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Animal Drug User Fee Act of 2003 |
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The ActThe Animal Drug User Fee Act of 2003 (ADUFA), amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and authorizes FDA to collect fees for certain applications and establishments, products and sponsors of those applications in support of the review of animal drugs. These additional resources will 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 program for human drugs that have been in place for over ten years. Like the Prescription Drug User Fee Act, and the recently enacted Medical Device User Fee and Modernization Act, this legislation will help FDA expedite and improve its review of applications for new animal drugs so that safe and effective new products will be available more quickly. |
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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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