Pub. L. 113-233 - Adding Ebola to the FDA Priority Review Voucher Program Act

113th Congress

Affects: 21 U.S.C. §§ 360n

SECTION 1. SHORT TITLE.

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

SEC. 2. 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)—

(1)(A) by redesignating subparagraph (Q) as subparagraph (R);

(1)(B) by inserting after subparagraph (P) the following:

(1)(B)“(Q) Filoviruses.”

(1)(B) ; and

(1)(C) in subparagraph (R), as so redesignated, by striking “regulation by” and inserting “order of”; and

(2) in subsection (b)—

(2)(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

(2)(B) in paragraph (4), by striking “365 days” and inserting “90 days”.

Legislative History

LEGISLATIVE HISTORY—S. 2917:

CONGRESSIONAL RECORD, Vol. 160 (2014):

Dec. 2, considered and passed Senate.

Dec. 3, considered and passed House.