H.R.6433: To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.
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To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. 7/30/2008--Reported to House amended. (There is 1 other summary) Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.Authorizes appropriations for FY2009-FY2013.Requires the Secretary to report to Congress and make publicly available information [...]
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