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HR 5729 113th Congress House Health Drug safety, medical device, and laboratory regulation Drug therapy Infectious and parasitic diseases

Adding Ebola to the FDA Priority Review Voucher Program Act

Introduced: November 18, 2014 Introduced by: Blackburn, Marsha Republican · Tennessee See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 21, 2014
Referred to the Subcommittee on Health.
Nov 18, 2014
Referred to the House Committee on Energy and Commerce.
Nov 18, 2014
Introduced in House
 Plain-English summary Congressional Research Service

Adding Ebola to the FDA Priority Review Voucher Program Act - Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.
What's happening now November 21, 2014

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 2
All 2 Republican 2