; (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 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 )