美国FDA 指导原则 CVM GFI 199动物仿制药使用费及费用减免 英文原版.pdfVIP

Contains Non-Binding Recommendations 199 Guidance for Industry Animal Generic Drug User Fees and Fee Waivers and Reductions Submit written comments on the guidance to the 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. FDA-2009-D-0189. 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/u cm042450.htm. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM) May 13, 2009 Contains Non-Binding Recommendations TABLE OF CONTENTS I. INTRODUCTION 3 II. TYPES OF FEES 4 A. Abbreviated Application Fee 4 B. Generic New Animal Drug Product Fee 4 C. Generic New Animal Drug Sponsor Fee 5 III. DETERMINING WHETHER YOU ARE SUBJECT TO THE GENERIC NEW ANIMAL DRUG SPONSOR FEE 5 IV. FEE WAIVER OR REDUCTION 8 V. PROCEDURES AND TIMING FOR REQUESTING WAIVERS OR REDUCTIONS OF FEES 9 A. Procedures Applicable To All Requests for Waivers or Reductions 9 B. Payment of Fees Pending a Decision on a Waiver/Reduction Request 1