Grants for Native American Tribal Organizations

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.

The intended outcome of this Notice of Funding Opportunity (NOFO) is to advance efforts for a nationally Integrated Food Safety System (IFSS) by supporting Manufactured Food Regulatory Program Standards (MFRPS), Food Protection Task Force (FPTF) programs, Dietary Supplement (DS) programs, and special projects. For the purposes of this NOFO, the term state encompasses all eligible organizations as defined in Section 3. MFRPS Development or Maintenance: The purpose of this Notice of Funding Opportunity (NOFO) section is to advance efforts for a nationally Integrated Food Safety System (IFSS) by assisting state manufactured food regulatory programs to achieve and maintain conformance with the most current version of the Manufactured Food Regulatory Program Standards (MFRPS). The MFRPS are intended to ensure that state manufactured food regulatory programs implement a high-quality regulatory program through the development and maintenance of a regulatory framework that builds on and emphasizes mutual reliance with all programs. Also, the program standards are intended to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. Conformance with these program standards will help federal and state programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods. Food Protection Task Force (FPTF): The purpose of this funding option is to establish and/or support a Food Protection Task Force (FPTF) with diverse membership representative of stakeholders across the state that is responsible for promoting the integration of an efficient statewide human and animal food (HAF) protection system that addresses state and region-specific needs and that maximize the protection of the public health. These efforts include: establishing a food safety/protection network of subject matter experts, fostering educational opportunities, developing replicable resources and systematically fostering communication, education, outreach, cooperation and collaboration within the states among federal, state, local, tribal and territorial HAF protection, public health, agriculture, and regulatory agencies, industry, academia, and consumers to initiate and/or support HAF protection activities to improve public health. A strong FPTF can also help improve human and animal food emergency surveillance, response, and post-response systems by focusing on preparedness, building strong communication channels, and establishing relationships with key players before food-related incidents occur. Dietary Supplements: The goal of this funding option is to facilitate the development of state driven dietary supplement regulatory framework and programs. The overall objective of this funding opportunity is to advance the adoption and implementation of the cGMPs for Dietary Supplements Rule codified at 21 CFR Part 111. Specifically, this track will provide funding support for dietary supplement training and program development activities. Special Projects: The purpose of this funding option is to develop and implement special projects that support innovation and integration in a IFSS using the MFRPS framework. This track will support other emerging food safety priorities that develop over the lifespan of the project. State programs will be expected to share project deliverables and resources developed with other programs.

This grant provides funding to nonprofit organizations, educational institutions, and government entities to improve public health initiatives and promote healthy lifestyles in Smith County.

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.

This state-funded program provides financial support to small cities, counties, and tribal communities in Idaho for infrastructure and economic development projects that promote job creation and growth in rural areas.

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.

This grant provides funding for youth-focused projects and programs that promote engagement, emotional well-being, and substance abuse intervention in Chippewa County.

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.

This grant provides funding to various organizations in north-central and northwest Kansas for projects that enhance community life in areas like education, health care, and the arts, with a focus on community involvement.

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.

Background: The Aquatic Nuisance Species Task Force (ANSTF) was established by the Nonindigenous Aquatic Nuisance Prevention and Control Act (NANPCA) of 1990, 16 U.S.C. 4721-28, as amended. The ANSTF serves to develop and implement a program for waters of the United States to prevent introduction and dispersal of ANS (also known as aquatic invasive species or AIS), monitor, control, and study such species, and disseminate related information. Co-chaired by the U.S. Fish and Wildlife Service and the National Oceanic and Atmospheric Administration, the ANSTF consists of Federal agency representatives and ex-officio representatives that work in conjunction with six regional panels and issue-specific subcommittees to coordinate efforts related to AIS across the Nation.Although prevention is the most cost-effective approach to eliminating or reducing the threat of invasive species, Early Detection and Rapid Response (EDRR) serves as a fail-safe when prevention measures are ineffective or unavailable. The Department of the Interior (DOI or the Department) in coordination with federal agencies, states, tribes, territories, and other partners published Safeguarding Americas Lands and Waters from Invasive Species A National Framework for Early Detection and Rapid Response in 2016. This report called for a focus on coordination and partnerships, science and technology, and strategic on-the-ground actions to detect invasive species that pose the greatest risk and swiftly respond to eradicate them before they establish, spread, and cause adverse impacts. As part of strategically implementing funding made available through the Bipartisan Infrastructure Law, DOI identified advancing a National EDRR Framework as a priority and took steps to invest in supporting some of the institutional components of such a framework. To that end, DOI is working with partners to identify, enhance, and collaborate on EDRR activities, build new tools, and support coordinated processes to proactively find and eradicate new invasive species before they establish, spread, and cause harm. Specifics include identifying high risk invasive species and invasion hotspots across the nation to inform early detection efforts, developing molecular tools to aid detection capabilities, expanding capacity for on-the-ground rapid response actions, including the establishment of a pilot Rapid Response Fund for aquatic invasive species, and creating an online clearinghouse where managers can share current information to guide implementation.The Rapid Response Fund addresses the need for readily available financial resources to assess and support response actions for quick containment or eradication of newly detected species. The Fund is a critical component of a National EDRR Framework and a priority need identified within the ANSTFs Strategic Plan for 2020-2025 (Objective 3.3, https://www.fws.gov/sites/default/files/documents/ANSTF-Strategic-Plan-2020-2025.pdf).Accordingly, the ANSTFs Rapid Response Fund Working Group developed The Model Process: Rapid Response Fund for Aquatic Invasive Species (https://www.fws.gov/media/model-process-rapid-response-fund-aquatic-invasive-species) in 2023 to outline a structure and process for a Rapid Response Fund for AIS. On July 19, 2023, the Model Process was unanimously approved by the 13 Federal agencies and 13 non-federal ex-officio members that serve on the ANSTF. This Notice of Funding Opportunity follows this process as detailed in the sections below. General information about the Fund and a list of Frequently Asked Questions can be found at: https://www.fws.gov/story/2023-08/rapid-response-fund-aquatic-invasive-species.In Fiscal Year 2023, BIL funds were directed to establish a pilot Rapid Response Fund for AIS within the existing authorities of the U.S. Fish and Wildlife Services Fish and Aquatic Conservation program, to be coordinated though the ANSTF. Accordingly, the U.S. Fish and Wildlife Service, on behalf of the ANSTF, invites proposals to support the rapid response to a new species introduction within freshwater, estuarine, or marine waters of the United States, including the U.S. territories.For the purposes of this Federal Rapid Response Fund,Rapid Response is defined as a process employed to eradicate the founding population of non-native, potentially invasive, species in a specific location before that species begins to reproduce or spreads so widely that eradication is no longer feasible. Eradication is defined as the removal or destruction of an entire population of an invasive species within a specified area. Eligibility requirements for this Rapid Response Fund are described in section C3 below, additional information on these requirements, as well as definitions, can be found in the ANSTF document The Model Process: Rapid Response Fund for Aquatic Invasive Species (https://www.fws.gov/media/model-process-rapid-response-fund-aquatic-invasive-species).

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.