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

项目摘要/摘要 甲型药物SLICE®(阿维菌素苯甲酸酯)的环境评价 淡水养殖鲑鱼用品。 Intervet Inc.(d/b/a默克动物健康)指的是由 食品和药物管理局/CVM/OMUMS(I-010418-L-0333-MR；2019年3月11日)，根据INAD I-010418进行控制 在淡水养殖的虹鲑鱼(Oncorhynchus Mykis)上发现了加州萨明可氏菌。英特维特 寻求美国FDA兽医中心(CVM)批准使用Slice® (阿维菌素苯甲酸酯)A类控制体外寄生虫(沙明可乐)的药物制品 Calforniens)对淡水养殖的鲑鱼(Oncorhynchus Mykis)的捕食。 英特威公司签署了一项合作研发协议(CRADA) 通过其努力，与美国鱼类和野生动物服务局(FWS)于2008年5月1日生效 水生动物药物批准伙伴关系(AADAP)计划，以支持新的 与水生动物有关的药物。根据这项协议，美国鱼类和野生动物管理局的水产 动物药品审批伙伴关系(AADAP)计划可以与CVM和其他顾问合作 (本例中为“指数”)代表英特威完成环境评估(EA) 用于淡水养殖鲑鱼的Slice®。如果英特威获得250,000.00美元的奖金 来自美国食品和药物管理局的小用途小物种(MUMS)赠款 计划，拨款将用于支付Exponent以完成使用Slice®的EA 淡水养殖的鲑鱼。Exponent以前有过使用EA的经验 Slice®在淡水鲑鱼和咸水中用于处理大西洋鲑鱼，并且是 熟悉有关该产品的现有数据和研究。详细的成本估算和时间表 对于EA，本申请中提供了补全功能。 对于这笔赠款，AADAP编写了EA完成协议，并于2月提交给CVM 2021年6月23日(2021年5月21日修订)，并于2021年6月3日获得云服务器验收。一个 题为“SLICE®(苯甲酸阿维菌素)的环境评估”的议定书副本 A类淡水养殖鲑鱼用药物品“和CVM接受通知书(I- 011370-H-0118-SP；2021年6月3日)。

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.