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The purpose of this FOA is to promote innovative research on music and health with an emphasis on developing music interventions aimed at understanding their mechanisms of action and clinical applications with little or no preliminary data. Because of the need for a multidisciplinary approach, collaborations among basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers are encouraged. The FOA utilizes a phased R61/R33 funding mechanism to support mechanistic research and to evaluate the clinical relevance of music interventions. The R61 phase will provide funding for up to two years to either investigate the biological mechanisms or behavioral processes underlying music interventions in relevant animal models, healthy human subjects, and/or clinical populations, or can be used to develop innovative technology or approaches to enhance music intervention research. The second R33 phase will provide up to three years of support for further mechanistic investigations, intervention development, or pilot clinical studies. The pilot clinical studies may focus on intervention optimization/refinement, feasibility, adherence, and/or identification of appropriate outcome measures to inform future clinical research. Transition from the R61 to the R33 phase of the award will depend on successful completion of pre-specified milestones established in the R61.

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.

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.

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.

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.

This is a reissue of the Emerging Global Leader Program (K43) to align with the clinical trials policy.

This Funding Opportunity Announcement (FOA) invites applications for the Morris K. Udall Centers of Excellence for Parkinsons Disease Research program. The overarching goal of the specialized Udall Centers program is to establish a network of Centers that work collaboratively as well as independently to define the causes of and discover improved treatments for Parkinsons disease (PD). A more immediate goal for each Center is to rapidly advance synergistic, interdisciplinary research programs while serving as national leaders in PD research. Udall Centers also serve as local resources by organizing research career enhancement activities for Center investigators and periodic outreach to the PD patient/advocacy community. Applicants are expected to identify and address an overall research theme that defines a critical challenge in PD research. The stated theme, proposed research projects, and associated cores will inform the etiology, pathogenesis or treatment of PD; investigations on related synucleinopathies may be included if such studies directly address the identified PD research challenge. Requirements include 1) a minimum of three research projects; 2) research cores that are each essential to accomplish the aims of at least two proposed research projects, plus an Administrative Core; 3) a mission statement and plan for career enhancement of Center trainees and investigators; and 4) a plan for effective outreach, including dissemination of Udall Center research results, to the local patient and advocacy community. The NINDS Udall Centers program prioritizes innovative and integrative research with significant potential for discovery. A considerable degree of 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. The Udall Center Director (PD/PI) must be an established leader in scientific research with visionary leadership skills and proven expertise

This Funding Opportunity Announcement (FOA) requests Exploratory Grant (P20) applications for the planning and initiation of collaborative activities to advance Parkinson's Disease (PD) research. The goal of this FOA is to convene new transdisciplinary research consortia and formalize the multi-institutional organizational and investigational structure necessary to resolve an essential challenge in Parkinson's disease (PD) through a subsequent NINDS Udall Center without Walls (CWOW) approach. The most compelling applications will: (i) identify a fundamental PD research priority; (ii) build an exemplary research consortium; (iii) gather supportive preliminary data; and (iv) demonstrate exceptional potential to pursue a targeted strategy to remove a critical impediment blocking advancement of the understanding and treatment of PD. The stated challenge and related research feasibility projects will inform the etiology, pathogenesis or treatment of PD; investigations on related synucleinopathies may be included if such studies directly address the central PD research challenge. To foster the development of innovative research collaborations, this FOA will provide support for new research consortia only; continuation of established projects and teams will not be supported. Proposed consortia must include the optimal combination of specialized expertise required to resolve the stated challenge using a goal-driven approach. The Program Director/Principal Investigator (PD/PI) must be eminently qualified to provide visionary scientific leadership and effective oversight of consortium administrative activities. Participating investigators should be recognized as world-class experts in their fields. Teams must be anchored by at least one PD researcher. To maximize potential for new insights and incorporation of cutting-edge approaches, consortia will actively integrate at least one investigator with primary expertise in another, complementary research area.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research to develop and validate new screening methods for autism spectrum disorders (ASD) that can be used in infancy (0-12 months of age). This FOA uses the R01 grant mechanism, while RFA-MH-19-121 uses the R21 grant mechanism. Pilot or exploratory projects with minimal preliminary data, or those proposing early-stage feasibility testing, may be most appropriate for the R21 mechanism. Applicants with strong preliminary data proposing validation, refinement or final stages of testing of existing tools or methods may wish to use this FOA (R01 mechanism).

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research that would develop and validate new screening methods for autism spectrum disorders (ASD) that can be used in infancy (0-12 months of age). This FOA uses the R21 grant mechanism, while RFA- MH-19-120 uses the R01 grant mechanism. Applicants with strong preliminary data proposing validation, refinement or final stages of testing of existing tools or methods may wish to use the R01 mechanism. Pilot or exploratory projects with minimal preliminary data, or those proposing early-stage feasibility testing, may be most appropriate for this FOA (R21 mechanism).