Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional) | RFA CA 22 022

Frequently Asked Questions (FAQs)

What is the funding opportunity RFA-CA-22-022 trying to support?

RFA-CA-22-022 (National Institutes of Health) supports early-stage, exploratory development work to improve immuno-oncology research by creating or advancing better cancer model systems. The emphasis is on models that more realistically reproduce human immunity within the tumor microenvironment so that preclinical immunotherapy studies better predict what happens in patients.

What is the central objective of this FOA?

The central objective is to develop model platforms that more faithfully capture the complexity and behavior of the human immune system as it interacts with tumors. The long-term goal is stronger translational confidence when moving from lab findings to clinical testing.

What kinds of models does NIH want under this opportunity?

NIH is looking for model systems that recapitulate the human immune system using human cells or tissues and that represent human immunity in the tumor microenvironment. Proposed platforms can be in vivo (for example, animal-based models) or in vitro (for example, organoids, co-culture platforms, microphysiological systems, or other engineered tumor-immune environments).

Does the model have to include human cells or tissues?

Yes. A key requirement is that proposed models must recapitulate the human immune system using human cells or tissues. The application is expected to clearly describe how human immune lineage cells are introduced and sustained in the model.

What does NIH mean by "recapitulating" the human immune system in the tumor microenvironment?

Based on the description provided, NIH is seeking models that realistically reproduce human immunity within the tumor microenvironment, including the complexity and behavior of human immune components when interacting with tumors. The intent is to build models that are more predictive for preclinical immunotherapy studies.

Are both in vivo and in vitro platforms allowed?

Yes. The FOA expects models to regenerate and/or reproduce human immune components in either in vivo systems (such as animal-based models) or in vitro systems (such as organoids, co-cultures, microphysiological systems, or other engineered tumor-immune environments).

What are examples of in vitro systems mentioned as relevant to this FOA?

Examples listed include organoids, co-culture platforms, microphysiological systems, and other engineered tumor-immune environments.

What are examples of in vivo systems mentioned as relevant to this FOA?

The FOA references in vivo systems such as animal-based models, as long as they incorporate human immune lineage cells or tissues to reconstruct or represent human immunity.

What does NIH expect applicants to explain about immune cell introduction and persistence?

The application needs to make clear how human immune lineage cells are introduced into the model and how they are sustained. It should also explain how the resulting immune representation matches or surpasses what is achieved by advanced murine models developed using HFT-based approaches referenced in the announcement.

Is it enough to simply add some immune cells to a tumor model?

No. The FOA sets a higher bar than simply including immune cells. Applicants are expected to demonstrate a level of human immune complexity and relevance that competes with or improves upon advanced mouse-based humanized immune modeling methods referenced in the announcement.

How does NIH want these models to compare to murine (mouse) models?

The application should describe how the model's human immune representation matches or surpasses what is achieved by murine models developed using HFT-based approaches referenced in the FOA. The expectation is strong human immune complexity and relevance in the tumor microenvironment.

What types of approaches are explicitly not responsive to this FOA?

Models that rely only on genetically manipulated immune systems without introducing human immune lineage cells are not considered responsive. A purely engineered or genetically altered host immune system, without incorporation of human immune cells or tissues, falls outside the scope described.

If a project uses genetic manipulation, is it automatically non-responsive?

Not necessarily. The non-responsive category described is models that rely only on genetically manipulated immune systems without introducing human immune lineage cells. The core requirement emphasized is human immune reconstruction or representation using human cells or tissues.

What funding mechanism is used for this opportunity?

This opportunity is listed as a Cooperative Agreement. That structure generally implies substantial NIH programmatic involvement during the project (for example, coordination, milestone expectations, or active engagement to help steer development toward program goals).

What does "substantial NIH involvement" typically imply in a cooperative agreement?

Based on the provided description, it can include coordination with NIH, milestone expectations, and active engagement by NIH staff to guide development toward the program's objectives.

Are clinical trials required under this FOA?

No. The clinical trial designation is "optional." Clinical trials are not required, but they may be permitted if they fit the program rules and are justified by the proposed work.

What activity code is used, and what does it suggest about project stage?

The FOA uses the R33 Exploratory/Developmental Grants Phase II activity code. As described, this is commonly associated with later-stage exploratory development where proof-of-concept has been established and the aim is to further develop, validate, and position the model or technology for broader use.

Who is eligible to apply?

Eligibility is broad and includes organizations across public, private, nonprofit, and academic sectors. Eligible applicants include various government entities, independent school districts, public and private institutions of higher education, federally recognized tribal governments, tribal organizations, public housing authorities, nonprofits (with and without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.

Are nonprofits eligible, including those without 501(c)(3) status?

Yes. The eligibility list includes nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status.

Are for-profit entities eligible?

Yes. The eligibility list includes for-profit organizations other than small businesses and also includes small businesses.

Are tribal governments and tribal organizations eligible?

Yes. The FOA includes federally recognized Native American tribal governments and also tribal organizations other than federally recognized governments.

Are institutions serving specific communities (for example, HBCUs or HSIs) eligible?

Yes. The FOA highlights additional eligible applicant categories such as Historically Black Colleges and Universities, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are specifically mentioned among additional eligible applicant categories.

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

Yes. The FOA includes non-U.S. entities (foreign organizations) among eligible applicants.

Are U.S. territories or possessions included in eligibility?

Yes. U.S. territories or possessions are listed among the additional eligible applicant categories.

Does the FOA mention specific NIH Assistance Listing (CFDA) numbers?

Yes. The opportunity falls under NIH assistance listings tied to cancer research: 93.393, 93.394, 93.395, 93.396, and 93.399.

What was the closing date listed for this opportunity?

The original closing date listed in the source data is 2022-11-17.

What was the creation date listed for this opportunity?

The creation date listed in the source data is 2022-03-24.

What other requirements should applicants be prepared to address beyond the summary?

The description notes that applicants typically need to pay close attention to the full FOA for items such as required milestones, data sharing expectations, model characterization standards, validation benchmarks, and any coordination requirements associated with the cooperative agreement structure.