Grants for Public and State controlled institutions of higher education - 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.

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 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 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.

This funding opportunity supports U.S.-based organizations in researching and advancing the use of digital health technologies for remote data collection in clinical trials, enhancing drug and biological product development.

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 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 Tobacco Grant Program, administered by the Office of the Attorney General, California Department of Justice, aims to foster a healthier California by curtailing illegal cigarette and tobacco sales and marketing to minors. This highly competitive program, enabled by Proposition 56, allocates funds to applicants with robust enforcement capabilities. Funded agencies will focus on enforcing tobacco-related laws, conducting retailer and online inspections, and enhancing local coordination and education efforts.

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.

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 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.

- Qualified fiscal sponsors, such as social service agencies or medical providers, must apply on behalf of clients for medical or health care related needs in Humboldt County. - The Angel Fund does not provide reimbursements and seldomly approves grants exceeding $500. Most grants fall within the range of $50 - $300. - The committee meets every Tuesday to review applications, with a two-week turnaround time required for application review and check processing. - Eligible expenses include items such as air purifiers, counseling for mental and behavioral health, eyeglasses and vision services, local bus passes, medical and dental travel expenses, prescriptions, and physical therapy equipment. - Ineligible expenses include adult dental care, car payments, childcare, counseling (long-term), hearing aids, rent, utility bills, weight loss programs, and more. For more information about the application process, potential applicants can refer to the virtual tutorial provided at the following link: [Application Process Tutorial](https://drive.google.com/file/d/1QOBWzmykC21vYwyo2GSnegsfAp9B9k6Y/view?usp=share_link)

This funding opportunity provides financial support for nonprofit organizations to create an engaging public awareness campaign that educates everyday Indonesians about preventing cyber scams through an immersive escape room experience.