21 U.S.C. § 360hh — Definitions

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