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This Funding Opportunity Announcement (FOA) supports translational exploratory/developmental research that directly advances the discovery of novel treatment strategies, i.e., medical countermeasures (MCMs), that address serious morbidity and mortality after acute exposure to highly toxic chemical threats. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pesticides, and ultra-potent synthetic (UPS) opioids. This FOA supports translational research that includes, but is not limited to, preliminary efficacy and/or early preclinical development studies towards discovery and validation of novel molecular entities or biologics as candidate MCMs. In addition to novel agents, new treatment strategies may involve repurposing already FDA-approved products or combinations of interventions based on established mechanisms of action. Projects supported by this FOA are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement program and/or other related initiatives.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This FOA is intended to support meritorious small research projects focused on analyses of genomics other -omics, clinical and phenotypic datasets related to Down syndrome research, with an emphasis on elucidating the underlying etiologies of risk and resiliencies to co-occurring health conditions. Development of approaches, tools, or algorithms appropriate for analyzing data relevant to Down syndrome and facilitating data sharing within the research community through the INCLUDE Data Hub may also be proposed.

The National Institutes of Health (NIH) hereby notify Small Business Concerns (SBCs) holding Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that funds are available for administrative supplements to enhance the diversity of the research and entrepreneurial workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research or in the SBIR and STTR programs. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

This FOA provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs.

This funding opportunity announcement (FOA) encourages the development and validation of animal models and human/animal tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder. The goal of this FOA is to promote a significant improvement in the translational relevance of animal models or ex vivo systems that will be utilized to facilitate future development of neurotherapeutics. Ideally, models proposed for this FOA would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program focused on enabling the exploratory and early stages of drug discovery.

This funding opportunity announcement (FOA) encourages research grant applications to develop in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological or neuromuscular disorders. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network (BPN) or other translational programs.