IB 
Union Calendar No. 451 
116TH CONGRESS 
2D SESSION 
H. R. 4439 
[Report No. 116–551] 
To amend the Federal Food, Drug, and Cosmetic Act to make permanent 
the authority of the Secretary of Health and Human Services to issue 
priority review vouchers to encourage treatments for rare pediatric dis-
eases. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 20, 2019 
Mr. BUTTERFIELD (for himself, Mr. MCCAUL, Ms. SPEIER, Mr. KELLY of 
Pennsylvania, Mr. ENGEL, Mr. BILIRAKIS, Ms. KELLY of Illinois, Mr. 
HUDSON, Mr. RUSH, and Mr. MULLIN) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
SEPTEMBER 29, 2020 
Additional sponsors: Mr. FITZPATRICK, Ms. DEGETTE, Mrs. RODGERS of 
Washington, Mrs. LURIA, Mr. RUTHERFORD, Mr. CARSON of Indiana, 
Mr. RODNEY DAVIS of Illinois, Ms. CLARKE of New York, Ms. BLUNT 
ROCHESTER, Ms. BARRAGA´N, Mr. SOTO, Mr. CA´RDENAS, Ms. KUSTER of 
New Hampshire, Mr. GRIFFITH, Mr. CARTER of Georgia, Mr. MAR-
SHALL, Mr. COHEN, Mr. WOODALL, Mr. DEFAZIO, Mr. BALDERSON, Mr. 
MALINOWSKI, Mr. BROOKS of Alabama, Ms. LOFGREN, Mr. KING of 
Iowa, Ms. PORTER, Mr. MARCHANT, Mr. MCEACHIN, Mr. DESAULNIER, 
Mrs. LESKO, Mr. FORTENBERRY, Ms. BONAMICI, Ms. SHERRILL, and 
Mr. WILSON of South Carolina 
SEPTEMBER 29, 2020 
Reported with amendments; committed to the Committee of the Whole House 
on the State of the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced September 20, 2019] 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
make permanent the authority of the Secretary of Health 
and Human Services to issue priority review vouchers 
to encourage treatments for rare pediatric diseases. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Creating Hope Reau-
thorization Act’’. 
SEC. 2. EXTENSION OF AUTHORITY TO ISSUE PRIORITY RE-
VIEW VOUCHERS TO ENCOURAGE TREAT-
MENTS FOR RARE PEDIATRIC DISEASES. 
Section 529(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360ff(b)) is amended— 
(1) by striking ‘‘September 30, 2020’’ each place 
it appears and inserting ‘‘September 30, 2024’’; and 
(2) by striking ‘‘September 30, 2022’’ and insert-
ing ‘‘September 30, 2026’’. 
Amend the title so as to read: ‘‘A bill to amend the 
Federal Food, Drug, and Cosmetic Act to extend the au-
thority of the Secretary of Health and Human Services 
to issue priority review vouchers to encourage treatments 
for rare pediatric diseases.’’. 
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Union Calendar No. 451 
116TH CONGRESS 
2D SESSION 
H. R. 4439 
[Report No. 116–551] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to make permanent the authority of the Sec-
retary of Health and Human Services to issue 
priority review vouchers to encourage treatments 
for rare pediatric diseases. 
SEPTEMBER 29, 2020 
Reported with amendments; committed to the Committee 
of the Whole House on the State of the Union and or-
dered to be printed 
VerDate Sep 11 2014 
01:23 Sep 30, 2020
Jkt 099200
PO 00000
Frm 00004
Fmt 6651
Sfmt 6651
E:\BILLS\H4439.RH
H4439
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