Supports Phase I (R61) exploratory/developmental projects to create highly innovative tools, devices, instrumentation, assays, and associated methods that improve the collection, handling, processing, preservation, and/or storage of cancer-relevant biospecimens and their derivatives. Applications must propose novel capabilities to preserve sample integrity, establish rigorous quality assessment/quality control metrics, or mitigate pre-analytical degradation of targeted analytes. These technologies should accelerate and enhance research in cancer biology, early detection and screening, clinical diagnosis, treatment, epidemiology, and/or health-disparities research. Projects that merely apply existing technologies without significant technical innovation will be deemed nonresponsive.
Eligibility Criteria
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Eligible organizations:
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U.S. and foreign institutions of higher education;
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Nonprofit organizations (with or without 501(c)(3) status);
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For-profit entities (including small businesses);
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Local, state, and tribal governments;
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Faith-based or community organizations;
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Public housing authorities/Indian housing authorities;
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Independent school districts;
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Regional organizations.
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PD/PI requirements: Must have an eRA Commons account.
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Project scope: Early-stage (inception through preliminary development) biospecimen science technology development (no clinical trials).
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Preliminary data: Not required but accepted. If feasibility is already established, consider the R33 companion (RFA-CA-25-004).
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Nonresponsive applications:
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Biological/clinical hypothesis–driven projects without novel technical innovation;
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Proof-of-concept technologies ready for validation;
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Whole-body or in vivo imaging instrumentation;
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Clinical trials or toxicology beyond technology validation;
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Biomarker discovery/validation;
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Drug or therapy development;
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Software/informatics-only solutions without integration into a device or method;
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Lacks well-defined, quantitative performance measures.
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Funding Details
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Mechanism: R61 Phase I Exploratory/Developmental Grant
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Direct costs: Up to 150,000 USD per year
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Project period: Up to 3 years
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Estimated awards (FY 2026): ~4, totaling 1,000,000 USD
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Clinical trials: Not allowed
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Budget constraints: Funds must be used for early-stage development and feasibility testing; pre-award costs allowed only as described in NIH Grants Policy Statement.
Key Deadlines
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Letter of Intent: 30 days prior to application due date
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Application Due Dates & Review Timelines:
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October 3, 2025 (Submit by 5:00 PM local time) → Scientific Merit Review: February 2026 → Advisory Council: May 2026 → Earliest Start: July 2026
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Expiration Date: October 4, 2025
Agency Contacts
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Scientific/Research: Kelly Crotty, Ph.D. (kelly.crotty@nih.gov; 240-255-0917)
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Peer Review: Referral Officer, NCI (ncirefof@dea.nci.nih.gov; 240-276-6390)
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Grants Management: Sean Hine (hines@mail.nih.gov; 240-276-6291)
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GrantsInfo: GrantsInfo@nih.gov; 301-480-7075
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Grants.gov Support: support@grants.gov; 800-518-4726