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Animal Drug User Fee Act |
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The ActOn August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA). ADUFA was originally passed in 2003 and was set to expire on September 30, 2008. The new amendments extend ADUFA until 2013. ADUFA amends the Food, Drug and Cosmetic Act to authorize FDA to collect fees to enhance the performance of the new animal drug review process and ensure that new animal drug products are safe and effective for animals as well as for the public 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. |
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FeesAnimal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009 (Federal Register,Sept. 15, 2008) Fee rate notices from previous years FormsGuidanceGuidance for Industry #170: Animal Drug
User Fees and Fee Waivers and Reductions Guidance for Industry #183: Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction (161 KB PDF) 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.hhs.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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