美国FDA 指导原则 CVM GFI 183 ADUFA兽药使用费超过成本减免 英文原版.pdfVIP

Contains Non-Binding Recommendations #183 Guidance for Industry Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction FINAL GUIDANCE This guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver/reduction provision. Comments and suggestions regarding the document should be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to /. All comments should be identified with the Docket No. 2006D-0301. For questions regarding this document, contact Steven Vaughn, Center for Veterinary Medicine (HFV- 100), Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, 240-276-8300, e- mail: steven.vaughn@. Additional copies of this guidance may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at /AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm04 2450.htm. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine March 9, 2007 - 1 - Contains Non-Binding Recommendations TABLE OF CONTENTS I. Introduction3 II. Standard Costs 3 A. Standard Costs Calculation4 B. Anticipated Costs 4 C. Applying Standard Costs to the Person Applying for the Waiver 4 D. Waiver Determination 5