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The National Institute of Neurological Disorders and Stroke seeks to promote diversity in all of research programs and to increase the participation of underrepresented groups. As the US population becomes increasingly diverse, reflection of that diversity among the biomedical research workforce is vital to our science enterprise and the NIH research mission (See NOT-OD-20-031). NIH is committed to implementing approaches to address the funding gap for researchers from diverse backgrounds and committed to instituting new ways to support diversity, equity, and inclusion, and identifying and dismantling any policies and practices that may harm our workforce and our science.

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.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) 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. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design.

This is a reissue of RFA-MH-19-136. 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.

NIH recognizes that the high cost of childcare impacts graduate students and post-doctoral researchers funded through NIH fellowships, and their ability to successfully complete their training and fully participate in the extramural research workforce. Therefore, this Notice announces that NCI, NHGRI, NIA, NIDCR, NIDDK, and NINDS (on behalf of the NIH Blueprint DSPAN) will defray childcare costs to recipients of Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) programs during the F99 phase of the award.

The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) provides support for biologic-based therapeutic discovery and development, from lead optimization through phase I clinical testing. This Funding Opportunity Announcement (FOA) supports preclinical discovery and development of potential therapeutic Biotechnology Products and Biologics including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies). Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, scaling, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biotherapeutic candidates developed in this program.

The NIH Helping to End Addiction Long TermSM (HEAL) Initiative NIH aims to improve our understanding, management and treatment of pain by funding high quality scientific research in this relatively understudied area of medicine. For the HEAL Initiative and NIH to meet their long-term goals of providing effective non-opioid options for the treatment of pain conditions and innovative approaches for treating opioid use disorders, it will be necessary to train a new generation of clinical pain researchers. Leveraging HEAL Initiative clinical research programs to train novice researchers and investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research will maximize the impact of HEAL funding for both current and future research endeavors. Increasing the number of individuals trained in high quality clinical pain research is a critical step toward ensuring the highest impact of HEAL, with studies that encompass a broad range of pain conditions and have the potential to include, address the needs of, and positively impact diverse and traditionally underserved patient populations.

The purpose of this NOSI is to encourage eligible NINDS awardees in the Alzheimers Disease and Alzheimers Disease-Related Dementias (AD/ADRD) research community to apply for administrative supplements in response to PA-21-071, "Research Supplements to Promote Diversity in Health-Related Research," or any reissues of this announcement through the expiration date of this Notice. The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031 for details) and encourages institutions to diversify their student populations by enhancing the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Goal 1 of The National Plan to Address Alzheimers Disease is to prevent and effectively treat AD/ADRD by 2025. This initiative addresses the critical need to increase the number of health professionals who are trained to meet the expanding demand for cognitive impairment and dementia diagnosis, care, and clinical research to meet Goal 1.

Reissue of RFA-NS-19-011: The purpose of the NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award is to support a defined pathway across career stages for outstanding graduate students who are from backgrounds that are nationally underrepresented in neuroscience research. This two-phase award will facilitate completion of the doctoral dissertation and transition of talented graduate students to strong neuroscience research postdoctoral positions, and will provide career development opportunities relevant to their long-term career goal of becoming independent neuroscience researchers.

The purpose of this Funding Opportunity Announcement (FOA) is to recruit Early Stage Investigators (ESI) to pursue research programs of interest to NIH Chemical Countermeasures Research Program (CCRP) under the Countermeasures Against Chemical Threats (CounterACT) grant/cooperative agreement program. ESI CounterACT R21 projects may be exploratory, applied, proof of principle, or high risk-high impact research to discover safe and effective therapeutics to mitigate toxicities resulting from exposures to highly toxic chemicals. A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged. However, if available, minimal preliminary data are allowed. All preliminary data should be clearly marked and limited to one-half page, which may include one figure. Applications including preliminary data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and will not go forward to review. Projects supported by this FOA will have an extended level of support (3 years) and are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive funding support from the NIH CounterACT programs or other related initiatives.