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.
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.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
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.
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