Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers (U54 Clinical Trial Not Allowed) | RFA CA 21 038

Opportunity Information: Apply for RFA CA 21 038

The Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers funding opportunity (RFA-CA-21-038) is an NIH cooperative agreement (U54) designed to build a coordinated, networked research infrastructure focused on precision cancer prevention and cancer interception. The central purpose is not to run clinical trials, but to organize and support collaborative, multi-team efforts that discover and advance molecularly targeted or immunologically targeted agents intended to stop, delay, or derail cancer development in people who are at elevated risk. In practical terms, the program is aimed at identifying and developing preventive or early-intervention agents that can act on specific biological mechanisms involved in early carcinogenesis, rather than relying only on broad, non-specific prevention approaches.

A key emphasis of the opportunity is the creation of an agile and effective network of centers that can work together rather than operate as isolated projects. The FOA references a companion FOA, signaling that NIH is building a broader CAP-IT ecosystem where different awards play complementary roles. The expectation is that awardees will participate in a coordinated program structure typical of a cooperative agreement, where NIH has substantial involvement in scientific direction, coordination, and milestone-driven progress. The ultimate research theme is targeted agent discovery for prevention and interception, meaning the science should be oriented toward finding agents that can be rationally matched to high-risk states, early lesions, or biological pathways that precede invasive cancer, with an eye toward precision use in defined populations.

This is a discretionary federal funding opportunity under NIH, categorized within education and health, and associated with CFDA numbers 93.394 and 93.395. The instrument type is a cooperative agreement, which generally implies more active programmatic stewardship by NIH compared with standard grants. The opportunity was created on July 15, 2021, and the original closing date listed is October 7, 2021. The text provided does not specify an award ceiling or the expected number of awards, so applicants would normally need to consult the full FOA to understand budget limits, project period expectations, and the anticipated scale of the center awards.

Eligibility is broad and includes many common public and private organizational types. Eligible applicants include state, county, 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; public housing authorities and Indian housing authorities; tribal organizations other than federally recognized governments; nonprofit organizations with or without 501(c)(3) status (when not operating as institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations as permitted by NIH. 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, regional organizations, eligible federal government agencies, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions.

At the same time, there are clear restrictions related to foreign participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S.-based applicant may include certain types of foreign collaborations or subcomponents if justified and compliant with NIH policy, even though a foreign institution cannot be the primary applicant.

Overall, CAP-IT Centers are meant to function as hubs for collaborative discovery and advancement of targeted prevention and interception agents, aligned to the biology of early cancer development and focused on high-risk populations. The “Clinical Trial Not Allowed” designation signals that the work supported under this specific U54 announcement should not include clinical trial activities as defined by NIH, keeping the scope centered on coordinated preclinical, translational, and discovery work needed to generate and prioritize candidate agents for precision prevention and interception within a networked national program.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers (U54 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 2021-07-15.
• Applicants must submit their applications by 2021-10-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 21 038

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