Scope: The University of Kentucky Division of Regulatory Services (UKDRS) Continued Development of a Risk-Based Animal Feed Inspection Program

Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed Division of Regulatory Services University of Kentucky Funding Opportunity: PAR-20-132 Agency: Food and Drug Administration (FDA) Funding Type: Cooperative Agreement Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed UKDRS Summary The University of Kentucky Division of Regulatory Services has achieved full implementation of the Animal Feed Regulatory Program Standards (AFRPS) and is currently in the Maintenance phase. We now seek additional funding under this cooperative agreement for the Optional Coordinated Preventive Control Regulatory Activities and Capacity Building to continue improving our feed regulatory program. This will allow UKDRS to maintain best practices, enhance food safety, and better direct regulatory efforts to reduce foodborne illness attributed to feed safety hazards. Funding is required to accomplish deliverables required under this PC capacity building option; however, UKDRS is not seeking the full amount available. UKDRS has been able to build the program efficiently and effectively during the AFRPS implementation and maintenance cooperative agreements to confidently project full implementation of the PC option within 3 years. Biosketches of staff members that currently hold the Executive Director, Feed Program Director, and AFRPS coordinator positions within UKDRS have been provided in the Senior/Key Personnel Profile section of this submission to demonstrate the degrees and experience appropriate for leading the fulfillment of this work. The University of Kentucky, Division of Regulatory Services (UKDRS) is already in the process of building capabilities and capacities to perform cGMP and PC regulatory work activities under state authority. UKDRS has accomplished deliverables required for year 1 and 2 of the PC inspection and compliance program coordination and development. We only seek funding for years 3-5 to fully develop the state program. This additional funding will allow UKDRS to incorporate personnel infrastructure essential for program capabilities for compliance and outreach related to preventive controls for animal food, add new technology and software for defensible documentation processes, and complete Phase 2 and 3 audits as described in Field Management Directive (FMD)-76.