Public Law 113-233 | Public Law 113–233: To expand the program of priority review to encourage treatments for tropical diseases.

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PUBLIC LAW 113–233—DEC. 16, 2014

128 STAT. 2127

Public Law

113–233

113th Congress

An Act

To expand the program of priority review to encourage treatments for tropical diseases.

Dec. 16, 2014

[S. 2917]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

Adding

Ebola to the FDA Priority Review Voucher Program Act.

SECTION 1.

21 USC 301 note.

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)—

(A)

redesignating

subparagraph (Q) as subparagraph (R);

(B)

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; and128 STAT. 2128

(B)

in paragraph (4), by

striking

“365 days” and

inserting

“90 days”.

Approved December 16, 2014.

LEGISLATIVE HISTORY—S. 2917:

CONGRESSIONAL RECORD, Vol. 160 (2014):

Dec. 2, considered and passed Senate.

Dec. 3, considered and passed House.

○

Public Law 113–233: To expand the program of priority review to encourage treatments for tropical diseases.

SHORT TITLE.

PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.

LEGISLATIVE HISTORY—S. 2917:

CONGRESSIONAL RECORD, Vol. 160 (2014):

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