republic-os/legal/us/code/title-42/chapter-6a/section-284m-1.md

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LegalText	42 U.S.C. § 284m–1	Pediatric Advisory Committee	us	united_states_code	code_section	42	THE PUBLIC HEALTH AND WELFARE	6A	PUBLIC HEALTH SERVICE	284m–1	42 U.S.C. § 284m–1	current	119-100	2026-06-26	official	https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc42@119-100.zip	/us/usc/t42/s284m–1	data/legal/raw/us/code/title-42/usc42.xml	e62e78274733d5d662b5a469c5b695275ca174c0f4794c8f4adf41957293b43e	644321055a08eb1f260a6a3e31ac157fa024756abf612a9fd6857e7e400cf24e	3e25f2c980f600e52161da88b979187fc95f64329a5ccff6f511750d7f8c16a5	2026-07-04	official	legal us-code

42 U.S.C. § 284m–1 - Pediatric Advisory Committee

Text

(a) In general 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) Purpose (1) In general 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) Matters included The matters referred to in paragraph (1) include—

(A) pediatric research conducted under sections 262, 284m, and 290b of this title and sections 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) Composition 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) Continuation of Operation of Committee Notwithstanding section 1013 of title 5, the advisory committee shall continue to operate to carry out the advisory committee’s responsibilities under sections 355a, 355c, and 360j(m) of title 21.

(Pub. L. 107–109, § 14, Jan. 4, 2002, 115 Stat. 1419, as amended by Pub. L. 108–155, § 3(b)(2), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 110–85, title III, § 306(b), title V, § 502(d), Sept. 27, 2007, 121 Stat. 865, 889; Pub. L. 112–144, title V, § 507(a), July 9, 2012, 126 Stat. 1045; Pub. L. 113–5, title III, § 307(c), Mar. 13, 2013, 127 Stat. 192; Pub. L. 117–286, § 4(a)(233), Dec. 27, 2022, 136 Stat. 4331.)

Notes

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.

Amendments2022—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 sections 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.