Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional) | RFA CA 23 015

Opportunity Information: Apply for RFA CA 23 015

The funding opportunity "Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional)" (Funding Opportunity Number RFA-CA-23-015) is a discretionary National Institutes of Health (NIH) cooperative agreement aimed at improving the realism and predictive value of immuno-oncology research models. Even though the title emphasizes informatics technologies, the core purpose described in the notice is to advance cancer model systems that more faithfully reproduce human immunity within the tumor microenvironment, with the practical goal of making preclinical immuno-oncology studies more reliable and more translatable to patient outcomes. In other words, the program is trying to close the gap between how tumors interact with the immune system in people versus how those interactions are approximated in traditional laboratory models.

A central requirement is that proposed projects must explicitly focus on recapitulating the human immune system in the cancer model by using human cells or tissues. The intent is to regenerate and/or recreate human immune components in either in vivo or in vitro immuno-oncology systems, and to do so at a level of immune representation that matches or exceeds what has been achieved in certain advanced murine models referenced as being developed using HFT. The FOA draws a bright line around what is considered responsive: models that rely only on genetic manipulation of an existing immune system, without introducing human immune lineage cells, are not considered responsive and would not meet the program's stated expectations. This makes the opportunity particularly relevant for teams working on humanized immune models, human immune-tumor co-culture platforms, organoid systems with immune integration, xenograft-like approaches that include human immune reconstitution, and related enabling technologies that better capture immune-tumor dynamics as they occur in humans.

The mechanism described for this opportunity is a cooperative agreement, which typically means NIH expects to have substantial programmatic involvement during the project period compared with a standard grant. The solicitation states it will use the R33 Exploratory/Developmental Grants Phase II research activity code, indicating an emphasis on early-stage but more advanced development work where feasibility has likely been established and the next step is strengthening, optimizing, validating, and demonstrating performance of the proposed approach. The listing also notes "Clinical Trial Optional," meaning applicants may propose a clinical trial if it is justified and fits the goals, but a clinical trial is not required.

In terms of funding scale, the opportunity lists an award ceiling of $300,000. The expected number of awards is not clearly specified in the provided source (it is shown as blank), so applicants would typically need to consult the full announcement for the anticipated range of awards and budget guidance beyond the ceiling figure. The original closing date is listed as 2023-11-17, and the creation date as 2022-12-22, which is important because it suggests the opportunity may have been time-limited; anyone considering applying would need to confirm whether NIH has reissued, extended, or replaced the FOA, or whether there are current related announcements.

Eligibility is broad and includes many types of U.S. governmental entities and organizations, along with certain international applicants. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth suggests NIH is encouraging participation across a wide range of institutional settings, including minority-serving institutions and organizations with strong community or regional footprints.

The administering agency is the National Institutes of Health, and the CFDA/assistance listing numbers associated with the opportunity are 93.393, 93.394, 93.395, 93.396, and 93.399, which correspond to NIH/NCI-related program areas. Overall, the opportunity is best understood as supporting early-stage, development-focused work that materially improves cancer immunology modeling by incorporating genuine human immune elements, with an emphasis on creating platforms that better predict how immuno-oncology therapies will behave in humans rather than in simplified or purely murine-immune contexts.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.394, 93.395, 93.396, 93.399.
• This funding opportunity was created on 2022-12-22.
• Applicants must submit their applications by 2023-11-17. (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.

Apply for RFA CA 23 015

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