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").
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.
The matters referred to in paragraph (1) include-
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.
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.
42 U.S.C. § 284m-1
EDITORIAL NOTES
CODIFICATIONSection 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 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.
- Advisory Committee
- The term "Advisory Committee" means the Green Building Advisory Committee established under section 484.1
- Secretary
- The term "Secretary" means the Secretary of Housing and Urban Development.1 See References in Text note below.
- Service
- The term "Service" means the Public Health Service;