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The mission of the NIH Countermeasures Against Chemical Threats (CounterACT) program is to develop new and improved therapeutics to treat and/or prevent injuries resulting from exposure to chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents and toxic industrial chemicals and materials. This Funding Opportunity Announcement (FOA) requests new research applications for Cooperative Agreement Research Projects (U01s) seeking support for research on the identification of small molecule or biologic lead compounds that are excellent candidates for therapeutic development. The scope of research supported by this FOA includes confirmation of molecular targets for therapeutic development, demonstration of in vitro activity of candidate therapeutics, preliminary in vivo proof-of-concept efficacy data, preliminary adsorption, distribution, metabolism, excretion, and toxicity (ADME/Tox) evaluations and pharmacokinetics/pharmacodynamics (PK/PD) data. These studies must result in the identification of at least one lead compound ready for advanced therapeutic development. Lead compounds are biologically active and synthetically feasible compounds where specificity, affinity, potency, target selectivity, efficacy, and safety have been established. Lead compounds should be ready for more advanced development under possible support from other programs such as the one described in the companion FOA "CounterACT Optimization of Therapeutic Lead Compound (U01)" (PAR-16-XXX). The scope of this FOA encompasses Technical Readiness Level (TRL) 3 - see TRLs. Each project must include annual milestones that create discrete go or no-go decision points in a progressive translational study plan.

The purpose of this funding opportunity announcement (FOA) is to invite applications for Clinical Centers (Hubs) in Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN).SIREN will enable conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, and hematologic, and trauma emergency events. SIREN will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and up to 10 clinical centers (Hubs). A Hub will typically be an academic center or tertiary referral center which will actively enroll patients into every clinical trial performed in SIREN, regardless of disease focus.A Hub will additionally provide scientific leadership and administrative oversight to its multiple satellite sites ("Spokes").Together the Hub and Spokes will provide access to a large and varying patient population for clinical trials. SIREN will implement a total of at least four large (1,000 patient) simple, pragmatic clinical trials in the emergency department and pre-hospital settings. The clinical trials will be meritorious, peerreviewed projects which will be awarded under separate funding announcements.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Clinical Coordinating Center (CCC) of Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). SIREN will enable conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, hematologic and trauma emergency events. SIREN will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and up to 10 clinical centers (Hubs).The CCC will facilitate implementation of clinical trials and will promote high quality and efficient timeliness in trial execution through such methods as master trial agreements and a central Institutional Review Board.SIREN will implement a total of at least four large (1,000 patient) simple, pragmatic clinical trials in the emergency department and pre-hospital settings. The clinical trials will be meritorious, peerreviewed projects which will be awarded under separate funding announcements.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Data Coordinating Center (DCC) for Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). SIREN will enable conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, hematologic, and trauma emergency events. SIREN will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and up to 10 clinical centers (Hubs).The DCC will have responsibility for data management, data quality, statistical analysis, Data Safety Monitoring Board(s) (DSMB) and reporting to regulatory and oversight groups. SIREN will implement a total of at least four large (1,000 patient) simple, pragmatic clinical trials in the emergency department and pre-hospital settings.The clinical trials will be meritorious, peerreviewed projects which will be awarded under separate funding announcements.

This Funding Opportunity Announcement (FOA) encourages bioengineering applications that will accelerate the development and adoption of promising tools and technologies that can address important biomedical problems.The objectives are to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need and are capable of enhancing our understanding of life science processes or the practice of medicine.Awards will focus on supporting multidisciplinary teams that apply an integrative, quantitative bioengineering approach to developing technologies, and engage biomedical researchers or clinicians throughout the project.The goal of the program is to support projects that can realize meaningful solutions within 5 10 years.

The purpose of this funding opportunity announcement (FOA) is to establish the Coordinating Center for the new Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Consortium. This FOA together with its companion FOA ("Small Vessel VCID Biomarkers Development Projects"; RFA-NS-16-020) establish the Small Vessel VCID Biomarkers Consortium. The Coordinating Center will consist of: (i) an Administrative Core responsible for organizing, coordinating and administratively driving Consortium activities; and (ii) a Data Core that will coordinate, receive, collect, and share data, including de-identified clinical data, from Small Vessel VCID Biomarker Development projects (see RFA-NS-16-020). A Milestone Plan with timelines is required in all applications. The timeline and milestones will be used to evaluate applications not only in peer review but also in consideration of the awarded project for funding of non-competing award years.

The purpose of this funding opportunity announcement (FOA) is to support research that evaluates and further develops candidate predictive, diagnostic, target engagement and progression candidate biomarkers of small vessel cerebrovascular disease in human vascular contributions to cognitive impairment and dementia (VCID) and vascular/Alzheimer's mixed dementias. Biomarkers development projects funded under this FOA, with support from the Coordinating Center (RFA-NS-16-019), will: study biomarkers as individual projects and concurrently establish the interactive consortium (UH2, years 1-2); and then work together as a consortium to perform collaborative cross-project multi-disciplinary studies to further evaluate and develop the most promising biomarker candidates (UH3, years 3-5) to the point of being ready for large scale multi-site clinical validation studies including towards FDA qualification of small vessel VCID biomarkers for phase II and phase III clinical trials (to be carried out under future separate funding).

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinsons disease and other Parkinsonian syndromes, as a component of the NINDS Parkinsons Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) The differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such asProgressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. In order to further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically.A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.

The purpose of this FOA is to support innovative interdisciplinary, multi-institute research that will lead to the identification and validation of molecular mechanisms relevant to human biology that contribute to tau toxicity associated with Frontotemporal Degeneration (FTD). It is anticipated that this research will also contribute to tool development that can be applied to target validation in FTD clinical trials.Applications must include an administrative core, a scientific governance structure, a minimum of three research projects with milestone plans, resource core(s) that support the basic research efforts of at least two proposed research projects, a data coordination core that will facilitate the distribution of data generated through the Center without Walls with the broad research community and a human biology validation core that will support the validation of mechanisms identified and resources developed under this FOA. Synergy must be evident among Center research projects and cores, such that successful completion of the aims could not be accomplished without the Center structure. This FOA is in response to the Alzheimer's Disease Related Dementias (ADRD) challenges outlined in the 2015 update to the National Plan to Address Alzheimer's Disease.

The purpose of this funding opportunity announcement (FOA) is to 1) expand the collection of clinical data and biological specimens in the NINDS Parkinsons Disease Biomarkers Program (PDBP), a community research resource, to include data from patients with Lewy Body Dementias (including Dementia with Lewy Bodies and Parkinson's Disease with Dementia), and 2) to support hypothesis-driven clinical research to discover biomarkers that will improve the efficiency and outcome of Phase II clinical trials for the Lewy Body dementias and to provide an expansion of this existing research resource center for dissemination of information and access by the scientific community for further advancing research in this field. Applications may include both of these goals if justified.