U2FFD007428

Path B NDA's continued implementation of FDA's Produce Safety Rule in Nebraska - NDA's continued implementation of FDA's Produce Safety Rule in Nebraska-Path B PAR-21-174 Summary/Abstract

The Nebraska Department of Agriculture Produce Safety Program (NDA PSP) will be pursuing Path B for this grant application to build upon the established Produce Safety Program in Nebraska. This is the path that the program is currently on and plans to remain so. There are no plans to implement the PSR into Nebraska state law; the NDA PSP will continue to operate under FDA authority.

The NDA PSP plans to conduct sprout inspections under Subpart M beginning in year 3. No NDA PSP staff has yet to be trained but there are plans to change that.

The program objectives are:
1. Expand NDA Produce Safety Program built during the initial 5-year grant.
2. Provide outreach and education to Nebraska growers.
3. Develop, train, and maintain NDA PSP staff.
4. Attend consortiums, conferences, and webinars annually as a team.
5. Utilize electronic inspection software for inspections.
6. Maintain, update, and build the electronic inventory program.
7. Inspect high priority covered farms every 3 years and low priority covered farms every 5 years.
8. Offer and provide on-farm readiness reviews prior to all inspections.

Expected outcomes: The program will continue their work to maintain and expand upon the electronic inventory, perform inspections of covered farms every 3-5 years based on priority, and will offer OFRRs annually. The program will capture regulatory inspection information utilizing electronic inspection software developed during the original five-year grant.

NDA's PSP will continue to act as a helpful resource to growers who are navigating the PSR through workshops, OFRRs, PSA trainings, and a variety of other outreach activities aimed at meeting the needs of Nebraska growers.

Program staff will remain fully trained and attend relevant events supporting professional growth and development within the program. Along with experience and FDA's guidance, training and events will positively impact the team's ability to maintain effective relationships with growers through outreach, education, and inspection.

Nebraska 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]

Lincoln, Nebraska 685216730 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 431% from $70,000 to $371,670.