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This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm ).

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2017-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.

This Funding Opportunity Announcement (FOA) issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in response to identified topics (see PHS 2017-2 SBIR/STTR Program Descriptions and Research Topics for NIH.

The purpose of the administrative supplement is to provide support for NIH-funded investigators to participate in an entrepreneurship training course, the Concept to Clinic: Commercializing Innovation (C3i) Program. The C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Through this program, the NIH fosters the development and commercialization of early-stage biomedical technologies by engaging investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. The curriculum and customized mentoring provided by the C3i Program are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation. Prospective applicants are strongly encouraged to contact NIH Scientific/Research staff for more information about the program before applying.

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects.

The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite currently awarded NIH StrokeNet centers and potential new stroke centers to participate as a Regional Coordinating Stroke Center in the NIH StrokeNet clinical trials network. The goal of this existing network is to maximize efficiencies to develop, promote and conduct high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment, and recovery with the objective to have a balanced portfolio between all three approaches. Exploratory Phase 1/2 and confirmatory Phase 3 clinical trials as well as biomarker-validation studies that are immediately preparatory to trials will be coordinated through separate National Clinical Coordinating (NCC) and National Data Management Centers (NDMC).

This FOA encourages requests for access to research resources for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants will be given access to the NIH StrokeNet infrastructure. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

This Funding Opportunity Announcement (FOA) invites research grant applications studying mechanisms of HIV-1 persistence in myeloid cells and strategies to target this reservoir in the central nervous system. Basic and translational research in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged but not required. RFA-MH-18-300 uses the R01 grant mechanism while RFA-MH-18-301 uses the R21 mechanism. High risk/high payoff projects that lack preliminary data or utilize existing data may be most appropriate for the R21 mechanism, while applicants with preliminary data may wish to apply using the R01 mechanism.

This Funding Opportunity Announcement (FOA) invites research grant applications studying mechanisms of HIV-1 persistence in myeloid cells and strategies to target this reservoir in the central nervous system. Basic and translational research in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged but not required. RFA-MH-18-300 uses the R01 grant mechanism while RFA-MH-18-301 uses the R21 mechanism. High risk/high payoff projects that lack preliminary data or utilize existing data may be most appropriate for the R21 mechanism, while applicants with preliminary data may wish to apply using the R01 mechanism.