Consumer Protection Grants

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

The Massachusetts Department of Agricultural Resources administers the Food Security Infrastructure Grant Program to strengthen the local food system, enhance equitable access to locally produced food, and improve resilience to supply and distribution disruptions. The program connects farmers, fishermen, and local producers to markets and builds the infrastructure required to produce and distribute healthy food efficiently and safely. Eligible projects are capital in nature and may include equipment purchases, contracted labor for implementation, and planning and design costs directly tied to capital improvements. Projects must address systemic inequities and expand access to fresh local food while improving the resiliency of the Commonwealths food system. Maximum funding per applicant is 500,000 dollars in both agriculture and local food system tracks. Applicants may be individuals, for profit entities, nonprofit organizations, municipalities, or other governmental entities that can meet application requirements and enter into contracts with the department. The grant period runs from July 1, 2024 to June 30, 2025, and projects must be located within Massachusetts with benefits to residents statewide. Applications are due May 2, 2024. Additional information is available from the Massachusetts Department of Agricultural Resources.

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 grant provides funding and resources to organizations seeking to establish or enhance recycling programs, focusing on waste diversion and recycling education.

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 program provides a 50% matching grant to eligible businesses that are located within an Economic Development Target Area (EDTA). The purpose is to improve the appearance of their building and the surrounding site. By visually enhancing the exterior of buildings, businesses increase their property values, maintain their marketability, and demonstrate confidence. The CFG program works to assist those owners to promote reinvestment, strengthen Fort Wayne’s commercial activity and enhance economic vitality in the City’s heart. Program Objectives Maintain vibrancy of core commercial areas by encouraging investments that enhance the visual aesthetics of commercial properties and lead to increased property values. Stimulate economic development by providing incentives to increase existing business investment, ensure business sustainability and create aesthetically pleasing areas that attract new business and consumers. Complement other revitalization efforts to ensure the maximum leverage of resources. Support local businesses and encourage local entrepreneurship, to further enhance the spirit of Fort Wayne

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.

This grant provides funding for projects that promote financial education and inclusion, particularly for underserved communities, through innovative programs and research initiatives.

The Specialty Crop Assistance program, administered by the Florida Department of Agriculture and Consumer Services (FDACS), provides assistance for eligible expenses related to COVID-19 that benefit the production and distribution of Florida specialty crops. Eligible expenses include Personal Protection Equipment (PPE) and facility adjustments for worker and product safety. The program is open to specialty crop growers, processors, and distributors. Funding is provided through the Specialty Crop Block Grant Program, with a minimum reimbursement of $565.00 and a maximum reimbursement of $300,000.00 over the life of the project. The program has a total fund availability of $2,735,124.99, and applications will be processed on a first come first served basis until funds are depleted. The last day to apply for assistance is September 1, 2025. To apply, organizations must register as a state vendor at www.myfloridamarketplace.com, provide a substitute W9 form to the Florida Department of Financial Services, register or login to the FDACS online portal, complete and upload the HR133 Assistance program application to the FDACS online portal, and upload proof of purchase such as invoices marked 'paid', cancelled checks, or other substantial documentation of costs to be reimbursed. Eligible items for reimbursement include various PPE items and facility adjustments for worker and product safety. For additional questions, applicants can contact Kimberly Murphy at (850) 617-7397 or email [email protected].

This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs.Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants.The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516.FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application.

The purpose of this FOA is to develop and maintain Rapid Response Teams (RRTs) to facilitate long-term improvements and innovation to the national integrated food safety system by unifying and coordinating federal/state/local human and animal food (HAF) emergency response efforts including:1) Strengthening the link among epidemiology, lab and environmental health/regulatory components;2) Improving States' regulatory and surveillance HAF protection programs to include using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards HAF emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts; and3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national response capacity/capability development.

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.

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.

The intended outcome of this Notice of Funding Opportunity (NOFO) is to advance efforts for a nationally Integrated Food Safety System (IFSS) by supporting Manufactured Food Regulatory Program Standards (MFRPS), Food Protection Task Force (FPTF) programs, Dietary Supplement (DS) programs, and special projects. For the purposes of this NOFO, the term state encompasses all eligible organizations as defined in Section 3. MFRPS Development or Maintenance: The purpose of this Notice of Funding Opportunity (NOFO) section is to advance efforts for a nationally Integrated Food Safety System (IFSS) by assisting state manufactured food regulatory programs to achieve and maintain conformance with the most current version of the Manufactured Food Regulatory Program Standards (MFRPS). The MFRPS are intended to ensure that state manufactured food regulatory programs implement a high-quality regulatory program through the development and maintenance of a regulatory framework that builds on and emphasizes mutual reliance with all programs. Also, the program standards are intended to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. Conformance with these program standards will help federal and state programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods. Food Protection Task Force (FPTF): The purpose of this funding option is to establish and/or support a Food Protection Task Force (FPTF) with diverse membership representative of stakeholders across the state that is responsible for promoting the integration of an efficient statewide human and animal food (HAF) protection system that addresses state and region-specific needs and that maximize the protection of the public health. These efforts include: establishing a food safety/protection network of subject matter experts, fostering educational opportunities, developing replicable resources and systematically fostering communication, education, outreach, cooperation and collaboration within the states among federal, state, local, tribal and territorial HAF protection, public health, agriculture, and regulatory agencies, industry, academia, and consumers to initiate and/or support HAF protection activities to improve public health. A strong FPTF can also help improve human and animal food emergency surveillance, response, and post-response systems by focusing on preparedness, building strong communication channels, and establishing relationships with key players before food-related incidents occur. Dietary Supplements: The goal of this funding option is to facilitate the development of state driven dietary supplement regulatory framework and programs. The overall objective of this funding opportunity is to advance the adoption and implementation of the cGMPs for Dietary Supplements Rule codified at 21 CFR Part 111. Specifically, this track will provide funding support for dietary supplement training and program development activities. Special Projects: The purpose of this funding option is to develop and implement special projects that support innovation and integration in a IFSS using the MFRPS framework. This track will support other emerging food safety priorities that develop over the lifespan of the project. State programs will be expected to share project deliverables and resources developed with other programs.

The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. FDA has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited. The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including (but not limited to) the selection of an appropriate comparator(s) and outcome measures, statistical analyses etc. Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.

This funding opportunity supports small, volunteer-run organizations with annual incomes under £350,000 that are working on grassroots projects for long-term social change and non-violent action.