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Animal Drug User Fees |
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The ActThe Animal Drug User Fee Act of 2003 (ADUFA), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and authorized FDA to collect fees to support the review of animal drugs. These additional resources support FDA's responsibilities under the Act to ensure that new animal drug products are safe and effective for animals as well as human consumers with respect to animals intended for food consumption. This program is similar to the very successful programs for human drugs and medical devices, the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act. New ProposalsThe Food and Drug Administration has sent to Congress two proposals for user fee programs for animal drug review. One proposal calls for the reauthorization of a user fee program that FDA has successfully implemented since 2004 for review of applications for non-generic, or "pioneer," new animal drugs. The other proposal is for a first-ever generics user fee program for generic animal drugs. |
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FeesAnimal Drug User Fee Rates and Payment Procedures for Fiscal Year 2008 (Federal Register, August 2, 2007) Fee rate notices from previous years FormsGuidanceGuidance for Industry #170: Animal Drug
User Fees and Fee Waivers and Reductions ReportsFY 2006 Performance Report [234 KB PDF] FY 2006 Financial Report [181 KB PDF] |
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More ADUFA InformationOther User Fee Information
ContactsEmail general questions to cvmadufa@fda.gov
Documents in Portable Document Format (PDF) retain their original format. To view or print these documents, you must use the Adobe Acrobat Reader, which is free and available directly from Adobe's Website with full installation instructions. |
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