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The purpose of this notice is to provide further clarification of the clinical trials permitted in PAR-19-040 "Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01 Clinical Trial Optional)". This notice is intended to provide more guidance in developing grant applications that are more responsive to the scientific scope of the Funding Opportunity Announcements.

The purpose of this notice is to provide further clarification of the clinical trials permitted in PAR-20-316 "Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional)". This notice is intended to provide more guidance in developing grant applications that are more responsive to the scientific scope of the Funding Opportunity Announcements.

The National Institute of Neurological Disorders and Stroke (NINDS) will be hosting an informational webinar on August 17, 2021 from 1PM 2PM (Eastern Time) for all potential applicants interested in these companion Funding Opportunity Announcements (FOAs): RFA-NS-21-009: Creating an Educational Nexus for Training in Experimental Rigor (CENTER) (UC2 Clinical Trial Not Allowed) RFA-NS-21-033: Materials to Enhance Training in Experimental Rigor (METER) (UE5 Clinical Trial Not Allowed) These two FOAs together aim to facilitate teaching of fundamental principles of rigorous biomedical research by developing a new online educational resource for use by a broad range of researchers in an array of learning environments. CENTER will support the establishment of a center to build, evaluate, and disseminate a user-friendly, harmonized, and openly accessible educational resource to promote awareness, understanding, and utilization of the principles of rigorous biomedical research. METER will support the compilation and refinement of the core scholarly content of educational units within this online resource.

The purpose of this notice is to inform applicants of a correction to the open date for PAR-21-267 "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)".

The purpose of this notice is to inform applicants of a correction to the open date for PAR-21-265 "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)."

The purpose of this notice is to inform applicants of a correction to the open date for PAR-21-266 "NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)".

This notice informs the research community that the NINDS and NIA intend to publish a joint Funding Opportunity Announcement on the Clinical Relevance of the Linkage between Environmental Toxicant Exposures and Alzheimers Disease and Alzheimers Disease Related Dementias. This Notice is being provided to allow potential applicants sufficient time to develop meaningful multidisciplinary collaborations and responsive projects. The FOA is expected to be published in January 2022 with an expected application due date in March 2022. This FOA will utilize the R01 activity code. Details of the planned FOA are provided below.

Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to brain recording and stimulating from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and quantitative, mechanistic models where appropriate. Awardees will join a consortium work group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

This FOA will support integrated, interdisciplinary research teams from prior BRAIN technology and/or integrated approaches teams, and/or new projects from the research community that focus on examining circuit functions related to behavior, using advanced and innovative technologies. The goal will be to support programs with a team science approach that can realize meaningful outcomes within 5-plus years. Awards will be made for 5 years, with a possibility of one competing renewal. Applications should address overarching principles of circuit function in the context of specific neural systems underlying sensation, perception, emotion, motivation, cognition, decision-making, motor control, communication, or homeostasis. Applications should incorporate theory-/model-driven experimental design and should offer predictive models as deliverables. Applications should seek to understand circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions. Applications are expected to employ approaches guided by specified theoretical constructs, and are encouraged to employ quantitative, mechanistic models where appropriate. Applications will be required to manage their data and analysis methods in a prototype framework that will be developed and used in the proposed U19 project and exchanged with other U19 awardees for further refinement and development. Model systems, including the possibility of multiple species ranging from invertebrates to humans, can be employed and should be appropriately justified. Budgets should be commensurate with multi-component teams of research expertise including neurobiologists, statisticians, physicists, mathematicians, engineers, computer scientists, and data scientists, as appropriate - that seek to cross boundaries of interdisciplinary collaboration.

The National Institutes of Health (NIH) intends to publish one Funding Opportunity Announcement (FOA) to solicit applications on the development of innovative quantitative imaging and other relevant biomarkers of myofascial tissues for pain management in human subjects using a two-phase grant funding mechanism. Candidates for such biomarkers may include objective measures based on minimally invasive imaging technologies, electrophysiological recordings, integration of multiparametric imaging and electrophysiological approaches, or their integration with other markers (e.g., immune factors, genomic markers, physiological factors, etc.) through multiscale modeling or machine learning analysis. The first phase of the award will provide funding for up to 2 years to develop quantitative measures that can differentiate myofascial tissue abnormalities in healthy, versus latent, versus active myofascial pain stages using cross-sectional correlations with clinical signs/symptoms. The second phase will provide up to 3 years of support to assess the ability of the measures developed in Phase 1 to monitor responses and/or predict outcomes in response to specified therapies to relieve myofascial pain in longitudinal interventional studies. Transition between the two phases of the award will be administratively reviewed and will be determined by successful completion of quantifiable transition milestones that need to be clearly specified in the application. The purpose of this notice is to allow potential applicants sufficient time to develop meaningful collaborations among technology developers, myofascial tissue experts, pain researchers, and clinicians. It will also allow potential applicants sufficient time to develop responsive projects to the two-phased FOA. The FOA is expected to be published in September 2021, with an expected application due date in December 2021. Details of the planned FOA are provided below.