Creating Hope Reauthorization Act
This bill reauthorizes a Food and Drug Administration (FDA) program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.)
Specifically, the bill reauthorizes the program through FY2024, but the FDA may award a voucher afterwards in certain instances.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4439 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 4439
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
_______________________________________________________________________
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Creating Hope Reauthorization Act''.
SEC. 2. PROVIDING FOR PERMANENT AUTHORITY TO ISSUE PRIORITY REVIEW
VOUCHERS TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC
DISEASES.
Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360ff(b)) is amended by striking paragraph (5).
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-551.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-551.
Placed on the Union Calendar, Calendar No. 451.
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H5023-5025)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4439.
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Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5023)
Motion to reconsider laid on the table Agreed to without objection.
The title of the measure was amended. Agreed to without objection.
Received in the Senate.