Federal Consumer Protection Grants

The Food and Drug Administration (FDA)/ Center for Food and Safety and Applied Nutrition (CFSAN) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2024 to the Illinois Institute of Technology to support the Institute for Food Safety and Health (IFSH). The purposes of this continued support are to:1. Carry out multidisciplinary applied research projects on pre- and postharvest processing preventive control measures, on food processing and packaging technologies, on the impact of these processing strategies on the nutritional quality of food, and on laboratory method performance (including method validation) that address research needs associated with FDA-regulated products, fill knowledge gaps identified in prevention strategies, and that are consistent with the Deputy Commissioner of Foods vision for the implementation of the new Human Foods Program (HFP) Science and Research Strategic Plan;2. Maintain and facilitate the further development of the IFSH collaborative research program by leveraging resources among U.S. government agencies, universities (including other IIT components), and the food industry to achieve practical Food Safety Modernization Act (FSMA)-based, technology-enabled New Era of Food Safety solutions to food safety and food processing issues.3. Engage with stakeholders to develop and implement training, outreach and communication programs, to identify research needs, and to facilitate the use of the information produced by the research program; and4. Support the implementation of the new unified HFP FSMA-based New Era of Food Safety priorities through research, education, and outreach, with emphasis on the development of strategies for prevention, exploration of opportunities for data sharing, and adoption of root cause analysis (RCA) into agency post-response efforts associated with the safe and sustained manufacturing, processing, packing, and holding of food.

This grant invites private sector companies and organizations to collaborate with USAID on projects that address economic growth, financial inclusion, and environmental sustainability, leveraging their resources and expertise to achieve shared development goals.

The purpose of this cooperative agreement is to contribute to the knowledge base of and development of food safety systems globally due to the increasingly diverse and complex food supply. This cooperative agreement will:1) enhance and broaden FDAs ability to address global food safety and public health issues associated with food,2) provide opportunities to leverage additional resources among WTO member countries, and3) support the FDAs Food Safety Modernization Act (FSMA) and its International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety- related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety. 4) Support global research and capacity building to improve best practices to build effective food safety systems in low- and middle-income countries

The Pool Safely Grant Program funding opportunity assists states, local governments, and Native American Tribal Governments in implementing enforcement and education programs to prevent the drowning and drain entrapment of children in pools and spas.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a Cooperative Agreement to the Duke Universitys Duke Clinical Research Institute (DCRI) to support the Clinical Trials Transformation Initiative (CTTI).

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is announcing its intent to accept and consider continuation of the award of a grant to the American Society of Nephrology (ASN) to support the Kidney Health Initiative (KHI).

The purpose of the SNAP Fraud Framework Implementation Grant Program is to support State agency efforts to improve and expand recipient fraud prevention, detection, and investigation efforts using the procedures, ideas and practices outlined in the SNAP Fraud Framework.Organizational Management: This objective aims to help States establish and communicate priorities, organize employees, and manage both large-scale and day-to-day processes. Many of the concepts described in this component are the foundation for successful program integrity initiatives.Performance Measurement: This objective offers recommendations encouraging States to consistently capture and analyze their own performance.Recipient Integrity Education: This objective provides targeted integrity education initiatives to help ensure recipients have the necessary information and tools to use SNAP benefits as intendedpreventing fraud before it occurs. When producing recipient integrity education materials, States are encouraged to educate the public and applicants about SNAP fraud, rather than emphasize the consequences as a deterrent to applying.Fraud Detection: Here, the SNAP Fraud Framework stresses the importance of proactively detecting fraud from the application process and continuing throughout the recipients time in the Program.Investigations and Dispositions: This objective aims to provide states with tools and suggestions to improve fraud case management from initial fraud referral through disposition.Analytics and Data Management: This objective details the necessary people, processes, and technology to launch and maintain an analytics capability. Data analytics can play a valuable role in preventing, detecting, and investigating SNAP fraud.Learning and Development: The final objective contains recommendations for States to invest in training and professional development opportunities to promote employee engagement and to ensure employees are aware of new and emerging trends in fraud.Please read the entire request for applications (RFA) for additional information.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit grant applications from neutral, independent institutions and/or organizations to support meetings (e.g., conferences, workgroups, roundtables) that convene a broad range of multiple stakeholders, including those with relevant expertise, to explore, research, and address issues related to medical products, policy, and surveillance methods and systems. Support includes, but is not limited to the design, planning, execution, synthesis, summary, and communication of findings from these forums to a broad range of organizations and individuals.

Notice of Funding Opportunity Description Background The Food and Drug Administration (FDA) protects the public health by ensuring that medical products intended to be marketed in the United States are safe and effective for their intended use. FDA stakeholders are exploring innovative ways to produce scientific evidence in support of regulatory submissions, including the development of new data sources, study designs, methodologies, and technologies. FDA encourages and facilitates the use of such innovative approaches while ensuring that the scientific evidence supporting marketing approvals meet our high evidentiary standards. The Prescription Drug User Fee Act VII (PDUFA VII) commitment letter represents the product of discussions between the FDA, regulated industry, and public stakeholders, as mandated by Congress. The performance and procedural goals and other commitments specified in the PDUFA VII commitment letter apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. The commitment letter includes goals relating to the use of digital health technologies (DHTs) to support drug development and review. A DHT is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. DHTs may rely on or work with other technologies that support their operation, such as general-purpose computing platforms (e.g., smartphones) and communication networks. Among other activities relating to the use of DHTs, FDA has established a Framework for the Use of DHTs in Drug and Biological Product Development to guide the use of DHT-derived data in regulatory decision-making for drugs (hereinafter Framework ). The Framework highlights FDA’s DHT efforts including workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents. In addition, FDA’s webpage DHTs for Drug Development (available at: https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development) provides an overview of the ongoing DHT efforts, including demonstration projects. A variety of project types are welcomed under this NOFO, applicable to drugs and biologics (not devices). FDA is particularly interested in projects that evaluate the use of DHTs in drug development. Project Objectives The overarching goal of this notice of funding opportunity (NOFO) is to explore the role of DHTs (e.g., actigraphy, photography, environmental sensors) in the evaluation of new drugs. These projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The objectives of these projects are to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs and enhance convenience for trial participants by allowing for remote data acquisition in clinical investigations. The scope includes, but is not limited to, projects that focus on: Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of environmental sensors to capture apnea in pediatric patients) Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina) Capturing early manifestations of chronic diseases (e.g., dementia) through the use of DHTs

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.

The purpose of this cooperative agreement is to contribute to the knowledge base of and development of food safety systems globally due to the increasingly diverse and complex food supply. This cooperative agreement will: 1) enhance and broaden FDAs ability to address global food safety and public health issues associated with food, 2) provide opportunities to leverage additional resources among WTO member countries, and3) support the FDAs Food Safety Modernization Act (FSMA) and its International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety- related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety. 4) Support global research and capacity building to improve best practices to build effective food safety systems in low- and middle-income countries

The purpose of this NOFO is: 1) To facilitate long-term improvements to the national food safety system by strengthening interagency collaboration, improving the states;apos; regulatory and surveillance protection programs for manufactured foods, conducting research, and promoting the Manufactured Food Regulatory Program Standards (MFRPS); and 2) The continued development, implementation, management, and support of a funding system for those state and territorial agencies that have primary responsibility for regulating Grade A milk or molluscan shellfish (or both). Such agencies may apply and be sub-awarded funds to facilitate training, equipment purchases, or provide for other priorities needed to implement the Grade "A" Milk Safety program and the National Shellfish Sanitation Program (NSSP) within their respective jurisdictions.

FDA announces the availability of fiscal year (FY) 2024 funds to support one or more projects to 1) collect antimicrobial use data from diverse animal sectors, including domestic livestock, poultry, companion animals (dogs, cats, and horses), and minor species (e.g., fish, sheep, goats) and 2) contribute to the development of data collection frameworks, including providing data and expertise as resources and a public-private partnership frameworks are established. This grant will support the continued advancement of FDA;apos;s initiatives to support antimicrobial stewardship in veterinary settings. It will also support the National Action Plan objectives to engage the animal health community and relevant stakeholders to advance strategies intended to improve understanding of antimicrobial use and foster antimicrobial stewardship in animal agriculture.

This funding opportunity supports researchers in developing innovative tools that can speed up drug development and improve regulatory processes, ultimately enhancing public health by facilitating faster access to effective treatments.

This Notice of Funding Opportunity is issued to announce the availability of a Cooperative Agreement designed to assist the FDA in developing, implementing, and improving a nationally consistent system of support which facilitates the implementation of state and territorial produce safety regulatory programs that are modernized and aligned with the standards set forth in the FDAs Regulation: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (commonly referred to as the Produce Safety Rule).This goal shall be accomplished in partnership with the FDA by identifying, generating, sharing, and leveraging resources andinformation which aids in the development and implementation of national, state, and territorial produce safety regulatoryprograms that are nationally uniform and consistent with the Produce Safety Rule, and which improve their effectiveness andenhance their capabilities.

The purpose of the funding opportunity is to expand and advance FDA's Office of Minority Health and Health Equity (OMHHE) work with stakeholders and partners for education, outreach, and public awareness activities on potential risks from skin lightening products containing hydroquinone and/or mercury.Applicants will research and propose innovative and community-based strategies and activities that have the potential to strengthen the science base for education and public health awareness on the use of and potential risks from over-the-counter (OTC) skin lightening products.

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.

The purpose of this funding opportunity announcement (FOA) is to fund innovative research that will strengthen and advance minority health and health equity objectives.Areas of interest include:Proposals that focus on advancing equity in clinical trials by supporting efforts to advance diversity in clinical trials, equitable data efforts by increasing data available on diverse groups including, but not limited to, ethnicity, race, age, disability and geography, and equity of voices by increasing understanding of diverse patient perspectives, preferences, and unmet needs.

The FDA seeks an application to continue to maintain, manage existing consortia groups convened and established by the Critical Path Institute. This is a renewal of the cooperative agreement #5U18FD005320 as part of the Critical Path Initiative. This is in support of Critical Path Initiative introduced in Section 566 of the Federal Food, Drug, and Cosmetic Act. This includes developing innovative, collaborative projects in research, education, and outreach for fostering drug product innovation, enabling the acceleration of development, manufacturing, and translational therapeutics, enhancing safety, efficacy, quality, and performance. This funding opportunity will provide support, depending on availability of FDA funding.

This Notice of Funding Opportunity (NOFO) invites applications for a cooperative agreement to support, manage and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts. FDA and grantees will work together to develop innovative, collaborative projects in research, education, and outreach. These projects can help foster drug product innovation to 1) support efforts to accelerate drug product development; 2) support approaches to advanced manufacturing; 3) facilitate translation of basic science discoveries into therapeutics; and 4) facilitate approaches to enhance the safety, efficacy, quality, and performance of drug products. Projects are identified by FDA. Multiple awards may be funded under this NOFO and are directly dependent on drug development priorities and subject to the availability of funding.