Grants for Public Housing Authorities

TheNational Institute of Allergy and Infectious Diseases (NIAID),intendstopublish a Notice of Funding Opportunity (NOFO) tosolicit applications for a Center of Excellence (CoE) for Systems Modeling of Infection and Immunity across Biological Scales that will: Develop and conduct innovative computational multi-scale modeling research for NIAID priority biomedical questions, including HIV/AIDS; Coordinate the NIAID and broader modeling community that conducts research on infectious- and immune-mediated diseases, through model and data sharing, opportunity funds, educational activities, and community-organizing activities; Conduct innovative research and coordination activities to improve data and model sharing in the NIAID and broader modeling community; Foster a diverse community of new and existing investigators dedicated to Infectious and Immune-mediated Disease (IID) multi-scale modelingand collaboration between experimental and computational scientists; Serve as point of contact to NIAID for the modeling community and pivot research activities to address acutely emerging NIAID needs, such as outbreaks, epidemics, or pandemics; Establish community development and educational opportunities in IID multi-scale modeling for students, post-doctoral fellows, and new/early-stage investigators; Enable new approaches for multi-scale model sharing and reproducibility aligned with theFAIR (Findable, Accessible, Interoperable, and Reusable) principles and theNIAID Data Ecosystem Portal. This Notice isbeing provided toallow potential applicants sufficient timetodevelop meaningful collaborations andprojects. Potentialapplicantsareencouraged tousethistimetodevelop leadership teams to cover the full range of expertise and experience to develop the coordinating cores and research projects that will represent and enable strong scientific and operational connections between the CoE and the larger IID modeling community. This NOFO will utilize theU54 activity code.Details for a pre-application webinar will be provided in the published NOFO.

The purpose of this Notice is to announce the intention of National Institutes of Neurological Disorders and Stroke (NINDS) to reissue RFA-NS-21-021 to solicit applications for research pursuing translational activities and small clinical studies to advance the development of low risk therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The NOFO is expected to be published in Spring 2024 with an expected application due date in Summer 2024. This NOFO will utilize the R61/R33 activity code. Details of the planned NOFO are provided below.

This program provides federal funds to non-profits and local organizations to improve housing, economic opportunities, and living conditions for low- and moderate-income residents in Federal Way.

This Notice of Intent to Publish is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects for the following Notice of Funding Opportunity (NOFO), which is expected to be published in January 2024, with an anticipatedapplication receipt date in May 2024. The Brain Research through Advancing Innovative Neurotechnologies(BRAIN) Initiative intends to promote a new initiative by publishing a NOFO to solicit applications that would support development and preclinical testing, beginning withproof of concept,of next-generation recording and/or modulation devices for human use to further our understanding of the human central nervous system and treat nervous system disorders. This NOFO will utilize the R18 activity code. Details of the planned NOFO are provided below.

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 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, a National Child Welfare Center for Court Innovation and Advancement (CCIA). The CCIA will serve as the technical assistance (TA) provider to State and Tribal Court Improvement Programs (CIPs and TCIPs respectively). The CCIA will also provide TA to continuously improve and promote high quality legal representation for parents, children, and the child welfare agency, including around prevention and at all stages of child welfare proceedings as well as improve the quality of dependency hearings and reviews.The CCIA will be the Childrens Bureaus (CB) principal TA provider to CIPs, TCIPs and the broader child welfare legal and judicial community. The CCIA will build the capacity of TA recipients to meet current and future standards and requirements described in statute and federal regulations (including those specified under titles IV-B and IV-E of the Social Security Act), improve organizational and system performance, and improve outcomes for children, youth, and families. In addition, the CCIA will be responsible for increasing the knowledge, skills, capacity, and resources of child welfare legal professionals.

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.