Sec. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES

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## SEC. 3013 REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES ###

(a)In general Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph

(5)and inserting the following: > > #### “(5) Termination of authority > > The Secretary may not award any priority review vouchers under paragraph

(1)after September 30, 2020, unless the rare pediatric disease product application— > > > ##### “(A) > > is for a drug that, not later than September 30, 2020, is designated under subsection

(d)as a drug for a rare pediatric disease; and > > > ##### “(B) > > is, not later than September 30, 2022, approved under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.” > . ###

(b)Report The Advancing Hope Act of 2016 (Public Law 114-229) is amended by striking section 3.

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U.S. Code

Priority review to encourage treatments for rare pediatric diseases
§ 360ff

public-private-law

Advancing Hope Act of 2016
Public Law 114-229

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Sec. 3013

REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES

U.S.C.§ 360ff

Pub. L.Public Law 114-229

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