SECTION 1. Short Title.
This Act may be cited as the “Adding Ebola to the FDA Priority Review Voucher Program Act”.
Adding Ebola to the FDA Priority Review Voucher Program Act
An Act
To expand the program of priority review to encourage treatments for tropical diseases.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
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—
in subsection (a)(3)—
by redesignating subparagraph (Q) as subparagraph (R);
by inserting after subparagraph (P) the following:
“(Q) Filoviruses.”
; and
in subparagraph (R), as so redesignated, by striking “ regulation by” and inserting “ order of”; and
in subsection (b)—
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
in paragraph (4), by striking “ 365 days” and inserting “ 90 days”.