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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 360ee1 FDA rare neurodegenerative disease grant program us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 360ee1 21 U.S.C. § 360ee1 current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s360ee1 data/legal/raw/us/code/title-21/usc21.xml 602e298041c9df4c6105d48e1eec235924fdf32149e12f749d25761f13cd3cc5 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 40466d41c3434da267b09ec9beedd1526751f440cdfd69acdd3cf439a5d7f96a 2026-07-04 official
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21 U.S.C. § 360ee1 - FDA rare neurodegenerative disease grant program

Text

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall award grants and contracts to public and private entities to cover the costs of research on, and development of interventions intended to prevent, diagnose, mitigate, treat, or cure, amyotrophic lateral sclerosis and other rare neurodegenerative diseases in adults and children, including costs incurred with respect to the development and critical evaluation of tools, methods, and processes—

(1) to characterize such neurodegenerative diseases and their natural history;

(2) to identify molecular targets for such neurodegenerative diseases; and

(3) to increase efficiency and productivity of clinical development of therapies, including through—

(A) the use of master protocols and adaptive and add-on clinical trial designs; and

(B) efforts to establish new or leverage existing clinical trial networks.

(Pub. L. 11779, § 5, Dec. 23, 2021, 135 Stat. 1537.)

Notes

Editorial Notes

Codification Section was enacted as part of the Accelerating Access to Critical Therapies for ALS Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.