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United States · Law · HR

H.R. 6432 (110th)

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes.

enactedUnited States· United States Congress· EN

Introduced

8 July 2008

Last action

Status

Became Public Law No: 110-316.

Sponsors

Subjects

Discovery layer

Source updated

7 April 2025

Summary

Animal Drug User Fee Amendments of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess a partial fee for a new drug application for a drug that combines active ingredients that have been approved separately. Sets forth the amount of revenue that animal drug fees are to generate for FY2009-FY2013. Reauthorizes appropriations for animal drug fees for FY2009-FY2013. Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the animal drug development process and the review of animal drug applications; and (2) the implementation of the authority for and use of animal drug fees. Sets forth a process for the Secretary to develop recommendations for the process of review of animal drug applications after FY2013. Specifies the reporting period and due date for periodic drug experience reports on antibiotic new animal drugs. Terminates the authority to assess and use animal drug fees on October 1, 2013.

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16 official files

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