Somatic Cell Genome Editing Program Translational Coordination and Dissemination Center (TCDC) (U24 - Clinical Trial Not Allowed) | RFA RM 22 017

Opportunity Information: Apply for RFA RM 22 017

This NIH funding opportunity (RFA RM 22 017) supports creating and operating a Translational Coordination and Dissemination Center (TCDC) for the Somatic Cell Genome Editing (SCGE) Consortium under a U24 cooperative agreement mechanism, with clinical trials not allowed under this specific award. The TCDC is positioned as the coordinating hub for the consortiums second phase (FY2023-2027), which is focused on moving genome editing therapeutics closer to the clinic by accelerating the kinds of preclinical and translational work needed to reach an Investigational New Drug (IND) application and, ultimately, first-in-human studies. While the SCGE program is not itself a single-product pipeline, the goal is to make the broader genome-editing field more ready for regulatory review by developing repeatable approaches, shared resources, and common standards that can be adopted by many groups.

A central theme of the opportunity is IND enablement and regulatory readiness. In Phase II, the SCGE program aims to facilitate IND-enabling studies that establish practical pathways to regulatory approval, and to capture and disseminate successful strategies for initiating first-in-human clinical trials. In other words, this award is not primarily about discovering new gene editing targets in a basic science sense; it is about organizing, integrating, and broadcasting the translational know-how, infrastructure, data practices, and regulatory playbooks that help promising genome-editing candidates progress toward human testing. The TCDC is expected to drive consortium-wide planning and execution that makes this process faster and more reliable across multiple projects, teams, and technologies.

The TCDC does not operate in isolation. The FOA describes a larger SCGE Consortium made up of the TCDC plus three additional components that together cover the key steps between a genome-editing concept and an IND package. Those components include: (1) development of technologies and assays that support IND submissions, (2) efforts to optimize genome editing-based therapeutic leads for safety and efficacy, and (3) platform clinical trials using genome editing technologies in one disease area. Even though platform trials are mentioned as a consortium component, the TCDC award itself is labeled clinical trial not allowed, meaning the TCDC should be understood as an enabling, coordinating, data, and dissemination core rather than an entity that conducts clinical intervention studies.

The responsibilities of the TCDC are framed as both internal coordination and external dissemination. Internally, the center is expected to lead consortium-wide activities that facilitate collaboration across the different consortium components, helping groups align on shared milestones, harmonized methods, and cross-project learning. This includes supporting efficient communication, fostering partnerships among participating teams, and ensuring that work products are connected rather than siloed. Externally, the TCDC is expected to support broad dissemination strategies that help the field learn how to prepare stronger regulatory submissions for genome-editing therapeutics. The FOA makes clear that dissemination is not an afterthought; it is a core deliverable, with an emphasis on spreading practical, regulator-relevant strategies that can be reused by others pursuing similar translational goals.

A major required output is a publicly available online platform for data collection and dissemination of consortium-wide activities. This platform is expected to serve as a central entry point for sharing consortium outputs, coordinating activities, and making information accessible beyond the immediate awardees. The FOA also emphasizes stewardship and preservation of data generated during SCGE Phase I, signaling that the TCDC should not only manage new materials produced in Phase II but also curate, maintain, and keep Phase I data usable and discoverable over time. In practice, this implies attention to long-term data management, standardized metadata, clear documentation, and policies that make shared data and resources genuinely usable for other researchers and stakeholders.

From an administrative standpoint, the opportunity is offered by the National Institutes of Health as a discretionary grant using the cooperative agreement model, which typically indicates substantial NIH involvement in project direction, coordination, and governance compared with a standard research grant. The activity category is health, and the CFDA (now Assistance Listing) number provided is 93.310. The original closing date listed is 2022-07-19, and the FOA was created on 2022-04-11, placing it in the timeline leading into the FY2023-2027 Phase II period described in the narrative.

Eligibility is broad across U.S.-based organizations and includes many common applicant types such as state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; and small businesses. It also includes federally recognized tribal governments, tribal organizations that are not federally recognized governments, and public housing or Indian housing authorities. The FOA 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as the applicant organization, but non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by NIH policy, which means certain international collaborations can be supported when they are part of an eligible U.S.-led application and meet NIH requirements.

Taken together, this opportunity is best understood as funding the operational and strategic backbone of the SCGE Consortiums translational push: coordinating multi-site efforts, preserving and organizing prior-phase outputs, building a public-facing platform for sharing data and lessons learned, and actively disseminating regulatory and IND-enabling strategies that help genome-editing therapeutics move more efficiently toward human clinical testing.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Somatic Cell Genome Editing Program Translational Coordination and Dissemination Center (TCDC) (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): 93.310.
• This funding opportunity was created on 2022-04-11.
• Applicants must submit their applications by 2022-07-19. (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 RM 22 017

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