Grants for Nonprofits - Consumer Protection

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 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.

Description: The Illinois Grocery Initiative aims to establish new grocery stores in food deserts to increase access to fresh food in underserved areas. This grant, under the funding opportunity number FY24-2 and CSFA number 420-35-3295, anticipates awarding 8 grants with a total program funding of $14,000,000. Eligible projects must involve capital expenditures, as operational costs are not covered. Grants will range from $160,000 to $2,400,000, and applicants are required to meet cost-sharing requirements. The application window opens on 04/09/2024 and closes on 05/24/2024. Indirect costs are allowed but restricted to capital-only expenditures. There are mandatory and optional technical assistance sessions provided to assist applicants, with registration required through provided links.

This program provides financial support to small-scale, sustainable farms in metro Atlanta to improve their operations and enhance their contributions to the local food system.

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.

This grant provides financial support to organizations that participate in California Public Utilities Commission activities, helping to remove barriers to their involvement in policy decision-making processes.

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 ConnectALL Initiative's Municipal Infrastructure Program (MIP) is designed to foster the development of open-access, publicly owned, and/or controlled last-mile fiber broadband infrastructure. This initiative aims to deliver reliable high-speed internet services to homes, businesses, and community anchor institutions throughout New York State. The program's mission aligns directly with the New York State Urban Development Corporation d/b/a Empire State Development ("ESD") objectives to promote a vigorous and growing state economy, encourage business investment and job creation, and support diverse, prosperous local economies across NYS. By addressing broadband access, the MIP contributes to ESD's broader strategy of using grants and other forms of assistance to facilitate economic development and improve quality of life for residents. The target beneficiaries of the MIP include communities across New York State that are currently experiencing connectivity challenges due to a lack of affordable, high-speed internet infrastructure. Specifically, the program aims to connect homes, businesses, and community anchor institutions. The primary impact goal is to improve broadband access, thereby reducing the digital divide and enabling greater participation in the digital economy. Expected outcomes include a significant increase in the availability of reliable, high-speed internet, leading to enhanced economic opportunities, improved educational access, and better access to essential services for residents and businesses in underserved areas. The program's priorities and focuses revolve around the construction of new infrastructure or the acquisition of existing infrastructure. This includes last-mile fiber connections to address last-mile infrastructure (cabling, wires, pole replacements, radios) and drops to buildings. It also emphasizes fiber connections to Internet Exchange Points or Data Centers, including middle-mile fiber and networking equipment. A key focus is on ensuring open-access and predominantly publicly controlled infrastructure, leveraging funding from the U.S. Department of Treasury Capital Projects Fund (CPF) to achieve these objectives. The ConnectALL Initiative's strategic priorities are deeply rooted in addressing fundamental connectivity gaps across the state. The theory of change posits that by investing in publicly controlled, open-access fiber broadband infrastructure, the state can stimulate economic growth, create jobs, and foster more equitable access to information and opportunities. The expected measurable results include the deployment of new fiber optic networks, the number of homes, businesses, and community anchor institutions connected, and ultimately, an improvement in the overall broadband speed and affordability available to New Yorkers. The total funding available for this program is $228 Million, with a maximum grant size of $30 million per award, indicating a significant investment to achieve these transformative goals.

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.

This funding opportunity provides financial support to a wide range of organizations, including governments, educational institutions, and nonprofits, to enhance surveillance and detection of antibiotic resistance in food products, ultimately improving public health and food safety.

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 Bitsie Clark Fund for Artists (The Bitsie Fund), housed at the Community Foundation for Greater New Haven, aims to support individual artists in pursuing new work and achieving specific creative and career goals. This aligns with the Foundation's broader mission to foster a thriving community by supporting local talent and development. The fund's focus is on individual artist development, rather than community development, signifying a strategic priority to invest directly in the artistic growth of residents within the Foundation's service area in Greater New Haven. In 2024, The Bitsie Fund will award two $5,000 grants, one specifically for a Black artist and another open to all eligible artists. This targeting reflects a commitment to equitable support within the artistic community and addresses potential disparities. The grant's impact goals are centered on enabling artists to tackle major artistic development goals, take risks on new directions in their work, or advance their careers. The expected outcomes include a more vibrant artistic community with empowered individual artists. The fund prioritizes individual artists at a significant point in their personal development, encouraging both established artists with a substantial body of recent work and those emerging in their field to apply. This inclusive approach to eligibility ensures a broad reach within the artist community. The focus is on supporting a wide array of creative disciplines including dance, music, theater, visual arts, design, craft, literary arts, voice, poetry, playwriting, composition, and film. Measurable results would be evidenced by artists successfully utilizing the funds for approved uses such as purchasing materials, compensating for time spent developing projects, hiring others, covering performance or touring costs, travel for proposals, renting studio space, and production expenses. Ultimately, the Bitsie Fund's theory of change posits that by directly supporting individual artists in these ways, it will contribute to their personal and professional growth, thereby enriching the cultural landscape of Greater New Haven.

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.

The CalMoneySmart Grant Program, administered by the California Department of Financial Protection and Innovation (DFPI), is an annual initiative dedicating a total of $2 million to nonprofit organizations. This program aligns with the foundation's mission to enhance financial well-being, specifically targeting individuals experiencing financial insecurity within California. The grants, ranging from $100,000 to $500,000, are awarded for a two-year period, with individual grants up to $200,000, to support programs that foster financial education and empowerment. The primary beneficiaries of this program are unbanked and underbanked consumers in California. The impact goals are centered on enabling these individuals to achieve financial stability by identifying and accessing lower-cost financial products and services, establishing or improving their credit, increasing their savings, and lowering their debt. The program prioritizes comprehensive financial literacy and practical tools to empower vulnerable populations. The core focuses of the CalMoneySmart grants include the design, development, or offering of free classroom- or web-based financial education and empowerment content. This content is specifically tailored to assist unbanked and underbanked consumers in navigating financial systems and making informed decisions. Additionally, the program supports the provision of individualized, free financial coaching, offering personalized guidance to help beneficiaries overcome specific financial challenges. Furthermore, the grants can be used to design, develop, or offer free financial products or services that help unbanked and underbanked consumers identify and access responsible financial products and services. The expected outcomes include a measurable improvement in the financial health of participants, evidenced by increased access to responsible financial products, improved credit scores, higher savings rates, and reduced debt burdens. The DFPI's strategic priority is to promote consumer protection and financial well-being, with a theory of change that by providing targeted financial education and access to appropriate resources, financially insecure Californians can achieve greater economic stability and security. Eligibility for the grant requires applicants to be 501(c)(3) tax-exempt organizations, in good standing with the California Secretary of State, and to have submitted a satisfactory final report for any prior DFPI grant funding. This ensures that the grants are awarded to reputable and effective organizations capable of delivering impactful programs.

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

This funding opportunity supports clinical trials aimed at developing new therapies for rare neurodegenerative diseases, such as ALS, and is open to a wide range of eligible organizations, including universities and nonprofits.

This funding opportunity provides financial support to U.S.-based organizations, including universities, nonprofits, and businesses, to help outsourcing facilities produce critical medications that are in short supply and vulnerable to fraud.

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.