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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 2018-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. This Parent Funding Opportunity Announcement does not accept clinical trials.

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 2018-2 SBIR/STTR Program Descriptions and Research Topics for NIH. This Parent Funding Opportunity Announcement does not accept clinical trials.

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. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery. NINDS intends that all multi-center clinical trials in stroke treatment, recovery, or prevention supported by NINDS will be conducted in the NIH StrokeNet and that only in exceptional circumstances will NINDS consider funding multi-site stroke clinical trials outside of this program. Applicants do not need to be part of the existing NIH StrokeNet infrastructure to apply under this FOA.

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. 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. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.

The purpose of this Funding Opportunity Announcement (FOA) is encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice.

The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.

The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support a Data Analysis and Coordination Center (DACC) for the Multicenter AIDS Cohort Study (MACS) and the Womens Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CCS). The DACC will work as a member of the MACS/WIHS-CCS consortium to advance knowledge of basic and clinical science, and the epidemiology of HIV infection in the US, with a focus on HIV-related comorbidities. A companion cooperative agreement will support MACS/WIHS-CCS Clinical Research Sites (CRS)

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to advance knowledge of the HIV infection, with a focus on HIV-related comorbidities by supporting current Clinical Research Sites (CRS) of the Multi-Center AIDS Cohort Study (MACS) and the Womens Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CCS). Through this FOA each CRS will implement the full MACS/WIHS-CCS unified science agenda and provide expertise to lead part of the unified science agenda (e.g., protocol development, as a reading center, or laboratory). Targeted recruitment will be supported with justification. A companion cooperative agreement will support the MACS/WIHS-CCS Data Analysis and Coordination Center (DACC).

This FOA encourages 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 a future trial, for biomarker validation studies, or for proof of mechanism 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). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.