The Early Detection Research Network: Clinical Validation Centers (U01 Clinical Trial Optional) | RFA CA 22 039

Opportunity Information: Apply for RFA CA 22 039

The Early Detection Research Network: Clinical Validation Centers (U01 Clinical Trial Optional) funding opportunity (RFA-CA-22-039) is a National Institutes of Health cooperative agreement designed to support the clinical validation stage of cancer early-detection research. Its central purpose is to strengthen and expand the Early Detection Research Network (EDRN, edrn.cancer.gov), a long-running national infrastructure focused on moving promising biomarkers and imaging approaches from discovery into rigorous testing and, ultimately, real-world clinical use. The program emphasizes methods that can detect cancers at earlier, more treatable stages and translate validated findings into clinical tests that can be used in healthcare settings.

A key feature of this opportunity is the focus on clinical validation, meaning applicants are expected to help run or contribute to well-structured studies that determine whether candidate biomarkers or imaging tools actually perform reliably in relevant patient populations and intended-use settings. The EDRN is positioned as an established, multicenter system for this work, with a track record that includes completion of more than 10 multicenter validation studies. Funding through a U01 mechanism signals that awardees will not simply receive funds and operate independently; instead, they will participate in a cooperative agreement where NIH has substantial scientific and programmatic involvement. This arrangement typically supports coordinated planning, common protocols, data and specimen standards, and network-wide collaboration to ensure results are reproducible and clinically meaningful. The “Clinical Trial Optional” language indicates that projects may include clinical trials if appropriate, but clinical trial activity is not automatically required for every application.

In terms of who can apply, eligibility is broad and spans many types of U.S.-based organizations. Eligible applicants include state, county, and local 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/Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofits both with and without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and certain “other” entities as permitted under NIH rules. The notice also highlights additional eligible 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, and U.S. territories or possessions. Taken together, this reflects an intent to encourage participation from a wide range of institutional types, including organizations that serve historically underrepresented communities.

At the same time, the opportunity places clear limits on non-U.S. participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply either. However, “foreign components” as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant organization can include certain types of foreign involvement when it meets NIH’s definition and requirements (for example, specialized expertise, resources, or study elements that must be conducted abroad), but the overall application and award must remain U.S.-based.

Administratively, this opportunity is categorized as a discretionary program using a cooperative agreement funding instrument, and it is tied to the health and education funding activity category under CFDA number 93.394. The listing shows an original closing date of 2022-09-19 and a creation date of 2022-07-18. An award ceiling and expected number of awards are not specified in the provided source data, which often means applicants need to consult the full RFA or NIH notices for budget expectations, project periods, and any network-specific caps or guidance. Overall, the opportunity is best understood as support for organizations prepared to operate as part of a coordinated national network that validates early cancer detection biomarkers and imaging approaches through multicenter clinical research, with the explicit goal of producing evidence strong enough to support translation into clinically usable tests.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Early Detection Research Network: Clinical Validation Centers (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): 93.394.
• This funding opportunity was created on 2022-07-18.
• Applicants must submit their applications by 2022-09-19. (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 22 039

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