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The purpose of the NIH Research Conference Grant (R13) is to support high quality conferences that are relevant to the public health and to the scientific mission of the participating Institutes and Centers.

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 BRAIN Initiative Notice of Funding Opportunity (NOFO) is to support scaled reagent production and distribution facilities involving technologies to access brain cell types. Facilities for production and distribution of these reagents by a broad and diverse set of neuroscientists will be encouraged. This NOFO is part of the BRAIN Initiative Armamentarium for Brain Cell Access transformative project. Efforts will be supported to produce and distribute gene transfer, gene regulation, and genome engineering reagents for use in both genetically tractable and less tractable systems, including primates and human tissue, which are relevant for future translational efforts. Reagents to be produced and distributed are those designed and validated under other NOFOs from the Armamentarium transformative project.

Guided by the goals established in BRAIN 2025: A Scientific Vision and reinforced by the Advisory Council to the Director Working Group on BRAIN 2.0 Neuroethics Subgroup, this Notice of Funding Opportunity (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. This NOFO encourages research project grant applications from multi-disciplinary teams focused on key ethical issues associated with BRAIN Initiative supported research areas. Efforts supported under this NOFO are intended to be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

Guided by the goals established in BRAIN 2025: A Scientific Vision and reinforced by the Advisory Council to the Director Working Group on BRAIN 2.0 Neuroethics Subgroup, this Notice of Funding Opportunity (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. This NOFO encourages research project grant applications from multi-disciplinary teams focused on key ethical issues associated with BRAIN Initiative supported research areas. Efforts supported under this NOFO are intended to be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

(Reissue PAR-21-056) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

(Reissue PAR-21-058). The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

(Reissue PAR-21-057) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

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.