WHAT THE LAW DOINCongress, in plain words

The law › Title 21, Food and Drugs › Chapter 9

21 U.S.C. 355a: Pediatric studies of drugs

Created in 1997 by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115). Changed by 10 later laws. No bill we track in this Congress changes it.

10 other sections of the Code cite this one, including 21 U.S.C. 353, 21 U.S.C. 355, 21 U.S.C. 355b, 21 U.S.C. 355c–1, 21 U.S.C. 355f.

2 parts of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (2).

This Congress

No bill we track in the 119th Congress changes this section.

    How it got here

    2021

    • Pub. L. 117–9 substituted "(c)(3)(E)" for "(c)(3)(D)". Law text · (c)

    2017

    • Pub. L. 115–52, §505(b)(2)(A), substituted "subsection (d)(4)" for "subsection (d)(3)" in introductory provisions of par. (1) and in par. (2). (FDA Reauthorization Act of 2017) Law text · (b), (c)
    • Pub. L. 115–52, §505(b)(1), added par. (3) and redesignated former pars. (3) to (5) as (4) to (6), respectively. (FDA Reauthorization Act of 2017) Law text · (d)
    • Pub. L. 115–52, §505(b)(2)(A), substituted "subsection (d)(4)" for "subsection (d)(3)". (FDA Reauthorization Act of 2017) Law text · (f)
    • Pub. L. 115–52, §505(a), added par. (7). (FDA Reauthorization Act of 2017) Law text · (f)
    • Pub. L. 115–52, §505(b)(2)(A), substituted "subsection (d)(4)" for "subsection (d)(3)". (FDA Reauthorization Act of 2017) Law text · (h)
    • Pub. L. 115–52, §608(1), struck out "under section 355(j)" after "approval of drugs" in heading. (FDA Reauthorization Act of 2017) Law text · (o)
    • Pub. L. 115–52, §608(2), substituted "under subsection (b)(2) or (j) of section 355 of this title" for "under section 355(j) of this title" and ", or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title, clause (iii) or (iv) of section 355(c)(3)(E) of this… (FDA Reauthorization Act of 2017) Law text · (o)
    • Pub. L. 115–52, §608(3), in introductory provisions, inserted "clauses (iii) and (iv) of section 355(c)(3)(E) of this title, or section 360cc of this title," after "section 355(j)(5)(F) of this title," and substituted "drug approved pursuant to an application submitted under subsect… (FDA Reauthorization Act of 2017) Law text · (o)
    • Pub. L. 115–52, §608(4), amended par. (3) generally. Prior to amendment, text read as follows: "This subsection does not affect— (FDA Reauthorization Act of 2017) Law text · (o)

    2016

    • Pub. L. 114–255 struck out subsec. (p) which related to Institute of Medicine study. (21st Century Cures Act) Law text · (p)

    2013

    • Pub. L. 113–5, §307(a)(1), added par. (5). (Pandemic and All- Hazards Preparedness Reauthorization Act of 2013) Law text · (d)
    • Pub. L. 113–5, §307(a)(2), added subpar. (C). (Pandemic and All- Hazards Preparedness Reauthorization Act of 2013) Law text · (n)

    2012

    • Pub. L. 112–144, §502(b), inserted at end "If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates." (Food and Drug Administration Safety and Innovation Act) Law text · (d)
    • Pub. L. 112–144, §502(a)(1), amended subsec. (h) generally. Prior to amendment, text read as follows: "Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including a regulation) other than this section and such study meets the complete… (Food and Drug Administration Safety and Innovation Act) Law text · (h)
    • Pub. L. 112–144, §509(a)(1), substituted "subsection (f)(6)(F)" for "subsection (f)(3)(F)". (Food and Drug Administration Safety and Innovation Act) Law text · (k)
    • Pub. L. 112–144, §509(a)(2)(A), substituted "first 18-month period" for "year one" in heading and "18-month" for "one-year" in text. (Food and Drug Administration Safety and Innovation Act) Law text · (l)
    • Pub. L. 112–144, §509(a)(2)(B), substituted "periods" for "years" in heading and "18-month period" for "one-year period" in text. (Food and Drug Administration Safety and Innovation Act) Law text · (l)
    • Pub. L. 112–144, §509(a)(2)(C), (D), added par. (3) and redesignated former par. (3) as (4). (Food and Drug Administration Safety and Innovation Act) Law text · (l), (4)
    • Pub. L. 112–144, §509(a)(3)(A), substituted "submitted" for "completed" in heading. (Food and Drug Administration Safety and Innovation Act) Law text · (n)
    • Pub. L. 112–144, §509(a)(3)(B)(i), substituted "have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request" for "have not been completed" in introductory provisions. (Food and Drug Administration Safety and Innovation Act) Law text · (n)
    • Pub. L. 112–144, §509(a)(3)(B)(ii), inserted ", or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 has not ended" after "expired" and struck out at end "Prio… (Food and Drug Administration Safety and Innovation Act) Law text · (n)
    • Pub. L. 112–144, §509(a)(3)(B)(iii), substituted "no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 apply," for "no… (Food and Drug Administration Safety and Innovation Act) Law text · (n)
    • Pub. L. 112–144, §509(a)(4), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "a statement of any appropriate pediatric contraindications, warnings, or precautions that the Secretary considers necessary." (Food and Drug Administration Safety and Innovation Act) Law text · (o)
    • Pub. L. 112–144, §501(a), struck out subsec. (q). Text read as follows: "A drug may not receive any 6-month period under subsection (b) or (c) unless— (Food and Drug Administration Safety and Innovation Act) Law text · (q)

    2010

    • Pub. L. 111–148 added pars. (4) to (6) and struck out former pars. (4) and (5) which read as follows: (Patient Protection and Affordable Care Act) Law text · (p)

    2007

    • Pub. L. 110–85 amended section generally. Prior to amendment, text consisted of subsecs. (a) to (n) relating to pediatric studies of drugs, including market exclusivity, conduct of pediatric studies, delay of effective date for certain applications, notice of determinations on studies requirement, … (Food and Drug Administration Amendments Act of 2007) Law text

    2003

    • Pub. L. 108–173, §1104(1), substituted "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
    • Pub. L. 108–173, §1104(2), substituted "(j)(5)(F)" for "(j)(5)(D)". (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)
    • Pub. L. 108–155, §3(a), substituted "355(j)(5)(B)" for "355(j)(4)(B)" in two places. (Pediatric Research Equity Act of 2003) Law text · (b)
    • Pub. L. 108–173, §1104(1), substituted "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (c)
    • Pub. L. 108–173, §1104(2), substituted "(j)(5)(F)" for "(j)(5)(D)". (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (c)
    • Pub. L. 108–155, §3(a), substituted "355(j)(5)(B)" for "355(j)(4)(B)" in two places. (Pediatric Research Equity Act of 2003) Law text · (c)
    • Pub. L. 108–173, §1104(3), substituted "355(j)(5)(F)" for "355(j)(5)(D)". (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (e)
    • Pub. L. 108–155, §2(b)(2), substituted "pediatric research requirements" for "regulations" in heading and "by a provision of law (including a regulation) other than this section" for "pursuant to regulations promulgated by the Secretary" in text. (Pediatric Research Equity Act of 2003) Law text · (h)
    • Pub. L. 108–155, §3(b)(1), struck out "Advisory Subcommittee of the Anti-Infective Drugs" before "Advisory Committee" wherever appearing. (Pediatric Research Equity Act of 2003) Law text · (i)
    • Pub. L. 108–173, §1104(3), substituted "355(j)(5)(F)" for "355(j)(5)(D)" wherever appearing. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (l)

    2002

    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (g) as (a). Former subsec. (a) redesignated (b). (Best Pharmaceuticals for Children Act) Law text · (a)
    • Pub. L. 107–109, §19(1)(A), (B), substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii). (Best Pharmaceuticals for Children Act) Law text · (a)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (a) as (b). (Best Pharmaceuticals for Children Act) Law text · (b)
    • Pub. L. 107–109, §2(1), struck out heading and text of subsec. (b). Text read as follows: "Not later than 180 days after November 21, 1997, the Secretary, after consultation with experts in pediatric research shall develop, prioritize, and publish an initial list of approved drugs for which additio… (Best Pharmaceuticals for Children Act) Law text · (b)
    • Pub. L. 107–109, §2(2), in introductory provisions, inserted "determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and" after "the Secretary" and struck out "concerning a drug identified in the li… (Best Pharmaceuticals for Children Act) Law text · (c)
    • Pub. L. 107–109, §19(1)(A), (B), substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii). (Best Pharmaceuticals for Children Act) Law text · (c)
    • Pub. L. 107–109, §19(4), substituted "subsection (b) or (c)" for "subsection (a) or (c)" in introductory provisions. (Best Pharmaceuticals for Children Act) Law text · (d)
    • Pub. L. 107–109, §§18(a), 19(4), substituted "subsection (b) or (c)" for "subsection (a) or (c)" and inserted "In reaching an agreement regarding written protocols, the Secretary shall take into account adequate representation of children of ethnic and racial minorities." after firs… (Best Pharmaceuticals for Children Act) Law text · (d)
    • Pub. L. 107–109, §19(4), substituted "subsection (b) or (c)" for "subsection (a) or (c)". (Best Pharmaceuticals for Children Act) Law text · (d)
    • Pub. L. 107–109, §4, added par. (4). (Best Pharmaceuticals for Children Act) Law text · (d)
    • Pub. L. 107–109, §19(1)(C), (4), substituted "section 355(j)(5)(D)" for "section 355(j)(4)(D)" and "subsection (b) or (c)" for "subsection (a) or (c)". (Best Pharmaceuticals for Children Act) Law text · (e)
    • Pub. L. 107–109, §19(2), (3), (5), redesignated subsec. (h) as (g) and substituted "subsection (b) or (c)" for "subsection (a) or (b)" in introductory provisions. Former subsec. (g) redesignated (a). (Best Pharmaceuticals for Children Act) Law text · (g)
    • Pub. L. 107–109, §7, inserted "(including neonates in appropriate cases)" after "pediatric age groups". (Best Pharmaceuticals for Children Act) Law text · (g)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g). (Best Pharmaceuticals for Children Act) Law text · (h)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (l) as (i). Former subsec. (i) redesignated (h). (Best Pharmaceuticals for Children Act) Law text · (i)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (m) as (j). Former subsec. (j) redesignated (n). (Best Pharmaceuticals for Children Act) Law text · (j)
    • Pub. L. 107–109, §8, added subsec. (j) and struck out heading and text of former subsec. (j). Text read as follows: "A drug may not receive any six-month period under subsection (a) or (c) of this section unless the application for the drug under section 355(b)(1) of this title is submitted on or b… (Best Pharmaceuticals for Children Act) Law text · (j)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (n) as (k). Former subsec. (k) redesignated (m). (Best Pharmaceuticals for Children Act) Law text · (k)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (o) as (l). Former subsec. (l) redesignated (i). (Best Pharmaceuticals for Children Act) Law text · (l)
    • Pub. L. 107–109, §5(b)(2), added subsec. (l). (Best Pharmaceuticals for Children Act) Law text · (l)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (k) as (m). Former subsec. (m) redesignated (j). (Best Pharmaceuticals for Children Act) Law text · (m)
    • Pub. L. 107–109, §9, added subsec. (m). (Best Pharmaceuticals for Children Act) Law text · (m)
    • Pub. L. 107–109, §19(4), which directed substitution of "subsection (b) or (c)" for "subsection (a) or (c)" in subsec. (m), was executed by making the substitution in introductory provisions of subsec. (n), to reflect the probable intent of Congress. (Best Pharmaceuticals for Children Act) Law text · (n)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (j) as (n). Former subsec. (n) redesignated (k). (Best Pharmaceuticals for Children Act) Law text · (n)
    • Pub. L. 107–109, §10, added subsec. (n). (Best Pharmaceuticals for Children Act) Law text · (n)
    • Pub. L. 107–109, §19(2), (3), redesignated subsec. (o) as (l). (Best Pharmaceuticals for Children Act) Law text · (o)
    • Pub. L. 107–109, §11(a), added subsec. (o). (Best Pharmaceuticals for Children Act) Law text · (o)

    Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.