; and (ii) shall not be collected for any fiscal year except to the extent provided in advance in appropriations Acts. (f) Clarification Nothing in this section affects any period of exclusivity under this Act or the protection of any patent. (g) Sunset The authority of the Secretary to carry out the generic priority review voucher program under this section shall terminate on October 1, 2023. . 202. Tropical disease product application Section 524(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n(a)(4)(A) ) is amended— (1) in clause (i), by striking and ; (2) in clause (ii), by adding and after the semicolon; and (3) by adding at the end the following: (iii) that contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant; . III Study on REMS 301. Study on REMS (a) In general The Comptroller General shall conduct a review of the implementation and effectiveness of section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ) (referred to in this section as the REMS program ), which section— (1) authorizes the Secretary of Health and Human Services to require a risk evaluation and mitigation strategy (referred to in this section as REMS )