Precompetitive Collaboration on Liquid Biopsy for Early Cancer Assessment: Data Management and Coordinating Unit (U24 Clinical Trial Not Allowed) | RFA CA 23 031

Opportunity Information: Apply for RFA CA 23 031

This NIH funding opportunity (RFA-CA-23-031) supports a cooperative agreement (U24, clinical trial not allowed) to establish and run a Data Management and Coordinating Unit for a precompetitive collaboration focused on liquid biopsy approaches for early cancer assessment. It sits within the broader mission of the National Cancer Institute's Early Detection Research Network (EDRN), which is built to discover, develop, and validate biomarkers and imaging methods that can detect cancers at earlier, more treatable stages and then move those advances toward clinical testing. The EDRN is positioned as a mature, multicenter infrastructure, and the notice highlights that it has already completed more than 10 multicenter validation studies, underscoring that this is meant to support coordinated, network-scale research rather than isolated projects.

The core purpose of the award is to provide the coordinating backbone for collaborative, precompetitive work in liquid biopsy, meaning the emphasis is on shared resources, standardized data practices, and cross-institution coordination that can benefit the field broadly rather than proprietary development. As a Data Management and Coordinating Unit, the funded group would be expected to manage and harmonize data flows across participating sites or projects, support consistent study operations and communications, and help ensure that datasets and associated documentation are organized in a way that enables rigorous evaluation, comparison, and eventual validation. Because the mechanism is a cooperative agreement, NIH/NCI program staff typically play an active role in oversight and coordination, with substantial federal involvement in guiding goals, milestones, and network integration.

The opportunity is categorized under health and education-related federal assistance and is associated with CFDA 93.394. The award ceiling listed is $450,000, and the original closing date shown is May 5, 2023, indicating this particular solicitation was time-bound to that cycle. The "clinical trial not allowed" designation means applicants are not permitted to propose a clinical trial as defined by NIH; the work should instead focus on coordination, data management, infrastructure, and other non-trial activities that enable or support the broader research enterprise.

Eligibility is broad and includes many types of U.S.-based organizations: 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 Native American tribal governments; tribal organizations that are not federally recognized; public housing/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in that specific classification); for-profit organizations other than small businesses; small businesses; and other eligible entities. The notice also explicitly calls out additional eligible applicant categories often emphasized in NIH funding, 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, eligible federal agencies, regional organizations, Indian/Native American tribal governments other than federally recognized entities (as applicable), and U.S. territories or possessions.

Foreign participation is specifically restricted. While the list mentions "Non-domestic (non-U.S.) Entities (Foreign Organizations)" in the context of "other eligible applicants," the eligibility section then clearly states that non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible to apply, and foreign components as defined by the NIH Grants Policy Statement are not allowed. In practice, that means the applicant organization must be domestic, and the project cannot include foreign components under NIH's definitions.

Overall, this solicitation is best understood as support for the operational and data coordination hub needed to make multi-site, multi-team liquid biopsy efforts comparable, reproducible, and validation-ready within the EDRN ecosystem. It is aimed at strengthening the shared infrastructure that allows biomarkers and related early detection tools to move from discovery through structured development and into robust, multicenter validation pathways.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Precompetitive Collaboration on Liquid Biopsy for Early Cancer Assessment: Data Management and Coordinating Unit (U24 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.
• This funding opportunity was created on 2023-03-14.
• Applicants must submit their applications by 2023-05-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $450,000.00 in funding.
• 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 23 031

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