The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.
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.
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-
At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.
21 U.S.C. § 393a
EDITORIAL NOTES
CODIFICATIONSection 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.
AMENDMENTS2017-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.