Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed

Notice of Funding Opportunity Description The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)is announcing the availability of up to $1,125,000 in FY 2024 to be awarded under Limited Competition to State animal food regulatory programs. The intended outcome of this NOFO is to advance efforts for a nationally integrated animal food safety system through the implementation and advancement of the Animal Food Regulatory Program Standards (AFRPS) by State animal food regulatory programs. Applicants must refer to the Eligibility section of this NOFO to determine which funding track they should apply for: AFRPS Development or AFRPS Maintenance. Applicants should take sustainability into account when designing projects proposed under this cooperative agreement to maximize the longevity of resulting outcomes, resources, and program infrastructure beyond the end of the project period. The AFRPS allows for the development of risk-based animal food safety programs by establishing a uniform basis for measuring, evaluating, and improving the performance of State animal food regulatory programs in the Unites States. By achieving and maintaining implementation of these program Standards, Federal and State food regulatory programs can better direct their regulatory activities toward preventing animal food safety hazards, that can cause illness or injury to animals or humans, in facilities that manufacture, process, pack, or hold animal food materials/supplies. Consequently, the safety and security of the United States animal food supply and protection of human public health will improve. The AFRPS are comprised of eleven Standards (See link below in Program Goals Section) which establish foundations for the critical elements that serve as an objective framework to evaluate and improve components of a State animal food program. These elements cover the State animal food program's regulatory foundation, training, inspection program, auditing, animal food-related illness or death and emergency response, enforcement program, outreach activities, planning and resources, laboratory services, sampling program, and assessment and improvement of Standard implementation. Achieving and maintaining implementation of the program Standards will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation. FDA recognizes that the time required for achieving full implementation of the AFRPS will vary between States. However, all State animal food regulatory programs will be expected to implement improvement plans to ensure continuous improvement and demonstrate that they are moving towards full implementation. State animal food regulatory programs receiving funds under this cooperative agreement will be expected to achieve and maintain full implementation within 5 total year or less of funding under an AFRPS Cooperative Agreement(s). Grantees will achieve and maintain implementation with the AFRPS (most recent published version). For the purpose of this funding opportunity, "full implementation" is defined as the State animal food regulatory program having all elements, systems, and programs, as required in the Program Elements and Documentation sections of the AFRPS; and can demonstrate the use of those elements, systems, or programs. If implementation is not achieved by the end of funding year 5, the State program will provide a detailed improvement plan on how the remaining AFRPS elements and documentation requirements will be fully implemented and demonstrated. The improvement plan will include: A detailed timeline including what needs to be accomplished to implement the element and/or documentation requirement, and when the work will be completed. The outcomes of the work provided under this cooperative agreement are as follows: 1. State animal food regulatory programs will take significant steps to achieve and maintain implementation of the AFRPS, which is recognized as a critical element to creating a national, fully integrated food safety system. 2. State animal food regulatory programs will contribute to the continuous improvement of the AFRPS through attendance at an annual face-to-face meeting, active participation in committees, and other initiatives supporting the AFRPS. 3. Develop strategies for achieving and maintaining implementation of the AFRPS that can be replicated or leveraged across state programs to promote national consistency. 4. Provide a foundation for supporting advisory/regulatory action based upon findings of regulatory activities conducted by State animal food regulatory programs. Only the following State animal food programs will be eligible to apply: State animal food regulatory programs with current FDA animal food safety inspection contracts (providing funding to State animal food regulatory programs) and are also enrolled in the AFRPS, or those that apply for an FDA animal food safety inspection contract and enroll in the AFRPS, are eligible to apply for funding under this cooperative agreement. An animal food safety inspection contract must be executed prior to this cooperative agreement being awarded. A condition of the award will be maintaining a current FDA animal food safety inspection contract in satisfactory condition throughout the cooperative agreement project period. The FDA will provide one year of funding for this project with the hopes of making another NOFO in FY 2025 to help align project objectives, outputs, reporting, terms and conditions, and project periods for all AFRPS project awardees, and to provide continued funding for awardees under this project to achieve the objectives of the project. The anticipated release of another NOFO in FY2025 will also help align project periods for awardees under this NOFO as well as those currently awarded under PAR-20-132 (for which the project period and funding will end on 6/30/2025). For AFRPS, it is anticipated that full implementation of the AFRPS will be achieved within 5 total funding years under an AFRPS Cooperative Agreement(s), based on a verification audit of your program to ensure the elements have been implemented.