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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.

T?o invite applications to an open competition to be one of up to 7 supported sites in the next phase of the NINDS small vessel vascular contributions to cognitive impairment and dementia (VCID) biomarkers consortium. The original consortium, established under RFA-NS-16-019 and RFA-NS-16-020, pursued initial stages of multi-site validation of 11 candidate imaging-based and fluid-based biomarkers. The primary objective of the next 5 years is to carry out comprehensive multi-site clinical validation of up to six of these 11 biomarkers to be selected by the NINDS in a process separate from this FOA. The focus will be validation in longitudinal studies of diverse all-comers populations that are typical in clinical settings in the United States. The network of sites will provide scientific expertise and experimental infrastructure to pursue these goals synergistically including with the Coordinating Center (RFA-NS-21-004). At the conclusion of clinical validation each biomarker will have a designated category and context of use as defined by the FDA and a finalized public protocol that describes all details needed to utilize the biomarker. The sites will drive the consortium scientifically and contribute administratively to comprehensive rigorous clinical validation of biomarkers for future clinical trials, including in large phase III trials, and for generating scientific breakthroughs in our understanding and treatment of VCID.

This FOA encourages applications at the intersection of HIV and aging by addressing two overarching objectives: 1) to improve understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) to improve approaches for testing, prevention, and treatment of HIV infection, and management of HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying our current understanding of aging science. Applications appropriate to this FOA should be consistent with the scientific priorities outlined by the NIH Office of AIDS Research (OAR) as described in NOT-OD-20-018.

This FOA encourages applications at the intersection of HIV and aging by addressing two overarching objectives: 1) to improve understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) to improve approaches for testing, prevention, and treatment of HIV infection, and management of HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying our current understanding of aging science. Studies that move the science of HIV and aging into new directions with little or no preliminary data are appropriate for this activity code.

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 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 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 NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support 1) research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus. Note that applications must be within the general scope of the parent award.

The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Funding Opportunity Announcement (FOA) may not include preliminary data. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Funding Opportunity Announcement does not accept applications proposing clinical trials.