Consumer Protection Grants

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 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.

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 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.

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.

This grant provides financial assistance to Maui-based businesses impacted by the August 2023 wildfires, helping them cover essential expenses like rent, utilities, and inventory.

- 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 to various organizations, including universities and non-profits, to improve veterinary diagnostic capabilities and address public health issues related to animal food safety and antimicrobial resistance.

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 Texas Department of Agriculture (TDA) offers the GO TEXAN - Event Grants as part of the Marketing Enhancement Grant Assistance Program. These grants aim to support Associate-level GO TEXAN partners who organize public events such as festivals and farmers markets, promoting Texas-made products and businesses under the GO TEXAN program. Eligible events must focus on advertising expenses and can only include one event per applicant within the designated timeline. Applications are accepted until May 16, 2024, and the projects can run from October 1, 2024, to December 31, 2025. Grant awards are determined based on the event’s adherence to GO TEXAN participation and program recognition, with funding available up to $20,000 depending on past participation and the extent of promotional activities.