Section text and notes
In general
section 217a of this titleThe Secretary of Health and Human Services shall, under 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”).
Purpose
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.
Matters included
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.
Continuation of Operation of Committee
section 1013 of title 5Notwithstanding , 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, § 14115 Stat. 1419 Pub. L. 108–155, § 3(b)(2)117 Stat. 1941 Pub. L. 110–85, title III, § 306(b)121 Stat. 865 Pub. L. 112–144, title V, § 507(a)126 Stat. 1045 Pub. L. 113–5, title III, § 307(c)127 Stat. 192 Pub. L. 117–286, § 4(a)(233)136 Stat. 4331 (, , , as amended by , , ; , title V, § 502(d), , , 889; , , ; , , ; , , .)
Editorial Notes
Codification
section 284m of this titleSection was formerly set out as a note under .
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
Pub. L. 117–286section 1013 of title 52022—Subsec. (d). substituted “,” for “section 14 of the Federal Advisory Committee Act,”.
Pub. L. 113–52013—Subsec. (b)(2)(D). added subpar. (D).
Pub. L. 112–1442012—Subsec. (d). 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 ”.
Pub. L. 110–85, § 306(b)(1)2007—Subsec. (a). , inserted “(including drugs and biological products) and medical devices” after “therapeutics”.
Pub. L. 110–85, § 306(b)(2)(A)Subsec. (b)(1). , inserted “(including drugs and biological products) and medical devices” after “therapeutics”.
Pub. L. 110–85, § 306(b)(2)(B)(i)Subsec. (b)(2)(A). , substituted “355c, 360(k), 360e, and 360j(m)” for “and 355c”.
Pub. L. 110–85, § 306(b)(2)(B)(ii)Subsec. (b)(2)(B). , 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”.
Pub. L. 110–85, § 306(b)(2)(B)(iii)Subsec. (b)(2)(C). , inserted “(including drugs and biological products) and medical devices” after “therapeutics”.
Pub. L. 110–85, § 502(d)Subsec. (d). , added subsec. (d).
Pub. L. 108–155, § 3(b)(2)(A)2003—, struck out “Pharmacology” after “Pediatric” in section catchline.
Pub. L. 108–155, § 3(b)(2)(D)Subsec. (a). , substituted “therapeutics” for “pharmacology”.
Pub. L. 108–155, § 3(b)(2)(B), inserted “or other appropriate authority” after “217a of this title”.
Pub. L. 108–155, § 3(b)(2)(D)Subsec. (b)(1). , 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”.
Pub. L. 108–155, § 3(b)(2)(C)(ii)Subsec. (b)(2). , substituted “355a, and 355c” for “and 355a”.
Pub. L. 108–155, § 3(b)(2)(D)Subsec. (b)(2)(B), (C). , substituted “therapeutics” for “pharmacology”.
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Pub. L. 108–155section 4 of Pub. L. 108–155section 355c of Title 21Amendment by effective , except as otherwise provided, see , set out as an Effective Date note under , Food and Drugs.