Defining Genomic Influence on Gene Network Regulation (U01 Clinical Trial Not Allowed) | RFA HG 20 044

Opportunity Information: Apply for RFA HG 20 044

The NIH funding opportunity titled "Defining Genomic Influence on Gene Network Regulation (U01 Clinical Trial Not Allowed)" (RFA HG 20 044) is a discretionary, health-focused cooperative agreement that supports research aimed at understanding how genomic differences shape human traits and disease through gene regulatory networks rather than single genes in isolation. The central idea is to move beyond one-variant/one-gene explanations and instead study how genetic variation influences coordinated systems of genes and regulatory elements that work together to drive biological outcomes. This FOA prioritizes projects that can connect genomic variation to changes in network behavior and ultimately to phenotypes relevant to human health and disease.

Projects funded under this announcement are expected to measure changes in the activity of genes and regulatory elements as cells or tissues undergo meaningful biological transitions. In practice, that could include developmental changes, responses to environmental stimuli, immune activation, cell differentiation, disease progression, treatment-like perturbations in model systems (without being a clinical trial), or other state changes where gene regulation shifts in a coordinated way. The FOA emphasizes capturing how these transitions reshape the activity of multiple genes and functional genomic elements (such as enhancers, promoters, and other regulatory regions) and then using those measurements to infer and test network-level relationships. The work is meant to link four layers together in a coherent, interpretable framework: genomic variation (differences in DNA sequence), functional elements (regulatory components and other genome features), genes (expression and regulation), and phenotypes (measurable traits related to health and disease).

A major expectation is the development of generalizable analytical approaches, meaning methods and models that can be applied beyond one dataset or one biological system. Applicants are encouraged to create computational, statistical, and integrative strategies that can reliably infer how genetic variants propagate their effects through regulatory elements and gene networks to influence phenotypes. This typically implies an emphasis on rigorous study design, reproducible pipelines, cross-system validation, and approaches that can scale to high-dimensional functional genomics data. The goal is not only to generate results for a single context, but also to produce broadly useful frameworks, tools, and principles that other researchers can adopt to interpret network-level genomic effects.

Awards made through this FOA will join the Impact of Genomic Variation on Function Consortium. That consortium structure matters because it signals that funded teams will not operate as standalone projects; instead, they are expected to coordinate with other consortium projects and components. As a cooperative agreement (U01), NIH will generally have substantial involvement, and recipients should anticipate collaborative planning, sharing of data or resources as appropriate, and participation in consortium activities intended to speed progress toward a shared understanding of how genomic variation impacts function and disease. In other words, the FOA is designed to build an integrated community effort where different projects contribute complementary data types, biological systems, and analytical approaches, while aligning on common goals, standards, and timelines.

Eligibility for this opportunity is broad. In addition to typical applicants such as public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), and a range of government entities (state, county, city/township, special districts, independent school districts, and eligible federal agencies), the FOA explicitly includes tribal governments and tribal organizations (including entities other than federally recognized tribal governments), public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses. It also highlights categories often emphasized in federal research outreach, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations. This wide eligibility suggests NIH is encouraging participation from diverse institutional types and geographic regions, including international contributions where appropriate.

Key administrative details from the source information include the NIH as the sponsoring agency, a cooperative agreement funding instrument (U01), the "Clinical Trial Not Allowed" designation, and an original closing date of November 4, 2020. The CFDA listing is 93.172. While the excerpt does not provide an award ceiling or the expected number of awards, the programmatic focus is clear: generate network-level functional genomic evidence and robust analytical methods, and contribute those outputs to a larger consortium effort aimed at accelerating understanding of how genetic variation affects human health and disease.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Defining Genomic Influence on Gene Network Regulation (U01 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): 93.172.
• This funding opportunity was created on 2020-08-03.
• Applicants must submit their applications by 2020-11-04. (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 HG 20 044

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