Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 Clinical Trial Not Allowed) | RFA NS 19 022

Opportunity Information: Apply for RFA NS 19 022

The NIH funding opportunity "Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 Clinical Trial Not Allowed)" (RFA-NS-19-022) supports a coordinated, multi-site research effort to identify and validate objective biological measures that can help clinicians and researchers better assess, predict, and track recovery in children ages 9 to 14 who experience concussion or repetitive head impacts. The central problem the FOA targets is that a meaningful subset of youth develop prolonged or persistent concussive symptoms, and current clinical tools often struggle to reliably forecast who will recover quickly versus who will experience lingering symptoms. The program is designed to improve that situation by developing biological measures with demonstrated sensitivity and specificity, then validating those measures externally so they are more likely to generalize across different cohorts and settings rather than only working in a single study sample.

A key scientific deliverable is the discovery and rigorous evaluation of candidate biological measures that can serve as biomarkers for persistent concussive symptoms. While the FOA text does not enumerate specific biomarker types, it clearly anticipates the use of clinical data alongside neuroimaging, physiological measures, and biospecimens, meaning applicants are expected to integrate multiple data streams that could plausibly capture injury effects and recovery trajectories. Importantly, the FOA emphasizes not just identifying signals, but determining how selective and sensitive they are and validating them beyond the original discovery cohort. In practice, that means the work should move past exploratory associations toward measures that can be trusted for prognosing risk and monitoring symptom persistence or resolution over time.

Another major expectation is that the resulting biological measures will be incorporated into risk stratification algorithms. The intent is to convert biomarker findings into practical tools that can support clinical decision-making, such as estimating an individual youths likelihood of prolonged recovery or grouping patients into meaningful subtypes for future interventional studies. This also supports a longer-term translational pipeline: better stratification can make future clinical trials more efficient by identifying the right participants, reducing heterogeneity, and helping investigators detect treatment effects that might otherwise be obscured by mixing different recovery profiles.

The award mechanism is a U54 cooperative agreement, which typically indicates substantial scientific and programmatic involvement by NIH staff and a more structured, team-science approach than a standard research project grant. The FOA frames the effort as a "Center Without Walls," signaling a distributed consortium model that connects investigators and sites rather than relying on a single physical center. Clinical trials are not allowed under this announcement, so the supported work must focus on biomarker discovery/validation, observational designs, and related infrastructure and analytics rather than testing interventions for efficacy.

Data sharing is presented as a core feature rather than an afterthought. Awardees are expected to broadly share clinical, neuroimaging, physiological, and biospecimen-related data to accelerate progress across the field of pediatric concussion and persistent symptoms. The emphasis on sharing indicates that NIH wants the outputs to serve as a community resource, enabling secondary analyses, replication, and method development by other researchers, which can speed standardization and improve confidence in proposed measures.

Eligibility is broad and includes many typical applicant categories such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, regional organizations, and U.S. territories or possessions, reflecting an interest in broad participation and potentially diverse study populations. Non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components as defined under the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain international collaborations when they meet NIH policy requirements.

Administratively, the opportunity falls under the NIH with a health-related activity category and CFDA numbers 93.853 and 93.865. The original closing date listed is April 10, 2019, with a creation date of February 7, 2019. The listed award ceiling is $2,250,000. Overall, the FOA is aimed at building a robust, shared-evidence foundation for pediatric concussion prognosis and monitoring by developing validated biological measures and embedding them into practical risk tools, while ensuring the resulting datasets and specimens can continue to drive discoveries well beyond the initial award period.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 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, 93.865.
• This funding opportunity was created on 2019-02-07.
• Applicants must submit their applications by 2019-04-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,250,000.00 in funding.
• 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.

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