ENVIROMENTAL ASSESSMENT for SLICE® (emamectin benzoate) Type A Medicated Article for Freshwater-Reared Salmonids

点击翻译按钮获取中文摘要

PROJECT SUMMARY/ABSTRACT ENVIRONMENTAL ASSESSMENT FOR SLICE® (emamectin benzoate) Type A Medicated Article for Freshwater-Reared Salmonids. Intervet Inc. (d/b/a Merck Animal Health) refers to MUMS designation # 54 granted by FDA/CVM/OMUMS (I-010418-L-0333-MR; 3/11/2019) under INAD I-010418 for the control of Salmincola californiensis on freshwater-reared Oncorhynchus mykiss (rainbow trout). Intervet seeks approval from the U.S. FDA, Center for Veterinary Medicine (CVM) for the use of SLICE® (emamectin benzoate) Type A Medicated Article for the control of ectoparasites (Salmincola californiensis) on freshwater-reared salmonids (Oncorhynchus mykiss). Intervet Inc. has entered into a Cooperative Research and Development Agreement (CRADA) effective May 01, 2008 with U.S. Fish and Wildlife Service (“FWS”) through the efforts of its Aquatic Animal Drug Approval Partnership (AADAP) program to support the development of new aquatic animal related drugs. Under this agreement, the U.S. Fish and Wildlife Service’s Aquatic Animal Drug Approval Partnership (AADAP) Program could work with CVM and other consultants (in this case “Exponent”) on behalf of Intervet to complete the Environmental Assessment (EA) for use of SLICE® in freshwater-reared salmonids. If Intervet is awarded a grant of $250,000.00 from the United States Food and Drug Administration’s Minor Use Minor Species (MUMS) grant program, the grant money will be used to pay Exponent to complete the EA for use of SLICE® in freshwater-reared salmonids. Exponent has previous experience working on the EA of the use of SLICE® in freshwater salmonids as well as in salt water for treatment of Atlantic salmon, and is familiar with the available data and studies on this product. A detailed cost estimate and schedule for EA completion is provided in this application. For the grant, AADAP wrote a protocol for EA completion and submitted it to CVM on February 23, 2021 (amended on May 21, 2021) and obtained acceptance from CVM on June 3, 2021. A copy of the protocol titled “ENVIRONMENTAL ASSESSMENT for SLICE® (emamectin benzoate) Type A Medicated Article for Freshwater-Reared Salmonids” and CVM acceptance letter (I- 011370-H-0118-SP; 6/3/2021) are provided in this application.