§393a — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary of Health and Human Services must create an Office of Pediatric Therapeutics inside the Food and Drug Administration. The office must coordinate all FDA work that affects children or the practice of pediatrics, including helping children get better access to medical devices. Its staff must work with other HHS employees and include one or more experts in research ethics for children, one or more experts in pediatric subgroups that reports by the Institute of Medicine and the Comptroller General say are less often studied (and at least one of these must be a neonatologist), one or more experts in pediatric epidemiology, and one or more pediatric experts as needed.

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.

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.

§393a Office of Pediatric Therapeutics

Summary

Title 21, §393a

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata