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This notice of opportunity announcement (NOFO) is issued by the National Institute of Neurological Disorders and Stroke to enable submission of program project grant applications that propose to conduct innovative, interactive research to answer significant scientific questions that are important for the mission of NINDS, via a synergistic collaboration between outstanding scientists who might not otherwise collaborate. The program project grant is designed to support research in which the funding of several interdependent highly meritorious projects as a group offers significant scientific advantages over support of these same projects as individual research grants.

This notice announces the availability of funds from the Office of Data Science Strategy (ODSS) to NIH-managed or NIH-majority-funded projects that may benefit from using the cloud. The purpose of this announcement is to explore and test potential opportunities for leveraging cloud solutions to enhance existing NIH activities. Projects already using cloud may apply to explore and test cloud capabilities not yet leveraged. This initiative is aligned with the NIH Strategic Plan for Data Science, which describes actions aimed at building a better data infrastructure and a modernized data ecosystem.

In alignment with the White House Initiative on Womens Health Research, the National Institutes of Health (NIH) is issuing this Notice of Special Interest to highlight interest in receiving research applications focused on diseases and health conditions that predominantly affect women (e.g., autoimmune diseases; depressive disorders, Alzheimers disease (AD) and Alzheimers disease-related dementias (ADRD), gender-based-violence), present and progress differently in women (e.g., cardiovascular disease; HIV; reproductive aging and its implications), or are female-specific (e.g., uterine fibroids; endometriosis; menopause).

This funding opportunity is part of a suite of NOFOs within the NIH HEAL Initiative to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal is to encourage initial translational efforts that will support a drug discovery program and advance projects to the point where they meet the entry criteria for the Pain Therapeutics Development Program. The scope will therefore be focused on development of assays to support a distinct testing funnel, screening efforts to identify hits, and initial characterization of hits and potential therapeutic agents (including small molecules, biologics, and natural products).

Reissue: RFA-NS-21-023 - 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, 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.

Reissue: RFA-NS-21-024: The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information 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. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

Awarded activities will facilitate the translation of novel recording and modulation technologies that can be used to treat and/or diagnose central nervous system (CNS) diseases and disorders and to better understand the human CNS, from proof of concept up to the stage of readiness for first in human (FIH) studies. Technologies may incorporate any signal modality (e.g., electrical, optical, magnetic, acoustic) or a combination thereof. Diverse team-based applications that integrate appropriate domains of expertise are encouraged.

This Notice of Funding Opportunity (NOFO) solicits applications to develop web-accessible data archives to capture, store, and curate data related to BRAIN Initiative activities. The data archives will work with the research community to incorporate tools that allow users to analyze and visualize the data, but the creation of such tools is not part of this NOFO. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this NOFO. A goal of this program is to advance research by creating a community resource data archive with appropriate standards and summary information that is broadly available and accessible to the research community for furthering research.

"Fluctuating cognition can occur in many types of dementia and is a core clinical feature of Dementia with Lewy Bodies. Cognitive fluctuations can last from seconds to days, are unpredictable (e.g., do not just occur in the evenings, as with sun-downing), and are associated with poor daily functioning for the patient. A number of small studies have suggested that cognitive fluctuations in subjects with dementia may be related to epileptiform discharges and impaired oscillatory activity on EEG, but it is not clear that these are the only factors involved in patient populations that often experience dysautonomia, orthostasis, and sleep disturbances. The etiology of cognitive fluctuations may be multi-factorial and may vary in different dementia populations. Understanding the physiology related to cognitive fluctuations is a critical next step to the development of treatment approaches and improving quality of life for these patients. This initiate would encourage research that will better characterize the physiology responsible for cognitive fluctuations in ADRD populations. Given their variable appearance and time course, it is anticipated that wearable digital devices will be important for capturing fluctuations in a timely fashion, and applicants should consider incorporating those device(s) capable of acquiring the relevant data to support the hypothesized mechanism(s). Applicants may focus on assessing multiple mechanisms in a specific ADRD population, or may chose to compare mechanisms across multiple types of ADRDs. "

The SuRE program supports research capacity building at eligible higher education institutions bythrough funding investigator-initiated biomedical research inbasic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE awards is to provide research grant support for faculty investigators at resource-limited institutions who are not currently funded by any NIH Research Project Grants (RPGs) - with the exception of SuRE or SuRE-First awards, to furnish students with high-quality undergraduate and/or graduate research experiences and to enhance the institutional scientific research culture.