; and (2) the Secretary acting through the Commissioner of Food and Drugs (or by vesting authority in the participating clinical trial site, as applicable) shall make the determinations required of the Secretary under subsection (b) or (c), as applicable, of section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) for the provision of the investigational drug to occur. (d) Definitions In this section: (1) The term Director means the Director of the National Institutes of Health. (2) The term eligible entity means an entity that is— (A) a small business concern (as defined in section 3(a) of the Small Business Act ( 15 U.S.C. 632(a) )) that is the sponsor of a drug that is the subject of an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ); or (B) a participating clinical trial site for such an applicant . (3) The term participating clinical trial means a phase 2 or phase 3 clinical trial conducted pursuant to an exemption 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) ) to investigate a drug intended to treat amyotrophic lateral sclerosis or another rapidly progressing neurodegenerative disease. (4) The term participating clinical trial site means a health care facility at which patients participating in a participating clinical trial receive treatment through such trial. (5) The term Secretary means the Secretary of Health and Human Services. (e) Funding (1) Authorization of appropriations There are authorized to be appropriated to carry out this section— (A) $75,000,000 for each of fiscal years 2021 and 2022