U2FFD007404

Path C Indiana Produce Safety Cooperative Agreement Program (CAP) - Project Summary

Over the next project period, the Indiana Produce Safety Team plans to take a research-to-practice approach with the intent to further advance the current program standards, ensure the produce inspection program is consistent with national standards, and promote acceptance and understanding of rule requirements among growers through education and outreach activities.

It is also expected that with detailed planning, collaboration with industrial partners and other regulatory agencies, Indiana can further advance its efforts towards achieving a national integrated food safety system through the implementation of the FDA Produce Safety Rule (PSR) (21 CFR 112).

Indiana Department of Health (IDOH), as a Path C applicant, is committed to implementing the PSR and conducting produce safety inspections under Indiana state authority (Indiana Code § 16-42-3.5). This statute can be found at http://iga.in.gov/legislative/laws/2020/ic/titles/016/#16-42-3.5 with key provisions including the following: adoption of FDA's Produce Safety Rule by reference that authorizes the IDOH regulatory team to implement the PSR as per 21 CFR 112 standards (may not be more stringent than written), and the state may suspend the implementation of the rule if the federal government does not provide sufficient funds to administer and enforce the requirements in 21 CFR 112.

Regarding sprout inspections (Subpart M), the Indiana regulatory team plans to continue to follow the lead of the FDA Detroit Office of Regulatory Affairs to set the ongoing inspection schedule. The Indiana Produce Safety Team's goal is to begin sprout farm inspections once inspectors are sufficiently trained.

Lastly, over the next 5 years, IDOH aims to verify 100% of the 2088 produce farms using the 2017 USDA National Agricultural Statistical Services (NASS) data as a baseline, educating and/or connecting with 1773 produce farms, and use the "inspection frequency" and "risk-based prioritization" models to inspect farms in the top 30% of the prioritization list every three years, and the remaining every five years. Annual target farm inspections are estimated at 20% of Indiana's non-exempt covered farms, which is approximately 54 farms based on the 2017 NASS data, and with 11 follow-up inspections.

Indiana plans to follow the Band 5 for "Education and Inventory" and Band 6 for "Regulatory" funding assignments for year 1 and 2, and then revise its ongoing operational needs based on the updated farm inventory development data.

Indiana Department Of Health

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]

Indianapolis, Indiana 462043010 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 301% from $600,500 to $2,409,126.