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.
Latest Action
Became Public Law No: 110-316.
Official Summary
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GovScope Watchdog™
AI Government Intelligence™This bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program. It establishes a new fee program related to generic new animal drugs and makes technical corrections to the Food and Drug Administration Amendments Act of 2007. The bill aims to update and improve the regulatory framework for animal drugs, including fee structures that support the FDA's review and oversight processes.
The legislation updates and extends user fee programs for animal drugs, including new fees for generic animal drugs, and corrects prior FDA amendments to enhance regulatory operations.
- Revises and extends the animal drug user fee program under the Federal Food, Drug, and Cosmetic Act.
- Establishes a new fee program specifically for generic new animal drugs.
- Makes technical corrections to the Food and Drug Administration Amendments Act of 2007.
['U.S. Food and Drug Administration (FDA) through enhanced funding mechanisms.', 'Animal drug manufacturers, including those producing generic animal drugs.', 'Veterinarians and animal health sectors benefiting from updated regulatory oversight.']
['Implementation of new fee structures may increase costs for generic animal drug manufacturers.', 'Potential administrative burden on the FDA to manage and enforce revised fee programs.', 'Oversight challenges related to ensuring fees are appropriately allocated and do not hinder drug availability.']
The bill was enacted during the 110th Congress and signed into law on August 14, 2008, reflecting ongoing efforts to update FDA regulatory authorities and funding mechanisms for animal drugs. It builds on the Food and Drug Administration Amendments Act of 2007 by addressing technical corrections and expanding fee programs.
Hidden impact flags detected: 2
GovScope reviewed 2 policy-risk categories. Hover for a quick definition. Click detected flags for bill-specific details.
['Potential for improved FDA funding stability through user fees, which may enhance the speed and quality of animal drug reviews.', 'Possible impact on drug pricing and availability due to new fees imposed on generic animal drug manufacturers.', 'Enhanced regulatory clarity and corrections may reduce legal or procedural uncertainties for stakeholders.']
The bill's establishment of new fee programs and revisions to existing ones underscore the importance of transparent reporting on fee collection and expenditure. Oversight mechanisms should ensure fees do not create undue barriers to market entry for generic animal drugs. Technical corrections to prior legislation highlight the need for ongoing legislative review to maintain regulatory clarity.
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