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.
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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Votes
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Versions
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Documents
16 official files
Public Law (text)
Public Law (text)
Public Law · EN · 14 August 2008
Public Law (PDF)
Public Law · EN · 14 August 2008
Public Law
summary · EN · 14 August 2008
Enrolled Bill (text)
Enrolled Bill · EN · 1 August 2008
Enrolled Bill (PDF)
Enrolled Bill · EN · 1 August 2008
Passed Senate without amendment
summary · EN · 1 August 2008
Received in Senate (text)
Received in Senate · EN · 31 July 2008
Received in Senate (PDF)
Received in Senate · EN · 31 July 2008
Reported in House (text)
Reported in House · EN · 30 July 2008
Reported in House (PDF)
Reported in House · EN · 30 July 2008
Engrossed in House (text)
Engrossed in House · EN · 30 July 2008
Engrossed in House (PDF)
Engrossed in House · EN · 30 July 2008
Passed House amended
summary · EN · 30 July 2008
Introduced in House (text)
Introduced in House · EN · 8 July 2008
Introduced in House (PDF)
Introduced in House · EN · 8 July 2008
Introduced in House
summary · EN · 8 July 2008
Sponsors
No sponsors or actors listed by the source.
Related records
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Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/110th-congress/house-bill/6432
- Open data entity: https://api.congress.gov/v3/bill/110/hr/6432