Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act

I 116TH CONGRESS 1ST SESSION H. R. 4553 To expand the tropical disease product priority review voucher program to encourage treatments for the Middle East respiratory syndrome, Nipah, and Rift Valley fever. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 27, 2019 Mr. BRENDAN F. BOYLE of Pennsylvania (for himself, Mr. MARSHALL, Mr. VEASEY, and Mr. FORTENBERRY) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To expand the tropical disease product priority review vouch- er program to encourage treatments for the Middle East respiratory syndrome, Nipah, and Rift Valley fever. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Adding Epidemic Dis- 4 eases to the FDA Priority Review Voucher Program Act’’. 5 VerDate Sep 11 2014 21:58 Oct 02, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4553.IH H4553 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 4553 IH SEC. 2. EXPANDING TROPICAL DISEASE PRODUCT PRI- 1 ORITY REVIEW VOUCHER PROGRAM TO EN- 2 COURAGE TREATMENTS FOR MIDDLE EAST 3 RESPIRATORY SYNDROME, NIPAH, AND RIFT 4 VALLEY FEVER. 5 Section 524(a)(3) of the Federal Food, Drug, and 6 Cosmetic Act (21 U.S.C. 360n(a)(3)) is amended— 7 (1) by redesignating subparagraph (S) as sub- 8 paragraph (V); and 9 (2) by inserting after subparagraph (R) the fol- 10 lowing: 11 ‘‘(S) Middle East respiratory syndrome. 12 ‘‘(T) Nipah. 13 ‘‘(U) Rift Valley fever.’’. 14 Æ VerDate Sep 11 2014 21:58 Oct 02, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H4553.IH H4553 pamtmann on DSKBC07HB2PROD with BILLS