WHAT THE LAW DOINCongress, in plain words

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

21 U.S.C. 360ff: Priority review to encourage treatments for rare pediatric diseases

Created in 2012 by the Food and Drug Administration Safety and Innovation Act (Public Law 112-144). Changed by 8 later laws. 1 bill in this Congress would change it; 1 new law this Congress changed it.

1 other section of the Code cite this one, including 42 U.S.C. 1396w–4a.

This Congress

  • H.R. 7148 Consolidated Appropriations Act, 2026 · became law · changed (b), (c)
  • H.R. 10359 Priority for Pediatric Cures Act · introduced · would change (b)

How it got here

2024

  • Pub. L. 118–83 substituted "December 20, 2024" for "September 30, 2024" in introductory provisions and in subpar. (A). (Continuing Appropriations and Extensions Act, 2025) Law text · (b)

2021

  • Pub. L. 117–9 added subpars. (A) and (B) and struck out former subpars. (A) and (B) which read as follows: Law text · (a), (B)

2020

  • Pub. L. 116–260 substituted "September 30, 2024" for "December 18, 2020" in introductory provisions and in subpar. (A) and substituted "September 30, 2026" for "December 18, 2022" in subpar. (B). (Consolidated Appropriations Act, 2021) Law text · (b)
  • Pub. L. 116–215 substituted "December 18, 2020" for "December 11, 2020" in introductory provisions and in subpar. (A) and substituted "December 18, 2022" for "December 11, 2022" in subpar. (B). (Further Continuing Appropriations Act, 2021, and Other Extensions Act) Law text · (b)
  • Pub. L. 116–159 substituted "December 11, 2020" for "September 30, 2020" in introductory provisions and in subpar. (A) and substituted "December 11, 2022" for "September 30, 2022" in subpar. (B). (Continuing Appropriations Act, 2021 and Other Extensions Act) Law text · (b)

2016

  • Pub. L. 114–229, §2(a)(1)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "The disease primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents." Law text · (a)
  • Pub. L. 114–229, §2(a)(1)(B), substituted "September 30, 2016" for "July 9, 2012". Law text · (a)
  • Pub. L. 114–229, §2(a)(2)(A), added par. (4) and struck out former par. (4). Prior to amendment, text read as follows: Law text · (b)
  • Pub. L. 114–255 added par. (5) and struck out former par. (5). Prior to amendment, text read as follows: "The Secretary may not award any priority review vouchers under paragraph (1) after December 31, 2016." (21st Century Cures Act) Law text · (b)
  • Pub. L. 114–229, §2(a)(2)(B), added par. (5) and struck out former par. (5). Prior to amendment, text read as follows: "The Secretary may not award any priority review vouchers under paragraph (1) after September 30, 2016." Law text · (b)
  • Pub. L. 114–229, §2(a)(3), inserted before period at end ", except that no sponsor of a rare pediatric disease product application may receive more than one priority review voucher issued under any section of this chapter with respect to the drug for which the application is made." Law text · (g)

2015

  • Pub. L. 114–113 substituted "September 30, 2016." for "the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section." (Consolidated Appropriations Act, 2016) Law text · (b)

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.