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Title 21, Food and DrugsRelease 119-110

§393a Office of Pediatric Therapeutics

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER X — MISCELLANEOUS › § 393a

Last updated Sep 22, 2026|Official source

Summary

The Secretary of Health and Human Services must create an Office of Pediatric Therapeutics inside the Food and Drug Administration to coordinate all FDA work that affects children or the practice of pediatrics, including improving children's access to medical devices. The Office must work with other HHS staff and must include one or more experts in ethics for pediatric research; one or more experts in a pediatric subgroup identified through reports from the Institute of Medicine and the Comptroller General as less likely to be studied under sections 355a or 355c (at least one of these must be a neonatologist); one or more pediatric epidemiologists; and one or more pediatric experts as needed.

Full Legal Text

Title 21, §393a

Food and Drugs, Source: USLM XML via OLRC

(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.

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

Sep 22, 2026

Release point: 119-110