Human Virome Program: Characterization of functional interactions between viruses and human and microbial hosts (U01 Clinical Trial Not Allowed) | RFA RM 23 017

Opportunity Information: Apply for RFA RM 23 017

The funding opportunity "Human Virome Program: Characterization of functional interactions between viruses and human and microbial hosts (U01 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) request for applications (RFA) issued under the NIH Common Fund Human Virome Program (HVP). The central purpose of the Human Virome Program is to deeply map and understand the human virome, meaning the full collection of viruses that reside in and on the human body, and to build the practical foundation needed to study it at scale. That foundation includes new tools, experimental and computational models, and improved methods that let researchers examine how the virome varies across people and environments, how it relates to host factors, and how it may shape health and disease. This particular notice focuses on moving beyond simple cataloging of viruses and instead emphasizes functional biology: how viruses interact with human tissues and with the broader microbiome.

Scientifically, the overarching goal is to study the three-way relationship between the virome, the human host, and the microbiota. Applications are expected to address where resident viruses live in the body (tissue tropism) and what tissues or cell types may serve as reservoirs for those viruses over time. The notice also calls for projects that define functional interactions, meaning the mechanisms by which viruses influence host biology and microbial communities, and how host and microbial factors in turn shape viral behavior. In practice, this can include investigating how resident viruses persist, how they modulate immune responses, how they alter microbial ecology, and how the local tissue environment constrains or enables viral replication, latency, or reactivation. The intent is to generate knowledge and capabilities that allow in-depth study of virome variation alongside host genetics, immune status, microbiome composition, and other contextual factors.

From an administrative standpoint, the award mechanism is a U01 cooperative agreement. A cooperative agreement is distinct from a standard research grant because NIH expects to have substantial programmatic involvement during the project, often through steering committees, coordinated milestones, data-sharing expectations, or other collaborative structures typical of large Common Fund initiatives. The activity area is health, and the listing is associated with CFDA number 93.310. The opportunity is explicitly labeled "Clinical Trial Not Allowed," which generally means applicants should not propose studies that meet NIH's definition of a clinical trial (for example, prospective assignment of human participants to interventions to evaluate effects on health-related biomedical outcomes). Human samples and observational human research may still be possible depending on design, but applicants have to stay within the non-clinical-trial boundaries laid out by NIH policy for this mechanism.

The agency is NIH, and the opportunity number is RFA-RM-23-017. The original closing date listed for applications is 2023-11-15, and the creation date is 2023-09-13. The award ceiling is stated as $750,000, indicating the maximum amount anticipated per award per the notice summary. The expected number of awards is not specified in the provided text. Because this is a Common Fund program, applicants should typically expect strong emphasis on producing broadly usable resources (data, assays, analytic pipelines, reference materials, or model systems) and on making outputs accessible to the wider research community, consistent with how Common Fund initiatives aim to accelerate multiple fields rather than only a single project area.

Eligibility is broad and includes many types of U.S.-based and domestic organizations. Eligible applicants include state, county, city or 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and additional categories captured under "Others." The notice also explicitly highlights certain institution types as other eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs (Asian American Native American Pacific Islander Serving Institutions), 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, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions.

At the same time, there are important limits related to foreign participation. Non-domestic (non-U.S.) entities (foreign organizations or foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which usually means a U.S. applicant can include certain well-justified foreign collaborations or performance sites as components of the project, subject to NIH rules and approvals. This structure preserves domestic leadership and accountability for the award while still allowing scientific collaboration internationally when it is necessary and appropriate.

Overall, this opportunity is aimed at teams that can characterize where resident viruses are found in the body, identify reservoirs, and then connect those maps to real biological function by studying interactions among viruses, human tissues, and microbial communities. It is positioned as part of a larger NIH Common Fund initiative, so applications are likely expected to be rigorous, scalable, and broadly enabling for the field, with methods and outputs designed to support future virome research and to clarify how the virome participates in human biology across health and disease.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Human Virome Program: Characterization of functional interactions between viruses and human and microbial hosts (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): 93.310.
• This funding opportunity was created on 2023-09-13.
• Applicants must submit their applications by 2023-11-15. (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 $750,000.00 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 RM 23 017

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