---
kind: "section"
citation: "42 U.S.C. § 284m–1"
title: "42"
title_heading: "The Public Health and Welfare"
number: "284m–1"
heading: "Pediatric Advisory Committee"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/284m-1"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter III — National Research Institutes"
  - "Part B — General Provisions Respecting National Research Institutes"
---

# §284m–1. Pediatric Advisory Committee

- (a) **In general—** The [Secretary](/usc/42/201.md?p=c) of Health and Human [Services](/usc/42/201.md?p=a) shall, under [section 217a of this title](/usc/42/217a.md) or other appropriate authority, convene and consult an [advisory committee](/usc/42/17061.md?p=2) on pediatric therapeutics (including [drugs](/usc/42/11851.md?p=4) and biological products) and medical devices (referred to in this section as the “[advisory committee](/usc/42/17061.md?p=2)”).
- (b) **Purpose—**
  - (1) **In general—** The [advisory committee](/usc/42/17061.md?p=2) shall advise and make recommendations to the [Secretary](/usc/42/201.md?p=c), through the Commissioner of Food and [Drugs](/usc/42/11851.md?p=4), on matters relating to pediatric therapeutics (including [drugs](/usc/42/11851.md?p=4) and biological products) and medical devices.
  - (2) **Matters included—** The matters referred to in [paragraph (1)](#b-1) include—
    - (A) pediatric research conducted under sections [262](/usc/42/262.md), [284m](/usc/42/284m.md), and [290b](/usc/42/290b.md) of this title and sections [351](/usc/21/351.md), [352](/usc/21/352.md), [355](/usc/21/355.md), [355a](/usc/21/355a.md), [355c](/usc/21/355c.md), [360(k)](/usc/21/360.md?p=k), [360e](/usc/21/360e.md), and [360j(m)](/usc/21/360j.md?p=m) of title 21;
    - (B) identification of research priorities related to therapeutics (including [drugs](/usc/42/11851.md?p=4) and biological products) and medical devices for pediatric populations and the need for additional diagnostics and [treatments](/usc/42/11851.md?p=11) for specific pediatric diseases or conditions;
    - (C) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including [drugs](/usc/42/11851.md?p=4) and biological products) and medical devices; and
    - (D) the development of countermeasures (as defined in [section 360bbb–4(a) of title 21](/usc/21/360bbb–4.md?p=a)) for pediatric populations.
- (c) **Composition—** The [advisory committee](/usc/42/17061.md?p=2) shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the [Secretary](/usc/42/201.md?p=c).
- (d) **Continuation of Operation of Committee—** Notwithstanding [section 1013 of title 5](/usc/5/1013.md), the [advisory committee](/usc/42/17061.md?p=2) shall continue to operate to carry out the [advisory committee](/usc/42/17061.md?p=2)’s responsibilities under sections 355a, 355c, and 360j(m) of title 21.

## Source credit

(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.

### 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 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 Amendment

Amendment 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.