42 USC 284m-1 - Pediatric Advisory Committee

United States Code

USC most recently checked for updates: Mar 23, 2025

§ 284m. Program for pediatric studies of drugs

§ 284n. Certain demonstration projects

U.S. Code
Notes

§ 284m–1.

Pediatric Advisory Committee

(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.)

cite as: 42 USC 284m-1