21 U.S.C. § 360ii — Program of control

Page 404 TITLE 21—FOOD AND DRUGS § 360hh Health Service Act [42 U.S.C. 201 et seq.] prior to December 13, 2016, with respect to the per- missibility of a sponsor referencing informa- tion contained in another application sub- mitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]. (June 25, 1938, ch. 675, § 529A, as added Pub. L. 114–255, div. A, title III, § 3012, Dec. 13, 2016, 130 Stat. 1091.) Editorial Notes REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (d)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classi- fication of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables. PART C—ELECTRONIC PRODUCT RADIATION CONTROL Editorial Notes CODIFICATION This part was classified to subpart 3 (§ 263c et seq.) of part F of subchapter II of chapter 6A of Title 42, The Public Health and Welfare, prior to its renumbering by Pub. L. 101–629, § 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779. § 360hh. Definitions As used in this part— (1) the term ‘‘electronic product radiation’’ means— (A) any ionizing or non-ionizing electro- magnetic or particulate radiation, or (B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product; (2) the term ‘‘electronic product’’ means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assem- bled article which is intended for use as a com- ponent, part, or accessory of a product de- scribed in clause (A) and which when in oper- ation emits (or in the absence of effective shielding or other controls would emit) such radiation; (3) the term ‘‘manufacturer’’ means any per- son engaged in the business of manufacturing, assembling, or importing of electronic prod- ucts; (4) the term ‘‘commerce’’ means (A) com- merce between any place in any State and any place outside thereof; and (B) commerce whol- ly within the District of Columbia; and (5) the term ‘‘State’’ includes the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Is- lands, Guam, and American Samoa. (June 25, 1938, ch. 675, § 531, formerly act July 1, 1944, ch. 373, title III, § 531, formerly § 355, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1174; amended Pub. L. 94–484, title IX, § 905(b)(1), Oct. 12, 1976, 90 Stat. 2325; renumbered § 531 and amended Pub. L. 101–629, § 19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) Editorial Notes CODIFICATION Section was classified to section 263c of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629. AMENDMENTS 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263c of Title 42, The Public Health and Welfare, as this sec- tion. 1990—Pub. L. 101–629, § 19(a)(1)(B), substituted ‘‘this part’’ for ‘‘this subpart’’ in introductory provisions. 1976—Par. (5). Pub. L. 94–484 defined ‘‘State’’ to in- clude Northern Mariana Islands. Statutory Notes and Related Subsidiaries SHORT TITLE For short title of Pub. L. 90–602, which enacted provi- sions now comprising this part (§§ 360hh to 360ss), as the ‘‘Radiation Control for Health and Safety Act of 1968’’, see section 1 of Pub. L. 90–602, set out as a Short Title of 1968 Amendments note under section 301 of this title. TRANSFER OF SUBPART; CONSTRUCTION Pub. L. 101–629, § 19(c), Nov. 28, 1990, 104 Stat. 4530, provided that: ‘‘The transfer of subpart 3 of part F of title III of the Public Health Service Act [42 U.S.C. 263b et seq.] to the Federal Food, Drug, and Cosmetic Act [this chapter] does not change the application of the re- quirements of such subpart and such Act to electronic products which were in effect on the date of the enact- ment of this Act [Nov. 28, 1990].’’ DEFINITION OF ‘‘SECRETARY’’ AND ‘‘DEPARTMENT’’ Pub. L. 90–602, § 3, Oct. 18, 1968, 82 Stat. 1186, as amended by Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: ‘‘As used in the amendments made by section 2 of this Act [enacting provisions now comprising sections 360hh to 360ss of this title], except when otherwise specified, the term ‘Secretary’ means the Secretary of Health and Human Services, and the term ‘Department’ means the Department of Health and Human Services.’’ NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Pub. L. 90–602, § 4, Oct. 18, 1968, 82 Stat. 1187, provided that: ‘‘The amendments made by section 2 of this Act [enacting provisions now comprising sections 360hh to 360ss of this title] shall not be construed as superseding or limiting the functions, under any other provision of law, of any officer or agency of the United States.’’ § 360ii. Program of control (a) Establishment The Secretary shall establish and carry out an electronic product radiation control program de- signed to protect the public health and safety from electronic product radiation. As a part of such program, he shall— (1) pursuant to section 360kk of this title, de- velop and administer performance standards for electronic products; (2) plan, conduct, coordinate, and support re- search, development, training, and operational activities to minimize the emissions of and Page 405 TITLE 21—FOOD AND DRUGS § 360jj the exposure of people to, unnecessary elec- tronic product radiation; (3) maintain liaison with and receive infor- mation from other Federal and State depart- ments and agencies with related interests, professional organizations, industry, industry and labor associations, and other organiza- tions on present and future potential elec- tronic product radiation; (4) study and evaluate emissions of, and con- ditions of exposure to, electronic product radi- ation and intense magnetic fields; (5) develop, test, and evaluate the effective- ness of procedures and techniques for mini- mizing exposure to electronic product radi- ation; and (6) consult and maintain liaison with the Secretary of Commerce, the Secretary of De- fense, the Secretary of Labor, the Atomic En- ergy Commission, and other appropriate Fed- eral departments and agencies on (A) tech- niques, equipment, and programs for testing and evaluating electronic product radiation, and (B) the development of performance stand- ards pursuant to section 360kk of this title to control such radiation emissions. (b) Powers of Secretary In carrying out the purposes of subsection (a), the Secretary is authorized to— (1)(A) collect and make available, through publications and other appropriate means, the results of, and other information concerning, research and studies relating to the nature and extent of the hazards and control of elec- tronic product radiation; and (B) make such recommendations relating to such hazards and control as he considers appropriate; (2) make grants to public and private agen- cies, organizations, and institutions, and to in- dividuals for the purposes stated in paragraphs (2), (4), and (5) of subsection (a) of this section; (3) contract with public or private agencies, institutions, and organizations, and with indi- viduals, without regard to section 3324 of title 31 and section 6101 of title 41; and (4) procure (by negotiation or otherwise) electronic products for research and testing purposes, and sell or otherwise dispose of such products. (c) Record keeping (1) Each recipient of assistance under this part pursuant to grants or contracts entered into under other than competitive bidding proce- dures shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such re- cipient of the proceeds of such assistance, the total cost of the project or undertaking in con- nection with which such assistance is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit. (2) The Secretary and the Comptroller General of the United States, or any of their duly au- thorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the re- cipients that are pertinent to the grants or con- tracts entered into under this part under other than competitive bidding procedures. (June 25, 1938, ch. 675, § 532, formerly act July 1, 1944, ch. 373, title III, § 532, formerly § 356, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered § 532 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(A), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) Editorial Notes CODIFICATION In subsec. (b)(3), ‘‘section 6101 of title 41’’ substituted for ‘‘section 3709 of the Revised Statutes of the United States (41 U.S.C. 5)’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts. Section was classified to section 263d of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629. AMENDMENTS 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263d of Title 42, The Public Health and Welfare, as this section. 1990—Subsec. (a)(1), (6). Pub. L. 101–629, § 19(a)(2)(A)(i), substituted ‘‘section 360kk’’ for ‘‘section 263f’’. Subsec. (b)(3). Pub. L. 101–629, § 19(a)(2)(A)(ii), sub- stituted reference to section 3324 of title 31 for ref- erence to section 3648 of the Revised Statutes (31 U.S.C. 529). Subsec. (c)(1), (2). Pub. L. 101–629, § 19(a)(1)(B), sub- stituted ‘‘this part’’ for ‘‘this subpart’’. Statutory Notes and Related Subsidiaries TRANSFER OF FUNCTIONS Atomic Energy Commission abolished and functions transferred by sections 5814 and 5841 of Title 42, The Public Health and Welfare. See also Transfer of Func- tions notes set out under those sections. NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion of law or any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title. § 360jj. Studies by Secretary (a) Report to Congress The Secretary shall conduct the following studies, and shall make a report or reports of the results of such studies to the Congress on or before January 1, 1970, and from time to time thereafter as he may find necessary, together with such recommendations for legislation as he may deem appropriate: (1) A study of present State and Federal con- trol of health hazards from electronic product radiation and other types of ionizing radiation, which study shall include, but not be limited to— (A) control of health hazards from radio- active materials other than materials regu- lated under the Atomic Energy Act of 1954 [42 U.S.C. 2011 et seq.]; (B) any gaps and inconsistencies in present controls; (C) the need for controlling the sale of cer- tain used electronic products, particularly an- tiquated X-ray equipment, without upgrading such products to meet the standards for new products or separate standards for used prod- ucts;