Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed) | RFA CA 22 003

Frequently Asked Questions (FAQs)

What is the title of this NIH/NCI funding opportunity?

The funding opportunity is titled "Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)."

Which NIH institute is offering this grant?

The opportunity is offered by the National Institutes of Health (NIH) through the National Cancer Institute (NCI).

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is RFA-CA-22-003.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.394.

What program is this funding opportunity part of?

This opportunity is part of NCI's broader Innovative Molecular Analysis Technologies (IMAT) Program.

What is the purpose of this grant opportunity?

The purpose is to support exploratory, early-stage projects that create highly innovative technologies to improve the quality and usefulness of biospecimens used in cancer research and clinical care.

What does the R61 mechanism mean in this context?

As an R61 mechanism, the award is intended to support high-risk, high-reward, early development work. The emphasis is on exploratory technology development rather than late-stage validation.

Are clinical trials allowed under this FOA?

No. The FOA explicitly states "Clinical Trial Not Allowed."

What is the maximum (ceiling) award amount shown for this opportunity?

The award ceiling shown in the source data is $150,000.

What was the closing date for this funding opportunity?

The closing date listed for this opportunity was September 22, 2022.

What major problem area is this FOA trying to solve?

The FOA focuses on problems that occur before a specimen is analyzed, specifically pre-analytical variation and degradation that can happen during specimen collection, processing, handling, transport, or storage.

What is meant by "pre-analytical variation" in the context of biospecimens?

Pre-analytical variation refers to changes in specimen quality or composition caused by factors prior to analysis, such as collection methods, delays before preservation, handling differences, transport conditions, and storage conditions. These factors can alter or degrade cancer-relevant analytes and affect downstream results.

What types of analytes or biomarkers are specifically mentioned as being affected by pre-analytical issues?

The FOA notes that many cancer-relevant analytes can change or break down, including nucleic acids, proteins, metabolites, circulating tumor components, and other biomarkers.

What kinds of technologies or solutions is NCI seeking to fund?

Projects are expected to develop tools, devices, instrumentation, and associated methods that prevent, reduce, measure, or otherwise address pre-analytical effects. This includes technologies that preserve or protect specimen integrity and/or establish verification criteria for quality assessment and quality control.

At what stage of the specimen lifecycle is the FOA focused?

The FOA targets the specimen lifecycle before analytic testing, including collection, processing, handling, transport, and storage, with the goal of making biospecimens more reliable starting material for downstream molecular analyses.

What are examples of practical areas of improvement highlighted by the FOA?

Examples described include stabilizing specimens at the point of collection, improving processing workflows, reducing time-to-preservation, monitoring environmental exposures such as temperature fluctuations, and enabling rapid checks to confirm whether a specimen is fit for a particular downstream assay.

Is the FOA looking for incremental improvements to standard operating procedures (SOPs)?

No. The emphasis is on innovation that meaningfully improves the ability to maximize or interrogate biospecimen quality and utility, rather than incremental tweaks to existing standard operating procedures.

Why is improving biospecimen quality important for cancer research and care?

Inconsistent biospecimen quality can lead to misleading results, failed assays, or irreproducible findings. By reducing pre-analytical variation and degradation, downstream molecular analyses can be more accurate, reproducible, and clinically meaningful.

What downstream cancer research and clinical areas could benefit from the technologies developed under this FOA?

NCI highlights potential impact across basic cancer biology, early detection and screening, clinical diagnosis, treatment decision-making, and epidemiology.

Does the FOA mention cancer health disparities?

Yes. The FOA recognizes relevance to cancer health disparities because pre-analytical variability can be more pronounced in settings with limited resources, constrained infrastructure, or longer transport times.

How could biospecimen technologies help address cancer health disparities according to the FOA?

Technologies that maintain specimen integrity in varied clinical and community contexts, or that help standardize quality assessment across different sites, can reduce bias and improve comparability of data across populations.

Who is eligible to apply for this grant opportunity?

Eligibility is broad and includes many organization types across public, private, academic, nonprofit, and governmental sectors, including U.S.-based and non-U.S. (foreign) entities as listed in the FOA details provided.

Are state, county, and local governments eligible applicants?

Yes. State, county, and local governments are listed as eligible applicants.

Are public institutions of higher education eligible?

Yes. Public and state-controlled institutions of higher education are eligible.

Are private institutions of higher education eligible?

Yes. Private institutions of higher education are eligible.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible.

Are nonprofits eligible to apply?

Yes. Nonprofits are eligible, including both 501(c)(3) and non-501(c)(3) organizations.

Are for-profit companies eligible to apply?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.

Are special districts, independent school districts, or housing authorities eligible?

Yes. Special districts, independent school districts, and public housing authorities/Indian housing authorities are included among eligible applicant types.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are called out as eligible.

Are non-U.S. (foreign) entities eligible to apply?

Yes. Non-U.S. (foreign) entities are explicitly listed as eligible.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The FOA calls out eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities, and Tribally Controlled Colleges and Universities.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed as eligible.

Are eligible federal agencies included in the eligibility list?

Yes. Eligible federal agencies are included among eligible applicants.

What kinds of expertise or disciplines does this opportunity aim to attract?

The opportunity is designed to attract innovators who can bring engineering, chemistry, molecular biology, clinical laboratory, and biospecimen science expertise together to improve the reliability of cancer biospecimens before they reach an analytic platform.