REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.

SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES. (a) In general.—Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5) and inserting the following: “(5) Termination of authority.—The Secretary may not award any priority review vouchers under paragraph (1) after September 30, 2020, unless the rare pediatric disease product application— “(A) is for a drug that, not later than September 30, 2020, is designated under subsection (d) as a drug for a rare pediatric disease; and “(B) is, not later than September 30, 2022, approved under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.” . (b) Report.—The Advancing Hope Act of 2016 (Public Law 114-229) is amended by striking section 3.