Cooperative Agreement to Support the Western Center for Food Safety (U19) Clinical Trials Not Allowed

Background
The U.S. Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2023 to the University of California-Davis (UC Davis) to support the Western Center for Food Safety (WCFS). The purposes of this continued support are to carry out multidisciplinary applied research addressing 'real world' issues related to food safety and food defense, agricultural practices, and the impact of agricultural practices on subsequent food processing associated with FDA-regulated products; develop and implement outreach and communication programs to facilitate the utilization of the knowledge produced by the research program; provide opportunities to leverage additional resources among U.S. government agencies, non-governmental organizations, universities, industry, and consumers to achieve real-world solutions that address food safety and food defense issues; and support the implementation of the Food Safety Modernization Act (FSMA) through research, education, and outreach with particular emphasis on the science behind the standards associated with the produce safety and preventive controls regulation.

Grant Details
The partnership between WCFS and FDA over the past 10 years has been very productive in supporting FDA's public health mission by conducting studies that address knowledge gaps surrounding the safe production of agricultural foods and education/outreach activities that provide the agricultural sector with science-based information about food safety best practices. The partnership has become increasingly important as FDA continues to fulfill its mandate to develop a prevention based food safety system under the FSMA law of 2011, specifically in regards to the standards for the produce safety and preventive controls regulations which were finalized in 2016. The research, education, and outreach provided via the partnership will enhance the ongoing implementation efforts of these regulation standards which will enable stakeholders to better achieve compliance. The Agency's research strategy involves identifying and prioritizing its research needs based on its policy making and implementation activities which include the development of critical guidance documents that accompany the regulations. The research strategy also includes addressing needs that emerge from root cause analyses that are conducted as follow up to outbreaks. WCFS has played a key role in conducting studies that were used to inform policy, including the produce safety and preventive controls standards, and will continue to do so as the Agency further implements FSMA and food safety activities, more broadly.

Eligibility Requirements
Competition is limited to the University of California - Davis (UC Davis), Western Center for Food Safety (WCFS). Foreign Institutions are not eligible to apply. Non-domestic components of U.S. Organizations are not eligible to apply. Foreign components are not allowed.

Period of Performance
The cooperative agreement will provide one (1) year of support with future recommended support for four (4) additional years contingent upon annual appropriations, availability of funding, and satisfactory recipient performance. The maximum project period is five (5) years.

Grant Value
$2,500,000 in FY 2023 for one (1) award. The total award budget should not exceed $3,000,000 per year for five years.