H.R. 1408 · 113th Congress
Animal Generic Drug User Fee Amendments of 2013
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Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
GardnerSponsor8 cosponsors · 2 D, 6 R
8 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Animal Generic Drug User Fee Amendments of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal…
What it does: CRS summary · Introduced in House · Apr 9, 2013
Animal Generic Drug User Fee Amendments of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees.
Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved.
Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.
Establishes the total amount of revenue each type of generic user fee shall generate.
Authorizes the Secretary of Health and Human Services (HHS) to accept payment of user fees prior to their due date.
Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees.
Terminates the authority to collect generic animal drug user fees October 1, 2018.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Animal Generic Drug User Fee Amendments of 2013
Latest action (Apr 12, 2013): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 9, 2013
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.