Submission Deadline 10/14/2026
Fiscal Capacity $50,135,013
HHS-NIH11 Grant — Key Facts
Opportunity Number PAR-25-075
Agency HHS-NIH11
Application Deadline 10/14/2026
Award Amount $50,135,013
Status Posted
Sector Health
Cost Sharing Not Required

Fiscal Parameters & Taxonomy

Authority HHS-NIH11
Status Posted

Who Can Apply

City or township governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) For profit organizations other than small businesses Special district governments Private institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification) State governments Independent school districts 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 Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses County governments

Eligibility Intelligence

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Program Description

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.

CFDA Programs

93.394 Cancer Detection and Diagnosis Research

Agency Contact

NIH Grants Information grantsinfo@nih.gov

✉ grantsinfo@nih.gov

📞 301-402-2541

Related Intelligence Guides

In-depth editorial guides covering this agency's programs, eligibility requirements, and application strategies.

GrantMetric Intelligence Systems — Independent federal grant intelligence platform. Not affiliated with Grants.gov, the U.S. Department of Health & Human Services, or any government agency. Grant data is sourced from the Grants.gov API for informational purposes only; always verify opportunity details directly with the funding agency before applying. Some links on this site are affiliate links — we may earn a commission at no additional cost to you. Full Disclaimer  ·  Last Reviewed: May 2026  ·  Data Methodology