U2FFD007439

Path C ADAI will continue to maintain a produce safety regulatory program to encourage the safe production of covered produce while using Path C as a guide to complete all objectives specified.

Program Summary

The Alabama Produce Program will not only help to sustain the produce industry but will assist Alabama producers in growing the industry in the face of regulations and evolving market expectations. By aiding produce farms of all sizes and stages of development to meet food safety requirements, access markets, and promote public health as sustainable agricultural businesses, our program will have a significant impact.

By focusing on outreach and education, technical assistance, as well as compliance, our program will assist all growers to adopt and implement on-farm food safety practices, furthering the Food Safety Modernization Act's vision of preventing foodborne illness. Continued assessment of the produce landscape in Alabama, while focusing on produce covered under the Produce Safety Rule (PSR) and determining the continued need for resources, will be instrumental in the continued implementation of the produce program.

With farm inventory being the basis for program planning, establishing a complete and accurate inventory of produce farms will assist in implementing corresponding objectives in the CAP program. Maintaining the current inspection program in place ensures that ADAI is working together with all produce programs nationwide in an integrated way to achieve our public health goals. By working together nationally, ADAI will focus on quality and consistency in developing and updating Standard Operating Procedures (SOPs) related to the inspection program. ADAI will work to prioritize inspections according to produce safety inspections assignment by using the PDAT tool and 'WINWAM software to pull the data needed for prioritizing inspections.

Continued development of ADALS compliance and enforcement program will be tailored to program Path C and the objective guidance provided by FDA. ADAI will utilize written procedures for conducting compliance and enforcement activities that establish a risk-based process to determine when a directed investigation, follow-up, or re-inspection is needed. A framework for compliance and enforcement progressive actions will be achieved by utilizing the current compliance and enforcement guidance available.

The development of the ADAI Produce Safety Program will involve a multi-year process. It is recognized by the Food Safety Division that developing a new produce safety program and achieving alignment with the Produce Safety Rule will require a further comprehensive self-assessment. This process will involve efforts to focus on continuous program improvement and innovation throughout and well beyond this 5-year grant period.

Alabama Department Of Agriculture & Industries

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]

Alabama United States

State-Wide

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 354% from $687,840 to $3,123,149.