Translational and Basic Science Research in Early Lesions (TBEL) Coordinating and Data Management Center (U24 Clinical Trial Not Allowed) | RFA CA 21 055

Opportunity Information: Apply for RFA CA 21 055

The Translational and Basic Science Research in Early Lesions (TBEL) Coordinating and Data Management Center (CDMC) opportunity is an NIH cooperative agreement (U24; clinical trial not allowed) designed to support the infrastructure and coordination needs of a broader TBEL research consortium focused on precancers and early cancers. At its core, TBEL is about tightening the link between basic discovery science and translational cancer research so investigators can better test cause-and-effect relationships that drive the earliest steps of cancer development. The program emphasizes that tumor initiation and early progression are not determined by the lesion alone, but by continuous interactions among the early lesion, its surrounding microenvironment, and host systemic influences (for example, immune, metabolic, hormonal, inflammatory, and other organism-level factors). The long-term aim is to clarify which mechanisms push early lesions toward malignancy and which mechanisms restrain or suppress that trajectory, ultimately enabling prevention strategies that are grounded in biology and can be tailored more precisely to risk and context.

In this structure, the CDMC is the operational backbone for the consortium rather than a stand-alone research center. The funded CDMC is expected to take on three major responsibilities across all participating projects and sites. First, it must coordinate consortium-wide activities, including recurring meetings, conferences, and other cross-consortium collaborations that keep multiple centers aligned on shared goals, methods, milestones, and opportunities for joint work. Second, it must provide statistical and computational analysis support to the consortium, which typically includes helping harmonize analytic approaches, advising on study design and power considerations where relevant to the consortiums work, supporting reproducible computational workflows, and ensuring analytic outputs are comparable across contributing sites. Third, it must establish and operate a program data hub that supports data capture, curation, and management, along with protocol development and registration. In practical terms, this implies building processes and systems for standardized data intake, metadata and quality control, secure storage and controlled access where needed, consistent data dictionaries/ontologies, and the documentation necessary for reuse, sharing, and coordinated analyses. The protocol support and registration component signals that the consortium is expected to work with well-defined, trackable study protocols, even though the FOA specifies that clinical trials are not allowed under this U24.

The CDMC is one component of a two-part TBEL ecosystem. The other major component consists of TBEL U54 Centers, which serve as the primary scientific engines of the program and are intended to bridge gaps between basic and translational research on early lesions and their microenvironments. While the U54 Centers conduct the main scientific projects, the CDMC enables those projects to function as a coherent network by creating shared operational standards, centralized data practices, and consistent analytic support. This division of roles is typical of NIH consortium programs, where the coordinating/data center ensures that results across multiple institutions can be integrated rather than remaining siloed.

A notable feature of the opportunity is that it is not limited to any specific precancer, early lesion, organ site, or cancer type. That openness suggests NIH is seeking a broad set of applicants and approaches, potentially spanning multiple tissue types and biological contexts, unified by the common theme of early lesion biology and the interplay among lesion, microenvironment, and systemic host factors. Administratively, the notice indicates it was issued to give prospective applicants lead time to prepare a competitive application, with the full funding opportunity announcement expected to be published in May 2021 and an anticipated application due date in October 2021. A pre-application webinar was planned, with details to be posted after FOA publication. The companion notice for the related U54 Centers is referenced as NOT-CA-21-XXX, signaling that applicants interested in the research-center component should track that parallel announcement.

Eligibility is broad and includes many U.S.-based organization types that commonly participate in NIH programs. Eligible applicants include state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; federally recognized Native American tribal governments; other tribal organizations; public housing/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses, as well as other categories NIH sometimes lists for inclusivity. The notice also highlights a range of mission- and community-focused institution types that are explicitly included, such as HBCUs, Hispanic-serving institutions, AANAPISISs, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and eligible federal agencies, along with faith-based or community-based organizations and U.S. territories or possessions. At the same time, foreign participation is explicitly restricted: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed. These constraints point to an expectation that the coordinating infrastructure, data hub, and consortium operations remain fully within allowable U.S.-based institutional boundaries.

From a funding mechanics standpoint, the award mechanism is a cooperative agreement, meaning NIH is expected to have substantial programmatic involvement compared with a standard research project grant. The opportunity is listed under NIH with CFDA numbers 93.394 and 93.396, and it is associated with Funding Opportunity Number RFA-CA-21-055. The original closing date provided is 2021-11-02. Although an award ceiling and expected number of awards are not specified in the provided text, the scope of responsibilities (consortium coordination, centralized analytics support, and a multi-site data hub) implies a significant infrastructure-oriented budget and staffing plan would be expected in a strong application, along with clear governance, data standards, and service models that can support multiple U54 Centers and other consortium participants over the project period.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Translational and Basic Science Research in Early Lesions (TBEL) Coordinating and Data Management Center (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, 93.396.
• This funding opportunity was created on 2021-08-31.
• Applicants must submit their applications by 2021-11-02. (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.

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