---
kind: "section"
citation: "21 U.S.C. § 355d"
title: "21"
title_heading: "Food and Drugs"
number: "355d"
heading: "Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/355d"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers


The [Secretary](/usc/21/321.md?p=d) shall establish an internal committee within the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration to carry out the activities as described in sections [355a(f)](/usc/21/355a.md?p=f) and [355c(f)](/usc/21/355c.md?p=f) of this title. Such internal committee shall include employees of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric [product](/usc/21/360eee.md?p=13) under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the [Secretary](/usc/21/321.md?p=d).


## Source credit

(June 25, 1938, ch. 675, § 505C, as added Pub. L. 110–85, title IV, § 403, Sept. 27, 2007, 121 Stat. 875; amended Pub. L. 112–144, title V, § 509(c), July 9, 2012, 126 Stat. 1049; Pub. L. 115–52, title V, § 505(f), Aug. 18, 2017, 131 Stat. 1047.)

## Notes

### Editorial Notes

### Amendments

2017—Pub. L. 115–52 inserted “or pediatric rare diseases” after “psychiatry”.

2012—Pub. L. 112–144 inserted “deferral extensions,” after “deferrals,” in section catchline and “neonatology,” after “pediatric ethics,” in text.