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Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap (known as the Valley of Death) between the end of the SBIR/STTR Phase II award and the commercialization stage. The goal of this FOA is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product/technology that requires Federal regulatory approval or to bring a complex research tool to market. This opportunity aims to facilitate the transition of previously funded SBIR and STTR Phase II projects to the commercialization stage by promoting partnerships between NINDS SBIR or STTR awardees and third-party investors and/or strategic partners in the Phase IIB competing renewal. Applicants are strongly encouraged to secure independent third-party funding throughout the Phase IIB project period.

A central goal of the BRAIN Initiative is to understand how electrical and chemical signals code information in neural circuits and give rise to sensations, thoughts, emotions and actions. While currently available technologies can provide some understanding, they may not be sufficient to accomplish this goal. For example, non-invasive technologies are low resolution and/or provide indirect measures such as blood flow, which are imprecise; invasive technologies can provide information at the level of single neurons producing the fundamental biophysical signals, but they can only be applied to tens or hundreds of neurons, out of a total number in the human brain estimated at 85 billion. Other BRAIN FOAs seek to develop novel technology (RFA-NS-17-003) or to optimize existing technology ready for in-vivo proof-of-concept testing and collection of preliminary data (RFA-NS-17-004) for recording or manipulating neural activity on a scale that is beyond what is currently possible. This FOA seeks applications for unique and innovative technologies that are in an even earlier stage of development than that sought in other FOAs, including new and untested ideas that are in the initial stages of conceptualization. In addition to experimental approaches, the support provided under this FOA might enable calculations, simulations, computational models, or other mathematical techniques for demonstrating that the signal sources and/or measurement technologies are theoretically capable of meeting the demands of large-scale recording or manipulation of circuit activity in humans or in animal models. The support might also be used for building and testing phantoms, prototypes, in-vitro or other bench-top models in order to validate underlying theoretical assumptions in preparation for future FOAs aimed at testing in animal models.

To address critical questions surrounding the long-term impact of substance exposure on child development, the NIH seeks to create a large, diverse cohort of pregnant women, who along with their offspring, will be followed for 10 years. The cohort will consist of mother and baby dyads recruited beginning in the 2nd trimester of pregnancy and through birth; and will include babies exposed pre- or perinatally to prescription and illicit opioids, marijuana, stimulants, alcohol and nicotine. A deep, nuanced understanding of factors that affect a childs health, brain, and behavioral development is expected to emerge from this study, which is an essential first step toward designing policies and interventions that promote well-being and resiliency in children. Applications are sought from qualified researchers with the capacity and expertise to recruit and retain vulnerable populations for studies that will include neuroimaging, cognitive and behavioral assessments along with collection and analysis of biospecimens from mom and baby.

The NIH Helping to End Addiction Long-termSM (HEAL) Initiative and the National Institute on Drug Abuse (NIDA), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Research on Womens Health (ORWH), the National Institute of Environmental Health Sciences (NIEHS), and the National Institute on Minority Health and Health Disparities (NIMHD), intend to jointly fund the HEALthy Brain and Child Development (HBCD) Study using the cooperative agreement award mechanism. This Funding Opportunity Announcement (FOA) solicits applications for unlinked Research Project Sites. This FOA runs in parallel with companion FOAs that solicit applications for linked Research Project Sites (RFA-DA-21-020), a single Consortium Administrative Core (RFA-DA-21-022) and a single Data Coordinating Center (RFA-DA-21-023). It is expected that investigators, upon funding, will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities.

The NIH Helping to End Addiction Long-termSM (HEAL) Initiative and the National Institute on Drug Abuse (NIDA), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Research on Womens Health (ORWH), the National Institute of Environmental Health Sciences (NIEHS), the National Institute on Minority Health and Health Disparities (NIMHD), and the Environmental influences on Child Health Outcomes (ECHO) Program, intend to jointly fund the HEALthy Brain and Child Development (HBCD) Study using the cooperative agreement award mechanism. This Funding Opportunity Announcement (FOA) solicits applications for the HBCD Consortium Administrative Core. This FOA runs in parallel with companion FOAs that solicit applications for a single Data Coordinating Center (RFA-DA-21-023) and multiple Research Project Sites (RFA-DA-21-020 and RFA-DA-21-021). It is expected that investigators, upon funding, will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities.

The NIH Helping to End Addiction Long-termSM (HEAL) Initiative and the National Institute on Drug Abuse (NIDA), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Research on Womens Health (ORWH), the National Institute of Environmental Health Sciences (NIEHS), the National Institute on Minority Health and Health Disparities (NIMHD), and the Environmental influences on Child Health Outcomes (ECHO) Program, intend to jointly fund the HEALthy Brain and Child Development (HBCD) Study using the cooperative agreement award mechanism. This Funding Opportunity Announcement (FOA) solicits applications for a Data Coordinating Center. This FOA runs in parallel with companion FOAs that solicit applications for research project sites (RFA-DA-21-020 and RFA-DA-21-021) and a single Consortium Administrative Core (RFA-DA-21-022). It is expected that investigators, upon funding, will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities.

This FOA seeks applications to perform single nucleus RNA sequencing (snRNA seq) and whole genome sequencing (WGS) in post-mortem brain tissue from 100 patients with PD and normal controls for the Accelerating Medicine Partnership in Parkinson's Disease (AMP PD). Applicants will be expected to have access to high quality brain tissue and perform sequencing in four separate brain regions, including some regions known to be affected by Parkinson's Disease (PD) and at least one region known to be relatively spared. It is intended that all sequencing data and any available pre-mortem clinical data will be broadly shared with the research community through the AMP PD Knowledge Portal.

This FOA is intended to: (1) increase our understanding of how music affects the brain when it is used therapeutically and/or (2) use that knowledge to better develop evidence-based music interventions to enhance health or treat specific diseases and disorders.

This FOA is intended to: (1) increase our understanding of how music affects the brain when it is used therapeutically and/or (2) use that knowledge to better develop evidence-based music interventions to enhance health or treat specific diseases and disorders. Proposed R01 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.

This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s). 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 the research includes target and candidate identification and characterization, through candidate optimization and demonstration of in vivo efficacy consistent with the product's intended use in humans. For applicants submitting U54 renewal applications, research under this FOA should culminate in an optimized lead compound ready for advanced development. The Centers will contain at least three research projects supported by an administrative core, up to three optional scientific cores, and a research education core. Each research project must include milestones that create discrete go or no-go decision points in a progressive translational study plan.