Grants for Public and State controlled institutions of higher education - Consumer Protection

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 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.

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 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 U.S. Department of Agriculture (USDA), Agriculture Marketing Services (AMS), is entering into cooperative agreement with Michigan Department of Agriculture and Rural Development (MDARD) for the Resilient Food Systems Infrastructure Program Cooperative Agreements (RFSI). Donor Name: Michigan Department of Agriculture & Rural Development (MDARD) State: Michigan County: All Counties Type of Grant: Grant Deadline: 06/17/2024 Size of the Grant: $100,000 to $500,000 Grant Duration: Grant Duration Not Mentioned Details: The purpose of the Michigan RFSI program is to build resilience in the middle-of-thefood-supply-chain and strengthen local and regional food systems by creating new revenue streams for Michigan producers. MDARD will make subawards in the form of Infrastructure Grants to middle-of-the-supply businesses to create more diverse local and regional market options and create more economic opportunities for communities, allowing them to retain more of the value chain dollar. RFSI investments aim to create a food systems infrastructure to support competitive and profitable market access for domestic farm products. The program also aims to: Support development of value‐added products available to consumers; Support proposals that provide fair prices, fair wages and new and safe job opportunities that keep profits in rural communities; and Increase diversity in processing options in terms of business model approaches, geography, and availability to underserved communities. Priorities USDA intends for RFSI program to focus funding Infrastructure Grant activities that: Expand capacity for processing, aggregation, and distribution of agricultural products to create more and better markets for producers; Modernize manufacturing, tracking, storage, and information technology systems; Enhance worker safety through adoption of new technologies or investment in equipment or facility improvements; Improve the capacity of entities to comply with federal, state, and local food safety requirements; Improve operations through training opportunities; Support construction of a new facility; Modernize or expand an existing facility (including expansion and modifications to existing buildings and/or construction of new buildings at existing facilities); Construction of wastewater management structures, etc.; Modernize processing and manufacturing equipment; and Develop, customize, or install equipment that reduces greenhouse gas emissions, increases efficiency in water use, improves air and/or water quality, and/or meets one or more of USDA’s climate action goals. Funding Information Michigan has been awarded over $10 million dollars. Equipment Only Grant: These projects offer a simplified application to fund smaller grants from $10,000 up to $100,000 Infrastructure Grants: Infrastructure grants will have a maximum award of $475,000. Eligibility Criteria The following entities are eligible for Infrastructure Grants made by MDARD: Agricultural producers or processors, or groups of agricultural producers and processors Nonprofit organizations operating middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural products Local government entities operating middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural products Tribal governments operating middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural products. Institutions such as schools, universities, or hospitals bringing producers together to establish cooperative or shared infrastructure or invest in equipment that will benefit multiple producers middle-of-the-supply-chain activities such as processing, aggregation, distribution of targeted agricultural product. For more information, visit MDARD.

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

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)