42 U.S.C. § 284m–1 — Pediatric Advisory Committee

(a) In general. The Secretary must convene and consult an advisory committee — under section 217a or other appropriate authority — on pediatric therapeutics (drugs and biological products) and medical devices; this section calls it the "advisory committee." (b) Purpose. (1) The advisory committee advises and makes recommendations to the Secretary, through the FDA Commissioner, on pediatric therapeutics and medical device matters. (2) Those matters include: (A) pediatric research done under sections 262, 284m, and 290b of this title, and several named sections of title 21; (B) identifying research priorities for pediatric therapeutics and devices, and the need for more pediatric diagnostics and treatments; (C) the ethics, design, and analysis of pediatric clinical trials; and (D) developing countermeasures (as defined in title 21) for children. (c) Composition. The committee must include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family groups, and other experts the Secretary chooses. (d) Continuation of operation. Despite section 1013 of title 5 — a law that would normally require this kind of committee to end — the advisory committee must keep operating, to carry out its responsibilities under the named sections of title 21.