Grants for Public Housing Authorities

This funding opportunity provides additional financial support to researchers with existing NIH grants to expand their projects and address new scientific challenges or opportunities.

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 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 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 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 researchers developing and testing strategies to prevent fetal alcohol spectrum disorders and improve interventions for affected individuals throughout their lives.

This grant provides funding for Au.D. audiologists to conduct rigorous biomedical research and complete their doctoral dissertations, fostering the development of independent researchers in the field.

This funding opportunity provides financial support for researchers to develop and test innovative strategies aimed at preventing prenatal alcohol exposure and improving outcomes for individuals affected by Fetal Alcohol Spectrum Disorders.

This funding opportunity provides financial support for early-stage researchers transitioning to independent careers in clinical and translational science, enabling them to conduct small-scale research projects that can lead to larger studies.

This funding opportunity provides financial support for the development of free educational resources aimed at improving training for the biomedical research workforce, including students, postdoctoral fellows, and faculty.

The purpose of this Funding Opportunity is to establish by cooperative agreement the National Center for Tribal Child Welfare Innovation and Advancement (Center). The Center will serve as the Childrens Bureaus (CB) primary vehicle for delivering effective, high-quality technical assistance (TA) to Title IV-B and Title IV-E American Indian and Alaska Native Nations. TA provided will enhance organizational and system performance, and improve outcomes for tribal children, youth, and families by honoring indigenous ways of knowing, and working collaboratively to ensure the preservation of tribal cultures.The Center will provide culturally relevant TA in these areas:1. Workforce Supports: Increase the knowledge, skills, and capacities of child welfare professionals in the tribal child welfare workforce2. Prevention Programs: Support for the development, enhancement, and expansion of tribal prevention programs3. Tribal Child Welfare Programs: Develop, enhance, and expand tribal child welfare programs4. Federal Requirements: Support successful implementation and compliance with federal requirements5. Tribal-State Collaboration: Develop and support meaningful state and tribal collaborations6. Data Management: Enhance capacity for data collection, analysis, visualization, and procurement of case management systems

The objective of this research proposal is to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for two major types of long acting injectables (LAIs) such as crystalline suspensions and polymer-based implants by considering their distinct characteristics. The goal of the project is to develop a bottom-up mechanistic PBPK model for these two LAI categories by accounting for the influence of critical formulation attributes of each LAI drug product type to predict its in vivo release mechanism. The model formulation parameters and relevant physiology should be informed with suitable in vitro and in vivo experiments. A suitable preclinical animal model can be used to validate the PBPK model based IVIVCs for both LAI suspensions and polymer based implants. The use of PBPK modelling provides a unique opportunity to understand how the physicochemical properties of drug molecules/polymer, implant specific properties, critical formulation attributes, and physiology, among other things, influence the in vivo release mechanisms of LAI drug products and their disposition characteristics. Moreover, once developed, a mechanistic PBPK model can help to define the 'safe space' for critical formulation attributes relevant to the reference listed drug (RLD) product, explain sources of PK variability and extrapolate predictions to human subjects by leveraging animal model data and by accounting for species-specific physiological differences.

This grant provides funding to nonprofit organizations, government entities, and churches in Northeast Ohio to support community-focused initiatives and services.

This funding opportunity supports nonprofit organizations that provide services to prevent child maltreatment and strengthen families, including education, home visiting, and refuge for those in unsafe living conditions.

Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs.

This program provides funding to nonprofit organizations and public entities for community projects that promote environmental sustainability, education, and workforce development, aiming to create safer and more vibrant living environments.

This funding opportunity supports collaborative research projects focused on heart, lung, and blood diseases, encouraging innovative approaches and participation from emerging scientists.

This grant provides funding to non-profit organizations and independent educational programs that promote medical knowledge and healthcare advancements in communities where B. Braun operates.

This grant provides funding to nonprofit organizations in the USA for health-related initiatives, excluding for-profit entities and specific ineligible activities.

This funding opportunity provides financial support for developing short courses that equip nurse scientists and researchers with the skills needed to advance firearm injury prevention research, focusing on health equity and innovative methodologies.