Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional) | PAR 25 266

Opportunity Information: Apply for PAR 25 266

The Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional) funding opportunity (PAR-25-266) is a National Institutes of Health (NIH) discretionary grant designed to push forward early-life health interventions by improving how serious conditions are detected and treated in newborns. The focus is on disorders that are potentially fatal or severely disabling and that either are already identified through newborn screening programs or are considered strong candidates for screening in the near future. The core idea is straightforward: newborn screening only delivers real public health value when there is both a reliable way to identify affected infants quickly and evidence that earlier identification leads to better outcomes because effective intervention or treatment is available.

A central emphasis of this opportunity is the development of novel screening approaches, which can include new tests, improved testing workflows, or emerging technologies that increase accuracy, speed, or feasibility of screening at population scale. In newborn screening, false positives and false negatives have real consequences for families and health systems, so projects that improve sensitivity, specificity, predictive value, or overall clinical utility fit well. The FOA also explicitly welcomes research on therapeutic interventions tied to screenable disorders, recognizing that screening is not just about detection but about enabling timely care. In practice, that can mean developing or refining treatments, testing early-intervention strategies, or generating evidence that starting treatment in the newborn period changes disease trajectory in meaningful ways.

The announcement also highlights interest in "high priority" genetic conditions. In this FOA, a high priority condition is one that is not currently recommended for routine newborn screening panels, but where early identification would significantly benefit infants because treatment or intervention exists (or could plausibly be implemented) and delays would lead to worse outcomes. This is an important niche: it supports research that helps move a condition from being a plausible screening candidate to being a well-justified one. That typically requires showing that screening is technically feasible, that it can be done accurately and at scale, and that early treatment meaningfully improves outcomes compared to later diagnosis through symptoms.

Mechanistically, this is an R21 exploratory/developmental grant, which is generally used for early-stage, high-impact, or proof-of-concept work that can open up new directions, generate preliminary data, or validate innovative approaches before larger clinical or implementation studies are pursued. The FOA is listed as "Clinical Trial Optional," meaning applicants may propose studies that do or do not meet the definition of a clinical trial, depending on what is necessary to answer their research question. The listed award ceiling is $200,000, and the closing date shown is 2027-11-16. The program is tied to CFDA number 93.865 and falls under the broad activity category of Health, Income Security, and Social Services.

Eligibility is broad and spans many types of organizations that can contribute to newborn screening and early-intervention research. Eligible applicants include state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and additional entities categorized as "Others." The FOA further calls out additional eligible applicant types such as Historically Black Colleges and Universities, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, along with faith-based or community-based organizations, U.S. territories or possessions, eligible federal agencies, regional organizations, and even non-U.S. (foreign) organizations. Taken together, that breadth signals NIH interest in enabling multidisciplinary, cross-sector collaboration, including partnerships among laboratory scientists, clinicians, public health programs, community organizations, and technology developers.

Overall, the opportunity is aimed at strengthening the evidence and tools needed to expand and improve newborn screening in a responsible way. Projects aligned with this FOA are those that help solve the two big gating issues for adding or improving screening for a condition: first, having an accurate, practical screening test; and second, demonstrating that finding the condition early leads to clear clinical benefit because an intervention can be started sooner, changing outcomes for infants who would otherwise face avoidable harm.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2024-12-02.
• Applicants must submit their applications by 2027-11-16.
• Each selected applicant is eligible to receive up to $200,000.00 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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