Opportunity Information: Apply for RFA CA 22 038

This funding opportunity (RFA-CA-22-038) is a National Cancer Institute (NCI) limited competition announcement to continue and strengthen the Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Center (CIMAC-CIDC) Network. The network was created to support cancer immunotherapy research by running standardized, high-quality correlative studies on biospecimens collected during immunotherapy clinical trials. Rather than funding new clinical trials, the emphasis is on generating and analyzing biomarker data that can be linked back to existing trial outcomes, with the long-term aim of improving how immunotherapies are selected, monitored, and optimized for cancer patients.

At the core of the program is a coordinated structure that includes multiple laboratory hubs (the CIMACs) and a centralized bioinformatics and data management hub (the CIDC). CIMAC laboratories are responsible for performing advanced immune monitoring and molecular profiling assays on a wide range of specimen types. These specimens can include tumor tissue and the tumor microenvironment, blood-derived samples, stool for microbiome work, and other clinically relevant biospecimens collected as part of immunotherapy trials. The assays described are broad and modern, spanning genomics, transcriptomics, proteomics, microbiome characterization, and immune phenotyping. The intent is to apply comprehensive, state-of-the-art immunoprofiling approaches in a consistent way across studies so results are comparable, reproducible, and useful beyond a single trial.

The CIDC role is to serve as the bioinformatics and immunologic data center that supports the network with data processing, integration, and analysis. In practical terms, this includes running established bioinformatics pipelines, harmonizing assay outputs, curating datasets, and enabling analyses that connect biomarker signals to clinical endpoints. A major theme is linkage: biomarker data produced by CIMAC assays is meant to be interpreted alongside clinical trial data to evaluate associations with response to therapy, resistance mechanisms, and immune-related adverse events. This coordinated CIMAC-CIDC workflow is designed to move beyond isolated biomarker findings and toward robust, clinically actionable insights.

The scientific goal driving the entire effort is biomarker discovery and validation in the context of cancer immunotherapy. NCI highlights three major outcome areas: biomarkers of response (who benefits and why), biomarkers of resistance (why therapies fail or stop working), and biomarkers of adverse events (who is at risk for toxicity and what biological pathways are involved). By repeatedly applying deep profiling to trial biospecimens and analyzing results in a unified data framework, the network aims to help the field understand immunotherapy biology and ultimately support better patient stratification, improved treatment combinations, and safer, more effective use of immune-based therapies.

Administratively, the opportunity uses the NIH cooperative agreement mechanism (U24), which generally means substantial federal scientific and programmatic involvement compared with a standard grant. The FOA is explicitly marked "Clinical Trial Not Allowed," reinforcing that the award is intended for infrastructure, assay execution, data generation, and correlative analyses, not for conducting interventional trials. The activity is categorized under education/health, and the CFDA listings associated with the opportunity are 93.394 and 93.395. The original application closing date listed is 2022-10-24, and the announcement was created on 2022-07-15.

Eligibility is restricted and U.S.-focused, consistent with the "limited competition" framing. Eligible applicants include public and state-controlled institutions of higher education, and the FOA explicitly excludes non-U.S. entities and foreign involvement in several forms: non-domestic (non-U.S.) institutions cannot apply; non-domestic components of U.S. organizations are not eligible; and foreign components, as defined by NIH policy, are not allowed. Anyone considering alignment with this program would need to rely on the full funding announcement for the detailed eligibility rules and any additional constraints tied to the limited competition status.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Competition: Cancer Immune Monitoring and Analysis Centers (CIMACs) and Cancer Immunologic Data Center (CIDC) (U24 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, 93.395.
  • This funding opportunity was created on 2022-07-15.
  • Applicants must submit their applications by 2022-10-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Public and State controlled institutions of higher education.
Apply for RFA CA 22 038

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Frequently Asked Questions (FAQs) - RFA-CA-22-038 (CIMAC-CIDC Network)

What is RFA-CA-22-038?

RFA-CA-22-038 is a National Cancer Institute (NCI) limited competition funding opportunity to continue and strengthen the Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Center (CIMAC-CIDC) Network. The program supports standardized, high-quality immune monitoring and biomarker data generation and analysis using biospecimens from cancer immunotherapy clinical trials.

What is the main purpose of this funding opportunity?

The main purpose is to support cancer immunotherapy research by running coordinated, standardized correlative studies on biospecimens collected during immunotherapy clinical trials, and by generating biomarker datasets that can be linked back to clinical outcomes. The emphasis is on biomarker data generation, integration, and analysis rather than launching new clinical trials.

Is this opportunity intended to fund new clinical trials?

No. The announcement is explicitly marked "Clinical Trial Not Allowed." It is intended for infrastructure, assay execution, biomarker data generation, and correlative analyses tied to existing immunotherapy clinical trials, not for conducting interventional clinical trials.

What does "limited competition" mean in this context?

The opportunity is described as a limited competition announcement with restricted eligibility. While this summary does not list the full set of restrictions, applicants are expected to rely on the full funding announcement for detailed eligibility requirements and any additional constraints specific to the limited competition status.

What is the CIMAC-CIDC Network?

The CIMAC-CIDC Network is a coordinated program designed to support cancer immunotherapy biomarker discovery and validation. It includes multiple laboratory hubs (CIMACs) that perform standardized immune monitoring and molecular profiling assays, and a centralized bioinformatics/data management hub (the CIDC) that processes, integrates, curates, and analyzes the resulting immunologic datasets alongside clinical trial data.

What are CIMACs?

CIMACs (Cancer Immune Monitoring and Analysis Centers) are laboratory hubs responsible for performing advanced immune monitoring and molecular profiling assays on biospecimens collected during immunotherapy clinical trials. The goal is to produce high-quality, standardized assay outputs that are comparable across studies.

What is the CIDC?

The CIDC (Cancer Immunologic Data Center) is the network's centralized bioinformatics and immunologic data center. Its role includes running established bioinformatics pipelines, harmonizing outputs across assays, curating datasets, integrating biomarker data with clinical trial data, and enabling analyses that relate biomarkers to clinical outcomes and endpoints.

What types of biospecimens can be included in CIMAC studies?

The network supports analyses across a wide range of clinically relevant biospecimens collected as part of immunotherapy trials. Examples described include tumor tissue and the tumor microenvironment, blood-derived samples, stool for microbiome characterization, and other relevant specimen types.

What types of assays and profiling approaches are supported?

The assays are described as broad and modern, spanning genomics, transcriptomics, proteomics, microbiome characterization, and immune phenotyping. A core intent is to apply comprehensive, state-of-the-art immunoprofiling approaches in a consistent way across studies.

Why does the program emphasize standardization and comparability?

Standardization is central so that immune monitoring and molecular profiling results are comparable, reproducible, and useful beyond a single clinical trial. The CIMAC-CIDC workflow is designed to generate consistent assay outputs that can be harmonized and analyzed together across studies.

What does "correlative studies" mean here?

In this context, correlative studies refer to biomarker and immune monitoring analyses performed on biospecimens collected during immunotherapy clinical trials, with the goal of correlating biological signals (biomarkers) to clinical endpoints such as response, resistance, and immune-related adverse events.

What are the main scientific goals of the CIMAC-CIDC Network?

The overarching scientific goal is biomarker discovery and validation in cancer immunotherapy. NCI highlights three major outcome areas: biomarkers of response (who benefits and why), biomarkers of resistance (why therapies fail or stop working), and biomarkers of adverse events (who is at risk for toxicity and what biological pathways are involved).

How is biomarker data intended to be used in this program?

Biomarker data produced by CIMAC assays is intended to be linked with clinical trial outcomes and endpoints. The CIDC supports analyses that connect biomarker signals to response to therapy, resistance mechanisms, and immune-related adverse events, aiming to move toward robust and clinically actionable insights.

What is the long-term aim of the network?

The long-term aim is to improve how immunotherapies are selected, monitored, and optimized for cancer patients by generating and analyzing standardized biomarker datasets tied to clinical outcomes, supporting better patient stratification, improved treatment combinations, and safer, more effective use of immune-based therapies.

What funding mechanism is used for this opportunity?

This opportunity uses the NIH cooperative agreement mechanism (U24). A cooperative agreement generally involves substantial federal scientific and programmatic involvement compared with a standard grant mechanism.

What does "substantial federal involvement" imply for a U24 cooperative agreement?

Based on the description provided, the U24 mechanism indicates more active NCI scientific and programmatic involvement than is typical for standard grants. Specific expectations and roles would be defined in the full funding announcement.

Which NIH institute is sponsoring this announcement?

The sponsor is the National Cancer Institute (NCI).

What is the activity category for this opportunity?

The activity is categorized under education/health.

What CFDA numbers are associated with this opportunity?

The CFDA listings associated with this opportunity are 93.394 and 93.395.

When was this opportunity created and when was the original application closing date?

The announcement was created on 2022-07-15, and the original application closing date listed is 2022-10-24.

Who is eligible to apply based on the information provided?

Eligibility is restricted and U.S.-focused. Eligible applicants include public and state-controlled institutions of higher education. Applicants should consult the full funding announcement for complete and detailed eligibility rules, especially because it is a limited competition opportunity.

Are non-U.S. (foreign) organizations allowed to apply?

No. Non-domestic (non-U.S.) institutions cannot apply.

Can a U.S. organization apply if it has a non-domestic component?

No. Non-domestic components of U.S. organizations are not eligible.

Are foreign components allowed under NIH policy for this opportunity?

No. Foreign components, as defined by NIH policy, are not allowed.

What kind of work is this funding meant to support?

The funding is meant to support the network infrastructure and coordinated operations needed to perform standardized assays, generate biomarker datasets from trial biospecimens, and carry out bioinformatics processing, harmonization, curation, and integrated analysis linking biomarkers to clinical outcomes.

Does this program focus on a single assay or a narrow biomarker type?

No. The description emphasizes broad, state-of-the-art immunoprofiling across multiple assay domains (genomics, transcriptomics, proteomics, microbiome, immune phenotyping) and multiple specimen types, executed in a standardized manner so data can be compared and integrated.

What makes the CIMAC-CIDC approach different from isolated biomarker studies?

The network is designed to move beyond isolated biomarker findings by using a coordinated workflow: standardized assay execution across CIMAC laboratories combined with centralized data processing and integration at the CIDC, allowing biomarker data to be interpreted alongside clinical trial data in a unified framework.

Where should applicants look for the complete eligibility and program requirements?

Applicants should rely on the full funding announcement for detailed eligibility rules, application requirements, and any additional constraints tied to the limited competition status.

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