Shellfish Safety Assistance Project

描述：(申请人提供) 州际贝类卫生会议(ISSC)建议与FDA/CFSAN合作，通过以下方式提高软体动物贝类计划的有效性和统一性：(A)改善联邦和州监管机构、行业和消费者之间的信息交流，(B)通过在程序和政策指导、技术培训、研究、消费者教育和确保符合国家贝类卫生计划等领域提供援助，加强国家活动；并提供对创伤弧菌和副溶血性弧菌的研究，创伤弧菌可以导致患有某些预先存在疾病的个人的严重疾病和死亡，副溶血性弧菌可以导致健康的个人和受影响的个人患病。这项研究旨在为建立以科学为基础的控制措施以保护消费者免受创伤弧菌和副溶血性弧菌感染提供信息。为了开展上述活动，ISSC将与FDA、代表环境和公共卫生机构的国家贝类控制官员、其他联邦机构以及来自工业界和学术界的代表进行具体合作。 标准 1)申请书清楚地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。 所有审查者都同意该应用程序演示并解决了 申请申请(RFA)中列出的目的和目标。申请者历史上证明了他们有能力加强FDA的贝类项目。申请人似乎在所有方面都更优秀，这从以前成立的相关委员会、小组委员会和工作组来证明，以解决RFA中所述的安全和研究事项。 虽然《框架协议》的目标很明确，但申请者未能提供所引用的具体目标的明确里程碑和时间表以及

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