View all text of Subchapter X [§ 391 - § 399i]
§ 393a. Office of Pediatric Therapeutics
(a) Establishment
(b) Duties
(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
(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.)