Analyses of animal food or drug related illnesses and large-scale animal food/fee
Analyses of animal food or drug related illnesses and large-scale animal food/fee
批准号:
8502903
负责人:
YAN ZHANG
金额:
$1.65万
依托单位国家:
美国
项目类别:
财政年份:
2012
资助国家:
美国
项目状态:
已结题
起止时间:
2012-09-01 至 2017-08-31
中文摘要
FDA CVM VET-LRN 计划 (U18) 拨款提案
对于 FOA # PA-12-194
摘要
俄亥俄州农业部 (ODA) 的这项拨款提案是为了响应
美国食品药品监督管理局 (FDA) 的资助机会公告 (FOA)
(FDA) 兽医中心 (CVM) 兽医实验室响应网络
Vet-LRN 计划 (U18) FOA 的研究# PA-12-194。
ODA 动物疾病诊断实验室 (ADDL) 提出此提案的目的
旨在解决以下三个关键项目领域:
1. 参与FDA/Vet-LRN样品分析,涉及动物食品或
药物相关疾病或其他大规模动物食品/饲料紧急情况
需要对相关诊断或动物食品进行浪涌能力测试的事件
样品。
2. 使用标准化方法、设备平台提供分析数据,
和电子结果报告方法。参与熟练程度
Vet-LRN 项目办公室 (VPO) 提供测试和方法培训
在兽医中心并实施标准化
实验室质量管理体系。
3. 参与小规模方法开发、方法验证和
矩阵扩展工作由 VPO 确定。
许多人预计该提案中概述的项目将成功实施
原因包括 ADDL 专业技术人员的丰富经验
工作人员。介绍了技术专业人员和工作人员的资格。作为一部分
提供了该提案、实验室设施和质量体系的详细视图。
该拨款提案还解决了 CVM 对样本分析承诺的请求:
以及实验室完成拟议研究的能力和意愿
及时的方式。一些附加文件,包括内部标准操作
程序(SOP)、能力验证(PT)结果和AAVLD证书
认证与项目叙述一起提供,以展示实验室的
提供开展该项目的能力和能力。我们有信心
我们能够实现该项目的目标并期待有工作机会
与 FDA 和其他实验室一起启动。
英文摘要
FDA CVM VET-LRN PROGRAM (U18) GRANT PROPOSAL
FOR FOA # PA-12-194
Abstract
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's
(FDA) Center for Veterinary Medicine (CVM) Veterinary Laboratory Response Network
Study for the Vet-LRN Program (U18) FOA # PA-12-194.
The purpose of this proposal from ODA's Animal Disease Diagnostic Laboratory (ADDL)
is to address the following three key project areas:
1. Participation in FDA/Vet-LRN sample analysis in the event of animal food or
drug related illnesses or other large-scale animal food/feed emergency
events requiring surge capacity testing of implicated diagnostic or animal food
samples.
2. Providing analytical data using standardized methods, equipment platforms,
and electronic results reporting methodologies. Participation in proficiency
testing and method training provided by the Vet-LRN Program Office (VPO)
at the Center for Veterinary Medicine and implementation of standardized
quality management systems for laboratories.
3. Participation in small-scale method development, method validation and
matrix extension work as determined by the VPO.
A successful implementation of the project outlined in the proposal is predicted for many
reasons including the extensive experience of the ADDL's professional and technical
staff. The qualifications of the technical professional and staff are presented. As part of
the proposal, a detailed view of the laboratory facilities and quality system are provided.
This grant proposal also addresses the CVM request for sample analysis commitment as
well as the laboratory's ability and willingness to complete the proposed research in a
timely manner. Several additional documents including the internal Standard Operating
Procedures (SOP), Proficiency Testing (PT) results, and certificate of AAVLD
accreditation are provided along with the project narrative to showcase the laboratory's
ability to provide the capacity and capability to conduct the project. We are confident that
we can meet the objectives of this project and look forward to the opportunity to work
with the FDA and other labs in its initiation.
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