HR 6433

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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.

Sponsor: Frank, Jr. Pallone (D) NJ

Status: Active

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Summary:

7/30/2008--Reported to House amended. 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 on: (1) progress toward the goal of expediting the generic new animal drug development process and the review of abbreviated applications for such drugs; and (2) the implementation of the authority for and use of generic new animal drug fees.Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

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Health policy

Administrative fees

Administrative procedure

Animals

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