The Early Detection Research Network: Biomarker Characterization Centers (U2C Clinical Trial Not Allowed) | RFA CA 21 035

Opportunity Information: Apply for RFA CA 21 035

The National Institutes of Health (NIH) released this funding opportunity (RFA-CA-21-035) to support Biomarker Characterization Centers (BCCs) within the Early Detection Research Network (EDRN). The EDRN is a long-running national research infrastructure focused on improving early cancer detection and cancer risk assessment by discovering, developing, and validating biomarkers and related imaging methods. This particular announcement uses a cooperative agreement mechanism (U2C), meaning awardees are expected to work in close partnership with NIH and with other EDRN-funded groups as part of a coordinated network effort rather than operating as fully independent, stand-alone projects. Clinical trials are not allowed under this FOA.

The central role of a Biomarker Characterization Center is to move promising biomarker ideas from early discovery toward readiness for broader validation. In practical terms, BCCs are expected to (1) discover new biomarkers, further develop them, and characterize and test their performance, or refine biomarkers that already exist; (2) develop, refine, and/or standardize the laboratory assays used to measure those biomarkers so results are reliable and comparable across sites; (3) provide resources and hands-on support that enable later-stage validation of EDRN biomarkers (for example, sharing methods, reagents, protocols, quality control approaches, and technical expertise); and (4) actively participate in collaborative projects with other EDRN laboratories and centers. The emphasis is on rigorous characterization and assay readiness: making sure a biomarker and its measurement method are analytically sound, reproducible, and suitable for the network to take forward into validation studies.

This FOA also explains how BCCs fit into the broader EDRN structure. Alongside BCCs, the network includes Clinical Validation Centers (CVCs) and a Data Management and Coordinating Center (DMCC). CVCs focus on clinical research to validate biomarkers and act as network resources by working with BCCs and the DMCC on collaborative biomarker validation studies. The DMCC provides the backbone for network-wide statistics and computation, informatics infrastructure, study design support, coordination and management of EDRN-sponsored validation studies, and logistical support for EDRN meetings and workshops. In other words, BCCs help generate and technically mature biomarkers and assays, CVCs help test them in clinical settings for validation, and the DMCC ensures the data, analysis, coordination, and network operations are robust and consistent.

Eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants listed include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and certain other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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.

Foreign participation is limited in a way that is typical for NIH. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply directly, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components (as defined by the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain international elements or collaborations when justified and structured according to NIH policy.

Administratively, the opportunity is categorized as discretionary funding and falls under health and education-related program areas, with CFDA numbers 93.393 and 93.394. The agency is NIH, and the original closing date listed is September 9, 2021. An award ceiling and expected number of awards are not specified in the provided source data. Overall, the program is designed to strengthen the national pipeline for early cancer detection by ensuring biomarkers and assays developed within EDRN are carefully characterized, standardized, and ready to be validated through coordinated, network-wide efforts.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Early Detection Research Network: Biomarker Characterization Centers (U2C 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): 93.393, 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 21 035

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