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

项目总结/摘要 SLICE®（甲氨基阿维菌素苯甲酸盐）A型加药的环境评估 淡水养殖鲑鱼的文章。 Intervet Inc.（d/B/a Merck Animal Health）是指由以下机构授予的MUMS编号54 FDA/CVM/OMUMS（I-010418-L-0333-MR; 2019年3月11日）根据INAD I-010418进行控制 的Salmincola californiensis对淡水饲养的虹鳟鱼（虹鳟鱼）。Intervet 寻求美国FDA兽医中心（CVM）批准使用SLICE® （甲氨基阿维菌素苯甲酸盐）控制体外寄生虫（沙门氏菌属）的A型药用制品 加州鲑鱼（Oncorhynchus mykiss）。 Intervet Inc.合作研究与开发协议（CRADA） 自2008年5月1日起，通过美国鱼类和野生动物管理局（“FWS”）的努力， 水生动物药物批准伙伴关系（AADAP）计划，以支持开发新的 水生动物相关药物。根据这项协议，美国鱼类和野生动物管理局的水产养殖 兽药批准合作伙伴关系（AADAP）计划可以与CVM和其他顾问合作 (in代表英特威完成环境评估（EA） 在淡水养殖的鲑鱼中使用SLICE®。如果英特威获得250，000.00美元的赠款， 美国食品和药物管理局的次要用途次要物种（MUMS）补助 计划，补助金将用于支付Exponent完成使用SLICE®的EA， 淡水饲养的鲑鱼Exponent以前有使用EA的经验， SLICE®在淡水鲑鱼以及盐水中处理大西洋鲑鱼， 熟悉本产品的现有数据和研究。详细的成本估算和时间表 在本申请中提供了EA完成。 为了获得资助，AADAP编写了一份EA完成协议，并于2月25日提交给CVM。 23，2021（于2021年5月21日修订），并于2021年6月3日获得CVM的接纳。一 标题为"SLICE®（甲氨基阿维菌素苯甲酸盐）的环境评估"的方案副本 淡水养殖鲑科动物A类药物制品"和CVM接受函（I- 011370-H-0118-SP; 6/3/2021）。

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.