Title 21 — Food and DrugsRelease 119-73not60
§393a Office of Pediatric Therapeutics
Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter X— MISCELLANEOUS › § 393a
Summary
The Secretary of Health and Human Services must create an Office of Pediatric Therapeutics inside the FDA. The office must coordinate all FDA work that affects children or the practice of pediatrics and help improve children’s access to medical devices. It must work with HHS staff and include experts in research ethics, certain understudied child groups (at least one must be a neonatologist), pediatric epidemiology, and other pediatric specialists as needed.
Full Legal Text
Title 21, §393a
Food and Drugs — Source: USLM XML via OLRC
(a)The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.
(b)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)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)At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.
Legislative History
Notes & Related Subsidiaries
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.
Reference
Citations & Metadata
Citation
21 U.S.C. § 393a
Title 21 — Food and Drugs
Last Updated
Apr 5, 2026
Release point: 119-73not60