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.Apply for RFA NS 19 022
- 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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FAQs: NIH RFA-NS-19-022 (PCS-EMA CWOW) U54 Clinical Trial Not Allowed
What is the main goal of this NIH funding opportunity?
The opportunity supports a coordinated, multi-site research effort to identify and validate objective biological measures that help clinicians and researchers assess, predict, and monitor recovery in children ages 9 to 14 who experience concussion or repetitive head impacts, with a focus on persistent concussive symptoms.
What problem is this program trying to solve?
A meaningful subset of youth develop prolonged or persistent concussive symptoms, and current clinical tools often have difficulty reliably predicting who will recover quickly versus who will experience lingering symptoms. The program aims to improve prognosis and monitoring by developing biological measures with strong performance and external validation.
Who is the target population for the research?
The program focuses on early and middle adolescents ages 9 to 14 who experience concussion or repetitive head impacts, especially those at risk for prolonged or persistent concussive symptoms.
What kind of research approach does the FOA emphasize?
It emphasizes discovery and rigorous evaluation of candidate biological measures (biomarkers) and then external validation so the measures are more likely to generalize across cohorts and settings rather than only working in a single study sample.
What types of biological measures or data does the FOA anticipate using?
While it does not list specific biomarker types, it anticipates integrating multiple data streams, including clinical data alongside neuroimaging, physiological measures, and biospecimens.
Is the goal only to find associations, or to produce clinically useful measures?
The FOA pushes beyond exploratory associations. It expects applicants to determine how sensitive and selective the candidate biological measures are, and to validate them beyond the original discovery cohort so they can be trusted for prognosing risk and monitoring symptoms over time.
What is meant by sensitivity and specificity in this context?
In the context of this FOA, sensitivity and specificity refer to how well a proposed biological measure can detect or predict persistent concussive symptoms (sensitivity) and how well it can distinguish those outcomes from other situations where persistent symptoms are not present (specificity).
What deliverables are expected from the funded work?
Key deliverables include (1) candidate biological measures for persistent concussive symptoms that are rigorously evaluated, (2) external validation of those measures, and (3) incorporation of the measures into risk stratification algorithms that support prognosis and monitoring.
What are risk stratification algorithms in the context of this program?
They are practical tools that use biological measures (and potentially other data streams) to estimate an individual youth's likelihood of prolonged recovery or to group patients into meaningful subtypes that could support future research and clinical decision-making.
How does this FOA connect to future clinical trials if clinical trials are not allowed here?
The FOA aims to improve risk stratification and reduce heterogeneity in participant populations, which can make future interventional studies more efficient. Better stratification can help identify the right participants and make treatment effects easier to detect in later clinical trials, even though trials are not part of this award.
Are clinical trials allowed under this announcement?
No. This funding opportunity is labeled "U54 Clinical Trial Not Allowed," meaning the supported work must focus on biomarker discovery and validation, observational designs, and related infrastructure and analytics rather than testing interventions for efficacy.
What award mechanism is used for this opportunity?
The mechanism is a U54 cooperative agreement, which typically involves substantial scientific and programmatic involvement by NIH staff and supports a structured, team-science approach.
What does "Center Without Walls" mean here?
It signals a distributed consortium model that connects investigators and sites across locations rather than relying on a single physical center, enabling coordinated multi-site work.
Is this intended to be a single-site project or a multi-site effort?
The FOA is designed as a coordinated, multi-site research effort, consistent with the "Center Without Walls" consortium model.
How important is data sharing in this program?
Data sharing is a core feature. Awardees are expected to broadly share clinical, neuroimaging, physiological, and biospecimen-related data to accelerate progress and enable secondary analyses, replication, and method development.
What kinds of data are expected to be shared?
The FOA highlights sharing of clinical data, neuroimaging data, physiological measures, and biospecimen-related data.
Why does the FOA emphasize external validation?
External validation is emphasized to ensure that proposed biological measures generalize across different cohorts and settings, improving confidence that the measures are reliable beyond a single discovery sample.
What is the translational intent of the program?
The translational intent is to move toward practical prognosis and monitoring tools by embedding validated biological measures into risk algorithms, building a foundation that can support improved clinical decision-making and more efficient future research.
Who is eligible to apply?
Eligibility is broad and includes 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.
Are any specific institution types explicitly highlighted as eligible?
Yes. The FOA explicitly highlights additional eligible applicant types such as 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.
Can non-U.S. (non-domestic) organizations apply?
No. Non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply.
Are any international collaborations allowed at all?
Yes, 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.
Which NIH program or agency is offering this opportunity?
The opportunity is offered by the NIH and is categorized as a health-related activity.
What is the FOA title and number?
The title is "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 the FOA number is RFA-NS-19-022.
What CFDA numbers are associated with this funding opportunity?
The CFDA numbers listed are 93.853 and 93.865.
What is the listed award ceiling?
The listed award ceiling is $2,250,000.
What are the key dates mentioned in the opportunity description?
The creation date is February 7, 2019, and the original closing date listed is April 10, 2019.
Does the FOA focus only on concussion, or also on repetitive head impacts?
It addresses children ages 9 to 14 who experience concussion or repetitive head impacts, with particular attention to persistent concussive symptoms and recovery trajectories.
What is meant by "persistent concussive symptoms" in this FOA?
It refers to prolonged or lingering symptoms following concussion or head impacts that do not resolve quickly for a subset of youth, creating challenges for prognosis and monitoring using current clinical tools.
How does the FOA describe the long-term value of the program outputs?
It aims to build a robust, shared-evidence foundation by producing validated measures and broadly shared datasets and biospecimen-related resources that can continue to drive discovery beyond the initial award period.
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