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The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

This Notice of Special Interest (NOSI) encourages the translation of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative-supported technologies from academic and other non-small business research sectors to the marketplace. Small Business Concerns (SBCs) are encouraged to submit Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications that propose to further develop, optimize, validate and scale such technologies for commercial dissemination. Additionally, SBIR and STTR applications supporting the development and commercialization of novel technologies that fit within the mission of the BRAIN Initiative are encouraged.

This NOFO encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

This NOFO invites applications at the intersection of HIV and aging by proposing research that aims to meet the following objectives: 1) Improve the understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) Improve approaches for testing, preventing, and treating HIV infection, and managing HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying current aging science approaches. Proposed research must be consistent with the HIV/AIDS Research Priorities outlined by NIHs Office of AIDS Research (OAR), as described inNOT-OD-20-018.

This NOFO invites applications at the intersection of HIV and aging by proposing research that aims to meet the following objectives: 1) Improve the understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) Improve approaches for testing, preventing, and treating HIV infection, and managing HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying current aging science approaches. Proposed research must be consistent with the HIV/AIDS Research Priorities outlined by NIHs Office of AIDS Research (OAR), as described inNOT-OD-20-018.

Reissue of RFA-NS-20-010: 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.

The purpose of this NOFO is to invite Research Project (R01) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Applications without a PEDP will not be reviewed.

The purpose of this NOFO is to invite Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information.

The purpose of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is to encourage applications that will develop and validate novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application. The development of new genetic and non-genetic tools for delivering genes, proteins and chemicals to cells of interest or approaches that are expected to target specific cell types and/or circuits in the nervous system with greater precision and sensitivity than currently established methods are encouraged. Tools that can be used in a number of species/model organisms rather than those restricted to a single species are highly desired. Applications that provide approaches that break through existing technical barriers to substantially improve current capabilities are highly encouraged.

This Notice of Special Interest (NOSI) highlights interest in receiving grant applications focused on mechanistic, genetic, and other studies to evaluate causes and consequences of and risk factors for sudden death in the young. Studies are required to use phenotypic data and/or DNA samples and/or associated sequence data from the NIH/CDC Sudden Death in the Young (SDY) Case Registry as foundations for their research. Studies may use SDY Case Registry phenotypic data and/or samples and/or sequence data alone or in combination with other cohorts. Results of such studies are required to adhere to the NIH Data Sharing Policy https://sharing.nih.gov/data-management-and-sharing-policy so that the data is disseminated widely and provides an evidence base to advance discussions about screening and prevention of SDY.