NIH is accepting applications under PAR-25-095, Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R01 Clinical Trial Not Allowed). The opportunity supports innovative analysis and integration of existing clinical, environmental, surveillance, health-services, vital-statistics, behavioral, lifestyle, genomic, molecular, and related datasets to address cancer risk, prevention, survival, treatment response, healthcare delivery, and other cancer outcomes.
Current deadlines: The next deadline for new applications is October 5, 2026 at 5:00 PM local time of the applicant organization. Renewal, resubmission, and revision applications are due November 5, 2026 at 5:00 PM local time. NIH extended the opportunity expiration date to November 6, 2026 through NOT-CA-26-011.
Funding: Application budgets are limited to $350,000 in direct costs per year. The maximum project period is five years. The number of awards depends on NIH appropriations and the number of meritorious applications.
Eligibility: Eligible organizations include public and private institutions of higher education, qualifying nonprofits, small businesses and other for-profit organizations, state and local governments, independent school districts, Tribal governments and organizations, public housing authorities, eligible federal agencies, and other applicant classes listed in the NOFO.
Cost sharing: No cost sharing or matching is required.
Scope and material restrictions: This mechanism is for secondary analysis and integration of existing data. The primary analyzed data should not be newly collected from study participants or newly generated from existing biological specimens. New data generation is limited to less than 10% of the budget and only for validation of key findings. Clinical trials are not allowed. Studies focused on non-human data only, ongoing analyses, or maintaining and distributing datasets are non-responsive.
Application requirements: Applications follow the NIH Research (R) instructions and include the SF424(R&R) components, budget, PHS 398 Research Plan, required Resource Sharing information, and any applicable human-subjects study record. A Data Management and Sharing Plan is required when the project will generate scientific data. Applicants using data they do not possess should confirm data availability and permissibility; letters of support and/or data-access approval are encouraged. Applicants must maintain the required SAM.gov/UEI, Grants.gov, and eRA Commons registrations.
Submission: Applications may be prepared and submitted through NIH ASSIST, an institutional system-to-system solution to Grants.gov, or Grants.gov Workspace, with status tracked in eRA Commons.
Direct Dr. Miltie review: For-profit organizations and small businesses are explicitly eligible and there is no mandatory match barrier, so a direct Dr. Miltie pathway is structurally possible. It is not submission-ready without a genuinely responsive cancer-research question, lawful access to suitable existing datasets, a qualified PI and complementary analytic/research team, appropriate statistical power and methodology, complete NIH registrations, and all applicable human-subjects and data-governance requirements. Institutional opportunities should also be routed to applicable state healthcare and education pathways.