Title 21 — Food and DrugsRelease 119-73

§360ee–1 FDA rare neurodegenerative disease grant program

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— - DRUGS AND DEVICES › Part Part B— - Drugs for Rare Diseases or Conditions › § 360ee–1

Last updated Apr 6, 2026|Official source

Summary

HHS, via the FDA Commissioner, must award grants and contracts to organizations for research and development to prevent, diagnose, lessen, treat, or cure ALS and other rare neurodegenerative diseases in adults and children. Funds may be used to develop and test tools and methods to (1) describe the disease and its course, (2) find molecular targets, and (3) speed up and improve clinical development, using master protocols, adaptive or add-on trials, and clinical trial networks.

Full Legal Text

Title 21, §360ee–1

Food and Drugs — Source: USLM XML via OLRC

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.

Legislative History

Notes & Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360ee–1

Title 21 — Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73