21 U.S.C. § 393a — Office of Pediatric Therapeutics

(a) Establishment The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration . (b) Duties The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices. (c) Staff The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include— (1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population; (2) subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States , less likely to be studied as a part of a written request issued under section 355a of this title or an assessment under section 355c of this title ; (3) one or more additional individuals with expertise in pediatric epidemiology; and (4) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b). (d) Neonatology expertise At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology. ( Pub. L. 107–109, § 6 , Jan. 4, 2002 , 115 Stat. 1414 ; Pub. L. 110–85, title III, § 306(a) , Sept. 27, 2007 , 121 Stat. 864 ; Pub. L. 112–144, title V, § 511 , July 9, 2012 , 126 Stat. 1050 ; Pub. L. 115–52, title V, § 505(d)(1) , Aug. 18, 2017 , 131 Stat. 1047 .) Editorial Notes Codification Section was enacted as part of the Best Pharmaceuticals for Children Act , and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. Amendments 2017—Subsec. (d). Pub. L. 115–52 substituted “At least” for “For the 5-year period beginning on July 9, 2012 , at least”. 2012—Subsec. (c)(2) to (4). Pub. L. 112–144, § 511(1) , added pars. (2) and (3) and redesignated former par. (2) as (4). Subsec. (d). Pub. L. 112–144, § 511(2) , added subsec. (d). 2007—Subsec. (b). Pub. L. 110–85 inserted “, including increasing pediatric access to medical devices” before period at end. CFR Title Parts 21 5 , 10 , 14 , 16

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