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

(a) Establishment: The Secretary^* of Health and Human Services must create an Office of Pediatric Therapeutics inside the Food^* and Drug^* Administration.

(b) Duties: This Office is responsible for coordinating and facilitating all FDA activities that could affect children, the practice of pediatrics, or any pediatric issue in any way — including increasing children's access to medical devices.

(c) Staff: The Office's staff must coordinate with Department^* of Health and Human Services employees who already handle pediatric therapeutics matters. The staff must include: (1) one or more people with expertise in the ethical issues raised by doing clinical research on children; (2) subject to (d), one or more people with expertise in a pediatric subgroup that reports from the Institute of Medicine and the Comptroller General show is less likely to be studied under a written research request (section 355a) or an assessment (section 355c) of this title; (3) one or more people with expertise in pediatric epidemiology, meaning how diseases and conditions affect children; and (4) one or more people with pediatric expertise as needed to carry out the duties described in (b).

(d) Neonatology expertise: At least one of the people described in (c)(2) must have expertise in neonatology — the medical care of newborn babies.