The Early Detection Research Network: Clinical Validation Centers (U01 Clinical Trial Optional) | RFA CA 21 033

Opportunity Information: Apply for RFA CA 21 033

The funding opportunity titled "The Early Detection Research Network: Clinical Validation Centers (U01 Clinical Trial Optional)" is a National Institutes of Health (NIH) cooperative agreement focused on strengthening the Early Detection Research Network (EDRN). The EDRN is a long-running, national infrastructure aimed at moving promising cancer detection ideas from the lab into real-world clinical use. Its central mission is to discover, develop, and clinically validate biomarkers and imaging approaches that can detect cancers at an early stage, when treatment is more likely to be effective. A major emphasis is translation: not just generating research findings, but producing evidence and processes that can support actual clinical tests. The program highlights that the EDRN has already supported and completed more than 10 multicenter validation studies, signaling that this opportunity is built around large-scale, coordinated research rather than isolated single-site projects.

This specific announcement supports "Clinical Validation Centers," which, based on the title and EDRN mission, are expected to serve as hubs that help run or contribute to rigorous clinical validation efforts. In practical terms, clinical validation is the stage where candidate biomarkers or imaging methods are tested in well-designed studies to determine whether they reliably detect cancer early, perform consistently across different populations and settings, and offer meaningful clinical value. Because the mechanism is a U01 cooperative agreement, awardees typically conduct their work with substantial NIH involvement, meaning NIH scientific staff may collaborate on study design expectations, milestones, network coordination, data harmonization, and other cross-site requirements common to large consortia. The "Clinical Trial Optional" label indicates that applicants may propose studies that include clinical trial elements, but they are not strictly required to do so; the work can be structured as appropriate to the validation aims.

The opportunity is categorized as discretionary funding, with an activity area in education and health, and it falls under CFDA number 93.394. The funding opportunity number is RFA-CA-21-033, and the sponsoring agency is the NIH. The original closing date listed is 2021-09-09, and the posting creation date is 2021-06-01. While an award ceiling and expected number of awards are referenced in the source data fields, the specific amounts and counts are not provided in the text you supplied.

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants 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; public housing authorities and Indian housing authorities; and Native American tribal organizations that are not federally recognized. The announcement also allows nonprofit organizations both with and without 501(c)(3) IRS status (when they are not institutions of higher education). For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with an "other" category that typically captures additional eligible entity types recognized by NIH policy or the specific announcement.

The notice also explicitly calls out additional eligible applicant categories to encourage participation from a diverse range of institutions and community-connected organizations. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal government agencies; faith-based or community-based organizations; regional organizations; and U.S. territories or possessions. This emphasis suggests the program is open to a wide variety of settings that may contribute patient populations, clinical expertise, laboratory and imaging capabilities, biorepository resources, or community engagement needed for robust, generalizable validation studies.

Foreign participation is restricted in a specific way. Non-domestic (non-U.S.) entities, described as foreign organizations or foreign institutions, are not eligible to apply as the primary applicant. In addition, non-domestic components of U.S. organizations are not eligible to apply as part of the applicant organization. However, "foreign components" are allowed as defined by the NIH Grants Policy Statement. This usually means a U.S. applicant may include certain international elements (for example, a defined collaboration, performance site, or resource contribution outside the U.S.) if it meets NIH policy definitions and is justified scientifically, even though the prime applicant organization must be domestic.

Overall, this opportunity is designed for organizations that can function as part of a coordinated national network dedicated to proving whether early cancer detection biomarkers and imaging methods truly work in real clinical contexts. It is particularly relevant to teams that can support multicenter validation standards: access to well-characterized patient cohorts and specimens, strong clinical and laboratory quality systems, data management capacity, and the willingness to operate within shared network protocols and NIH-coordinated milestones typical of a cooperative agreement structure.

• 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 2021-06-01.
• Applicants must submit their applications by 2021-09-09. (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 21 033

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