Opportunity Information: Apply for RFA NS 20 016
This grant 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)," is a National Institutes of Health (NIH) cooperative agreement (U54) administered under the Department of Health and Human Services. The program is focused on early and middle adolescents ages 11 to 17 who have experienced concussion and/or repetitive head impacts and who either already show prolonged symptoms or may be at risk of developing persistent concussive symptoms. The core aim is to move beyond symptom checklists alone by developing and validating objective biological measures that can help clinicians assess injury impact, predict who is likely to have prolonged recovery, and monitor recovery trajectories over time.
A central emphasis of the FOA is the discovery and rigorous evaluation of biological measures, meaning potential biomarkers or objective indicators drawn from domains such as biospecimens (for example, blood-based markers), neuroimaging, and physiological measures. The announcement specifically calls for efforts that do more than identify possible signals: applicants are expected to characterize how sensitive and selective these measures are (in practical terms, how well they detect meaningful concussion-related pathology and how well they distinguish persistent concussive symptoms from other conditions or normal variation). In addition, the FOA highlights the importance of external validation, indicating that proposed measures should be tested for generalizability beyond the original development setting so that they have a credible path toward real-world clinical utility.
Another key deliverable expected from funded work is the integration of these biological measures into risk stratification algorithms. The intent is to combine biomarker information with clinical, imaging, and physiological data to create tools that can sort patients into clinically meaningful risk categories. These algorithms are meant to support clinical decision-making (such as identifying adolescents who may need closer follow-up, more intensive management, or tailored recovery plans) and to help define subgroups for future clinical trials, improving the ability to match interventions to the patients most likely to benefit. While the funding mechanism is research-oriented, the program is clearly framed around producing outputs that can be translated into improved clinical care and better-designed future studies.
The initiative is structured as a "Center Without Walls," which typically signals a collaborative, multi-site, and highly coordinated research model rather than a single-lab effort. Consistent with that model, the FOA makes broad data sharing a critical feature rather than an optional add-on. Awardees are expected to share clinical data, neuroimaging data, physiological data, and biospecimen-related data widely to accelerate progress across the field. This emphasis reflects the need for large, harmonized datasets in concussion research, especially when studying persistent symptoms in adolescents where variability in development, activity exposure, and recovery can be substantial.
Administrative details in the source information indicate this is a discretionary funding opportunity (Funding Opportunity Number RFA NS 20 016) with an award ceiling of $2,000,000 and an expectation of one award. The activity category is health research (CFDA 93.853). The FOA was created on February 10, 2020, with an original closing date of June 26, 2020. It is designated "Clinical Trial Not Allowed," meaning proposed projects should not be designed as clinical trials as defined by NIH, even though they may involve human participants, observational study designs, prospective monitoring, and the collection of biological and imaging data to develop and validate prognostic or monitoring measures.
Eligibility is broad and includes many types of organizations that could contribute to a multidisciplinary adolescent concussion research program. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the FOA’s additional eligibility guidance. Overall, the opportunity is aimed at building a coordinated research effort capable of generating validated, shareable, clinically relevant biological measures and algorithms for predicting and tracking persistent concussive symptoms in adolescents exposed to concussion and repetitive head impacts.Apply for RFA NS 20 016
- The Department of Health and Human Services, National Institutes of Health in the health 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.
- This funding opportunity was created on Feb 10, 2020.
- Applicants must submit their applications by Jun 26, 2020. (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 $2,000,000.00 in funding.
- 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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Frequently Asked Questions (FAQ)
What is the title of this grant opportunity?
The opportunity is 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)."
Which federal agency and department are sponsoring this program?
This is a National Institutes of Health (NIH) funding opportunity administered under the U.S. Department of Health and Human Services (HHS).
What funding mechanism is being used?
The program uses an NIH cooperative agreement mechanism: U54.
What does it mean that this is a cooperative agreement (U54)?
Based on the information provided, the mechanism is described as a cooperative agreement, which typically indicates a coordinated, collaborative research effort (aligned here with the "Center Without Walls" model) rather than a single independent project.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA NS 20 016.
What is the focus population for this program?
The program is focused on early and middle adolescents ages 11 to 17 who have experienced concussion and/or repetitive head impacts and who either already have prolonged symptoms or may be at risk of developing persistent concussive symptoms.
What health problem is this grant trying to address?
The program targets persistent concussive symptoms in adolescents, especially cases involving prolonged recovery or elevated risk of prolonged symptoms following concussion and/or repetitive head impacts.
What is the central aim of the research supported by this program?
The core aim is to develop and validate objective biological measures to help clinicians assess injury impact, predict who is likely to have prolonged recovery, and monitor recovery trajectories over time, moving beyond symptom checklists alone.
What types of "biological measures" are emphasized?
The announcement highlights biological measures drawn from domains such as biospecimens (for example, blood-based markers), neuroimaging, and physiological measures.
Is the program only about discovering possible biomarkers?
No. The program emphasizes discovery and rigorous evaluation, meaning proposed measures are expected to be characterized for sensitivity and selectivity and to have credible potential for clinical utility.
What does the FOA mean by evaluating sensitivity and selectivity of measures?
As described, applicants are expected to evaluate how well measures detect meaningful concussion-related pathology (sensitivity) and how well they distinguish persistent concussive symptoms from other conditions or normal variation (selectivity).
Is external validation required or encouraged?
External validation is highlighted as important. The information states proposed measures should be tested for generalizability beyond the original development setting to support a credible path toward real-world clinical utility.
What is meant by "risk stratification algorithms" in this program?
The program expects integration of biological measures into risk stratification algorithms that combine biomarker information with clinical, imaging, and physiological data to sort patients into clinically meaningful risk categories.
How are the risk stratification algorithms intended to be used?
They are intended to support clinical decision-making (for example, identifying adolescents needing closer follow-up, more intensive management, or tailored recovery plans) and to help define subgroups for future clinical trials.
Does this program fund clinical trials?
No. The opportunity is designated "U54 Clinical Trial Not Allowed," meaning proposed projects should not be designed as clinical trials as defined by NIH.
Can projects still involve human participants and data collection?
Yes. The information states that, even though clinical trials are not allowed, projects may involve human participants, observational study designs, prospective monitoring, and collection of biological and imaging data to develop and validate prognostic or monitoring measures.
What is the "Center Without Walls" model in this FOA?
It is described as a collaborative, multi-site, and highly coordinated research model rather than a single-lab effort.
Is data sharing a required component?
Yes. Broad data sharing is described as a critical feature rather than optional. Awardees are expected to share clinical, neuroimaging, physiological, and biospecimen-related data widely.
What kinds of data are expected to be shared?
The information specifies sharing of clinical data, neuroimaging data, physiological data, and biospecimen-related data.
Why does the FOA emphasize broad data sharing?
The stated rationale is to accelerate progress across the field and to support large, harmonized datasets, which are especially needed in adolescent concussion research where variability in development, exposure, and recovery can be substantial.
What is the maximum award amount (award ceiling)?
The award ceiling is $2,000,000.
How many awards are expected?
The information indicates an expectation of one award.
Is this a discretionary funding opportunity?
Yes. It is described as a discretionary funding opportunity.
What is the activity category or program area?
The activity category is health research.
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.853.
When was the FOA created?
The FOA was created on February 10, 2020.
What was the original closing date?
The original closing date was June 26, 2020.
Who is eligible to apply?
Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the FOA's additional eligibility guidance.
Are schools and school districts eligible?
Yes. The listed eligible applicants include independent school districts.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are included in the eligibility list.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with and without 501(c)(3) status are included, with the note that higher education institutions are excluded from those nonprofit categories as stated in the provided eligibility summary.
What kinds of outcomes or deliverables does the FOA seem to prioritize?
Based on the description provided, prioritized deliverables include validated objective biological measures (with characterized sensitivity/selectivity and external validation) and integrated risk stratification algorithms that can support clinical decision-making and inform subgroup definition for future clinical trials.
Is the program oriented toward clinical translation?
Yes. While the mechanism is research-oriented, the program is framed around producing outputs that can be translated into improved clinical care and better-designed future studies.
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