The law › Title 21, Food and Drugs › Chapter 9
21 U.S.C. 360ee: Grants and contracts for development of drugs for rare diseases and conditions
Created in 1983 by Public Law 97-414. Changed by 12 later laws. 1 bill in this Congress would change it.
- past change
- enacted this Congress
- proposed
This Congress
- H.R. 8205 Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 · sent to president · would change (b), (c), (e), (f)
How it got here
2022
- Pub. L. 117–328, §3107(1), added par. (4). (Consolidated Appropriations Act, 2023) Law text · (a)
- Pub. L. 117–328, §3107(2), which directed the substitution of "$30,000,000 for each of fiscal years 2023 through 2027" for "$6,328,767 for the period beginning on October 1, 2022, and ending on December 23, 2022", could not be executed because "$6,328,767" did not appear after the inte… (Consolidated Appropriations Act, 2023) Law text · (c)
- Pub. L. 117–229 substituted "$6,904,110 for the period beginning on October 1, 2022 and ending on December 23, 2022" for "$6,328,767 for the period beginning on October 1, 2022, and ending on December 16, 2022". (Further Continuing Appropriations and Extensions Act, 2023) Law text · (c)
- Pub. L. 117–180 substituted "$6,328,767 for the period beginning on October 1, 2022, and ending on December 16, 2022" for "$30,000,000 for each of fiscal years 2018 through 2022". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
2017
- Pub. L. 115–52 substituted "2018 through 2022" for "2013 through 2017". (FDA Reauthorization Act of 2017) Law text · (c)
2016
- Pub. L. 114–255, §3015(1), added par. (1) and struck out former par. (1) which read as follows: "defraying the costs of qualified testing expenses incurred in connection with the development of drugs for rare diseases and conditions,". (21st Century Cures Act) Law text · (a)
- Pub. L. 114–255, §3015(2), added subpar. (C). (21st Century Cures Act) Law text · (b)
2012
- Pub. L. 112–144, §906(a), struck out "after the date such drug is designated under section 360bb of this title and" after "which occurs". (Food and Drug Administration Safety and Innovation Act) Law text · (b)
- Pub. L. 112–144, §906(b), amended subsec. (c) generally. Prior to amendment, text read as follows: "For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000 for each of fiscal years 2008 through 2012." (Food and Drug Administration Safety and Innovation Act) Law text · (c)
2007
- Pub. L. 110–85 amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: "For grants and contracts under subsection (a) of this section, there are authorized to be appropriated such sums as already have been appropriated for fiscal year 2002, and $25,000,000 for e… (Food and Drug Administration Amendments Act of 2007) Law text · (c)
2002
- Pub. L. 107–281 amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: "For grants and contracts under subsection (a) of this section there are authorized to be appropriated $10,000,000 for fiscal year 1988, $12,000,000 for fiscal year 1989, $14,000,000 for fis… Law text · (c)
1997
- Pub. L. 105–115 struck out "or 357" after "355(b)". (Food and Drug Administration Modernization Act of 1997) Law text · (b), (B)
1988
- Pub. L. 100–290, §3(a)(1), (b)(1), inserted "(1)" after "assist in" and added pars. (2) and (3). · (a)
- Pub. L. 100–290, §3(a)(2), (b)(2), inserted "(1) in the case of a drug," after "means", added cls. (2) and (3), and substituted "under section 360bb of this title" for "under this subsection" in last sentence. · (b)
- Pub. L. 100–290, §3(b)(3), added par. (3). · (b)
- Pub. L. 100–290, §3(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: "For grants and contracts under subsection (a) of this section there are authorized to be appropriated $4,000,000 for fiscal year 1986, $4,000,000 for fiscal year 1987, and $4,000,00… · (c)
1985
- Pub. L. 99–91, §5(a)(1), struck out "clinical" before "testing". · (a)
- Pub. L. 99–91, §5(a)(2), substituted provisions defining "qualified testing" for provisions defining "qualified clinical testing". · (b)
- Pub. L. 99–91, §5(b), substituted provisions authorizing appropriations for fiscal years 1986 to 1988, for provisions authorizing appropriations for fiscal years 1983 and the two succeeding fiscal years. · (c)
1984
- Pub. L. 98–551 substituted "which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which" for "which occurs so infrequently in the United States that". · (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.