42 U.S.C. 284m: Program for pediatric studies of drugs

2022

• Pub. L. 117–328, which directed the substitution of "$25,000,000 for each of fiscal years 2023 through 2027" for "$5,273,973 for the period beginning on October 1, 2022 and ending on December 23, 2022", could not be executed because "$5,273,973" did not appear after the intervening … (Consolidated Appropriations Act, 2023) Law text · (d)
• Pub. L. 117–229 substituted "$5,753,425 for the period beginning on October 1, 2022 and ending on December 23, 2022" for "$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022". (Further Continuing Appropriations and Extensions Act, 2023) Law text · (d)
• Pub. L. 117–180 substituted "$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022" for "$25,000,000 for each of fiscal years 2018 through 2022". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (d)

2017

• Pub. L. 115–52, §501(1), inserted "and identification of biomarkers for such diseases, disorders, or conditions," after "biologics,". (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §501(2)(A)(i), amended subpar. (B) generally. Prior to amendment, text read as follows: "Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and sha… (FDA Reauthorization Act of 2017) Law text · (c)
• Pub. L. 115–52, §501(2)(A)(ii), substituted "action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7)." for "appropriate a… (FDA Reauthorization Act of 2017) Law text · (c)
• Pub. L. 115–52, §501(2)(B)(i), substituted "Within" for "During" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (c)
• Pub. L. 115–52, §501(2)(B)(ii), substituted "include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of" for "place in the public docket file a copy of the report and of". (FDA Reauthorization Act of 2017) Law text · (c)
• Pub. L. 115–52, §501(2)(B)(iii), struck out "in the Federal Register and" after "publish". (FDA Reauthorization Act of 2017) Law text · (c)
• Pub. L. 115–52, §501(3), (4), redesignated subsec. (e) as (d) and struck out former subsec. (d). Prior to amendment, text of subsec. (d) read as follows: "Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health, … (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §501(5), substituted "2018 through 2022" for "2013 through 2017". (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §501(4), redesignated subsec. (e) as (d). (FDA Reauthorization Act of 2017) Law text · (e)

2013

• Pub. L. 113–5, §307(b)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "In developing and prioritizing the list under paragraph (1), the Secretary shall consider— (Pandemic and All- Hazards Preparedness Reauthorization Act of 2013) Law text · (a)
• Pub. L. 113–5, §307(b)(2), substituted "paragraphs (1) and (2)(A) of subsection (a)" for "subsection (a)". (Pandemic and All- Hazards Preparedness Reauthorization Act of 2013) Law text · (b)

2012

• Pub. L. 112–144, §509(d)(1)(A), inserted "or section 262(m) of this title," after "Cosmetic Act,". (Food and Drug Administration Safety and Innovation Act) Law text · (c)
• Pub. L. 112–144, §509(d)(1)(B), inserted "or section 262(k) of this title" after "Cosmetic Act". (Food and Drug Administration Safety and Innovation Act) Law text · (c)
• Pub. L. 112–144, §509(d)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "there is no patent protection or market exclusivity protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act; and". (Food and Drug Administration Safety and Innovation Act) Law text · (c)
• Pub. L. 112–144, §509(d)(2), struck out "for drugs lacking exclusivity" after "applications" in heading, and in text struck out "under section 505 of the Federal Food, Drug, and Cosmetic Act" after "for the drug" and substituted "505A of the Federal Food, Drug, and Cosmetic Act or s… (Food and Drug Administration Safety and Innovation Act) Law text · (c)
• Pub. L. 112–144, §507(d), substituted "to carry out this section, $25,000,000 for each of fiscal years 2013 through 2017." for "to carry out this section— (Food and Drug Administration Safety and Innovation Act) Law text · (e)

2010

• Pub. L. 111–148 inserted ", biological products," after "including drugs". (Patient Protection and Affordable Care Act) Law text · (a)

2007

• Pub. L. 110–85 amended section generally. Prior to amendment, section related to development of list of drugs for which pediatric studies are needed, award of contracts for pediatric studies, process for requesting contract proposals to conduct certain pediatric studies, reporting of completed stud… (Food and Drug Administration Amendments Act of 2007) Law text
• Pub. L. 109–482 struck out subsec. (d) which related to authorization and availability of appropriations. (National Institutes of Health Reform Act of 2006) Law text · (d)

2003

• Pub. L. 108–155 struck out "Advisory Subcommittee of the Anti-Infective Drugs" before "Advisory Committee" wherever appearing. (Pediatric Research Equity Act of 2003) Law text · (c), (9), (11)