Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional) | PAR 25 170

Opportunity Information: Apply for PAR 25 170

The National Institutes of Health (NIH) is offering a cooperative agreement funding opportunity titled "Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)" under Funding Opportunity Number PAR-25-170. The goal is to speed up the development and validation of biomarkers or clinical outcome assessments that are derived from digital health technologies (DHTs), such as wearable sensors, smartphone-based measures, or other remote data-capture tools, so they can be credibly used in clinical trials. A central emphasis is on creating measures that work for remote monitoring and that can serve as primary or secondary clinical trial endpoints, which means the outputs should be reliable and meaningful enough to support decision-making in studies that evaluate treatments or interventions.

A key requirement is that applicants must develop and test these digitally derived assessments across at least three different diseases or conditions. This multi-condition expectation is meant to increase real-world clinical impact, improve statistical feasibility (by demonstrating performance across varied populations and contexts), and promote standardization so that the same or closely comparable digital measures can be used more broadly rather than being narrowly tailored to a single disorder. In practice, the NIH is signaling that it wants tools that can generalize, with clear evidence that the measurement approach is robust across different clinical scenarios, rather than a one-off digital metric that only works in one setting.

The award mechanism is the phased UG3/UH3 cooperative agreement approach. Typically, this structure supports an initial milestone-driven phase (UG3) focused on planning, proof-of-concept work, and early validation steps, followed by a second phase (UH3) that expands to more rigorous testing and implementation once predefined milestones are met. Because it is a cooperative agreement rather than a standard grant, awardees should expect substantial NIH involvement in project oversight, including collaborative guidance, milestone tracking, and coordination around deliverables that support broader adoption and standardization. The announcement is labeled "Clinical Trial Optional," meaning applicants may propose a clinical trial if it is appropriate to their aims, but it is not mandatory for every application.

Partnerships with non-profit patient advocacy organizations are required. This reflects a strong expectation that measure development is grounded in patient priorities and real-world usability, and that patient communities help shape what outcomes matter, how burdensome data collection is, and how acceptable remote monitoring approaches are in everyday life. These partnerships also typically strengthen recruitment and retention strategies, improve cultural and contextual fit of digital tools, and help ensure that resulting endpoints are meaningful to patients and caregivers, not just technically measurable.

Eligibility is broad and spans many organization types, including state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other entities. The announcement also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

At the same time, there are clear restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply under this opportunity. In other words, the applicant organization must be U.S.-based, and the funded components of the work must be conducted within eligible U.S. organizational structures rather than through non-U.S. branches or foreign organizational applicants.

This opportunity is categorized as discretionary funding and uses the cooperative agreement instrument type, with activity areas listed under education and health. It references CFDA numbers 93.399 and 93.853. The opportunity was created on 2024-11-13, and the original closing date listed is 2026-06-22. While an award ceiling and expected number of awards are not specified in the provided source information, the structure and requirements make it clear that NIH is looking for ambitious, cross-condition, patient-centered programs that produce standardized, clinically credible digital endpoints suitable for remote monitoring in clinical trials.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.399, 93.853.
• This funding opportunity was created on 2024-11-13.
• Applicants must submit their applications by 2026-06-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for PAR 25 170

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