HR 1408 · 113th Congress · Health

Animal Generic Drug User Fee Amendments of 2013

Introduced 2013-04-09· Sponsored by Rep. Gardner, Cory [R-CO-4]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2013-04-12)

Plain Language Summary

[AI summary unavailable — showing source text] 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 paym…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (8)

2 Democrats6 Republicans