2.0.1.10 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.11 Rules and regulations for the BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons. | DOC | [87 FR 54887, Sept. 8, 2022, as amended at 91 FR 1691, Jan. 15, 2026] | The BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons will be conducted once every five years and covers years ending in 2 and 7. BEA will describe the proposed information collection in a public notice and will solicit comments according to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501-3520). All legal authorities, provisions, definitions, and requirements contained in §§ 801.1, 801.2, and 801.4, 22 U.S.C. 3104(c), and 22 U.S.C. 3105 are applicable to this survey. Specific additional rules and regulations for the BE-120 survey are given in this section. More detailed instructions are given on the report form and in instructions accompanying the report form. (a) Response required. A response is required, every fifth year, from persons subject to the reporting requirements of the BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons, contained in this section, whether or not they are contacted by BEA. Also, a person, or its agent, that is contacted by BEA about reporting on this survey, either by sending a report form or by written inquiry, must respond in writing pursuant to this section. This may be accomplished by: (1) Completing and returning the BE-120 by the due date of the survey; or (2) If exempt, by completing the determination of reporting status section of the BE-120 survey and returning it to BEA by the due date of the survey. (b) Who must report. A BE-120 report is required of each U.S. person that had transactions with foreign persons in the categories covered by the survey during the fiscal year covered by the survey. (c) What must be reported. (1) A U.S. person that had combined sales to foreign persons that exceeded $2 million, and/or combined purchases from foreign persons that exceeded $1 million in the services and intellectual property categories covered by the survey during its fiscal year, on an accrual basis, is required to provide data on total sales … | ||||||
| 15:15:4.1.1.1.2.0.1.11 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.12 Rules and regulations for the BE-140 Benchmark Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons. | DOC | [87 FR 54888, Sept. 8, 2022, as amended at 91 FR 1691, Jan. 15, 2026] | The BE-140 Benchmark Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons will be conducted once every five calendar years and covers years ending in 3 and 8. BEA will describe the proposed information collection in a public notice and will solicit comments according to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501-3520). All legal authorities, provisions, definitions, and requirements contained in §§ 801.1, 801.2, and 801.4, 22 U.S.C. 3104(c), and 22 U.S.C. 3105 are applicable to this survey. Specific additional rules and regulations for the BE-140 survey are given in this section. More detailed instructions are given on the report form and in instructions accompanying the report form. (a) Response required. A response is required from U.S. insurance companies subject to the reporting requirements of the BE-140 Benchmark Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons, contained in this section, whether or not they are contacted by BEA. Also, a U.S. insurance company, or its agent, that is contacted by BEA about reporting on this survey, either by transmission of a report form or by written inquiry, must respond in writing pursuant to this section. This may be accomplished by: (1) Completing and returning the BE-140 by the due date of the survey; or (2) If exempt, by completing the determination of reporting status section of the BE-140 survey and returning it to BEA by the due date of the survey. (b) Who must report. A BE-140 report is required of each U.S. insurance company that had insurance transactions with foreign persons in the categories covered by the survey during the calendar year covered by the survey. (c) What must be reported. (1) A U.S. insurance company that had transactions with foreign persons that exceeded $2 million in the insurance categories covered by the survey during its calendar year, on an accrual basis, is required to provide data on the total transactions of each of the covered types of insura… | ||||||
| 15:15:4.1.1.1.2.0.1.12 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.13 Rules and regulations for the BE-180 Benchmark Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons. | DOC | [87 FR 54889, Sept. 8, 2022, as amended at 91 FR 1691, Jan. 15, 2026] | The BE-180 Benchmark Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons will be conducted every five years and covers fiscal years ending in 4 and 9. BEA will describe the proposed information collection in a public notice and will solicit comments according to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501-3520). All legal authorities, provisions, definitions, and requirements contained in §§ 801.1, 801.2, and 801.4, 22 U.S.C. 3104(c), and 22 U.S.C. 3105 are applicable to this survey. Specific additional rules and regulations for the BE-180 survey are given in this section. More detailed instructions are given on the report form and in instructions accompanying the report form. (a) Response required. A response is required from persons subject to the reporting requirements of the BE-180 Benchmark Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons, contained in this section, whether or not they are contacted by BEA. Also, a person, or its agent, that is contacted by BEA about reporting on this survey, either by sending a report form or by written inquiry, must respond in writing pursuant to this section. This may be accomplished by: (1) Completing and returning the BE-180 by the due date of the survey; or (2) If exempt, completing the determination of reporting status section of the BE-180 survey and returning it to BEA by the due date of the survey. (b) Who must report. A BE-180 report is required of each U.S. person that is a financial services provider or intermediary, or whose consolidated U.S. enterprise includes a separately organized subsidiary, or part, that is a financial services provider or intermediary, and that had financial services transactions with foreign persons in the categories covered by the survey during the fiscal year covered by the survey. (c) BE-180 definition of financial services provider. The definition of financial services provider used for this surve… | ||||||
| 15:15:4.1.1.1.2.0.1.2 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.2 Definitions. | DOC | For purposes of the Act and for reporting requirements under this part: (a) United States, when used in a geographic sense, means the several States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States. (b) Foreign, when used in a geographic sense, means that which is situated outside the United States or which belongs to or is characteristic of a country other than the United States. (c) Person means any individual, branch, partnership, associated group, association, estate, trust, corporation, or other organization (whether or not organized under the laws of any State), and any government (including a foreign government, the United States Government, a State or local government, and any agency, corporation, financial institution, or other entity or instrumentality thereof, including a government-sponsored agency). (d) United States person means any person resident in the United States or subject to the jurisdiction of the United States. (e) Foreign person means any person resident outside the United States or subject to the jurisdiction of a country other than the United States. (f) Business enterprise means any organization, association, branch, or venture which exists for profit-making purposes or to otherwise secure economic advantage, and any ownership of any real estate. (g) Services are economic activities whose outputs are other than tangible goods. This term includes, but is not limited to, banking, other financial services, insurance, transportation, communications and data processing, retail and wholesale trade, advertising, accounting, construction, design, engineering, management consulting, real estate, professional services, entertainment, education, and health care. (h) International investment means: (1) The ownership or control, directly or indirectly, by contractual commitment or otherwise, by foreign persons of any interest in property in the United States, or of stock, other securities, or short- and lon… | |||||||
| 15:15:4.1.1.1.2.0.1.3 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.3 Reporting requirements. | DOC | [85 FR 31052, May 22, 2020, as amended at 87 FR 54887, Sept. 8, 2022] | Except for surveys subject to rulemaking in §§ 801.7, 801.8, 801.10, 801.11, 801.12, and 801.13, reporting requirements for all other surveys conducted by the Bureau of Economic Analysis shall be as follows: (a) Notice of specific reporting requirements, including who is required to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be published by the Director of the Bureau of Economic Analysis in the Federal Register prior to the implementation of a survey; (b) In accordance with section 3104(b)(2) of title 22 of the United States Code, persons notified of these surveys and subject to the jurisdiction of the United States shall furnish, under oath, any report containing information which is determined to be necessary to carry out the surveys and studies provided for by the Act; and (c) Persons not notified in writing of their filing obligation by the Bureau of Economic Analysis are not required to complete the survey. | ||||||
| 15:15:4.1.1.1.2.0.1.4 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.4 Recordkeeping requirements. | DOC | [79 FR 47575, Aug. 14, 2014, as amended at 79 FR 53291, Sept. 9, 2014; 79 FR 69759, Nov. 24, 2014] | In accordance with section 3104(b)(1) of title 22 of the United States Code, persons subject to the jurisdiction of the United States shall maintain any information essential for carrying out the surveys and studies provided for by the Act. | ||||||
| 15:15:4.1.1.1.2.0.1.5 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | §§ 801.5-801.6 [Reserved] | DOC | ||||||||
| 15:15:4.1.1.1.2.0.1.6 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.7 Rules and regulations for the BE-13, Survey of New Foreign Direct Investment in the United States. | DOC | [90 FR 42534, Sept. 3, 2025, as amended at 91 FR 1691, Jan. 15, 2026] | The BE-13, Survey of New Foreign Direct Investment in the United States, is conducted to collect data on the acquisition or establishment of U.S. business enterprises by foreign investors and the expansion of existing U.S. affiliates of foreign companies to establish new facilities where business is conducted. Foreign direct investment is defined as the ownership or control by one foreign person (foreign parent) of 10 percent or more of the voting securities of an incorporated U.S. business enterprise, or an equivalent interest of an unincorporated U.S. business enterprise, including a branch. BEA will describe the proposed information collection in a public notice and will solicit comments according to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501-3520). All legal authorities, provisions, definitions, and requirements contained in §§ 801.1, 801.2, and 801.4, 22 U.S.C. 3104(c), and 22 U.S.C. 3105 are applicable to this survey. Specific additional rules and regulations for the BE-13 survey are given in paragraphs (a) through (d) of this section. More detailed instructions are given on the report forms and instructions. (a) Response required. A response is required from persons subject to the reporting requirements of the BE-13, Survey of New Foreign Direct Investment in the United States, contained herein, whether or not they are contacted by BEA. Also, a person, or their agent, who is contacted by BEA about reporting in this survey, either by sending them a report form or by written inquiry, must respond in writing pursuant to this section. This may be accomplished by filing the properly completed BE-13 report (BE-13A, BE-13B, BE-13D, BE-13E, or BE-13 Claim for Exemption). (b) Who must report. A BE-13 report is required of any U.S. business enterprise, except certain private funds, see exception in item (b.4.), in which: (1) A foreign direct investment in the United States relationship is created; (2) An existing U.S. affiliate of a foreign parent establishes a new U.S. business enterpri… | ||||||
| 15:15:4.1.1.1.2.0.1.7 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.8 Rules and regulations for the BE-10, Benchmark Survey of U.S. Direct Investment Abroad. | DOC | [84 FR 60915, Nov. 12, 2019, as amended at 91 FR 1691, Jan. 15, 2026] | A BE-10, Benchmark Survey of U.S. Direct Investment Abroad, will be conducted every five years and covers years ending in 4 and 9. All legal authorities, provisions, definitions, and requirements contained in §§ 801.1, 801.2, and 801.4, 22 U.S.C. 3104(c), and 22 U.S.C. 3105 are applicable to this survey. Specific additional rules and regulations for the BE-10 survey are given in paragraphs (a) through (d) of this section. More detailed instructions are given on the report forms and instructions. (a) Response required. A response is required from persons subject to the reporting requirements of the BE-10, Benchmark Survey of U.S. Direct Investment Abroad, contained in this section, whether or not they are contacted by BEA. Also, a person, or their agent, contacted in writing by BEA about reporting in this survey must respond by filing a properly completed BE-10 report (BE-10A and BE-10B, BE-10C, BE-10D, and/or BE-10 Claim for Not Filing). (b) Who must report. A BE-10 report is required of any U.S. person that had a foreign affiliate—that is, that had direct or indirect ownership or control of at least 10 percent of the voting stock of an incorporated foreign business enterprise, or an equivalent interest in an unincorporated foreign business enterprise, including a branch—at the end of the U.S. person's fiscal year that ended in the calendar year covered by the survey. Foreign affiliates that are private funds and meet certain criteria are exempt from the BE-10 survey. Specifically, if a foreign affiliate meets all of the criteria in paragraphs (b)(1) though (3) of this section, the U.S. reporter is not required to file a BE-10 form for that affiliate except to indicate exemption from the survey if contacted by BEA: (1) The foreign affiliate is a private fund; and (2) The private fund foreign affiliate does not own, directly or indirectly through another business enterprise, an “operating company”— i.e., a business enterprise that is not a private fund or a holding company—in which the consolidated U.S. r… | ||||||
| 15:15:4.1.1.1.2.0.1.8 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.9 [Reserved] | DOC | ||||||||
| 15:15:4.1.1.1.2.0.1.9 | 15 | Commerce and Foreign Trade | VIII | 801 | PART 801—SURVEY OF INTERNATIONAL TRADE IN SERVICES BETWEEN U.S. AND FOREIGN PERSONS AND SURVEYS OF DIRECT INVESTMENT | § 801.10 Rules and regulations for BE-12, Benchmark Survey of Foreign Direct Investment in the United States. | DOC | [87 FR 58954, Sept. 29, 2022, as amended at 91 FR 1691, Jan. 15, 2026] | A BE-12, Benchmark Survey of Foreign Direct Investment in the United States, will be conducted once every five years and covers years ending in 2 and 7. BEA will describe the proposed information collection in a public notice and will solicit comments accounting to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501-3520). All legal authorities, provisions, definitions, and requirements contained in §§ 801.1, 801.2, and 801.4, 22 U.S.C. 3104(c), and 22 U.S.C. 3105 are applicable to this survey. Specific additional rules and regulations for the BE-12 survey are given in paragraphs (a) through (e) of this section. More detailed instructions are given on the report forms and instructions. (a) Response required. A response is required from persons subject to the reporting requirements of the BE-12, Benchmark Survey of Foreign Direct Investment in the United States, contained in this section, whether or not they are contacted by BEA. Also, a person, or their agent, contacted by BEA about reporting in this survey must respond in writing pursuant to this section. This may be accomplished by filing a properly completed BE-12 report (BE-12A, BE-12B, BE-12C, or BE-12 Claim for Not Filing). (b) Who must report. A BE-12 report is required for each U.S. affiliate (except certain private funds as described in paragraphs (b)(1) through (3) of this section), that is, for each U.S. business enterprise in which a foreign person (foreign parent) owned or controlled, directly or indirectly, 10 percent or more of the voting securities in an incorporated U.S. business enterprise, or an equivalent interest in an unincorporated U.S. business enterprise, at the end of the business enterprise's fiscal year that ended in the calendar year covered by the survey. Certain private funds are exempt from reporting on the BE-12 survey. If a U.S. business meets ALL of the following 3 criteria, it is not required to file any BE-12 report except to indicate exemption from the survey if contacted by BEA: (1) The U.S. business enter… | ||||||
| 20:20:4.0.3.3.2.0.92.1 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.1 Purpose and scope of this part. | DOL | This part 801 describes the establishment and the organizational structure of the Benefits Review Board of the Department of Labor, sets forth the general rules applicable to operation of the Board, and defines terms used in this chapter. | |||||||
| 20:20:4.0.3.3.2.0.92.2 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.2 Definitions and use of terms. | DOL | [52 FR 27290, July 20, 1987, as amended at 52 FR 28640, July 31, 1987] | (a) For purposes of this chapter, except where the content clearly indicates otherwise, the following definitions apply: (1) Acts means the several Acts listed in §§ 801.102 and 802.101 of this chapter, as amended and extended, unless otherwise specified. (2) Board means the Benefits Review Board established by section 21 of the LHWCA (33 U.S.C. 921) as described in § 801.101, and as provided in this part and Secretary of Labor's Order No. 38-72 (38 FR 90). Mention in these regulations of the “permanent Board” refers to the five permanent Board members only. (3) Chairman or Chairman of the Board means Chairman of the Benefits Review Board. The Chairman of the Board is officially entitled Chief Administrative Appeals Judge. (4) Secretary means the Secretary of Labor. (5) Department means the Department of Labor. (6) Judge means an administrative law judge appointed as provided in 5 U.S.C. 3105 and subpart B of 5 CFR part 930, who is qualified to preside at hearings under 5 U.S.C. 557 and is empowered by the Secretary to conduct formal hearings whenever necessary in respect of any claim for benefits or compensation arising under the Acts. (7) Chief Administrative Law Judge means the Chief Administrative Law Judge of the Department of Labor. (8) Director means the Director of the Office of Workers' Compensation Programs of the Department of Labor (hereinafter OWCP). (9) Deputy commissioner means a person appointed as provided in sections 39 and 40 of the LHWCA or his designee, authorized by the Director to make decisions and orders in respect to claims arising under the Acts. (10) Party or Party in Interest means the Secretary or his designee and any person or business entity directly affected by the decision or order from which an appeal to the Board is taken. (11) Day means calendar day. (12) Member means a member of the Benefits Review Board. Unless specifically stated otherwise, the word “member” shall apply to permanent, temporary and interim members. Permanent Board memb… | ||||||
| 20:20:4.0.3.3.2.0.92.3 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.3 Applicability of this part to 20 CFR part 802. | DOL | Part 802 of title 20, Code of Federal Regulations, contains the rules of practice and procedure of the Board. This part 801, including the definitions and usages contained in § 801.2, is applicable to part 802 of this chapter as appropriate. | |||||||
| 20:20:4.0.3.3.2.0.93.4 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.101 Establishment. | DOL | By Pub. L. 92-576, 82 Stat. 1251, in an amendment made to section 21 of the Longshore and Harbor Workers' Compensation Act (33 U.S.C. 921), there was established effective November 26, 1972, a Benefits Review Board, which is composed of members appointed by the Secretary of Labor. | |||||||
| 20:20:4.0.3.3.2.0.93.5 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.102 Review authority. | DOL | (a) The Board is authorized, as provided in 33 U.S.C. 921(b), as amended, to hear and determine appeals raising a substantial question of law or fact taken by any party in interest from decisions or orders with respect to claims for compensation or benefits arising under the following Acts, as amended and extended: (1) The Longshore and Harbor Workers' Compensation Act (LHWCA), 33 U.S.C. 901 et seq.; (2) The Defense Base Act (DBA), 42 U.S.C. 1651 et seq.; (3) The District of Columbia Workmen's Compensation Act (DCWCA), 36 D.C. Code 501 et seq. (1973); (4) The Outer Continental Shelf Lands Act (OCSLA), 43 U.S.C. 1331 et seq.; (5) The Nonappropriated Fund Instrumentalities Act (NFIA), 5 U.S.C. 8171 et seq.; (6) Title IV, section 415 and part C of the Federal Mine Safety and Health Act of 1977, Public Law 95-164, 91 Stat. 1290 (formerly the Federal Coal Mine Health and Safety Act, hereinafter, FCMHSA, of 1969) as amended by the Black Lung Benefits Reform Act of 1977, Public Law 92-239, 92 Stat. 95, the Black Lung Benefits Revenue Act of 1977, Public Law 95-227, 92 Stat. 11, and the Black Lung Benefits Amendments of 1981, Public Law 97-119, 95 Stat. 1643 (30 U.S.C. 901 et seq. ). | |||||||
| 20:20:4.0.3.3.2.0.93.6 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.103 Organizational placement. | DOL | As prescribed by the statute, the functions of the Benefits Review Board are quasi-judicial in nature and involve review of decisions made in the course of the administration of the above statutes by the Employment Standards Administration in the Department of Labor. It is accordingly found appropriate for organizational purposes to place the Board in the Office of the Deputy Secretary and it is hereby established in that Office, which shall be responsible for providing necessary funds, personnel, supplies, equipment, and records services for the Board. | |||||||
| 20:20:4.0.3.3.2.0.93.7 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.104 Operational rules. | DOL | The Deputy Secretary of Labor may promulgate such rules and regulations as may be necessary or appropriate for effective operation of the Benefits Review Board as an independent quasi-judicial body in accordance with the provisions of the statute. | |||||||
| 20:20:4.0.3.3.2.0.94.10 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.203 Disqualification of Board Members. | DOL | (a) During the period in which the Chairman or the other members serve on the Board, they shall be subject to the Department's regulations governing ethics and conduct set forth at 20 CFR part 0. (b) Notice of any objection which a party may have to any Board member who will participate in the proceeding shall be made by such party at the earliest opportunity. The Board member shall consider such objection and shall, in his or her discretion, either proceed with the case or withdraw. | |||||||
| 20:20:4.0.3.3.2.0.94.8 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.201 Composition of the Board. | DOL | (a) The Board shall be composed of five permanent members appointed by the Secretary from among individuals who are especially qualified to serve thereon. Each permanent member shall serve an indefinite term subject to the discretion of the Secretary. (b) The member designated by the Secretary as Chairman of the Board shall serve as chief administrative officer of the Board and shall have the authority, as delegated by the Secretary, to exercise all administrative functions necessary to operate the Board. (c) The four remaining members shall be the associate members of the Board. (d) Upon application of the Chairman of the Board, the Secretary may designate up to four Department of Labor administrative law judges to serve as temporary Board members in addition to the five permanent Board members. Up to four such temporary members may serve at any one time. The term of any temporary Board member shall not exceed 1 year from date of appointment. | |||||||
| 20:20:4.0.3.3.2.0.94.9 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.202 Interim appointments. | DOL | (a) Acting Chairman. In the event that the Chairman of the Board is temporarily disabled or unavailable to perform his or her duties as prescribed in this chapter VII, he or she shall designate a permanent member to serve as Acting Chairman until such time as the Secretary designates an Acting Chairman. In the event that the Chairman is physically unable to make such designation, the next senior permanent member shall serve as Acting Chairman until such time as the Secretary of Labor designates an Acting Chairman. (b) Interim members. In the event that a permanent member of the Board is temporarily unable to carry out his or her responsibilities because of disqualification, illness, or for any other reason, the Secretary of Labor may, in his or her discretion, appoint a qualified individual to serve in the place of such permanent member for the duration of that permanent member's inability to serve. | |||||||
| 20:20:4.0.3.3.2.0.95.11 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.301 Quorum and votes of the permanent Board; panels within the Board. | DOL | (a) For the purpose of carrying out its functions under the Acts, whenever action is taken by the entire permanent Board sitting en banc, three permanent members of the Board shall constitute a quorum, and official action of the permanent Board can be taken only on the concurring vote of at least three permanent members. (b) The Board may delegate any or all of its powers except en banc review to panels of three members. Each panel shall consist of at least two permanent members. Two members of the panel shall constitute a quorum and official panel action can be taken only on the concurring vote of two members of the panel. (c) A panel decision shall stand unless vacated or modified by the concurring vote of at least three permanent members sitting en banc. (d) En banc action is not available in cases arising under the District of Columbia Workmen's Compensation Act. | |||||||
| 20:20:4.0.3.3.2.0.95.12 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.302 Procedural rules. | DOL | Procedural rules for performance by the Board of its review functions and for insuring an adequate record for any judicial review of its orders, and such amendments to the rules as may be necessary from time to time, shall be promulgated by the Deputy Secretary. Such rules shall incorporate and implement the procedural requirements of section 21(b) of the Longshore and Harbor Workers' Compensation Act. | |||||||
| 20:20:4.0.3.3.2.0.95.13 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.303 Location of Board's proceedings. | DOL | [62 FR 10666, Mar. 7, 1997] | The Board shall hold its proceedings at 200 Constitution Avenue, NW., Room N-5101, Washington, DC 20210, unless for good cause the Board orders that proceedings in a particular matter be held in another location. | ||||||
| 20:20:4.0.3.3.2.0.95.14 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.304 Business hours. | DOL | The office of the Clerk of the Board at Washington, DC shall be open from 8:30 a.m.-5:00 p.m. on all days, except Saturdays, Sundays, and legal holidays, for the purpose of receiving notices of appeal, petitions for review, other pleadings, motions, and other papers. | |||||||
| 20:20:4.0.3.3.2.0.96.15 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.401 Representation before the Board. | DOL | On any issues requiring representation of the Secretary, the Director, Office of Workers' Compensation Programs, a deputy commissioner, or an administrative law judge before the Board, such representation shall be provided by attorneys designated by the Solicitor of Labor. Representation of all other persons before the Board shall be as provided by the rules of practice and procedure promulgated under § 801.302 (see part 802 of this chapter). | |||||||
| 20:20:4.0.3.3.2.0.96.16 | 20 | Employees' Benefits | VII | 801 | PART 801—ESTABLISHMENT AND OPERATION OF THE BOARD | § 801.402 Representation of Board in court proceedings. | DOL | Except in proceedings in the Supreme Court of the United States, any representation of the Benefits Review Board in court proceedings shall be by attorneys designated by the Solicitor of Labor. | |||||||
| 21:21:8.0.1.1.2.1.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. | FDA | (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. (b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for “Company,” “Incorporated,” etc., may be used and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. (c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ___”, “Distributed by _____”, or any other wording that expresses the facts. (d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice). (e) If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading. | ||||
| 21:21:8.0.1.1.2.1.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.3 Definitions. | FDA | [78 FR 58817, Sept. 24, 2013] | As used in this part: Automatic identification and data capture (AIDC) means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process. Center Director means the Director of the Center for Devices and Radiological Health or the Director of the Center for Biologics Evaluation and Research, depending on which Center has been assigned lead responsibility for the device. Combination product has the meaning set forth in § 3.2(e) of this chapter. Convenience kit means two or more different medical devices packaged together for the convenience of the user. Device package means a package that contains a fixed quantity of a particular version or model of a device. Expiration date means the date by which the label of a device states the device must or should be used. FDA, we, or us means the Food and Drug Administration. Finished device means any device or accessory to any device that is suitable for use or capable of functioning. Global Unique Device Identification Database (GUDID) means the database that serves as a repository of information to facilitate the identification of medical devices through their distribution and use. Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a device. Implantable device means a device that is intended to be placed in a surgically or naturally formed cavity of the human body. A device is regarded as an implantable device for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner of Food and Drugs determines otherwise in order to protect human health. Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act. Labeler means: … | |||
| 21:21:8.0.1.1.2.1.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.4 Meaning of intended uses. | FDA | [86 FR 41401, Aug. 2, 2021] | The words intended uses or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firm's knowledge that such device was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. | |||
| 21:21:8.0.1.1.2.1.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.5 Medical devices; adequate directions for use. | FDA | Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of: (a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner. (b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions. (c) Frequency of administration or application. (d) Duration of administration or application. (e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors. (f) Route or method of administration or application. (g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process. | ||||
| 21:21:8.0.1.1.2.1.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.6 Medical devices; misleading statements. | FDA | Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic. | ||||
| 21:21:8.0.1.1.2.1.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.15 Medical devices; prominence of required label statements; use of symbols in labeling. | FDA | [41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016] | (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of: (1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase; (2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed; (3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information; (4) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (5) Insufficiency of label space for the placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or (6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter. (b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502(b) of the act, shall apply if such insufficiency is caused by: (1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (2) The use of label space to give greater conspicuousness to any word, statement,… | |||
| 21:21:8.0.1.1.2.1.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.16 Medical devices; Spanish-language version of certain required statements. | FDA | If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, such labeling is authorized under § 801.15(c). | ||||
| 21:21:8.0.1.1.2.1.1.9 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.18 Format of dates provided on a medical device label. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02. (b) Exceptions. (1) A combination product that properly bears a National Drug Code (NDC) number is not subject to the requirements of paragraph (a) of this section. (2) If the device is an electronic product to which a standard is applicable under subchapter J of this chapter, Radiological Health, the date of manufacture shall be presented as required by § 1010.3(a)(2)(ii) of this chapter. | |||
| 21:21:8.0.1.1.2.2.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.20 Label to bear a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter. (2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter. (b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions. | |||
| 21:21:8.0.1.1.2.2.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013, as amended at 90 FR 55979, Dec. 4, 2025] | (a) In general. The following types of devices are excepted from the requirement of § 801.20; a device within one or more of the following exceptions is not required to bear a unique device identifier (UDI): (1) A finished device manufactured and labeled prior to the compliance date established by FDA for § 801.20 regarding the device. This exception expires with regard to a particular device 3 years after the compliance date established by FDA for the device. (2) A class I device that FDA has by regulation exempted from the good manufacturing practice requirements of part 820 of this chapter, exclusive of any continuing requirement for recordkeeping under § 820.35 of this chapter. (3) Individual single-use devices, all of a single version or model, that are distributed together in a single device package, intended to be stored in that device package until removed for use, and which are not intended for individual commercial distribution. This exception is not available for any implantable device. The device package containing these individual devices is not excepted from the requirement of § 801.20, and must bear a UDI. (4) A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use. (5) A custom device within the meaning of § 812.3(b) of this chapter. (6) An investigational device within the meaning of part 812 of this chapter. (7) A veterinary medical device not intended for use in the diagnosis of disease or other conditions in man, in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body of man. (8) A device intended for export from the United States. (9) A device held by the Strategic National Stockpile and granted an exception or alternative under § 801.128(f)(2). (10) A device for which FDA has established a performance standard under section 514(b) of the Federal Food, Drug, and Cosmetic Act and has provided therein an exception from the requirement of § 801.20, or for whic… | |||
| 21:21:8.0.1.1.2.2.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.35 Voluntary labeling of a device with a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with § 801.20. If a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information concerning the device under subpart E of part 830 of this chapter. (b) A device may bear both a Universal Product Code (UPC) and a UDI on its label and packages. | |||
| 21:21:8.0.1.1.2.2.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.40 Form of a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter. The UDI must be presented in two forms: (1) Easily readable plain-text, and (2) Automatic identification and data capture (AIDC) technology. (b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by § 1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information. (c) If the AIDC technology is not evident upon visual examination of the label or device package, the label or device package must disclose the presence of AIDC technology. (d) A class I device that bears a Universal Product Code (UPC) on its label and device packages is deemed to meet all requirements of subpart B of this part. The UPC will serve as the unique device identifier required by § 801.20. | |||
| 21:21:8.0.1.1.2.2.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.45 Devices that must be directly marked with a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013, as amended at 90 FR 55979, Dec. 4, 2025] | (a) In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. (b) UDI for direct marking. The UDI provided through a direct marking on a device may be: (1) Identical to the UDI that appears on the label of the device, or (2) A different UDI used to distinguish the unpackaged device from any device package containing the device. (c) Form of a UDI when provided as a direct marking. When a device must bear a UDI as a direct marking, the UDI may be provided through either or both of the following: (1) Easily readable plain-text; (2) Automatic identification and data capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand. (d) Exceptions. The requirement of paragraph (a) of this section shall not apply to any device that meets any of the following criteria: (1) Any type of direct marking would interfere with the safety or effectiveness of the device; (2) The device cannot be directly marked because it is not technologically feasible; (3) The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use. (4) The device has been previously marked under paragraph (a) of this section. (e) Exception to be noted in design and development files. A labeler that decides to make use of an exception under paragraph (d) of this section must document the basis of that decision in the design and development files required by § 820.10(c) of this chapter. | |||
| 21:21:8.0.1.1.2.2.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.50 Labeling requirements for stand-alone software. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of paragraph (b) of this section and conveys the version number in its production identifier. (b) Regardless of whether it is or is not distributed in packaged form, stand-alone software regulated as a medical device must provide its unique device identifier through either or both of the following: (1) An easily readable plain-text statement displayed whenever the software is started; (2) An easily readable plain-text statement displayed through a menu command (e.g., an “About * * *” command). (c) Stand-alone software that is distributed in both packaged form and in a form that is not packaged (e.g., when downloaded from a Web site) may be identified with the same device identifier. | |||
| 21:21:8.0.1.1.2.2.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.55 Request for an exception from or alternative to a unique device identifier requirement. | FDA | [78 FR 58818, Sept. 24, 2013, as amended at 80 FR 18093, Apr. 3, 2015; 81 FR 11428, Mar. 4, 2016; 85 FR 18441, Apr. 2, 2020] | (a) A labeler may submit a request for an exception from or alternative to the requirement of § 801.20 or any other requirement of this subpart for a specified device or a specified type of device. A written request for an exception or alternative must: (1) Identify the device or devices that would be subject to the exception or alternative; (2) Identify the provisions of this subpart that are the subject of the request for an exception or alternative; (3) If requesting an exception, explain why you believe the requirements of this subpart are not technologically feasible; (4) If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise, or rapid device identification than the requirements of this subpart or how the alternative would better ensure the safety or effectiveness of the device that would be subject to the alternative; (5) Provide, if known, the number of labelers and the number of devices that would be affected if we grant the requested exception or alternative; and (6) Provide other requested information that the Center Director needs to clarify the scope and effects of the requested exception or alternative. (b) A written request for an exception or alternative must be submitted by sending it: (1) If the device is regulated by the Center for Biologics Evaluation and Research (CBER), by email to: cberudirequests@fda.hhs.gov or by correspondence to: Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993. (2) In all other cases, by email to: GUDIDSupport@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002. (c) The Center Director may grant an exception or alternative, either in response to a request or on his or her own initiative, if the Center Director dete… | |||
| 21:21:8.0.1.1.2.2.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices. | FDA | [78 FR 58820, Sept. 24, 2013, as amended at 81 FR 11428, Mar. 4, 2016; 85 FR 18441, Apr. 2, 2020] | (a) On the date your device must bear a unique device identifier (UDI) on its label, any National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to that device is rescinded, and you may no longer provide an NHRIC or NDC number on the label of your device or on any device package. (b) If your device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and beginning on that date, you may no longer provide an NHRIC or NDC number of the label of your device or on any device package. (c) A labeler who has been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use that labeler code under a system for the issuance of UDIs, provided that — (1) Such use is consistent with the framework of the issuing agency that operates that system; and (2) No later than September 24, 2014, the labeler submits, and obtains FDA approval of, a request for continued use of the assigned labeler code. A request for continued use of an assigned labeler code must be submitted by email to: GUDIDSupport@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002. (d) Each request for continued use of an assigned labeler code must provide— (1) The name, mailing address, email address, and phone number of the labeler who is currently using the labeler code; (2) The owner/operator account identification used by the labeler to submit registration and listing information using FDA's Unified Registration and Listing System (FURLS). (3) The FDA labeler code that the labeler wants to continue using. | |||
| 21:21:8.0.1.1.2.3.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.60 Principal display panel. | FDA | The term principal display panel, as it applies to over-the-counter devices in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring designs, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side; (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; and (c) In the case of any other shape of container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious “principal display panel” such as the top of a triangular or circular package, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of di… | ||||
| 21:21:8.0.1.1.2.3.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.61 Statement of identity. | FDA | (a) The principal display panel of an over-the-counter device in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of the common name of the device followed by an accurate statement of the principal intended action(s) of the device. Such statement shall be placed in direct conjunction with the most prominent display of the name and shall employ terms descriptive of the principal intended action(s). The indications for use shall be included in the directions for use of the device, as required by section 502(f)(1) of the act and by the regulations in this part. (c) The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. | ||||
| 21:21:8.0.1.1.2.3.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.62 Declaration of net quantity of contents. | FDA | (a) The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size: Provided, That: (1) In the case of a firmly established general consumer usage and trade custom of declaring the quantity of a device in terms of linear measure or measure of area, such respective term may be used. Such term shall be augmented when necessary for accuracy of information by a statement of the weight, measure, or size of the individual units or of the entire device. (2) If the declaration of contents for a device by numerical count does not give accurate information as to the quantity of the device in the package, it shall be augmented by such statement of weight, measure, or size of the individual units or of the total weight, measure, or size of the device as will give such information; for example, “100 tongue depressors, adult size”, “1 rectal syringe, adult size”, etc. Whenever the Commissioner determines for a specific packaged device that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination of these does not facilitate value comparisions by consumers, he shall by regulation designate the appropriate term or terms to be used for such article. (b) Statements of weight of the contents shall be expressed in terms of avoirdupois pound and ounce. A statement of liquid measure of the contents shall be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid-ounce subdivisions thereof, and shall express the volume at 68 °F (20 °C). See also paragraph (p) of this section. (c) The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there exists a firmly established, general consumer usage and trade custom of employing different common fractions i… | ||||
| 21:21:8.0.1.1.2.3.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. | FDA | [61 FR 20101, May 3, 1996] | (a) All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall carry one of the following warnings: (1) The EPA warning statement: Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative statement: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) [or other class I substance, if applicable]: Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT. (b) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase. This provision does not replace or relieve a person from any requirements imposed under 40 CFR part 82. | |||
| 21:21:8.0.1.1.2.4.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.109 Prescription devices. | FDA | [41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016] | A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met: (a) The device is: (1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or (ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and (2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice. (b) The label of the device, other than surgical instruments, bears: (1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and (2) The method of its application or use. (c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which di… | ||||
| 21:21:8.0.1.1.2.4.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.110 Retail exemption for prescription devices. | FDA | A device subject to § 801.109 shall be exempt at the time of delivery to the ultimate purchaser or user from section 502(f)(1) of the act if it is delivered by a licensed practitioner in the course of his professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order. | |||||
| 21:21:8.0.1.1.2.4.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.116 Medical devices having commonly known directions. | FDA | A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual. | |||||
| 21:21:8.0.1.1.2.4.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.119 In vitro diagnostic products. | FDA | [78 FR 58820, Sept. 24, 2013] | A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in § 809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act if it meets the requirements of subpart B of this part and the requirements of § 809.10 of this chapter. | ||||
| 21:21:8.0.1.1.2.4.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.122 Medical devices for processing, repacking, or manufacturing. | FDA | A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. | |||||
| 21:21:8.0.1.1.2.4.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. | FDA | A device subject to § 801.109 shall be exempt from section 502(f)(1) of this act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing. | |||||
| 21:21:8.0.1.1.2.4.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.127 Medical devices; expiration of exemptions. | FDA | (a) If a shipment or delivery, or any part thereof, of a device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device. (b) The exemptions conferred by §§ 801.119, 801.122, and 801.125 shall continue until the devices are used for the purposes for which they are exempted, or until they are relabeled to comply with section 502(f)(1) of the act. If, however, the device is converted, or manufactured into a form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the device is labeled as required by § 801.109. | |||||
| 21:21:8.0.1.1.2.4.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile. | FDA | [72 FR 73601, Dec. 28, 2007, as amended at 78 FR 58820, Sept. 24, 2013] | (a) The appropriate FDA Center Director may grant an exception or alternative to any provision listed in paragraph (f) of this section and not explicitly required by statute, for specified lots, batches, or other units of a medical device, if the Center Director determines that compliance with such labeling requirement could adversely affect the safety, effectiveness, or availability of such devices that are or will be included in the Strategic National Stockpile. (b)(1)(i) A Strategic National Stockpile official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores devices that are or will be included in the Strategic National Stockpile may submit, with written concurrence from a Strategic National Stockpile official, a written request for an exception or alternative described in paragraph (a) of this section to the Center Director. (ii) The Center Director may grant an exception or alternative described in paragraph (a) of this section on his or her own initiative. (2) A written request for an exception or alternative described in paragraph (a) of this section must: (i) Identify the specified lots, batches, or other units of the medical device that would be subject to the exception or alternative; (ii) Identify the labeling provision(s) listed in paragraph (f) of this section that are the subject of the exception or alternative request; (iii) Explain why compliance with the labeling provision(s) could adversely affect the safety, effectiveness, or availability of the specified lots, batches, or other units of a medical device that are or will be held in the Strategic National Stockpile; (iv) Describe any proposed safeguards or conditions that will be implemented so that the labeling of the device includes appropriate information necessary for the safe and effective use of the device, given the anticipated circumstances of use of the device; (v) Provide a draft of the proposed labeling of the specified lots, batches, or other units of the medica… | ||||
| 21:21:8.0.1.1.2.5.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | E | Subpart E—Other Exemptions | § 801.150 Medical devices; processing, labeling, or repacking. | FDA | (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements of section 502(b) and (f) of the act if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such device is to be processed, labeled, or repacked; or (2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such device in such establishment as will insure, if such specifications are followed, that such device will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such device from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them. (b) An exemption of a shipment or other delivery of a device under paragraph (a)(1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed. (c) An exemption of a shipment or other delivery of a device under paragraph (a)(2) of this section… | ||||
| 21:21:8.0.1.1.2.7.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures. | FDA | (a) The American Dental Association and leading dental authorities have advised the Food and Drug Administration of their concern regarding the safety of denture reliners, repair kits, pads, cushions, and other articles marketed and labeled for lay use in the repairing, refitting, or cushioning of ill-fitting, broken, or irritating dentures. It is the opinion of dental authorities and the Food and Drug Administration that to properly repair and properly refit dentures a person must have professional knowledge and specialized technical skill. Laymen cannot be expected to maintain the original vertical dimension of occlusion and the centric relation essential in the proper repairing or refitting of dentures. The continued wearing of improperly repaired or refitted dentures may cause acceleration of bone resorption, soft tissue hyperplasia, and other irreparable damage to the oral cavity. Such articles designed for lay use should be limited to emergency or temporary situations pending the services of a licensed dentist. (b) The Food and Drug Administration therefore regards such articles as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act, unless the labeling: (1)(i) Limits directions for use for denture repair kits to emergency repairing pending unavoidable delay in obtaining professional reconstruction of the denture; (ii) Limits directions for use for denture reliners, pads, and cushions to temporary refitting pending unavoidable delay in obtaining professional reconstruction of the denture; (2) Contains in a conspicuous manner the word “emergency” preceding and modifying each indication-for-use statement for denture repair kits and the word “temporary” preceding and modifying each indication-for-use statement for reliners, pads, and cushions; and (3) Includes a conspicuous warning statement to the effect: (i) For denture repair kits: “Warning—For emergency repairs only. Long term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This k… | ||||
| 21:21:8.0.1.1.2.7.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses. | FDA | [41 FR 6896, Feb. 13, 1976, as amended at 44 FR 20678, Apr. 6, 1979; 47 FR 9397, Mar. 5, 1982; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000; 69 FR 18803, Apr. 9, 2004] | (a) Examination of data available on the frequency of eye injuries resulting from the shattering of ordinary crown glass lenses indicates that the use of such lenses constitutes an avoidable hazard to the eye of the wearer. (b) The consensus of the ophthalmic community is that the number of eye injuries would be substantially reduced by the use in eyeglasses and sunglasses of impact-resistant lenses. (c)(1) To protect the public more adequately from potential eye injury, eyeglasses and sunglasses must be fitted with impact-resistant lenses, except in those cases where the physician or optometrist finds that such lenses will not fulfill the visual requirements of the particular patient, directs in writing the use of other lenses, and gives written notification thereof to the patient. (2) The physician or optometrist shall have the option of ordering glass lenses, plastic lenses, or laminated glass lenses made impact resistant by any method; however, all such lenses shall be capable of withstanding the impact test described in paragraph (d)(2) of this section. (3) Each finished impact-resistant glass lens for prescription use shall be individually tested for impact resistance and shall be capable of withstanding the impact test described in paragraph (d)(2) of this section. Raised multifocal lenses shall be impact resistant but need not be tested beyond initial design testing. Prism segment multifocal, slab-off prism, lenticular cataract, iseikonic, depressed segment one-piece multifocal, bioconcave, myodisc and minus lenticular, custom laminate and cemented assembly lenses shall be impact resistant but need not be subjected to impact testing. To demonstrate that all other types of impact-resistant lenses, including impact-resistant laminated glass lenses (i.e., lenses other than those described in the three preceding sentences of this paragraph (c)(3)), are capable of withstanding the impact test described in this regulation, the manufacturer of these lenses shall subject to an impact test a statistically sign… | |||
| 21:21:8.0.1.1.2.7.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.415 Maximum acceptable level of ozone. | FDA | (a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals. (b) Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure; thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration. (c) A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and/or misbranded within the meaning of sections 501 and 502 of the act if it is used or intended for use under the following conditions: (1) In such a manner that it generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part per million by volume of air (when measured under standard conditions at 25 °C (77 °F) and 760 millimeters of mercury) in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals, and offices. This applies to any such device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product. (2) To generate ozone and release it into the atmosphere in hospitals or other establishments occupied by the ill or infirm. (3) To generate ozone and release it into the atmosphe… | ||||
| 21:21:8.0.1.1.2.7.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.417 Chlorofluorocarbon propellants. | FDA | [43 FR 11318, Mar. 17, 1978] | The use of chlorofluorocarbon in devices as propellants in self-pressurized containers is generally prohibited except as provided in § 2.125 of this chapter. | |||
| 21:21:8.0.1.1.2.7.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.422 Prescription hearing aid labeling. | FDA | [87 FR 50755, Aug. 17, 2022] | (a) Scope. This section specifies the labeling requirements for prescription hearing aids. Any hearing aid that does not satisfy the requirements of § 800.30 of this chapter shall be a prescription device. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter. This section does not apply to group auditory trainers. (b) Definitions for the purposes of this section. This section uses the following definitions: Dispenser. A dispenser is any person, as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of hearing aids to any member of the consuming public or any employee, agent, salesperson, and/or representative of such a person. Hearing aid. A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. Prescription hearing aid. A prescription hearing aid is a hearing aid that is not an over-the-counter (OTC) hearing aid as defined in § 800.30 of this chapter or a hearing aid that does not satisfy the requirements in § 800.30 of this chapter. Rebuilt hearing aid. A prescription hearing aid is “rebuilt” if the manufacturer has inspected and tested the device, made any necessary modifications to ensure it meets applicable regulatory requirements, including the requirements in this section, and adequately reprocessed the device for the next user. Sale. Sale includes a lease, rental, or any other purchase or exchange for value. Used hearing aid. A hearing aid is “used” if a user has worn it for any period of time. However, a hearing aid shall not be “used” merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user. A hearing aid evaluation is “bona fide” if it was conducted in the p… | |||
| 21:21:8.0.1.1.2.7.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.430 User labeling for menstrual tampons. | FDA | [47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989; 55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR 18803, Apr. 9, 2004; 69 FR 52171, Aug. 25, 2004; 75 FR 20914, Apr. 22, 2010] | (a) This section applies to scented or scented deodorized menstrual tampons as identified in § 884.5460 and unscented menstrual tampons as identified in § 884.5470 of this chapter. (b) Data show that toxic shock syndrome (TSS), a rare but serious and sometimes fatal disease, is associated with the use of menstrual tampons. To protect the public and to minimize the serious adverse effects of TSS, menstrual tampons shall be labeled as set forth in paragraphs (c), (d), and (e) of this section and tested for absorbency as set forth in paragraph (f) of this section. (c) If the information specified in paragraph (d) of this section is to be included as a package insert, the following alert statement shall appear prominently and legibly on the package label: Attention: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information. Attention: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information. (d) The labeling of menstrual tampons shall contain the following consumer information prominently and legibly, in such terms as to render the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use: (1)(i) Warning signs of TSS, e.g., sudden fever (usually 102° or more) and vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash that looks like a sunburn; (ii) What to do if these or other signs of TSS appear, including the need to remove the tampon at once and seek medical attention immediately; (2) The risk of TSS to all women using tampons during their menstrual period, especially the reported higher risks to women under 30 years of age and teenage girls, the estimated incidence of TSS of 1 to 17 per 100,000 menstruating women and girls per year, and the risk of death from contracting TSS; (3) The advisability of using tampons with the minimum… | |||
| 21:21:8.0.1.1.2.7.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. | FDA | [61 FR 20101, May 3, 1996] | (a)(1) All prescription and restricted device products containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall, except as provided in paragraph (b) of this section, bear the following warning statement: Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase. (b)(1) For prescription and restricted device products, the following alternative warning statement may be used: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) [or name of other class I substance, if applicable]: This product contains [or is manufactured with, if applicable] [ insert name of substance ], a substance which harms the environment by destroying ozone in the upper atmosphere. Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician. (2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prom… | |||
| 21:21:8.0.1.1.2.7.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.435 User labeling for latex condoms. | FDA | [62 FR 50501, Sept. 26, 1997] | (a) This section applies to the subset of condoms as identified in § 884.5300 of this chapter, and condoms with spermicidal lubricant as identified in § 884.5310 of this chapter, which products are formed from latex films. (b) Data show that the material integrity of latex condoms degrade over time. To protect the public health and minimize the risk of device failure, latex condoms must bear an expiration date which is supported by testing as described in paragraphs (d) and (h) of this section. (c) The expiration date, as demonstrated by testing procedures required by paragraphs (d) and (h) of this section, must be displayed prominently and legibly on the primary packaging (i.e., individual package), and higher levels of packaging (e.g., boxes of condoms), in order to ensure visibility of the expiration date by consumers. (d) Except as provided under paragraph (f) of this section, the expiration date must be supported by data demonstrating physical and mechanical integrity of the product after three discrete and representative lots of the product have been subjected to each of the following conditions: (1) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at 70 °C (plus or minus 2 °C) for 7 days; (2) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at a selected temperature between 40 and 50 °C (plus or minus 2 °C) for 90 days; and (3) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at a monitored or controlled temperature between 15 and 30 °C for the lifetime of the product (real time storage). (e) If a product fails the physical and mechanical integrity tests commonly used by industry after the completion of the accelerated storage tests described in par… | |||
| 21:21:8.0.1.1.2.7.1.9 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.437 User labeling for devices that contain natural rubber. | FDA | [62 FR 51029, Sept. 30, 1997, as amended at 63 FR 46175, Aug. 31, 1998] | (a) Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and protect the public health. (b) This section applies to all devices composed of or containing, or having packaging or components that are composed of, or contain, natural rubber that contacts humans. The term “natural rubber” includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation. (1) The term “natural rubber latex” means rubber that is produced by the natural rubber latex process that involves the use of natural latex in a concentrated colloidal suspension. Products are formed from natural rubber latex by dipping, extruding, or coating. (2) The term “dry natural rubber” means rubber that is produced by the dry natural rubber process that involves the use of coagulated natural latex in the form of dried or milled sheets. Products are formed from dry natural rubber by compression molding, extrusion, or by converting the sheets into a solution for dipping. (3) The term “contacts humans” means that the natural rubber contained in a device is intended to contact or is likely to contact the user or patient. This includes contact when the device that contains natural rubber is connected to the patient by a liquid path or an enclosed gas path; or the device containing the natural rubber is fully or partially coated with a powder, and such powder may carry natural rubber proteins that may contaminate the environment of the user or patient. (c) Devices containing natural rubber shall be labeled as set forth in paragraphs (d) through (h) of this section. Each required labeling statement shall be prominently and legibly displayed in conformance with section 502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352(c)). (d) Devices… | |||
| 28:28:2.0.6.5.2.0.127.1 | 28 | Judicial Administration | VIII | 801 | PART 801—FEDERAL TORT CLAIMS ACT PROCEDURE | § 801.1 Claims filed under the Federal Tort Claims Act. | CSOSA | If an agency employee is acting within the scope of his or her employment and causes injury to a member of the public, any claim for money damages for personal injury, death, damage to property, or loss of property caused by the employee's negligent or wrongful act or omission is a claim against the United States and must first be presented by the injured party to the appropriate federal agency for administrative action under the Federal Tort Claims Act. General provisions for processing such administrative claims are contained in 28 CFR part 14. The provisions in this part supplement the general provisions in order to describe specific procedures to follow when filing a claim with the Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA”) or the District of Columbia Pretrial Services Agency (“PSA”). | |||||||
| 28:28:2.0.6.5.2.0.127.2 | 28 | Judicial Administration | VIII | 801 | PART 801—FEDERAL TORT CLAIMS ACT PROCEDURE | § 801.2 Filing a claim. | CSOSA | (a) Who may file the claim? You may file a claim for money damages against CSOSA or PSA if you believe that a CSOSA or PSA employee has injured you or has damaged or lost property that you own. You may file a claim on behalf of an injured or deceased person or owner of damaged or lost property if you are acting as agent, executor, administrator, parent, guardian, legal or other representative provided you submit evidence of your authority to act on behalf of the claimant. (b) What information do you need to submit in your claim? (1) The easiest way to ensure that you will include all necessary information for your claim is to submit a completed Standard Form 95 (“SF 95”). The SF 95 is available from the Office of the General Counsel, CSOSA, (see address in paragraph (c) of this section) and on the Internet at http://www.usdoj.gov/civil/forms/forms.htm. (2) If you do not use the SF 95, you must submit written notification of the incident that resulted in the injury, loss, or damage. Along with this notification, you must present a claim for money damages in a sum certain (that is, a precise dollar amount) for injury to or loss of property, personal injury, or death alleged to have occurred on the basis of the incident. Failure to include the precise dollar amount for your claim may mean that you will have difficulty pursuing your claim in court. (c) Where do you submit the claim? You should submit the claim (whether against CSOSA or PSA) directly to the Office of the General Counsel, CSOSA, 633 Indiana Avenue NW., Washington, DC 20004. Claims submitted to any other office of CSOSA or PSA are forwarded to the Office of the General Counsel. (d) When must you submit the claim? You must submit the claim so that CSOSA/PSA receives the claim within 2 years after the claim accrues. Mailing the claim by that date is not sufficient if CSOSA/PSA does not receive the claim by that date. Generally speaking, a claim accrues at the time of the injury. In those instances where neither the injury nor its cause is imm… | |||||||
| 28:28:2.0.6.5.2.0.127.3 | 28 | Judicial Administration | VIII | 801 | PART 801—FEDERAL TORT CLAIMS ACT PROCEDURE | § 801.3 Processing the claim. | CSOSA | (a) Will CSOSA/PSA contact you about your claim? (1) If you have provided all necessary information to process your claim, you will receive an acknowledgement indicating the filing date (that is, the date CSOSA/PSA received your claim) and the assigned claim number. Refer to the claim number in any further correspondence you may have with CSOSA/PSA on the claim. (2) If you have failed to include all necessary information, CSOSA/PSA will return your claim to you with a request for the necessary additional information. (3) If your claim should have been filed with another agency, CSOSA/PSA will forward the claim to the appropriate agency and notify you of the transfer, or return the claim to you if the appropriate agency cannot be determined or if the transfer is otherwise not feasible. (b) Who is responsible for offering settlement or denial on the claim? The General Counsel is responsible for investigating the claim and, after consultation with PSA (if the claim is against PSA) and the Department of Justice when appropriate, determining whether the claim should be settled or denied. (c) How long does CSOSA/PSA have to consider your claim? CSOSA/PSA has 6 months from the date of filing to make a settlement offer or to deny your claim. If you amend your claim (see § 801.2(e)) or request that your claim be reconsidered (see § 801.4(b)(1)), CSOSA/PSA has an additional 6 months from the date of the amendment or the filing of the request for reconsideration to make a final disposition of the claim. (d) Will appreciation or depreciation be considered? Yes, appreciation or depreciation is considered in settling a claim for lost or damaged property. | |||||||
| 28:28:2.0.6.5.2.0.127.4 | 28 | Judicial Administration | VIII | 801 | PART 801—FEDERAL TORT CLAIMS ACT PROCEDURE | § 801.4 Final disposition of claim. | CSOSA | (a) What if you accept the settlement offer? If you accept a settlement offer, you give up your right to bring a lawsuit against the United States or against any employee of the government whose action or lack of action gave rise to your claim. (b) What if your claim is denied? (1) If your claim is denied, you have 30 days from the date of CSOSA/PSA's written notification to make a written request that the agency reconsider the denial. (2) If your claim is denied or you reject the settlement offer, you have 6 months from the date of mailing of CSOSA/PSA's notice of denial to file a civil action in the appropriate U.S. District Court. (c) What if you do not hear from CSOSA/PSA within 6 months of the filing date? If you do not hear from CSOSA/PSA within 6 months of the filing date for the claim, you may consider your claim denied. You may then proceed with filing a civil action in the appropriate U.S. District Court. | |||||||
| 29:29:3.1.1.3.54.1.482.1 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.1 Purpose and scope. | DOL-WHD | (a) Effective December 27, 1988, the Employee Polygraph Protection Act of 1988 (EPPA or the Act) prohibits most private employers (Federal, State, and local government employers are exempted from the Act) from using any lie detector tests either for pre-employment screening or during the course of employment. Polygraph tests, but no other types of lie detector tests, are permitted under limited circumstances subject to certain restrictions. The purpose of this part is to set forth the regulations to carry out the provisions of EPPA. (b) The regulations in this part are divided into six subparts. Subpart A contains the provisions generally applicable to covered employers, including the requirements relating to the prohibitions on lie detector use and the posting of notices. Subpart A also sets forth interpretations regarding the effect of section 10 of the Act on other laws or collective bargaining agreements. Subpart B sets forth rules regarding the statutory exemptions from application of the Act. Subpart C sets forth the restrictions on polygraph usage under such exemptions. Subpart D sets forth the recordkeeping requirements and the rules on the disclosure of polygraph test information. Subpart E deals with the authority of the Secretary of Labor and the enforcement provisions under the Act. Subpart F contains the procedures and rules of practice necessary for the administrative enforcement of the Act. | ||||
| 29:29:3.1.1.3.54.1.482.2 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.2 Definitions. | DOL-WHD | [56 FR 9064, Mar. 4, 1991, as amended at 82 FR 2230, Jan. 9, 2017] | For purposes of this part: (a) Act or EPPA means the Employee Polygraph Protection Act of 1988 (Pub. L. 100-347, 102 Stat. 646, 29 U.S.C. 2001-2009). (b) (1) The term commerce has the meaning provided in section 3(b) of the Fair Labor Standards Act of 1938 (29 U.S.C. 203(b)). As so defined, commerce means trade, commerce, transportation, transmission, or communication among the several States or between any State and any place outside thereof. (2) The term State means any of the fifty States and the District of Columbia and any Territory or possession of the United States. (c) The term employer means any person acting directly or indirectly in the interest of an employer in relation to an employee or prospective employee. A polygraph examiner either employed for or whose services are retained for the sole purpose of administering polygraph tests ordinarily would not be deemed an employer with respect to the examinees. (d) (1) The term lie detector means a polygraph, deceptograph, voice stress analyzer, psychological stress evaluator, or any other similar device (whether mechanical or electrical) that is used, or the results of which are used, for the purpose of rendering a diagnostic opinion regarding the honesty or dishonesty of an individual. Voice stress analyzers, or psychological stress evaluators, include any systems that utilize voice stress analysis, whether or not an opinion on honesty or dishonesty is specifically rendered. (2) The term lie detector does not include medical tests used to determine the presence or absence of controlled substances or alcohol in bodily fluids. Also not included in the definition of lie detector are written or oral tests commonly referred to as “honesty” or “paper and pencil” tests, machine-scored or otherwise; and graphology tests commonly referred to as handwriting tests. (e) The term polygraph means an instrument that— (1) Records continuously, visually, permanently, and simultaneously changes in cardiovascular, respiratory, and electroderma… | |||
| 29:29:3.1.1.3.54.1.482.3 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.3 Coverage. | DOL-WHD | [56 FR 9064, Mar. 4, 1991; 56 FR 14469, Apr. 10, 1991] | (a) The coverage of the Act extends to “any employer engaged in or affecting commerce or in the production of goods for commerce.” (Section 3 of EPPA; 29 U.S.C. 2002.) In interpreting the phrase “affecting commerce” in other statutes, courts have found coverage to be coextensive with the full scope of the Congressional power to regulate commerce. See, for example, Godwin v. Occupational Safety and Health Review Commission, 540 F. 2d 1013, 1015 (9th Cir. 1976). Since most employers engage in one or more types of activities that would be regarded as “affecting commerce” under the principles established by a large body of court cases, virtually all employers are deemed subject to the provisions of the Act, unless otherwise exempt pursuant to section 7 (a), (b), or (c) of the Act and §§ 801.10 or 801.11 of this part. (b) The Act also extends to all employees of covered employers regardless of their citizenship status, and to foreign corporations operating in the United States. Moreover, the provisions of the Act extend to any actions relating to the administration of lie detector, including polygraph, tests which occur within the territorial jurisdiction of the United States, e.g., the preparation of paperwork by a foreign corporation in a Miami office relating to a polygraph test that is to be administered on the high seas or in some foreign location. | |||
| 29:29:3.1.1.3.54.1.482.4 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.4 Prohibitions on lie detector use. | DOL-WHD | [56 FR 9064, Mar. 4, 1991; 56 FR 14469, Apr. 10, 1991] | (a) Section 3 of EPPA provides that, unless otherwise exempt pursuant to section 7 of the Act and §§ 801.10 through 801.14 of this part, covered employers are prohibited from: (1) Requiring, requesting, suggesting or causing, directly or indirectly, any employee or prospective employee to take or submit to a lie detector test; (2) Using, accepting, or inquiring about the results of a lie detector test of any employee or prospective employee; and (3) Discharging, disciplining, discriminating against, denying employment or promotion, or threatening any employee or prospective employee to take such action for refusal or failure to take or submit to such test, on the basis of the results of a test, for filing a complaint, for testifying in any proceeding, or for exercising any rights afforded by the Act. (b) An employer who reports a theft or other incident involving economic loss to police or other law enforcement authorities is not engaged in conduct subject to the prohibitions under paragraph (a) of this section if, during the normal course of a subsequent investigation, such authorities deem it necessary to administer a polygraph test to an employee(s) suspected of involvement in the reported incident. Employers who cooperate with police authorities during the course of their investigations into criminal misconduct are likewise not deemed engaged in prohibitive conduct provided that such cooperation is passive in nature. For example, it is not uncommon for police authorities to request employees suspected of theft or criminal activity to submit to a polygraph test during the employee's tour of duty since, as a general rule, suspect employees are often difficult to locate away from their place of employment. Allowing a test on the employer's premises, releasing an employee during working hours to take a test at police headquarters, and other similar types of cooperation at the request of the police authorities would not be construed as “requiring, requesting, suggesting, or causing, directly or indirectly, any… | |||
| 29:29:3.1.1.3.54.1.482.5 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.5 Effect on other laws or agreements. | DOL-WHD | (a) Section 10 of EPPA provides that the Act, except for subsections (a), (b), and (c) of section 7, does not preempt any provision of a State or local law, or any provision of a collective bargaining agreement, that prohibits lie detector tests or is more restrictive with respect to the use of lie detector tests. (b)(1) This provision applies to all aspects of the use of lie detector tests, including procedural safeguards, the use of test results, the rights and remedies provided examinees, and the rights, remedies, and responsibilities of examiners and employers. (2) For example, if the State prohibits the use of polygraphs in all private employment, polygraph examinations could not be conducted pursuant to the limited exemptions provided in section 7 (d), (e) or (f) of the Act; a collective bargaining agreement that provides greater protection to an examinee would apply in addition to the protection provided in the Act; or more stringent licensing or bonding requirements in a State law would apply in addition to the Federal bonding requirement. (3) On the other hand, industry exemptions and applicable restrictions thereon, provided in EPPA, would preempt less restrictive exemptions established by State law for the same industry, e.g., random testing of current employees in the drug industry not prohibited by State law but limited by this Act to tests administered in connection with ongoing investigations. (c) EPPA does not impede the ability of State and local governments to enforce existing statutes or to enact subsequent legislation restricting the use of lie detectors with respect to public employees. (d) Nothing in section 10 of the Act restricts or prohibits the Federal Government from administering polygraph tests to its own employees or to experts, consultants, or employees of contractors, as provided in subsections 7(b) and 7(c) of the Act, and § 801.11 of this part. | ||||
| 29:29:3.1.1.3.54.1.482.6 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.6 Notice of protection. | DOL-WHD | Every employer subject to EPPA shall post and keep posted on its premises a notice explaining the Act, as prescribed by the Secretary. Such notice must be posted in a prominent and conspicuous place in every establishment of the employer where it can readily be observed by employees and applicants for employment. Copies of such notice may be obtained from local offices of the Wage and Hour Division. | ||||
| 29:29:3.1.1.3.54.1.482.7 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.7 Authority of the Secretary. | DOL-WHD | [56 FR 9064, Mar. 4, 1991, as amended at 82 FR 2230, Jan. 9, 2017] | (a) Pursuant to section 5 of the Act, the Secretary is authorized to: (1) Issue such rules and regulations as may be necessary or appropriate to carry out the Act; (2) Cooperate with regional, State, local, and other agencies, and cooperate with and furnish technical assistance to employers, labor organizations, and employment agencies to aid in effectuating the purposes of the Act; and (3) Make investigations and inspections as necessary or appropriate, through complaint or otherwise, including inspection of such records (and copying or transcription thereof), questioning of such persons, and gathering such information as deemed necessary to determine compliance with the Act or these regulations; and (4) Require the keeping of records necessary or appropriate for the administration of the Act. (b) Section 5 of the Act also grants the Secretary authority to issue subpoenas requiring the attendance and testimony of witnesses or the production of any evidence in connection with any investigation or hearing under the Act. The Secretary may administer oaths, examine witnesses, and receive evidence. For the purpose of any investigation or hearing provided for in the Act, the authority contained in sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49, 50), relating to the attendance of witnesses and the production of books, papers, and documents, shall be available to the Secretary. (c) In case of disobedience to a subpoena, the Secretary may invoke the aid of a United States District Court which is authorized to issue an order requiring the person to obey such subpoena. (d) Any person may report a violation of the Act or these regulations to the Secretary by advising any local office of the Wage and Hour Division, U.S. Department of Labor, or any authorized representative of the Administrator. The office or person receiving such a report shall refer it to the appropriate office of the Wage and Hour Division for the region or area in which the reported violation is alleged to have occurred. (e) T… | |||
| 29:29:3.1.1.3.54.1.482.8 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | A | Subpart A—General | § 801.8 Employment relationship. | DOL-WHD | (a) EPPA broadly defines “employer” to include “any person acting directly or indirectly in the interest of an employer in relationship to an employee or prospective employee” (EPPA section 2(2)). (b) EPPA restrictions apply to State Employment Services, private employment placement agencies, job recruiting firms, and vocational trade schools with respect to persons who may be referred to potential employers. Such entities are not liable for EPPA violations, however, where the referrals are made to employers for whom no reason exists to know that the latter will perform polygraph testing of job applicants or otherwise violate the provisions of EPPA. (c) EPPA prohibitions against discrimination apply to former employees of an employer. For example, an employee may quit rather than take a lie detector test. The employer cannot discriminate or threaten to discriminate in any manner against that person (such as by providing bad references in the future) because of that person's refusal to be tested, or because that person files a complaint, institutes a proceeding, testifies in a proceeding, or exercises any right under EPPA. | ||||
| 29:29:3.1.1.3.54.2.482.1 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | B | Subpart B—Exemptions | § 801.10 Exclusion for public sector employers. | DOL-WHD | (a) Section 7(a) provides an exclusion from the Act's coverage for the United States Government, any State or local government, or any political subdivision of a State or local government, acting in the capacity of an employer. This exclusion from the Act also extends to any interstate governmental agency. (b) The term United States Government means any agency or instrumentality, civilian or military, of the executive, legislative, or judicial branches of the Federal Government, and includes independent agencies, wholly-owned government corporations, and nonappropriated fund instrumentalities. (c) The term any political subdivision of a State or local government means any entity which is either. (1) Created directly by a state or local government, or (2) Administered by individuals who are responsible to public officials ( i.e. , appointed by an elected public official(s) and/or subject to removal procedures for public officials, or to the general electorate. (d) This exclusion from the Act applies only to the Federal, State, and local government entity with respect to its own public employees. Except as provided in sections 7 (b) and (c) of the Act, and § 801.11 of the regulations, this exclusion does not extend to contractors or nongovernmental agents of a government entity, nor does it extend to government entities with respect to employees of a private employer with which the government entity has a contractual or other business relationship. | ||||
| 29:29:3.1.1.3.54.2.482.2 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | B | Subpart B—Exemptions | § 801.11 Exemption for national defense and security. | DOL-WHD | (a) The exemptions allowing for the administration of lie detector tests in the following paragraphs (b) through (e) of this section apply only to the Federal Government; they do not allow private employers/contractors to administer such tests. (b) Section 7(b)(1) of the Act provides that nothing in the Act shall be construed to prohibit the administration of any lie detector test by the Federal Government, in the performance of any counterintelligence function, to any expert, consultant or employee of any contractor under contract with the Department of Defense; or with the Department of Energy, in connection with the atomic energy defense activities of such Department. (c) Section 7(b)(2)(A) provides that nothing in the Act shall be construed to prohibit the administration of any lie detector test by the Federal Government, in the performance of any intelligence or counterintelligence function of the National Security Agency, the Defense Intelligence Agency, or the Central Intelligence Agency, to any individual employed by, assigned to, or detailed to any such agency; or any expert or consultant under contract to any such agency; or any employee of a contractor to such agency; or any individual applying for a position in any such agency; or any individual assigned to a space where sensitive cryptologic information is produced, processed, or stored for any such agency. (d) Section 7(b)(2)(B) provides that nothing in the Act shall be construed to prohibit the administration of any lie detector test by the Federal Government, in the performance of any intelligence or counterintelligence function, to any expert, or consultant (or employee of such expert or consultant) under contract with any Federal Government department, agency, or program whose duties involve access to information that has been classified at the level of top secret or designated as being within a special access program under section 4.2 (a) of Executive Order 12356 (or a successor Executive Order). (e) Section 7(c) provides that nothing in th… | ||||
| 29:29:3.1.1.3.54.2.482.3 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | B | Subpart B—Exemptions | § 801.12 Exemption for employers conducting investigations of economic loss or injury. | DOL-WHD | (a) Section 7(d) of the Act provides a limited exemption from the general prohibition on lie detector use in private employment settings for employers conducting ongoing investigations of economic loss or injury to the employer's business. An employer may request an employee, subject to the conditions set forth in sections 8 and 10 of the Act and §§ 801.20, 801.22, 801.23, 801.24, 801.25, 801.26, and 801.35 of this part, to submit to a polygraph test, but no other type of lie detector test, only if— (1) The test is administered in connection with an ongoing investigation involving economic loss or injury to the employer's business, such as theft, embezzlement, misappropriation or an act of unlawful industrial espionage or sabotage; (2) The employee had access to the property that is the subject of the investigation; (3) The employer has a reasonable suspicion that the employee was involved in the incident or activity under investigation; (4) The employer provides the examinee with a statement, in a language understood by the examinee, prior to the test which fully explains with particularity the specific incident or activity being investigated and the basis for testing particular employees and which contains, at a minimum: (i) An identification with particularity of the specific economic loss or injury to the business of the employer; (ii) A description of the employee's access to the property that is the subject of the investigation; (iii) A description in detail of the basis of the employer's reasonable suspicion that the employee was involved in the incident or activity under investigation; and (iv) Signature of a person (other than a polygraph examiner) authorized to legally bind the employer; and (5) The employer retains a copy of the statement and proof of service described in paragraph (a)(4) of this section for at least 3 years and makes it available for inspection by the Wage and Hour Division on request. (See § 801.30(a).) (b) For the exemption to apply, the condition of an “ongoing investigat… | ||||
| 29:29:3.1.1.3.54.2.482.4 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | B | Subpart B—Exemptions | § 801.13 Exemption of employers authorized to manufacture, distribute, or dispense controlled substances. | DOL-WHD | [56 FR 9064, Mar. 4, 1991; 56 FR 14469, Apr. 10, 1991] | (a) Section 7(f) provides an exemption from the Act's general prohibition regarding the use of polygraph tests for employers authorized to manufacture, distribute, or dispense a controlled substance listed in schedule I, II, III, or IV of section 202 of the Controlled Substances Act (21 U.S.C. 812). This exemption permits the administration of polygraph tests, subject to the conditions set forth in sections 8 and 10 of the Act and §§ 801.21, 801.22, 801.23, 801.24, 801.25, 801.26, and 801.35 of this part, to: (1) A prospective employee who would have direct access to the manufacture, storage, distribution, or sale of any such controlled substance; or (2) A current employee if the following conditions are met: (i) The test is administered in connection with an ongoing investigation of criminal or other misconduct involving, or potentially involving, loss or injury to the manufacture, distribution, or dispensing of any such controlled substance by such employer; and (ii) The employee had access to the person or property that is the subject of the investigation. (b)(1) The terms manufacture, distribute, distribution, dispense, storage, and sale, for the purposes of this exemption, are construed within the meaning of the Controlled Substances Act (21 U.S.C. 812 et seq. ), as administered by the Drug Enforcement Administration (DEA), U.S. Department of Justice. (2) The exemption in section 7(f) of the Act applies only to employers who are authorized by DEA to manufacture, distribute, or dispense a controlled substance. Section 202 of the Controlled Substances Act (21 U.S.C. 812) requires every person who manufactures, distributes, or dispenses any controlled substance to register with the Attorney General ( i.e. , with DEA). Common or contract carriers and warehouses whose possession of the controlled substance is in the usual course of their business or employment are not required to register. Since this exemption is intended to apply only to employees and prospective employees of persons or entities regis… | |||
| 29:29:3.1.1.3.54.2.482.5 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | B | Subpart B—Exemptions | § 801.14 Exemption for employers providing security services. | DOL-WHD | (a) Section 7(e) of the Act provides an exemption from the general prohibition against polygraph tests for certain armored car, security alarm, and security guard employers. Subject to the conditions set forth in sections 8 and 10 of the Act and §§ 801.21, 801.22, 801.23, 801.24, 801.25, 801.26, and 801.35 of this part, section 7(e) permits the use of polygraph tests on certain prospective employees provided that such employers have as their primary business purpose the providing of armored car personnel, personnel engaged in the design, installation, and maintenance of security alarm systems, or other uniformed or plainclothes security personnel; and provided the employer's function includes protection of: (1) Facilities, materials, or operations having a significant impact on the health or safety of any State or political subdivision thereof, or the national security of the United States, such as— (i) Facilities engaged in the production, transmission, or distribution of electric or nuclear power, (ii) Public water supply facilities, (iii) Shipments or storage of radioactive or other toxic waste materials, and (iv) Public transportation; or (2) Currency, negotiable securities, precious commodities or instruments, or proprietary information. (b)(1) Section 7(e) permits the administration of polygraph tests only to prospective employees. However, security service employers may administer polygraph tests to current employees in connection with an ongoing investigation, subject to the conditions of section 7(d) of the Act and § 801.12 of this part. (2) The term prospective employee generally refers to an individual who is not currently employed by and who is being considered for employment by an employer. However, the term “prospective employee” also includes current employees under circumstances similar to those discussed in paragraph (d) of § 801.13 of this part, i.e., if the employee was initially hired for a position which was not within the exemption provided by section 7(e) of the Act, and subsequen… | ||||
| 29:29:3.1.1.3.54.3.482.1 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | C | Subpart C—Restrictions on Polygraph Usage Under Exemptions | § 801.20 Adverse employment action under ongoing investigation exemption. | DOL-WHD | (a) Section 8(a) (1) of the Act provides that the limited exemption in section 7(d) of the Act and § 801.12 of this part for ongoing investigations shall not apply if an employer discharges, disciplines, denies employment or promotion or otherwise discriminates in any manner against a current employee based upon the analysis of a polygraph test chart or the refusal to take a polygraph test, without additional supporting evidence. (b) “Additional supporting evidence”, for purposes of section 8(a) of the Act, includes, but is not limited to, the following: (1)(i) Evidence indicating that the employee had access to the missing or damaged property that is the subject of an ongoing investigation; and (ii) Evidence leading to the employer's reasonable suspicion that the employee was involved in the incident or activity under investigation; or (2) Admissions or statements made by an employee before, during or following a polygraph examination. (c) Analysis of a polygraph test chart or refusal to take a polygraph test may not serve as a basis for adverse employment action, even with additional supporting evidence, unless the employer observes all the requirements of sections 7(d) and 8(b) of the Act, as described in §§ 801.12, 801.22, 801.23, 801.24, and 801.25 of this part. | ||||
| 29:29:3.1.1.3.54.3.482.2 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | C | Subpart C—Restrictions on Polygraph Usage Under Exemptions | § 801.21 Adverse employment action under security service and controlled substance exemptions. | DOL-WHD | (a) Section 8(a) (2) of the Act provides that the security service exemption in section 7(e) of the Act and § 801.14 of this part and the controlled substance exemption in section 7(f) of the Act and § 801.13 of this part shall not apply if an employer discharges, disciplines, denies employment or promotion, or otherwise discriminates in any manner against a current employee or prospective employee based solely on the analysis of a polygraph test chart or the refusal to take a polygraph test. (b) Analysis of a polygraph test chart or refusal to take a polygraph test may serve as one basis for adverse employment actions of the type described in paragraph (a) of this section, provided that the adverse action was also based on another bona fide reason, with supporting evidence therefor. For example, traditional factors such as prior employment experience, education, job performance, etc. may be used as a basis for employment decisions. Employment decisions based on admissions or statements made by an employee or prospective employee before, during or following a polygraph examination may, likewise, serve as a basis for such decisions. (c) Analysis of a polygraph test chart or the refusal to take a polygraph test may not serve as a basis for adverse employment action, even with another legitimate basis for such action, unless the employer observes all the requirements of section 7 (e) or (f) of the Act, as appropriate, and section 8(b) of the Act, as described in §§ 801.13, 801.14, 801.22, 801.23, 801.24, and 801.25 of this part. | ||||
| 29:29:3.1.1.3.54.3.482.3 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | C | Subpart C—Restrictions on Polygraph Usage Under Exemptions | § 801.22 Rights of examinee—general. | DOL-WHD | (a) Pursuant to section 8(b) of the Act, the limited exemption in section 7(d) of the Act for ongoing investigations, and the security service and controlled substance exemptions in 7(e) and (f) of the Act (described in § 801.12, 801.13, and 801.14 of this part) shall not apply unless all of the requirements set forth in this section and §§ 801.23 through 801.25 of this part are met. (b) During all phases of the polygraph testing the person being examined has the following rights: (1) The examinee may terminate the test at any time. (2) The examinee may not be asked any questions in a degrading or unnecessarily intrusive manner. (3) The examinee may not be asked any questions dealing with: (i) Religious beliefs or affiliations; (ii) Beliefs or opinions regarding racial matters; (iii) Political beliefs or affiliations; (iv) Sexual preferences or behavior; or (v) Beliefs, affiliations, opinions, or lawful activities concerning unions or labor organizations. (4) The examinee may not be subjected to a test when there is sufficient written evidence by a physician that the examinee is suffering from any medical or psychological condition or undergoing any treatment that might cause abnormal responses during the actual testing phase. “Sufficient written evidence” shall constitute, at a minimum, a statement by a physician specifically describing the examinee's medical or psychological condition or treatment and the basis for the physician's opinion that the condition or treatment might result in such abnormal responses. (5) An employee or prospective employee who exercises the right to terminate the test, or who for medical reasons with sufficient supporting evidence is not administered the test, shall be subject to adverse employment action only on the same basis as one who refuses to take a polygraph test, as described in §§ 801.20 and 801.21 of this part. (c) Any polygraph examination shall consist of one or more pretest phases, actual testing phases, and post-test phases, which must be conducted in accord… | ||||
| 29:29:3.1.1.3.54.3.482.4 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | C | Subpart C—Restrictions on Polygraph Usage Under Exemptions | § 801.23 Rights of examinee—pretest phase. | DOL-WHD | (a) The pretest phase consists of the questioning and other preparation of the prospective examinee before the actual use of the polygraph instrument. During the initial pretest phase, the examinee must be: (1) Provided with written notice, in a language understood by the examinee, as to when and where the examination will take place and that the examinee has the right to consult with counsel or an employee representative before each phase of the test. Such notice shall be received by the examinee at least forty-eight hours, excluding weekend days and holidays, before the time of the examination, except that a prospective employee may, at the employee's option, give written consent to administration of a test anytime within 48 hours but no earlier than 24 hours after receipt of the written notice. The written notice or proof of service must set forth the time and date of receipt by the employee or prospective employee and be verified by his or her signature. The purpose of this requirement is to provide a sufficient opportunity prior to the examination for the examinee to consult with counsel or an employee representative. Provision shall also be made for a convenient place on the premises where the examination will take place at which the examinee may consult privately with an attorney or an employee representative before each phase of the test. The attorney or representative may be excluded from the room where the examination is administered during the actual testing phase. (2) Informed orally and in writing of the nature and characteristics of the polygraph instrument and examination, including an explanation of the physical operation of the polygraph instrument and the procedure used during the examination. (3) Provided with a written notice prior to the testing phase, in a language understood by the examinee, which shall be read to and signed by the examinee. Use of appendix A to this part, if properly completed, will constitute compliance with the contents of the notice requirement of this paragraph. If … | ||||
| 29:29:3.1.1.3.54.3.482.5 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | C | Subpart C—Restrictions on Polygraph Usage Under Exemptions | § 801.24 Rights of examinee—actual testing phase. | DOL-WHD | (a) The actual testing phase refers to that time during which the examiner administers the examination by using a polygraph instrument with respect to the examinee and then analyzes the charts derived from the test. Throughout the actual testing phase, the examiner shall not ask any question that was not presented in writing for review prior to the testing phase. An examiner may, however, recess the testing phase and return to the pre-test phase to review additional relevant questions with the examinee. In the case of an ongoing investigation, the examiner shall ensure that all relevant questions (as distinguished from technical baseline questions) pertain to the investigation. (b) No testing period subject to the provisions of the Act shall be less than ninety minutes in length. Such “test period” begins at the time that the examiner begins informing the examinee of the nature and characteristics of the examination and the instruments involved, as prescribed in section 8(b) (2)(B) of the Act and § 801.23 (a)(2) of this part, and ends when the examiner completes the review of the test results with the examinee as provided in § 801.25 of this part. The ninety-minute minimum duration shall not apply if the examinee voluntarily acts to terminate the test before the completion thereof, in which event the examiner may not render an opinion regarding the employee's truthfulness. | ||||
| 29:29:3.1.1.3.54.3.482.6 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | C | Subpart C—Restrictions on Polygraph Usage Under Exemptions | § 801.25 Rights of examinee—post-test phase. | DOL-WHD | (a) The post-test phase refers to any questioning or other communication with the examinee following the use of the polygraph instrument, including review of the results of the test with the examinee. Before any adverse employment action, the employer must: (1) Further interview the examinee on the basis of the test results; and (2) Give to the examinee a written copy of any opinions or conclusions rendered in response to the test, as well as the questions asked during the test, with the corresponding charted responses. The term “corresponding charted responses” refers to copies of the entire examination charts recording the employee's physiological responses, and not just the examiner's written report which describes the examinee's responses to the questions as “charted” by the instrument. | ||||
| 29:29:3.1.1.3.54.3.482.7 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | C | Subpart C—Restrictions on Polygraph Usage Under Exemptions | § 801.26 Qualifications of and requirements for examiners. | DOL-WHD | (a) Section 8 (b) and (c) of the Act provides that the limited exemption in section 7(d) of the Act for ongoing investigations, and the security service and controlled substances exemptions in section 7 (e) and (f) of the Act, shall not apply unless the person conducting the polygraph examination meets specified qualifications and requirements. (b) An examiner must meet the following qualifications: (1) Have a valid current license, if required by the State in which the test is to be conducted; and (2) Carry a minimum bond of $50,000 provided by a surety incorporated under the laws of the United States or of any State, which may under those laws guarantee the fidelity of persons holding positions of trust, or carry an equivalent amount of professional liability coverage. (c) An examiner must also, with respect to examinees identified by the employer pursuant to § 801.30(c) of this part: (1) Observe all rights of examinees, as set out in §§ 801.22, 801.23, 801.24, and 801.25 of this part; (2) Administer no more than five polygraph examinations in any one calendar day on which a test or tests subject to the provisions of EPPA are administered, not counting those instances where an examinee voluntarily terminates an examination prior to the actual testing phase; (3) Administer no polygraph examination subject to the provisions of the Act which is less than ninety minutes in duration, as described in § 801.24(b) of this part; (4) Render any opinion or conclusion regarding truthfulness or deception in writing. Such opinion or conclusion must be based solely on the polygraph test results. The written report shall not contain any information other than admissions, information, case facts, and interpretation of the charts relevant to the stated purpose of the polygraph test and shall not include any recommendation concerning the employment of the examinee; and (5) Maintain all opinions, reports, charts, written questions, lists, and other records relating to the test, including statements signed by examinees adv… | ||||
| 29:29:3.1.1.3.54.4.482.1 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | D | Subpart D—Recordkeeping and Disclosure Requirements | § 801.30 Records to be preserved for 3 years. | DOL-WHD | [56 FR 9064, Mar. 4, 1991, as amended at 82 FR 2230, Jan. 9, 2017] | (a) The following records shall be kept for a minimum period of three years from the date the polygraph examination is conducted (or from the date the examination is requested if no examination is conducted): (1) Each employer who requests an employee to submit to a polygraph examination in connection with an ongoing investigation involving economic loss or injury shall retain a copy of the statement that sets forth the specific incident or activity under investigation and the basis for testing that particular employee, as required by section 7(d)(4) of the Act and described in § 801.12 (a)(4) of this part. (2) Each employer who administers a polygraph examination under the exemption provided by section 7(f) of the Act (described in § 801.13 of this part) in connection with an ongoing investigation of criminal or other misconduct involving, or potentially involving, loss or injury to the manufacture, distribution or dispensing of a controlled substance, shall retain records specifically identifying the loss or injury in question and the nature of the employee's access to the person or property that is the subject of the investigation. (3) Each employer who requests an employee or prospective employee to submit to a polygraph examination pursuant to any of the exemptions under section 7(d), (e) or (f) of the Act (described in §§ 801.12, 801.13, and 801.14) shall retain a copy of the written statement that sets forth the time and place of the examination and the examinee's right to consult with counsel, as required by section 8 (b)(2)(A) of the Act and described in § 801.23(a)(1) of this part. (4) Each employer shall identify in writing to the examiner persons to be examined pursuant to any of the exemptions under section 7 (d), (e) or (f) of the Act (described in §§ 801.12, 801.13, and 801.14 of this part), and shall retain a copy of such notice. (5) Each employer who retains an examiner to administer examinations pursuant to any of the exemptions under section 7 (d), (e) or (f) of the Act (described in §§ 80… | |||
| 29:29:3.1.1.3.54.4.482.2 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | D | Subpart D—Recordkeeping and Disclosure Requirements | § 801.35 Disclosure of test information. | DOL-WHD | Section 9 of the Act prohibits the unauthorized disclosure of any information obtained during a polygraph test by any person, other than the examinee, directly or indirectly, except as follows: (a) A polygraph examiner or an employer (other than an employer exempt under section 7 (a), (b), or (c) of the Act (described in §§ 801.10 and 801.11 of this part)) may disclose information acquired from a polygraph test only to: (1) The examinee or an individual specifically designated in writing by the examinee to receive such information; (2) The employer that requested the polygraph test pursuant to the provisions of this Act (including management personnel of the employer where the disclosure is relevant to the carrying out of their job responsibilities); (3) Any court, governmental agency, arbitrator, or mediator pursuant to an order from a court of competent jurisdiction requiring the production of such information; (4) The Secretary of Labor, or the Secretary's representative, when specifically designated in writing by the examinee to receive such information. (b) An employer may disclose information from the polygraph test at any time to an appropriate governmental agency without the need of a court order where, and only insofar as, the information disclosed is an admission of criminal conduct. (c) A polygraph examiner may disclose test charts, without identifying information (but not other examination materials and records), to another examiner(s) for examination and analysis, provided that such disclosure is for the sole purpose of consultation and review of the initial examiner's opinion concerning the indications of truthfulness or deception. Such action would not constitute disclosure under this part provided that the other examiner has no direct or indirect interest in the matter. | ||||
| 29:29:3.1.1.3.54.5.482.1 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | E | Subpart E—Enforcement | § 801.40 General. | DOL-WHD | (a) Whenever the Secretary believes that the provisions of the Act or these regulations have been violated, such action shall be taken and such proceedings instituted as deemed appropriate, including the following: (1) Petitioning any appropriate District Court of the United States for temporary or permanent injunctive relief to restrain violation of the provisions of the Act or this part by any person, and to require compliance with the Act and this part, including such legal or equitable relief incident thereto as may be appropriate, including, but not limited to, employment, reinstatement, promotion, and the payment of lost wages and benefits; (2) Assessing a civil penalty against any employer who violates any provision of the Act or this part in an amount of not more than $10,000 for each violation, in accordance with regulations set forth in this part; or (3) Referring any unpaid civil money penalty which has become a final and unappealable order of the Secretary or a final judgment of a court in favor of the Secretary to the Attorney General for recovery. (b)(1) Any employer who violates this Act shall be liable to the employee or prospective employee affected by such violation for such legal or equitable relief as may be appropriate, including, but not limited to, employment, reinstatement, promotion, and the payment of lost wages and benefits. (2) An action under this subsection may be maintained against the employer in any Federal or State court of competent jurisdiction by an employee or prospective employee for or on behalf of such employee, prospective employee and others similarly situated. Such action must be commenced within a period not to exceed 3 years after the date of the alleged violation. The court, in its discretion, may allow reasonable costs (including attorney's fees) to the prevailing party. (c) The taking of any one of the actions referred to in paragraph (a) of this section shall not be a bar to the concurrent taking of any other appropriate action. | ||||
| 29:29:3.1.1.3.54.5.482.2 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | E | Subpart E—Enforcement | § 801.41 Representation of the Secretary. | DOL-WHD | (a) Except as provided in section 518(a) of title 28, U.S. Code, relating to litigation before the Supreme Court, the Solicitor of Labor may appear for and represent the Secretary in any civil litigation brought under section 6 of the Act, as described in § 801.40 of this part. (b) The Solicitor of Labor, through authorized representatives, shall represent the Administrator in all administrative hearings under the provisions of section 6 of the Act and this part. | ||||
| 29:29:3.1.1.3.54.5.482.3 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | E | Subpart E—Enforcement | § 801.42 Civil money penalties—assessment. | DOL-WHD | [56 FR 9064, Mar. 4, 1991; 56 FR 14469, Apr. 10, 1991, as amended at 81 FR 43452, July 1, 2016; 82 FR 5382, Jan. 18, 2017; 83 FR 13, Jan. 2, 2018; 84 FR 219, Jan. 23, 2019; 85 FR 2298, Jan. 15, 2020; 86 FR 2969, Jan. 14, 2021; 87 FR 2335, Jan. 14, 2022; 88 FR 2217, Jan. 13, 2023; 89 FR 1817, Jan. 11, 2024; 90 FR 1861, Jan. 10, 2025] | (a) A civil money penalty in an amount not to exceed $26,262 for any violation may be assessed against any employer for: (1) Requiring, requesting, suggesting or causing an employee or prospective employee to take a lie detector test or using, accepting, referring to or inquiring about the results of any lie detector test of any employee or prospective employee, other than as provided in the Act or this part; (2) Taking an adverse action or discriminating in any manner against any employee or prospective employee on the basis of the employee's or prospective employee's refusal to take a lie detector test, other than as provided in the Act or this part; (3) Discriminating or retaliating against an employee or prospective employee for the exercise of any rights under the Act; (4) Disclosing information obtained during a polygraph test, except as authorized by the Act or this part; (5) Failing to maintain the records required by the Act or this part; (6) Resisting, opposing, impeding, intimidating, or interfering with an official of the Department of Labor during the performance of an investigation, inspection, or other law enforcement function under the Act or this part; or (7) Violating any other provision of the Act or this part. (b) In determining the amount of penalty to be assessed for any violation of the Act or this part, the Administrator will consider the previous record of the employer in terms of compliance with the Act and regulations, the gravity of the violations, and other pertinent factors. The matters which may be considered include, but are not limited to, the following: (1) Previous history of investigation(s) or violation(s) of the Act or this part; (2) The number of employees or prospective employees affected by the violation or violations; (3) The seriousness of the violation or violations; (4) Efforts made in good faith to comply with the provisions of the Act and this part; (5) If the violations resulted from the actions or inactions of an examiner, the steps taken by the employ… | |||
| 29:29:3.1.1.3.54.5.482.4 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | E | Subpart E—Enforcement | § 801.43 Civil money penalties—payment and collection. | DOL-WHD | [84 FR 59931, Nov. 7, 2019] | Where the assessment is directed in a final order of the Department, the amount of the penalty is immediately due and payable to the United States Department of Labor. The person assessed such penalty shall remit promptly the amount thereof, as finally determined, to the Secretary. Payment shall be made by certified check or money order made payable and delivered or mailed according to the instructions provided by the Department; through the electronic pay portal located at www.pay.gov or any successor system; or by any additional payment method deemed acceptable by the Department. | |||
| 29:29:3.1.1.3.54.6.482.1 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | F | Subpart F—Administrative Proceedings | § 801.50 Applicability of procedures and rules. | DOL-WHD | The procedures and rules contained in this subpart prescribe the administrative process for assessment of civil money penalties for violations of the Act or of these regulations. | ||||
| 29:29:3.1.1.3.54.6.483.2 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | F | Subpart F—Administrative Proceedings | § 801.51 Written notice of determination required. | DOL-WHD | Whenever the Administrator determines to assess a civil money penalty for a violation of the Act or this part, the person against whom such penalty is assessed shall be notified in writing of such determination. Such notice shall be served in person or by certified mail. | ||||
| 29:29:3.1.1.3.54.6.483.3 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | F | Subpart F—Administrative Proceedings | § 801.52 Contents of notice. | DOL-WHD | The notice required by § 801.51 of this part shall: (a) Set forth the determination of the Administrator and the reason or reasons therefor; (b) Set forth a description of each violation and the amount assessed for each violation; (c) Set forth the right to request a hearing on such determination; (d) Inform any affected person or persons that in the absence of a timely request for a hearing, the determination of the Administrator shall become final and unappealable; and (e) Set forth the time and method for requesting a hearing, and the procedures relating thereto, as set forth in § 801.53 of this part. | ||||
| 29:29:3.1.1.3.54.6.483.4 | 29 | Labor | V | C | 801 | PART 801—APPLICATION OF THE EMPLOYEE POLYGRAPH PROTECTION ACT OF 1988 | F | Subpart F—Administrative Proceedings | § 801.53 Request for hearing. | DOL-WHD | [56 FR 9064, Mar. 4, 1991; 56 FR 14469, Apr. 10, 1991, as amended at 60 FR 46531, Sept. 7, 1995] | (a) Any person desiring to request an administrative hearing on a civil money penalty assessment pursuant to this part shall make such request in writing to the official who issued the determination at the Wage and Hour Division address appearing on the determination notice, no later than 30 days after the date of receipt of the notice referred to in § 801.51 of this part. (b) The request for hearing must be received by the Administrator at the address set forth in the notice issued pursuant to § 801.52 of this part, within the time set forth in paragraph (a) of this section. For the affected person's protection, if the request is by mail, it should be by certified mail, return receipt requested. (c) No particular form is prescribed for any request for hearing permitted by this subpart. However, any such request shall: (1) Be typewritten or legibly written; (2) Specify the issue or issues stated in the notice of determination giving rise to such request; (3) State the specific reason or reasons why the person requesting the hearing believes such determination is in error; (4) Be signed by the person making the request or by an authorized representative of such person; and (5) Include the address at which such person or authorized representative desires to receive further communications relating thereto. |
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title_name TEXT,
chapter TEXT,
subchapter TEXT,
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