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.

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”.

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.