§284m–1 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Secretary of Health and Human Services must set up and use an advisory committee about medicines, biological products, and medical devices for children. The committee gives advice to the Secretary through the FDA Commissioner. It looks at pediatric research under certain public health and FDA laws, helps pick research priorities and needed tests or treatments, reviews the ethics and design of children’s clinical trials, and advises on developing medical countermeasures for kids. The committee must include people from pediatric health groups, pediatric researchers, patient and family organizations, and other experts the Secretary chooses. It must keep working to carry out duties under sections 355a, 355c, and 360j(m) of Title 21.

Title 42, §284m–1

The Public Health and Welfare — Source: USLM XML via OLRC

(a)The Secretary of Health and Human Services shall, under section 217a of this title or other appropriate authority, convene and consult an advisory committee on pediatric therapeutics (including drugs and biological products) and medical devices (referred to in this section as the “advisory committee”).

(b)(1)The advisory committee shall advise and make recommendations to the Secretary, through the Commissioner of Food and Drugs, on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices.

(2)The matters referred to in paragraph (1) include—

(A)pediatric research conducted under section 262, 284m, and 290b of this title and section 351, 352, 355, 355a, 355c, 360(k), 360e, and 360j(m) of title 21;

(B)identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;

(C)the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices; and

(D)the development of countermeasures (as defined in section 360bbb–4(a) of title 21) for pediatric populations.

(c)The advisory committee shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the Secretary.

(d)Notwithstanding section 1013 of title 5, the advisory committee shall continue to operate to carry out the advisory committee’s responsibilities under section 355a, 355c, and 360j(m) of title 21.

Notes & Related Subsidiaries

Editorial Notes

Codification Section was formerly set out as a note under section 284m of this title. Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Public Health Service Act which comprises this chapter.

Amendments

2022—Subsec. (d). Pub. L. 117–286 substituted “section 1013 of title 5,” for “section 14 of the Federal Advisory Committee Act,”. 2013—Subsec. (b)(2)(D). Pub. L. 113–5 added subpar. (D). 2012—Subsec. (d). Pub. L. 112–144 substituted “to carry out the advisory committee’s responsibilities under section 355a, 355c, and 360j(m) of title 21” for “during the five-year period beginning on September 27, 2007”. 2007—Subsec. (a). Pub. L. 110–85, § 306(b)(1), inserted “(including drugs and biological products) and medical devices” after “therapeutics”. Subsec. (b)(1). Pub. L. 110–85, § 306(b)(2)(A), inserted “(including drugs and biological products) and medical devices” after “therapeutics”. Subsec. (b)(2)(A). Pub. L. 110–85, § 306(b)(2)(B)(i), substituted “355c, 360(k), 360e, and 360j(m)” for “and 355c”. Subsec. (b)(2)(B). Pub. L. 110–85, § 306(b)(2)(B)(ii), added subpar. (B) and struck out former subpar. (B) which read as follows: “identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions; and”. Subsec. (b)(2)(C). Pub. L. 110–85, § 306(b)(2)(B)(iii), inserted “(including drugs and biological products) and medical devices” after “therapeutics”. Subsec. (d). Pub. L. 110–85, § 502(d), added subsec. (d). 2003—Pub. L. 108–155, § 3(b)(2)(A), struck out “Pharmacology” after “Pediatric” in section catchline. Subsec. (a). Pub. L. 108–155, § 3(b)(2)(D), substituted “therapeutics” for “pharmacology”. Pub. L. 108–155, § 3(b)(2)(B), inserted “or other appropriate authority” after “217a of this title”. Subsec. (b)(1). Pub. L. 108–155, § 3(b)(2)(D), substituted “therapeutics” for “pharmacology”. Pub. L. 108–155, § 3(b)(2)(C)(i), struck out “and in consultation with the Director of the National Institutes of Health” after “Commissioner of Food and Drugs”. Subsec. (b)(2). Pub. L. 108–155, § 3(b)(2)(C)(ii), substituted “355a, and 355c” for “and 355a”. Subsec. (b)(2)(B), (C). Pub. L. 108–155, § 3(b)(2)(D), substituted “therapeutics” for “pharmacology”.

Statutory Notes and Related Subsidiaries

Effective Date

of 2003 AmendmentAmendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an

Effective Date

note under section 355c of Title 21, Food and Drugs.

§284m–1 Pediatric Advisory Committee

Summary

Title 42, §284m–1

Notes & Related Subsidiaries

Editorial Notes

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

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