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The goal of this effort is to support the development and validation of next generation platforms and analytic approaches to precisely quantify behaviors in humans and link them with simultaneously recorded brain activity. Tools used for analyzing behavior should be multi-modal and should be able to be linked to brain activity and thus have the accuracy, specificity, temporal resolution, and flexibility commensurate with tools used to measure and modulate the brain circuits that give rise to those behaviors. This phased award will support novel tool development (i.e., hardware/software) in the R61 phase and synchronization of novel tools for measuring behavior and human brain activity in the R33 phase.

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to support a cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible outstanding postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM.

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to enhance workforce diversity in the research workforce and maintain a strong cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the pool of diverse and independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, an ancillary clinical trial, or an independent Basic Experimental Studies with Humans (BESH). Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing an independent clinical trial, a clinical trial feasibility study, an ancillary clinical trial, or an independent BESH as lead investigator, should apply to the companion FOA (RFA-NS-22-024).

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to support a cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible outstanding postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM.

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to enhance workforce diversity in the research workforce and maintain a strong cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the pool of diverse and independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, an ancillary clinical trial, or an independent Basic Experimental Studies with Humans (BESH). Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (RFA-NS-22-025).

This funding opportunity announcement (FOA) is designed to support integrated efforts of three or more (up to six) PDs/PIs to pursue bold, impactful, and challenging research in basic and clinical pain domains to understand the biology of specific human pain conditions as well as pain associated with diverse diseases/disorders, including mechanistic underpinning of heterogeneity and stratification of patients with specific pain conditions and co-morbidities. The research approach should be interdisciplinary in nature, and the research teams are expected to establish a common goal that requires collaboration, synergy, and managed team interactions. Proposed research should not represent a collection of individual efforts or parallel projects. Proposed research should support a cohesive, single, well-integrated research plan with a singular focus, one set of aims, and a budget without subprojects. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for experimentation, analysis, and interpretation. Teams are encouraged to consider transformative objectives with defined 5-year outcomes that will produce major advances in the understanding of human pain conditions and are likely to improve strategies for effective managementof human pain.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome (DS). As part of the INCLUDE Project, NIH is interested in expanding and diversifying the skilled DS clinical research workforce. The intent of this Funding Opportunity Announcement (FOA) is to encourage applications that develop creative and innovative short courses to train the next generation of DS researchers in state-of-the-art clinical research skills that will improve the understanding of the co-occurring clinical features in DS and support development of new treatments for health conditions experienced by those with DS.

This Funding Opportunity Announcement (FOA) intends to support a group of Specialized Collaboratories that will adopt scalable technology platforms and streamlined sampling strategies and assay cascade to create comprehensive and highly granular brain cell atlases in human, non-human primates, and mouse, in coordination and collaboration with other BICAN projects. In particular, the Specialized Collaboratories are expected to complement the Comprehensive Centers in BICAN with distinct capabilities, competencies, and research aims. The overarching goal of the BICAN is to build reference brain cell atlases that will be widely used throughout the research community, providing a molecular and anatomical foundational framework for the study of brain function and disorders.

This FOA solicits the development of theories, computational models, and analytical tools to derive understanding of brain function from complex neuroscience data. Proposed projects could develop tools to integrate existing theories or formulate new theories; conceptual frameworks to organize or fuse data to infer general principles of brain function; multiscale/multiphysics models to generate new testable hypotheses to design/drive future experiments; new analytical methods to either support or refute a stated hypothesis about brain function. It is expected that the tools developed under this FOA will be made widely available to the neuroscience research community for their use and modification. Investigative studies should be limited to model parameter estimation and/or validity testing of the tools being developed.

This FOA provides support using the STTR cooperative agreement mechanisms for the development, regulatory qualification and commercialization of alternative approaches methods (NAMs) that specifically utilizes the neuromuscular junction Tissue Chips (TC) platforms that will replace the LD50 assay (mouse lethality bioassay (MLB) as a potency assay for botulinum toxin.

The NIH NCATS and FDA are partners in this FOA and will collaborate and coordinate efforts with award recipients. The goal of this collaboration is to establish the Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) as a Drug Development Tool (DDT). A main objective for this funding opportunity would be to position BoT PATCh as an alternative test method that can be utilized as a stand-alone replacement for MLB. As a cooperative agreement, small business concerns (SBCs) will be expected to work with NIH and FDA staff to develop and implement the final validation plan for the proposed alternative test method.