2016 US Code
Title 42 - The Public Health and Welfare
Chapter 6A - Public Health Service
Subchapter III - National Research Institutes
Part B - General Provisions Respecting National Research Institutes
Sec. 284m-1 - Pediatric Advisory Committee

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 include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the Secretary.

Notwithstanding section 14 of the Federal Advisory Committee Act, 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.)

Section 14 of the Federal Advisory Committee Act, referred to in subsec. (d), is section 14 of Pub. L. 92–463, which is set out in the Appendix to Title 5, Government Organization and Employees.

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.

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.