PRIA, Government Policy, Made Personal

Summary

The Department of Health and Human Services, through the FDA Commissioner, must give grants and contracts to public and private groups to pay for research and development to prevent, diagnose, lessen, treat, or cure amyotrophic lateral sclerosis and other rare neurodegenerative diseases in adults and children. The money can be used to build and test tools to track disease progress, find molecular targets, and make clinical trials faster and more efficient — for example using master protocols, adaptive or add‑on trial designs, and creating or using clinical trial networks.

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.

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.

§360ee–1 Fda Rare Neurodegenerative Disease Grant Program

Summary

Title 21, §360ee–1

Notes & Related Subsidiaries

Editorial Notes

Citations & Metadata