Source: https://uscode.house.gov/view.xhtml?req=(title:21%20section:393%20edition:prelim)
Timestamp: 2020-01-19 18:51:45
Document Index: 337536783

Matched Legal Cases: ['§ 393', '§1003', '§903', '§503', '§2631', '§406', '§1003', '§101', '§201', '§103', '§406', '§503', '§102', '§129', '§1124', '§1125', '§413', '§205', '§502']

[USC02] 21 USC 393: Food and Drug Administration
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21 USC 393: Food and Drug Administration Text contains those laws in effect on January 18, 2020
The Secretary, through the Commissioner, shall be responsible for executing this chapter and for-
The plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to-
The Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that-
Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding-
(1) information about food facilities including-
(2) information about food imports including-
(3) information on the foreign offices of the Food and Drug Administration including-
(June 25, 1938, ch. 675, §1003, formerly §903, as added Pub. L. 100–607, title V, §503(a), Nov. 4, 1988, 102 Stat. 3121 ; amended Pub. L. 100–690, title II, §2631, Nov. 18, 1988, 102 Stat. 4244 ; Pub. L. 105–115, title IV, §§406, 414, Nov. 21, 1997, 111 Stat. 2369 , 2377; renumbered §1003 and amended Pub. L. 111–31, div. A, title I, §§101(b)(2), 103(m), June 22, 2009, 123 Stat. 1784 , 1838; Pub. L. 111–353, title II, §201(b), Jan. 4, 2011, 124 Stat. 3925 .)
2011-Subsecs. (h), (i). Pub. L. 111–353 added subsecs. (h) and (i).
2009-Subsec. (d)(2)(C). Pub. L. 111–31, §103(m), struck out "and" after "cosmetics," and inserted ", and tobacco products" after "devices".
1997-Subsec. (b). Pub. L. 105–115, §406(a)(2), added subsec. (b). Former subsec. (b) redesignated (d).
1988-Subsec. (b)(2). Pub. L. 100–690 substituted "shall be responsible for executing this chapter and" for "shall be responsible".
Pub. L. 100–607, title V, §503(c), Nov. 4, 1988, 102 Stat. 3121 , provided that:
Pub. L. 108–282, title I, §102(b)(7), Aug. 2, 2004, 118 Stat. 905 , provided that: "The Secretary of Health and Human Services shall establish within the Center for Veterinary Medicine (of the Food and Drug Administration), an Office of Minor Use and Minor Species Animal Drug Development that reports directly to the Director of the Center for Veterinary Medicine. This office shall be responsible for overseeing the development and legal marketing of new animal drugs for minor uses and minor species. There is authorized to be appropriated to carry out this subsection $1,200,000 for fiscal year 2004 and such sums as may be necessary for each fiscal year thereafter."
Pub. L. 105–115, title I, §129, Nov. 21, 1997, 111 Stat. 2331 , provided that: "Not later than 18 months after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn."
Pub. L. 112–144, title XI, §1124, July 9, 2012, 126 Stat. 1114 , provided that:
"(a) In General.-Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall develop a strategy and implementation plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decisionmaking.
"(b) Requirements.-The strategy and implementation plan developed under subsection (a) shall be consistent with the user fee performance goals in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on January 13, 2012, and the Medical Device User Fee Agreement commitment letter transmitted by the Secretary to Congress on April 20, 2012, and shall-
"(5) set forth how the Food and Drug Administration will ensure that advances in regulatory science for medical products are adopted, as appropriate, on an ongoing basis and in an [sic] manner integrated across centers, divisions, and branches of the Food and Drug Administration, including by senior managers and reviewers, including through the-
"(c) Performance Reports.-The annual performance reports submitted to Congress under sections 736B(a) [21 U.S.C. 379h–2(a)] (as amended by section 104 of this Act), 738A(a) [21 U.S.C. 379j–1(a)] (as amended by section 204 of this Act), 744C(a) [21 U.S.C. 379j–43(a)] (as added by section 303 of this Act), and 744I(a) [21 U.S.C. 379j–53(a)] (as added by section 403 of this Act) of the Federal Food, Drug, and Cosmetic Act for each of fiscal years 2014 and 2016, shall include a report from the Secretary on the progress made with respect to-
"(d) Medical Product.-In this section, the term 'medical product' means a drug, as defined in subsection (g) of section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)]."
Pub. L. 112–144, title XI, §1125, July 9, 2012, 126 Stat. 1115 , provided that:
"(a) HHS Report.-Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall-
"(1) report to Congress on-
"(2) develop-
"(b) GAO Report.-Not later than January 1, 2016, the Comptroller General of the United States shall issue a report regarding the strategic plan described in subsection (a)(1)(A) and related actions carried out by the Food and Drug Administration. Such report shall assess the progress the Food and Drug Administration has made on-
Pub. L. 105–115, title IV, §413, Nov. 21, 1997, 111 Stat. 2376 , provided that:
"(a) List and Analysis.-The Secretary of Health and Human Services shall, acting through the Food and Drug Administration-
"(b) Study.-The Secretary of Health and Human Services, acting through the Food and Drug Administration, shall conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study shall include data from other studies that have been made of such use.
"(c) Study of Mercury Sales.-
"(1) Study.-The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate-
"(2) Regulations.-If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or inhalation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious ceremonies."
Pub. L. 102–571, title II, §205, Oct. 29, 1992, 106 Stat. 4502 , directed Comptroller General to conduct a study of management of activities of the Food and Drug Administration that are related to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances and submit an interim report to Congress, not later than 6 months after Oct. 29, 1992, with a final report to be submitted not later than 12 months after Oct. 29, 1992.
Pub. L. 100–607, title V, §502, Nov. 4, 1988, 102 Stat. 3120 , provided that: "Congress finds that-