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 diseases. 

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. MARSHALL, 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] 


kjohnson on DSK79L0C42PROD with BILLS
2 

•HR 4439 RH

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. 


kjohnson on DSK79L0C42PROD with BILLS
3 

•HR 4439 RH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Creating Hope Reau5 thorization Act’’. 

6 SEC. 2. EXTENSION OF AUTHORITY TO ISSUE PRIORITY RE7 VIEW VOUCHERS TO ENCOURAGE TREAT8 MENTS FOR RARE PEDIATRIC DISEASES. 

9 Section 529(b) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 360ff(b)) is amended— 

11 (1) by striking ‘‘September 30, 2020’’ each place 

12 it appears and inserting ‘‘September 30, 2024’’; and 

13 (2) by striking ‘‘September 30, 2022’’ and insert14 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 authority of the Secretary of Health and Human Services 

to issue priority review vouchers to encourage treatments 

for rare pediatric diseases.’’. 


kjohnson on DSK79L0C42PROD with BILLS
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 

for rare pediatric diseases. priority review vouchers to encourage treatments retary of Health and Human Services to issue Act to make permanent the authority of the SecSEPTEMBER 29, 2020 

Reported with amendments; committed to the Committee 

dered to be printed of the Whole House on the State of the Union and orVerDate Sep 11 2014 01:23 Sep 30, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6651 Sfmt 6651 E:\BILLS\H4439.RH H4439

kjohnson on DSK79L0C42PROD with BILLS