Sec. 302. Grants for novel trial designs and other innovations in drug development
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The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall award grants for— incorporating complex adaptive and other novel trial designs into clinical protocols and applications for drugs pursuant to an exemption for investigational use under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ); and the collection of patient experience data with respect to drugs and the use of such data and related information in drug development.
In awarding grants under this section, the Secretary shall prioritize the incorporation of digital health technologies and real world evidence in drug development. In this section: The term digital health technologies has the meaning given to such term in section 301. The term patient experience data has the meaning given to such term by section 569C(d) of the Federal Food, Drug, and Cosmetic Act, as redesignated by section 204 of this Act. The term real world evidence has the meaning given to that term in section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g ).
To carry out this section, there is authorized to be appropriated $25,000,000 for each of fiscal years 2022 through 2024.
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Sec. 302
Grants for novel trial designs and other innovations in drug development
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