The purpose of this funding opportunity announcement (FOA) is to have an open competition to support a Coordinating Center for the next phase of the NINDS small vessel vascular contributions to cognitive impairment and dementia (VCID) biomarkers consortium. The original consortium was established under RFA-NS-16-019 and RFA-NS-16-020. The goal of the next phase, under RFA-NS-20-004 (Coordinating Center) and RFA-NS-20-005 (sites), is to complete clinical validation of biomarkers initially developed during the first 5-year funding cycle of this program. The Coordinating Center will consist of: (i) an Administrative Core responsible for organizing, coordinating and administratively driving Consortium activities; and (ii) a Data Core that will coordinate, receive, collect, and share data, including de-identified clinical data. The Coordinating Center will drive the consortium administratively and contribute scientifically to validation of biomarkers with specified context of use for future clinical trials, including in large phase III trials, with general and diverse populations, and for generating scientific breakthroughs in our understanding and treatment of VCID.

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to enhance the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. 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, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.