Shellfish Safety Assistance Project

说明：（申请人提供） 州际贝类卫生会议（ISSC）建议与FDA/CFSAN合作，通过（a）改善联邦和州监管机构、行业和消费者之间的信息交流，以及（B）通过在程序和政策指导、技术培训、研究、消费者教育、并保证遵守国家贝类卫生方案;并规定对创伤弧菌和副溶血弧菌进行研究，创伤弧菌可导致患有某些预先存在的疾病的人患上严重疾病和死亡，副溶血弧菌可导致健康人以及受损的人患病。 本研究旨在提供信息，以建立科学的控制，以保护消费者免受创伤弧菌和副溶血性弧菌感染。 为了开展上述活动，ISSC将与FDA、代表环境和公共卫生机构的州贝类控制官员、其他联邦机构以及工业界和学术界的代表进行具体合作。 标准 1)申请书明确说明了对安全计划和弧菌研究合作协议的目的和目标的理解。 所有评审员都认为，该应用程序展示并解决了 申请表（RFA）中列出的目的和目标。 申请人已经证明了他们有能力加强FDA的贝类项目。 申请人在所有方面均表现出上级，这可通过之前建立相关委员会、小组委员会和工作组来解决RFA中所述的安全性和研究问题来证明。 虽然RFA的目标明确，但申请人未能为所引用的具体目标提供明确的里程碑和时间表，

DESCRIPTION: (Provided by applicant) The Interstate Shellfish Sanitation Conference (ISSC) proposes to work cooperatively with FDA/CFSAN to enhance both the effectiveness and uniformity of the molluscan shellfish program by (a) improving information exchange between Federal and State regulatory agencies, industry, and the consumer, and (b) strengthening State activities by providing assistance in such areas as procedural and policy guidance, technical training, research, consumer education, and the assurance of conformity to the National Shellfish Sanitation Program; and provide for research on Vibrio vulnificus, which can cause serious illness and death in individuals with certain preexisting conditions and on Vibrio parahaemolyicus, which can cause illness in healthy individuals as well as compromised individuals. This research is intended to provide information to establish science-based controls to protect the consumers from Vibrio vulnificus and Vibrio parahaemolyticus infection. To carry out the above activities ISSC will cooperate specifically with FDA, the State shellfish control officials representing both environmental and public health agencies, other Federal agencies, and representatives from industry, academia. CRITERIA 1) The application clearly states an understanding of the purpose and objectives of the cooperative agreement regarding the safety program and Vibrio research. All the reviewers agreed that the application demonstrates and addresses the purpose and objectives listed in the Request for Applications (RFA). The applicant has historically proven their ability to enhance FDA's shellfish program. The applicant appears superior in all respects, evidenced by the previous establishment of relevant committees, subcommittees, and workgroups to address the safety and research matters described in the RFA. While the objectives of the RFA are clear the applicant failed to provide distinct milestones and timelines for the specific aims cited as well as