FDA FERN Microbiological Cooperative Agreement Continuation Program

FDA-Fern微生物合作协议续 申请（U18）资助 项目摘要 这项来自俄亥俄州农业部（ODA）的拨款提案是在 对食品和药物管理局的资助机会公告（FOA）的回应 美国食品药品监督管理局（FDA）食品紧急反应网络（FERN）。 本提议的目标是加强快速部署能力和 FERN用于检测食品中的微生物病原体 传染病爆发或大规模食品紧急事件。的目的 ODA消费者保护实验室（CPL）食品 微生物实验室是对微生物实验室的补充、发展、完善和利用， 实验室应对以下事件的能力： 需要实验室快速反应能力。将向FERN和 FDA用于与微生物污染相关的分析， 有意或无意的引入，提供7天24小时服务， 周回答。 该提案涉及林业发展局确定的三个关键项目领域， 这个项目的关键功能作为提案的一部分， 提供了实验室设施的视图，并补充了 实验室支持服务和校园安全计划。实施 建议书中概述的项目，资格和工作经验 CPL的工作人员也介绍了。此外，实验室管理规范 也有详细的解释。 这项拨款提案也解决了FDA对样品分析的要求 承诺以及实验室将数据输入 eLEXNET并及时将分析结果通知FERN。 几个附加文件，如能力验证计划（PT） 已沿着

FDA-FERN MICROBIOLOGICAL COOPERATIVE AGREEMENT CONTINUATION PROGRAM (U18) GRANT PROPOSAL Project Summary This grant proposal from the Ohio Department of Agriculture (ODA) is in response to a Funding Opportunity Announcement (FOA) from the Food and Drug Administration (FDA) Food Emergency Response Network (FERN). The goal of this proposal is to enhance the surge capacity and the capability of the FERN for the detection of microbiological pathogens in response to a food borne disease outbreak or a large scale food emergency event. The purpose of this application from ODA's Consumer Protection Laboratory's (CPL) Food Microbiology laboratory is to complement, develop, improve and utilize the capacity and capability of the laboratory in response to an event during which laboratory surge capacity is needed. Support will be provided to FERN and the FDA for analyses related to microbiological contamination, resulting from either intentional or unintentional introduction with availability of a 24 hour - 7 days a week response. This proposal addresses the three key project areas that FDA has identified as the critical functions integral to this project. As part of the proposal, a detailed view of the laboratory facilities is provided and supplemented with details of the laboratory support services and the campus security plan. To implement the projects outlined in the proposal, the qualifications and the work experience of CPL's staff is also presented. Additionally, the laboratory management practices are also explained in great detail. This grant proposal also addresses the FDA request for sample analysis commitment as well as the laboratory's ability and willingness to enter data into eLEXNET and notify FERN of analytical results in a timely manner. Several additional documents such as the Proficiency Testing Schedule (PT) have been provided along with the