Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) | RFA CA 24 011

Opportunity Information: Apply for RFA CA 24 011

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)," Funding Opportunity Number RFA-CA-24-011 (CFDA 93.394). The program is focused on biospecimen science, specifically on technologies and methods that improve the quality, integrity, and downstream usefulness of biological samples collected for cancer research and clinical care. The key problem this NOFO targets is pre-analytical variability and degradation, meaning the losses and changes that can happen to important molecules (targeted analytes) before a sample is ever analyzed, during collection, processing, handling, transport, and storage. By reducing these pre-analytical issues, the NIH aims to strengthen the reliability and reproducibility of cancer research findings and help clinical workflows produce more dependable results.

This is an R33 mechanism, which generally fits projects that have already cleared major feasibility hurdles and can show supportive preliminary data, but still need additional development work and rigorous validation before the technology is ready for broader community adoption. In other words, the NOFO is not looking for early, unproven concepts with no evidence; it is looking for emerging tools or methodologies that have a credible foundation and now need to be matured, stress-tested, benchmarked, and validated under realistic and diverse conditions. The intent is to push promising technologies across the gap between "it seems like it works" and "it is validated well enough that other labs and clinical settings can trust and use it."

The kinds of activities supported include the development and validation of tools, devices, instrumentation, and associated procedures that either preserve/protect biospecimen integrity or allow better measurement of biospecimen quality. That can include methods that prevent or slow degradation of nucleic acids, proteins, metabolites, or other cancer-relevant biomarkers; systems that standardize handling steps; or approaches that establish clear verification criteria for quality assessment and quality control (QA/QC). A major emphasis is on performance under diverse conditions, reflecting real-world variability in collection sites, workflows, storage constraints, shipping conditions, and time-to-processing delays that often drive inconsistent results. The expectation is that successful projects will produce technologies that make biospecimens more fit-for-purpose for downstream analyses, which can range from basic biology studies to translational and clinical applications.

The broader impact the NIH is seeking is acceleration and improvement across multiple areas of cancer research and care: cancer biology, early detection and screening, clinical diagnosis, treatment, epidemiology, and work related to cancer health disparities. The health disparities connection is important because pre-analytical variability can be worse in settings with fewer resources or less standardized infrastructure; technologies that stabilize samples, enable robust QC, or tolerate variable conditions can help ensure that data and clinical insights are reliable across different populations and care environments. Overall, the NOFO is trying to reduce the noise and bias introduced before analysis even begins, which can otherwise lead to false signals, missed biomarkers, irreproducible findings, or inequitable clinical performance.

Eligibility is broad and includes a wide mix of U.S. and non-U.S. organizations: state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The NOFO also explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities, and U.S. territories or possessions.

Administratively, the opportunity was created on 2023-11-28, with an original closing date of 2024-10-01. The award ceiling listed is $300,000. The listing does not specify the expected number of awards in the provided source text. The activity category is listed under Education and Health, and the funding instrument is a grant. The clinical trial status is explicitly "Clinical Trial Not Allowed," meaning applicants should not propose projects that meet NIH definitions of a clinical trial, even if the work is related to clinical samples; the focus is on technology development and validation rather than interventional testing in human participants as a trial.

In practical terms, a competitive application under this NOFO would typically describe a technology that already has evidence of feasibility, define the remaining development steps needed to make it robust and usable, and lay out a rigorous validation plan that demonstrates performance, reliability, and utility for cancer-relevant biospecimens. Strong proposals would also make clear how the technology reduces pre-analytical variation, how it will be tested across realistic conditions, what QA/QC metrics or acceptance criteria will be established, and how the final output will be adoptable by the broader research or clinical community.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
• This funding opportunity was created on 2023-11-28.
• Applicants must submit their applications by 2024-10-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $300,000.00 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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