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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 Funding Opportunity Announcement (FOA) intends to support a group of large-scale Comprehensive Centers that will adopt scalable technology platforms and streamlined sampling strategies and assay cascade to create comprehensive and highly granular brain cell atlases of human and non-human primates with an emphasis on human. The Centers are expected to characterize all brain cell types (neurons, glia, and other non-neuronal cells) at high-resolution. 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.

The National Institutes of Health (NIH) Office of Nutrition Research (ONR) and participating NIH Institutes and Centers (ICs) intend to publish a Funding Opportunity Announcement (FOA) for new applications that will support new institutional research training programs (predoctoral, postdoctoral or both) in artificial intelligence (AI) for precision nutrition (AIPrN) that will focus on integration of the domains of precision nutrition, AI including machine learning (ML), systems biology, systems science, Big Data, and computational analytics. The goal is to build a future workforce that will be able to use growing data resources to tackle complex biomedical challenges in nutrition science that are beyond human intuition. It is hoped such research will lead to the development of innovative solutions to combat diet-related chronic diseases within the mission areas of the participating ICs. The vision of the AIPrN training program is to support the development of a diverse research workforce capable who will possess advanced competencies in AI including machine learning and data science analytics to apply to an increasingly complex landscape of Big Data from the molecular, to organismal, to community and societal scales related to nutrition and diet related conditions.

This Funding Opportunity Announcement (FOA) intends to support a Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE) that will be composed of four components to establish respectively (1) a common sequencing data processing pipeline, (2) a common imaging data processing pipeline, (3) a comprehensive brain cell knowledge base, and (4) an engaging and outreach component to coordinate the research within and beyond BICAN. The overall goals of CUBIE are to (i) enable the exploration of large-scale brain cell atlas data and knowledge, and inspire research in brain function and disorders; and (ii) ensure research rigor and data reproducibility by making the data to be findable, accessible, interoperable, and reusable, and the process transparent. An application is expected to propose only one of the above four respective components.

Reissue RFA-NS-11-009: The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite applications to participate as a Clinical Coordinating Center in the Network for Excellence in Neuroscience Clinical Trials. This clinical research network will develop and conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials. The network will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. While the network will not be specific to one disease, it will have the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. This FOA solicits applications for the Clinical Coordinating Center (CCC). Separate FOAs solicit applications for the Clinical Sites and the Data Coordinating Center.

Reissue RFA-NS-11-010: The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite applications to participate as a Data Coordinating Center in the Network for Excellence in Neuroscience Clinical Trials. This clinical research network will develop and conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials. The network will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. While the network will not be specific to one disease, it will have the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. This FOA solicits applications for the Data Coordinating Center (DCC). Separate FOAs solicit applications for the Clinical Sites and the Clinical Coordinating Center.

The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite currently awarded NeuroNEXT sites and potential new sites to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). This clinical research network develops and conducts multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies for neurological disorders, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials. The network provides a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. While the network is not specific to one disease, it has the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. This FOA solicits applications for Clinical Sites. Separate FOAs solicit applications for the Clinical Coordinating Center and the Data Coordinating Center.

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.

This FOA provides support using the SBIR 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.

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to accelerate implementation of effective non-opioid interventions for chronic pain management in rural and remote populations. Projects include pragmatic, implementation, or hybrid effectiveness-implementation trials to improve pain management and reduce the use of inappropriate opioid medications. Awards made under this FOA will initially support a milestone-driven, planning phase (UG3) of 1 to 2 years, with possible transition to an implementation phase (UH3) of up to 4 years duration (5 years total for the two phases). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The overall goal of this initiative is to support the "real world" implementation of effective interventions to manage pain in rural and remote areas. Results from the trials supported by this funding opportunity announcement (FOA) should inform policy makers, payers, community stakeholders, as well as health care providers and patients in the primary care, emergency department, hospital, home health, or dental setting. This FOA requires that the investigators partner with one or more rural healthcare system(s) to plan and implement the intervention. During the planning phase, investigators must develop an additional one or more community-based partnership(s). Studies may propose to integrate multi-component, bundled, or multi-level interventions that have demonstrated efficacy.