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The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug (IND) application. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

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

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discovery of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur. The purpose of this specific FOA is to establish Cancer Immunoprevention Research Projects that will function as components of a Cancer Immunotherapy Consortium (CIC), which will also include Cancer Immunotherapy Research Projects. The CIC will form an integrated network of multi-disciplinary, collaborative teams with the overarching goals of accelerating translational research of innate and adaptive immune mechanisms that contribute to tumor initiation and progression, and evaluating new or improved immunopreventive and immunotherapeutic strategies (including combinations with standard or other therapies). Studies should be largely pre-clinical involving clinically-relevant models and endpoints, and have the potential for rapid translation into early-phase clinical applications.

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. The purpose of this FOA is to promote research to accelerate the discovery of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The purpose of this FOA is to expand organ site-specific Cancer Immunotherapy Research Projects as components of the Immuno-Oncology Translation Network (IOTN). The IOTN will form an integrated network of multi-disciplinary, collaborative teams with the overarching goals of accelerating translational research of innate and adaptive immune mechanisms that contribute to tumor progression and evaluating new or improved immunotherapeutic strategies (including combinations with standard or other therapies) resulting in durable anti-cancer responses. Studies should be largely pre-clinical involving clinically-relevant models and endpoints.

The purpose of this FOA is to promote research to both understand the mechanisms by which music is uniquely processed in the brain and optimize music medicine to enrich our lives and treat illness. This FOA encourages a broad variety of R01 research projects from basic to applied approaches, across the lifespan, and in both healthy and diseased individuals. It encourages partnerships and collaborations among basic researchers, technological development researchers, music intervention experts, and/or other clinical researchers.

This FOA is intended to encourage exploratory studies to : (1) increase our understanding of how music affects the brain, body, and behavior and (2) use that knowledge to develop evidence-based music interventions to enhance health or treat specific diseases and disorders. Proposed R21 projects can investigate how music is processed by or modifies the brain, or how it affects specific biological functions during childhood development and learning, adulthood, and aging. Projects can also include preliminary interventions that provide a basis for therapeutic interventions. When appropriate, collaborations among basic researchers, technology developers, music intervention experts, or other clinical researchers are highly encouraged.

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.