Shellfish Safety Assistance Project

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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