Opportunity Information: Apply for RFA NS 21 004
This grant opportunity, RFA-NS-21-004, is a National Institutes of Health (NIH) cooperative agreement (U24) from the Department of Health and Human Services, specifically supporting the National Institute of Neurological Disorders and Stroke (NINDS). It funds a single award to operate the Coordinating Center for the next phase of the NINDS Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Consortium. The program builds directly on an earlier 5-year consortium established under RFA-NS-16-019 and RFA-NS-16-020, and it is aligned with the broader next-phase structure that includes this Coordinating Center award and separate awards for participating research sites (referenced as RFA-NS-20-005 for sites). Importantly, the mechanism is labeled "Clinical Trial Not Allowed," meaning the Coordinating Center itself is not meant to initiate or run an interventional clinical trial, even though its work is intended to support and enable future trials.
The central purpose of the Coordinating Center is to organize and drive a consortium-wide effort to complete clinical validation of small vessel VCID biomarkers that were initially developed during the first funding cycle. In practical terms, this means taking promising candidate biomarkers (for example, imaging, fluid, digital, or other measures relevant to small vessel disease and VCID) and rigorously evaluating their performance in real clinical research settings so they can be trusted as measures for diagnosis, prognosis, stratification, or treatment response. A key emphasis is defining a clear "context of use" for each biomarker, which is essentially a precise statement of what the biomarker is for and under what conditions it should be used. That kind of clarity is critical if biomarkers are going to be incorporated into later-stage studies, including large phase III clinical trials, and eventually translated into broader clinical and research practice.
The Coordinating Center is expected to be structured around two major components. First is an Administrative Core, which is responsible for the overall coordination and day-to-day management of the consortium. This includes organizing meetings, aligning timelines and milestones across the network, supporting cross-site communication, ensuring consistent implementation of consortium policies and procedures, and keeping the program moving as a unified enterprise rather than a collection of disconnected projects. Second is a Data Core, which is responsible for coordinating the receipt, management, curation, and sharing of consortium data, including de-identified clinical data. This implies development and maintenance of data pipelines and harmonized data standards, quality control processes, and mechanisms to make data accessible to consortium members and, where applicable, to the wider scientific community in ways that protect participant privacy while maximizing scientific value.
Scientifically, the Coordinating Center is not just a logistical hub; it is also expected to contribute to the validation work in a meaningful way. That includes helping to design consortium-level analyses, harmonize outcome measures, ensure biomarker measurements are comparable across sites, and support statistical and methodological approaches that make validation claims robust. The FOA highlights the need for relevance to general and diverse populations, signaling that the consortium should aim for findings that are not narrowly applicable to a single subgroup. This focus on diversity and generalizability matters because VCID and small vessel disease impact heterogeneous communities, and biomarkers intended for broad clinical trials must work reliably across different demographic and clinical backgrounds.
From an eligibility standpoint, the announcement is broadly open: state and local governments, tribal governments and organizations, public and private higher education institutions, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other entities as described in the full notice can apply. The funding activity category is health, and the opportunity is listed under CFDA numbers 93.853 and 93.866. The opportunity was created on November 23, 2020, with an original application closing date of March 9, 2021. While an "Award Ceiling" of 0 is shown in the summary data, that typically indicates the ceiling is not specified in this condensed listing rather than implying no funds; the detailed FOA usually provides budget expectations and allowable cost structures.
Overall, this opportunity is about building the operational and scientific backbone needed to turn early biomarker discoveries in small vessel VCID into clinically validated tools. By funding one Coordinating Center to manage administration and data, NINDS is aiming to ensure consistency, rigor, and efficiency across multiple collaborating sites, with the end goal of delivering biomarkers that are ready to be used in future clinical trials and to accelerate progress in understanding and treating vascular contributions to cognitive impairment and dementia.Apply for RFA NS 21 004
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Small Vessel VCID Biomarkers Validation Consortium Coordinating Center (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
- This funding opportunity was created on Nov 23, 2020.
- Applicants must submit their applications by Mar 09, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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