美国FDA 指导原则 CVM GFI 150对使用丁香油作为鱼类麻醉剂的关注 英文原版.pdfVIP

150 Guidance for Industry Concerns Related to the use of Clove Oil as an Anesthetic for Fish (This version of the guidance replaces the version that was made available in June 11, 2002. This guidance document has been revised to clarify our position on the use of clove oil as an anesthetic for fish.) This level 2 guidance document provides information regarding the use of clove oil and its components as an anesthetic for fish. Comments and suggestions regarding this guidance document should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to . All comments should be identified with the exact title of the document. For questions regarding information about regulatory discretion, contact Scott Melton, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-8666, email: scott.melton@ . U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine April 24, 2007 Concerns Related to the use Clove Oil as an Anesthetic for Fish This document represents the Agency’s current thinking on concerns related to the use of clove oil as an anesthetic for fish. It does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used as long as it satisfies the requirements of the applicable statute and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidanc