Funding Opportunity RFA-MH-19-235 from the NIH Guide for Grants and Contracts. The overall goal of this Funding Opportunity Announcement (FOA) is to identify, in animals, in vivo neurophysiological and behavioral measures for use as assays in the early screening phase of treatment development. The FOA will support efforts to optimize and evaluate measures of neurophysiological and behavioral processes that may serve as surrogate markers of neural processes of clinical interest based on available knowledge of the neurobiology of mental illnesses. The screening assays thus developed from this FOA are expected to build upon systems neurobiology and clinical neuroscience to enhance the scientific value of preclinical animal data contributing to a therapeutic development pipeline by assessing the impact of therapeutic targets and treatment candidates on neurobiological mechanisms of clinical relevance to mental illnesses. The objectives of the FOA will be accomplished by supporting basic and translational neuroscientists who are committed to improving the efficiency and scientific value of the therapeutic development pipeline by advancing the discovery of in vivo physiological and behavioral measures reflecting circuit engagement as tools for early phase target validation and therapeutic screening for mental illness treatment development. The efforts supported by this initiative focus on measures in animals as a first step in generating translational assay measures that are adaptable across early therapeutic screens in animals to evaluation in humans. As such, this FOA may be considered a prequel to build a suite of assays that are evaluated in future projects for coherence of assay performance between the preclinical species and healthy humans (see PAR-16-065; Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3)). In summary, this FOA will support efforts to improve the tool kit of assays available for early phase testing of novel therapeutic agents by incorporating measures proximal to neural systems that impact mental h

Notice NOT-TW-18-007 from the NIH Guide for Grants and Contracts

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Notice NOT-OD-19-026 from the NIH Guide for Grants and Contracts

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Notice NOT-AG-18-041 from the NIH Guide for Grants and Contracts

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Notice NOT-TR-19-011 from the NIH Guide for Grants and Contracts

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Notice NOT-MH-18-063 from the NIH Guide for Grants and Contracts

Notice NOT-AG-18-040 from the NIH Guide for Grants and Contracts

Notice NOT-AG-18-037 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-OD-18-102 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA) is to provide support to help restore research resources, including animal colonies and related materials and equipment that were lost or damaged due to Hurricanes Harvey, Irma, and Maria. Benefits of this award are restricted to the FEMA declared major disaster states, which are: Texas, Florida, US Virgin Islands, Puerto Rico, Georgia and South Carolina. Applications submitted in response to this announcement will be considered for funding only with funds received under the Bipartisan Budget Act of 2018 P.L. 115-123; P.L. 11572; and P.L. 11556. Funds will be provided in a single award with a 24-month budget and project period. No-cost extensions will not be available. Support will be considered for replacement only of those animals and other materials that were extant before Hurricanes Harvey, Irma, and Maria and were being used in connection with funded grant support or otherwise being used actively but were lost due to the hurricane(s). These funds cannot duplicate nor overlap with reimbursement provided by the Federal Emergency Management Agency (FEMA), under a contract for insurance, or by self-insurance.

Funding Opportunity PAR-19-041 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) solicits applications from research institutions damaged by Hurricanes Harvey, Irma, and Maria to support recovery and restoration of research infrastructure and research capabilities destroyed or damaged by the hurricanes. Benefits of this award are restricted to the counties that FEMA declared a major disaster area in the following states and territories: Georgia, Florida, Louisiana, South Carolina, Texas, US Virgin Islands, and Puerto Rico

Funding Opportunity RFA-NS-19-013 from the NIH Guide for Grants and Contracts. This FOA invites applications that will systematically and comprehensively characterize alpha-synuclein and amyloid-beta subspecies present in human Lewy Body Dementia (LBD) post-mortem brain tissue, identify toxic subspecies and potential mechanisms of toxicity, and characterize any interactions between the proteins that may contribute to increased toxicity and/or explain selective vulnerabilities of cells/circuits. Applications are required to include at least 3 hypothesis-driven projects that address these goals, an administrative core, and other cores as appropriate. Applicants will be expected to focus on the use of human tissues. All applications will be expected to include plans for developing a publicly-available library of fully characterized alpha-synuclein and amyloid-beta subspecies found in LBD.

Funding Opportunity PAR-19-039 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Cooperative Agreement (U01) Research Projects for research on the identification of small molecule or biologic lead compounds that are excellent candidates for therapeutic development. The mission of the CounterACT program is to foster and support research and development of new and improved therapeutics for 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, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. 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 should result in the identification of at least one lead compound ready for optimization. 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-18-NNN). The scope of this FOA encompasses Technical Readiness Level (TRL) 1-3 - see TRLs. Each project must include annual milestones that create discrete go or no-go decision points in a progressive translational study plan.

Funding Opportunity PAR-19-040 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Cooperative Agreement (U01) Research Projects for research on the optimization of small molecule or biologic compounds that are excellent candidates for therapeutic development. The mission of the CounterACT Program is to foster and support research and development of new and improved therapeutics for 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, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. A previously identified lead compound is required to be eligible for this funding opportunity. In this regard, lead compounds are defined as biologically active compounds or hits where affinity, potency, target selectivity, and preliminary safety have been established. The scope of research supported by this FOA includes development of appropriate human-relevant animal models and generation of in vivo efficacy data consistent with the intended use of the product in humans. It also includes bioanalytical assay development and validation, laboratory-scale and scaleable manufacturing of the product, and non-GLP toxicity and pharmacology studies. The scope of this FOA encompasses Technical Readiness Levels (TRLs) 4-5 - see TRLs. Each project must include annual milestones that create discrete go or no-go decision points in a progressive translational study plan.