Somatic Mosaicism across Human Tissues (SMaHT) Program: Genome Characterization Centers (UM1 Clinical Trial Not Allowed) | RFA RM 22 013

Opportunity Information: Apply for RFA RM 22 013

The National Institutes of Health (NIH) announced this funding opportunity (RFA-RM-22-013) to create Genome Characterization Centers (GCCs) as a core part of the Somatic Mosaicism across Human Tissues (SMaHT) Network. The larger SMaHT effort is aimed at uncovering how somatic genomic variation, meaning DNA changes that arise after conception and are present in only some cells or tissues, contributes to fundamental biology and to disease mechanisms. In practical terms, the program is trying to move the field beyond isolated case studies by generating consistent, large-scale datasets that can reveal where somatic variants occur across the body, how frequent they are, and what patterns might matter for health and disease.

Under this opportunity, GCCs are expected to operate as high-throughput production centers that generate state-of-the-art genomic data. The central deliverable is deep genomic characterization of somatic variants across a defined panel of human tissues: roughly 10 to 15 distinct tissue types per donor, collected from about 150 donors. That design signals a major emphasis on comparing tissues within the same individual, which is essential for somatic mosaicism because a variant can be present in one tissue at a detectable level but absent or far rarer in another. The resulting data should support mapping the landscape of somatic mutations across tissues and donors, including low-frequency variants that require sensitive methods and rigorous quality control to distinguish real biological signals from technical artifacts.

The funding mechanism is a cooperative agreement (UM1), which typically means NIH expects to be actively involved in coordinating the program rather than simply issuing a grant and stepping back. In this setting, the GCCs are not meant to function as isolated sequencing facilities. Instead, they are intended to be tightly integrated members of a network, collaborating on shared standards, harmonized laboratory and computational methods, common quality metrics, and coordinated timelines for production and data release. A key partner for the GCCs is the SMaHT Data Analysis Center, and the announcement makes clear that the relationship is ongoing and operational: GCCs generate the primary data and work closely with the analysis hub to help build the framework for a comprehensive catalog of somatic variants. That catalog concept implies more than raw sequencing reads; it suggests curated, interpretable variant callsets, documentation of confidence levels, and supporting metadata that allow the broader community to use the resource responsibly.

The activity category is health, and the program is listed under CFDA 93.310. Clinical trials are explicitly not allowed under this UM1, which generally indicates the work should focus on genomic characterization and resource generation rather than prospective interventions, randomization, or clinical outcome testing. Even though donors and human tissues are involved, the intent is to build foundational genomic infrastructure and datasets, not to evaluate treatments or clinical procedures as a trial.

Eligibility is broad across many U.S.-based organizational types, reflecting NIH’s interest in drawing from academic, nonprofit, government, and industry capabilities needed for complex large-scale genomics. Eligible applicants include state, county, and local 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 authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education under those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other organizations. The announcement also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it clearly restricts foreign participation: non-U.S. (foreign) institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

From an operational standpoint, a successful GCC application would be expected to demonstrate the capacity to process large numbers of samples reliably and reproducibly, apply cutting-edge genome characterization approaches suited to detecting somatic variation across tissues, and maintain strong quality systems. Because the program aims to support a network-wide variant catalog, the GCC role is not just to generate data quickly, but to generate data that are comparable across centers and over time, with clear traceability from sample through assay through final data product. The closing date listed for the opportunity was July 8, 2022, and it was created on February 23, 2022, indicating it was part of a time-bounded NIH initiative to stand up these network components on a defined schedule.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Somatic Mosaicism across Human Tissues (SMaHT) Program: Genome Characterization Centers (UM1 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 2022-02-23.
• Applicants must submit their applications by 2022-07-08. (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 22 013

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