TROPICAL DISEASE PRODUCT APPLICATION.

SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION. (a) In general.—Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended— (1) in clause (i), by striking “and” at the end; and (2) by adding at the end the following: “(iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and “(iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.” . (b) [21 U.S.C. 360n note] Effective Date.—The amendments made by subsection (a) shall apply to human drug applications submitted after September 30, 2017.