Human Virome Program: Developing novel and innovative tools to interrogate and annotate the human virome (U01 Clinical Trial Not Allowed) | RFA RM 23 018

Opportunity Information: Apply for RFA RM 23 018

The funding opportunity titled "Human Virome Program: Developing novel and innovative tools to interrogate and annotate the human virome (U01 Clinical Trial Not Allowed)" (RFA-RM-23-018) is a National Institutes of Health (NIH) Request for Applications under the NIH Common Fund Human Virome Program (HVP). It uses a cooperative agreement mechanism (U01), which means awardees should expect substantial involvement from NIH program staff in coordinating, steering, and shaping aspects of the work as the broader program develops. The overall purpose is to push the field past current bottlenecks that make it difficult to reliably detect, classify, and interpret the viruses that live in and on humans, and to build broadly usable resources that help researchers understand how the virome varies across people and contexts and how it interacts with host biology in ways that may matter for health and disease.

At its core, this opportunity is aimed at technology and methods development rather than clinical testing of interventions. The notice explicitly indicates "Clinical Trial Not Allowed," signaling that applications should not propose prospective studies that assign human participants to interventions to evaluate health outcomes. Instead, the emphasis is on creating and validating tools, models, methods, and computational approaches that enable deeper and more accurate interrogation of the human virome. The program’s framing highlights two major needs: first, better ways to identify and characterize viruses (including difficult-to-detect or previously unannotated viruses), and second, stronger computational biology and bioinformatics capabilities to analyze virome data, interpret function, and connect viral signals to host and environmental factors.

The scientific scope is broad, but it is tightly focused on overcoming practical and methodological obstacles that currently limit robust virome research. Competitive projects would typically center on novel experimental or analytical approaches that improve sensitivity and specificity of viral detection; increase confidence in taxonomic assignment; support functional annotation; or enable comparative analyses across populations, body sites, and time. This can include tool-building that strengthens the full pipeline from sample processing and assay design through sequencing or other readouts to downstream analytics, data integration, and interpretation. The opportunity also signals a strong interest in computational tool development, including bioinformatics workflows, reference resources, and methods that address common virome challenges like sparse reference databases, high diversity, rapid evolution, contamination/background, and distinguishing true infections or colonization from transient signals.

In terms of who can apply, eligibility is expansive across U.S.-based organizations and includes many government and non-government applicant types: 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; other tribal organizations; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions. At the same time, it draws a clear boundary around foreign participation: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, which generally means a U.S. applicant organization can include certain types of foreign collaborations or elements within the rules NIH sets for foreign components, even though the primary applicant must be domestic.

The opportunity is listed under the Health activity category with CFDA number 93.310 and is administered by NIH. Key administrative details provided include an original closing date of November 14, 2023, and an award ceiling listed as 350,000 (as presented in the source information). The listing notes expected awards but does not provide a number in the provided text. Because this is a cooperative agreement, prospective applicants typically need to plan for program-level coordination expectations, data sharing norms, and alignment with Common Fund goals, even when the core deliverable is a tool or method rather than a traditional hypothesis-driven biological study.

Taken together, this NOFO is essentially a targeted push to build the next generation of virome-enabling technologies and analytics. Rather than funding projects that simply apply existing virome methods to a single cohort or disease area, the emphasis is on innovations that can generalize and unlock broader discovery: better detection and characterization of viruses, better annotation and interpretation of what those viruses are doing, and better computational frameworks to analyze virome data at scale and relate it to host factors and health-relevant biology.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Human Virome Program: Developing novel and innovative tools to interrogate and annotate the human virome (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 2023-11-14. (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 $350,000.00 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 23 018

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: