H.R.1408 - Animal Generic Drug User Fee Amendments of 2013113th Congress (2013-2014)
|Sponsor:||Rep. Gardner, Cory [R-CO-4] (Introduced 04/09/2013)|
|Committees:||House - Energy and Commerce|
|Latest Action:||04/12/2013 Referred to the Subcommittee on Health.|
|Notes:||For further action, see S.622, which became Public Law 113-14 on 6/13/2013.|
This bill has the status Introduced
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Summary: H.R.1408 — 113th Congress (2013-2014)All Bill Information (Except Text)
Introduced in House (04/09/2013)
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.