Advanced Development and Validation of Emerging Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) | RFA CA 24 009

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the NIH National Cancer Institute (NCI) funding call titled "Advanced Development and Validation of Emerging Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)," RFA-CA-24-009. It supports later-stage development and validation of promising cancer-relevant molecular and cellular measurement and analysis technologies so they become more mature, reliable, and usable by the broader research community.

Which NIH institute and program is sponsoring this NOFO?

The sponsor is the National Institutes of Health (NIH), specifically the National Cancer Institute (NCI). The NOFO sits within NCI's Innovative Molecular Analysis Technologies (IMAT) Program, which supports next-generation tools that can expand what researchers can measure, how accurately they can measure it, and how widely those capabilities can be adopted.

What grant mechanism does this NOFO use?

This solicitation uses the NIH R33 mechanism. It is intended for later-stage exploratory development where key feasibility questions have largely been resolved, and the work focuses on advancing performance and completing rigorous development and validation needed for broader adoption.

What stage of technology development is this opportunity aiming to support?

It targets technologies that have moved beyond early feasibility and now need advanced development and validation to become community-ready. Applicants are expected to have supportive preliminary data showing the core concept works and that major technical roadblocks have been addressed, while also demonstrating that important work remains to improve reliability, validation, and usability.

What kinds of technologies are a fit for this NOFO?

The focus is on emerging molecular and cellular analysis technologies that can target, probe, or assess molecular and cellular features of cancer in meaningfully new or improved ways. The technology should strengthen basic cancer biology research and clinically oriented cancer research by enabling new analytical capabilities at molecular and cellular scales.

What are the main goals NCI expects applicants to achieve under this R33?

NCI is looking for projects centered on rigorous development and validation, such as improving performance, establishing robustness and reproducibility, defining operating parameters and limitations, benchmarking against appropriate standards or reference methods, and demonstrating that other researchers can adopt the technology (rather than it remaining a bespoke, one-off system).

Does the proposed work need to be connected to cancer?

Yes. While a technology may ultimately be general-purpose, the work proposed under this NOFO must be anchored in improving molecular and/or cellular characterization of cancer. The "center of gravity" should be the technology and the new analytical capability it brings to understanding cancer at molecular and cellular levels.

What areas of cancer research impact are encouraged?

The NOFO highlights broad potential impact across the cancer continuum, including cancer biology, early detection and screening, clinical diagnosis, treatment, cancer control, and epidemiology. Projects may also explicitly address challenges connected to cancer health disparities.

Are clinical trials allowed under this funding opportunity?

No. Clinical trials are not allowed under this R33 NOFO, as stated in the title ("Clinical Trial Not Allowed"). Validation and evaluation plans should be designed accordingly and should not be structured as a clinical trial.

If clinical trials are not allowed, what kinds of validation activities are still appropriate?

Appropriate activities include non-trial study designs such as analytical validation, performance testing using appropriate biospecimens, reproducibility assessments (including across sites or operators when relevant), benchmarking against standards or reference methods, and other evaluation approaches that strengthen confidence, credibility, and adoption without being a clinical trial.

What is out of scope for this NOFO?

Applications are out of scope if they mainly use existing, established technologies where the only novelty is the selected biological system, clinical cohort, or research question. If the project is essentially a biology or clinical study that happens to use an established method, it is not a fit for this solicitation and will not be reviewed.

Where must the novelty be for an application to be considered responsive?

The novelty should be in the technology or methodology itself. Examples described in the NOFO include a new measurement modality, a substantially improved assay or platform, a new way to interrogate cellular or molecular features, or a major advance in validation and performance that would make an emerging approach broadly usable.

Is this opportunity focused more on answering a biological question or on building a tool?

It is technology-centered. The strongest-fit projects are those where the proposed technology enables capabilities that are currently difficult or impossible, and where the application plan is centered on systematic development and validation rather than on answering a specific standalone biological or clinical question.

What is the award ceiling for this opportunity?

The posted award ceiling is $300,000.

What is the CFDA number and activity category listed for this opportunity?

The CFDA number is 93.394, and the activity category is listed as Education and Health.

What are the key dates listed in the opportunity description?

The opportunity was created on 2023-11-29, and the original closing date is 2024-10-01.

Who is eligible to apply?

Eligibility is broad and includes: 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 Native American tribal governments; other Native American tribal organizations; public housing and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

Are non-U.S. (foreign) organizations eligible?

Yes. The NOFO explicitly notes that non-domestic (non-U.S.) entities (foreign organizations) are among the eligible organization types.

Are minority-serving institutions and other specialized organization types eligible?

Yes. The NOFO highlights additional eligible organizations including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among the additional eligible organizations.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among the additional eligible organizations.

Are federal agencies eligible to apply?

Yes. The NOFO lists eligible federal agencies among the eligible applicant types.

What does "community-ready" mean in the context of this NOFO?

Based on the description provided, "community-ready" refers to a technology reaching a level of maturity where it is reliable, validated, robust, reproducible, well-characterized in terms of operating parameters and limitations, benchmarked appropriately, and realistically adoptable by other researchers beyond the original development team.

What does NCI mean by emphasizing robustness and reproducibility?

The NOFO emphasizes development and validation work that demonstrates the technology performs consistently and reliably. This includes establishing reproducibility and robustness, potentially across operators or sites where relevant, so the broader community can trust and replicate the technology's outputs.

Can a project be "clinically oriented" without being a clinical trial?

Yes. The NOFO indicates the work can support clinical cancer research in the sense of enabling tools for clinical investigation, diagnostics development, or translational studies, as long as the proposed work itself is not structured as a clinical trial.

What is the practical expectation for preliminary data in an R33 application under this NOFO?

Applicants are expected to provide supportive preliminary data showing the core concept works and that major technical roadblocks have been addressed. The application should then justify why substantial development and validation work is still needed to make the technology mature and broadly usable.

How does this NOFO relate to the IMAT program's broader goals?

The IMAT program broadly supports next-generation tools that change what researchers can measure, how accurately they can measure it, and how widely those capabilities can be adopted. This NOFO fits that mission by focusing specifically on pushing emerging molecular and cellular analysis technologies from early feasibility into rigorous, validated, community-ready platforms for cancer research.