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

CAP-IT Centers (RFA-CA-21-038) Frequently Asked Questions

What is the CAP-IT Centers funding opportunity?

The Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers opportunity (RFA-CA-21-038) is an NIH cooperative agreement (U54) intended to build a coordinated network of research centers focused on precision cancer prevention and cancer interception through targeted agent discovery.

What is the main purpose of the CAP-IT Centers program?

The central purpose is to organize and support collaborative, multi-team efforts that discover and advance molecularly targeted or immunologically targeted agents designed to stop, delay, or derail cancer development in people at elevated risk.

Is this program intended to run clinical trials?

No. The opportunity is designated "Clinical Trial Not Allowed." The scope is centered on coordinated discovery, preclinical, and translational work to generate, prioritize, and advance candidate agents for precision prevention and interception, rather than conducting NIH-defined clinical trials under this announcement.

What does "precision cancer prevention and interception" mean in this context?

In this program, precision prevention and interception refers to developing preventive or early-intervention agents that act on specific biological mechanisms involved in early carcinogenesis, with the intent to match agents rationally to high-risk states, early lesions, or pathways that precede invasive cancer in defined at-risk populations.

What types of agents is the program focused on discovering and advancing?

The program focuses on molecularly targeted agents and immunologically targeted agents intended for cancer prevention and interception, particularly those aligned to mechanisms active in early cancer development.

What is meant by "targeted agent discovery for prevention and interception"?

This means the research should be oriented toward finding candidate agents that can be matched to specific biological pathways, early lesions, or high-risk conditions, with the goal of intervening before invasive cancer develops.

What is a CAP-IT Center expected to do beyond its own research projects?

CAP-IT Centers are expected to function as hubs within an agile, coordinated network. The intent is for centers to work together rather than operate as isolated projects, enabling collaborative, multi-team efforts across the program.

How does the cooperative agreement (U54) structure affect the program?

A U54 cooperative agreement generally involves substantial NIH involvement in scientific direction, coordination, and milestone-driven progress. In practice, this implies active programmatic stewardship and participation in a coordinated program structure.

Is NIH expected to be involved in the scientific direction of the award?

Yes. The opportunity describes a cooperative agreement structure where NIH has substantial involvement in coordination, scientific direction, and progress expectations, including milestone-driven activities.

Does this opportunity operate as part of a broader NIH program ecosystem?

Yes. The FOA references a companion FOA, indicating NIH is building a broader CAP-IT ecosystem with complementary awards that work together within a coordinated program.

Which federal agency is offering this funding opportunity?

This is a discretionary federal funding opportunity under the National Institutes of Health (NIH).

What is the funding instrument type?

The instrument type is a cooperative agreement, specifically a U54.

How is this opportunity categorized?

It is categorized within education and health as described in the opportunity summary information provided.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.394 and 93.395.

When was this opportunity created and when was it originally due?

The opportunity was created on July 15, 2021, and the original closing date listed is October 7, 2021.

Does the provided information state an award ceiling or the expected number of awards?

No. The text provided does not specify an award ceiling or the expected number of awards. Applicants would typically consult the full FOA for budget limits, project period expectations, and the anticipated scale of center awards.

Who is eligible to apply?

Eligibility is broad and includes many public and private organization types, including 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.

Are minority-serving institutions and other specific organization types explicitly included as eligible?

Yes. The FOA explicitly highlights additional eligible applicant categories including 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.

Can a foreign (non-U.S.) institution apply as the main applicant?

No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are also not eligible to apply as the applicant organization.

Are any foreign activities allowed at all under this opportunity?

Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement. This typically means a U.S.-based applicant may include certain foreign collaborations or subcomponents if justified and compliant with NIH policy, even though a foreign institution cannot be the primary applicant.

What kinds of research activities are most aligned with CAP-IT based on the description provided?

The description emphasizes coordinated preclinical, translational, and discovery activities needed to discover, generate, prioritize, and advance targeted candidate agents for precision prevention and interception, particularly in high-risk populations and early disease states.

What overall role are CAP-IT Centers meant to play?

CAP-IT Centers are intended to serve as hubs for collaborative discovery and advancement of targeted prevention and interception agents, aligned to the biology of early cancer development and organized as a coordinated, networked national program.