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.

  • 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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