21 U.S.C. § 360ee
Grants and contracts for development of drugs for rare diseases and conditions
United States · Title 21 — FOOD AND DRUGS · Status: effective
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- Citation
- 21 U.S.C. § 360ee, Grants and contracts for development of drugs for rare diseases and conditions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454295
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Full text
The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses, (2) defraying the costs of developing medical devices for rare diseases or conditions, (3) defraying the costs of developing medical foods for rare diseases or conditions, and (4) developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions.
For purposes of subsection (a):
The term “qualified testing” means—
human clinical testing—
prospectively planned and designed observational studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition and in the development of a therapy, including studies and analyses to—
For grants and contracts under subsection (a), there is authorized to be appropriated $6,904,110 for the period beginning on October 1, 2022 and ending on December 23, 2022.11 See 2022 Amendment notes below.
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Orphan Drug ActHouse: no recorded tallySenate: no recorded tally
- Health Promotion and Disease Prevention Amendments of 1983House: no recorded tallySenate: no recorded tally
- Orphan Drug Amendments of 1985House: no recorded tallySenate: no recorded tally
- Orphan Drug Amendments of 1988House: no recorded tallySenate: no recorded tally
- Food and Drug Administration Modernization Act of 1997House: no recorded tallySenate: 98–2
- Rare Diseases Orphan Product Development Act of 2002House: no recorded tallySenate: no recorded tally
- Food and Drug Administration Amendments Act of 2007House: 405–7Senate: no recorded tally
- Food and Drug Administration Safety and Innovation ActHouse: no recorded tallySenate: 96–1
- 21st Century Cures ActHouse: no recorded tallySenate: no recorded tally
- FDA Reauthorization Act of 2017House: no recorded tallySenate: 94–1
- Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023
- Further Continuing Appropriations and Extensions Act, 2023House: 224–201Senate: no recorded tally
- Consolidated Appropriations Act, 2023House: 225–201Senate: no recorded tally