113 S2917 RS: Adding Ebola to the FDA Priority Review Voucher Program Act U.S. Senate 2014-11-12 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

IICalendar No. 602113th CONGRESS2d SessionS. 2917IN THE SENATE OF THE UNITED STATESNovember 12, 2014Mr. Harkin (for himself, Mr. Alexander, Ms. Mikulski, Mr. Enzi, Mrs. Murray, Mr. Burr, Mr. Casey, Mr. Isakson, Mrs. Hagan, Mr. Hatch, Mr. Franken, Mr. Roberts, Mr. Bennet, Mr. Kirk, Mr. Whitehouse, Mr. Scott, Ms. Baldwin, Mr. Murphy, Ms. Warren, Ms. Klobuchar, Mr. Blumenthal, Mr. Markey, Mr. Brown, Mr. Coburn, Ms. Collins, Mr. Durbin, Mr. Kaine, Mr. Blunt, Ms. Ayotte, Mrs. Boxer, Mr. Vitter, Mr. Cornyn, Mr. McConnell, Mr. Coons, Mr. Schumer, Mr. Moran, Mr. Portman, Mr. Booker, Mrs. Feinstein, Ms. Murkowski, Mr. Chambliss, Mr. Warner, Mrs. Gillibrand, Ms. Stabenow, Mr. Heinrich, and Mrs. Shaheen) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsNovember 19, 2014Reported by Mr. Harkin, without amendmentA BILLTo expand the program of priority review to encourage treatments for tropical diseases.

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Short title

This Act may be cited as the Adding Ebola to the FDA Priority Review Voucher Program Act.

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Priority review to encourage treatments for tropical diseases

Section 524 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n) is amended—(1)in subsection (a)(3)—(A)by redesignating subparagraph (Q) as subparagraph (R);(B)by inserting after subparagraph (P) the following:(Q)Filoviruses.; and(C)in subparagraph (R), as so redesignated, by striking regulation by and inserting order of; and(2)in subsection (b)—(A)in paragraph (2), by adding There is no limit on the number of times a priority review voucher may be transferred before such voucher is used. after the period at the end; and(B)in paragraph (4), by striking 365 days and inserting 90 days.

November 19, 2014Reported without amendment