U2FFD007442

Path B Implementation of the FDA Produce Safety Rule in Delaware - Project Summary

Project Title: Implementation of the FDA Produce Safety Rule in Delaware.

Project Description: We intend to continue the implementation of the FDA's Produce Safety Rule within Delaware by choosing Program Path B. Continuing the success of this project will be an effort through the Delaware Department of Agriculture along with the help of the University of Delaware Cooperative Extension, Delaware State University Cooperative Extension, Delaware Fruit & Vegetable Growers Association, as well as state agencies and extension in the neighboring states. This plan will include education and training for produce farmers covered under the rule, as well as a regulatory program which will include regulator training.

Project Goals: The project will develop a project plan for alignment of Delaware Department of Agriculture's regulations and activities with FDA's Produce Safety Rule. Goals include improving farm registration of covered produce farms, improving documentation, conducting routine produce safety inspections, providing farmers with education of, and training on, the Produce Safety Rule, completing an assessment of Delaware Department of Agriculture's regulatory authority for produce safety and the resources needed to continue a successful program.

Expected Outcomes: We believe that the partnerships and plans that will emerge from the work outlined in this proposal will create a federal-state relationship which will leverage the existing expertise, knowledge, and resources of the Delaware Department of Agriculture along with the University of Delaware & Delaware State Cooperative Extension and regional state partners within the Delmarva Peninsula, resulting in consistent and successful on-farm inspections as envisioned by FSMA and the FDA.

Project Objectives:
1. Program Documentation
2. Program Administration
3. Education, Outreach, and Technical Assistance
4. Farm Inventory
5. Inspection Program
6. Compliance and Enforcement
7. Produce Related Event Response Planning and Implementation

Budget: $350,000 for year one, $350,000 for year two, $350,000 for year three, $350,000 for year four, and $350,000 for year five, totaling $1,750,000 for the five-year grant period.

State Of Delaware Department Of Agriculture

TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

FDA Office of Regulatory Affairs (ORA) [HHS - FDA]

Dover, Delaware 199015515 United States

Single Zip Code

The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed (PAR-21-174)

Amendment Since initial award the total obligations have increased 280% from $350,000 to $1,328,560.