Grants for State governments - Consumer Protection

This grant provides funding for individuals and organizations in Washington, DC, to create projects that celebrate and preserve the culture and heritage of local communities, culminating in a public event to showcase their work.

This program provides financial assistance to small business and commercial property owners in Jackson, Mississippi, to improve the appearance of their buildings and attract more customers and investors.

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.

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 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 individuals and organizations in Washington, DC, to document and preserve the oral histories of local residents, focusing on community collaboration and culturally significant themes.

This funding opportunity supports a national initiative to educate and empower Medicare beneficiaries and their families against fraud and abuse, by providing resources and training to organizations dedicated to this mission across the U.S. and its territories.

This funding opportunity provides financial support to state, local, and tribal governments to prevent childhood lead poisoning and improve blood lead level surveillance in high-risk communities.

Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products. To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.

The Greenhouse Accelerator Program Juntos Crecemos Edition is a five-month, mentor-guided program to support the acceleration of emerging Hispanic food and beverages innovations that are transforming the way consumers live their lives. Donor Name: PepsiCo State: All States County: All Counties Type of Grant: Program Deadline: 05/06/2024 Size of the Grant: $10,000 to $100,000 Grant Duration: Grant Duration Not Mentioned Details: This edition is an extension of the initial Greenhouse Accelerator program launched in 2018, in collaboration with PepsiCo Juntos Crecemos, part of PepsiCo’s Pep+ transformation agenda, designed to provide short and long-term support to Hispanic small businesses. The mission is to identify up to 8 high-potential emerging Hispanic-owned food and beverage consumer packaged goods small businesses. Driving growth for Hispanic founders in the food and beverage industry with operating businesses in the U.S. Program Benefits What the Greenhouse Accelerator can offer you: Grants Guaranteed $20,000 USD grant for each finalist. Winner awarded an additional $100,000 USD Guidance Expert guidance and learning modules across all aspects of business development Network Access and exposure to PepsiCo network and resources, industry experts, VCs and investors Collaboration Unlocking of potential collaboration opportunities with PepsiCo Mentorship Hands-on mentorship and support for refining business models, fortifying strategies, and enhancing impact Growth Accelerated pathways to launch, scale, and grow your breakthrough innovations. Eligibility Requirements  Net-revenue between $100,000 to $2,000,000 USD in the last financial year Be a Hispanic-owned business licensed and operating in the United States Be willing to work with PepsiCo Greenhouse Accelerator mentors and public relations team throughout six-month Accelerator program and attend Accelerator events. An external third party will review all submissions. The selection committee will choose finalists based on the following criteria: A clear go-to-market strategy and plan for sustained in-market execution Post-prototype, ready for review with a multinational corporation or company Uniqueness in the market Balanced gender and ethnic diversity Clear & active social responsibility mission aligned with PepsiCo’s Juntos Crecemos Strategy Aligned with PepsiCo’s PepsiCo Positive Strategy Scalable business model. For more information, visit PepsiCo.

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.

The "Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required" grant aims to fund clinical trials that test the effectiveness and safety of new treatments for rare diseases, with the goal of increasing the number of approved treatments for these conditions.

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo chemically controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereo chemically pure form; 2) assessment of the biological activity of each stereo chemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs.

The ConnectALL Initiative is accepting applications for its Municipal Infrastructure Program to support the development of open-access and publicly owned and/or controlled last mile fiber broadband infrastructure to deliver reliable high-speed internet service to homes, businesses, and community anchor institutions across the state. Donor Name: ConnectALL Initiative State: New York County: All Counties Type of Grant: Grant Deadline: (mm/dd/yyyy) 08/12/2024 Size of the Grant: More than $1 million Grant Duration: Grant Duration Not Mentioned Details: The mission of the New York State Urban Development Corporation d/b/a Empire State Development (“ESD”) is to promote a vigorous and growing state economy, encourage business investment and job creation, and support diverse, prosperous local economies across New York State (“NYS”) through the efficient use of loans, grants, tax credits, real estate development, marketing, and other forms of assistance. To support broadband access for communities across the state, ESD’s ConnectALL Office (“CAO”), offers a Municipal Infrastructure Program (“MIP”) Request for Applications (“RFA”).  Through this RFA, CAO intends to establish the Municipal Infrastructure Program (“MIP”) to support the development of open-access and predominantly publicly controlled last mile fiber broadband infrastructure that will directly connect homes, businesses, and community anchor institutions to reliable high-speed internet service, using funding from the U.S. Department of Treasury Capital Projects Fund (“CPF”). The objective of this RFA is to improve broadband access in communities across the state facing connectivity challenges due to the lack of affordable, high-speed internet infrastructure. Funding Information Total funding available: $228 Million Grant size: $30 million max per award Eligible Uses of Funds Eligible uses for program funding include construction of new infrastructure or acquisition of existing infrastructure under the following categories:  Last mile fiber connections to address: Last mile infrastructure: The cabling, wires, necessary pole replacements and make-ready and/or radios that ISPs use to distribute the internet from local Internet Exchanges to network and/or customer endpoints.  Drops to a building: The cabling or wires necessary to make the connection from passing fiber or cable on a street pole or in-street conduit into a building structure.  Fiber connections to Internet Exchange Points or Data Centers:  Middle mile fiber: The fiber necessary to transport internet services to a local Data Center where an Applicant is connecting its CPF-funded last mile infrastructure.  Networking equipment: The routers, switches, and other equipment necessary to interconnect networks in a Data Center.  Acquisition of existing infrastructure assets and related agreements:  Acquisition: The purchase of network assets from a public or private entity for incorporation by an Applicant into a Project Area, and related legal agreements. Eligibility Criteria Public Entities: Municipalities (cities, counties, towns, villages); Tribal Nations; state and local authorities; entities established pursuant to Section 99-y of the NYS General Municipal Law; not-for-profit entities with authorization from public entities; and regional planning boards formed under the provisions of NYS General Municipal Law. Municipal Utilities: Local government entities, including those established by a municipality as nonprofit Utility Cooperatives Eligible Private Partner Applicants, fitting one or more of the following descriptions, may submit applications with letters of endorsement from an Eligible Public Applicant. Eligible Private Partner Applicants can have an ownership structure that may be in the form of public-private partnership, private or shareholder ownership, nongovernmental nonprofit, non-utility cooperative, or community trust. Internet Service Providers (ISPs): Entities providing internet services to consumers, not limited to providers of cable television or telephone services.  Managed Service Providers (MSPs): Entities operating networks and providing service to residents and businesses by using existing internet infrastructure or partnering with construction entities to build networks.  Broadband Infrastructure Builders: Entities that construct and/or deploy open-access broadband infrastructure assets.  Broadband Infrastructure Owners: Entities that own, operate, or hold last mile or middle mile fiber infrastructure. For more information, visit ConnectALL Initiative.

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement. The proposed work directly supports the U.S. FDAs stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities. In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.

The Food Safety Education Fund grants program is funded through assessments of $3 to $5 from each licensed Michigan food establishment to provide food safety training and education to consumers; and training and education to food service establishment employees and agents of the director who enforce Michigan’s food regulations (i.e., local health department sanitarians and Michigan Department of Agriculture and Rural Development food safety inspectors). Donor Name: Michigan Department of Agriculture & Rural Development (MDARD) State: Michigan County: All Counties Type of Grant: Grant Deadline: 06/24/2024 Size of the Grant: $100,000 to $500,000 Grant Duration: 1 Year Details: Funding Information Up to $365,000 is available for the 2024-2025 grant cycle for projects focused on food safety training and education. Of the $365,600, $242,500 will be available for consumer food safety education and $114,100 for education to food service establishment employees and agents of the director of MDARD. The monies that go into the fund come from assessments of $3.00 to $5.00 on food establishment licenses. Grant Period The Michigan Department of Agriculture and Rural Development (MDARD) is now accepting proposals for grants that will run from October 1, 2024, through September 30, 2025. Multi-year proposals will be considered on an individual basis, contingent on future year funding. Eligibility Criteria  The Michigan Food Law of 2000, Section 4117, directs money in the fund to be used for providing food safety training and education to consumers, food service establishment employees and agents of the director who enforce the Michigan Food Law of 2000. Applicants must be Michigan governmental and non-profit organizations and entities. Producers, marketers, processors, growers are NOT eligible for this grant opportunity. Proposals with subgrantees will be considered. Proposals should not include funding for required routine training such as HACCP or manager certification such as ServSafe. Proposal Considerations and Selection Criteria  Proposals will be scored and selected based on the following criteria: Goals/objectives to improve food safety Statewide need and audience Measurable outcomes Partnering with other organizations Matching funds Opportunities to build upon previously funded projects. For more information, visit MDARD.

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.

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.

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.

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