Human Virome Program: Developing novel and innovative tools to interrogate and annotate the human virome (U01 Clinical Trial Not Allowed) | RFA RM 24 009

Opportunity Information: Apply for RFA RM 24 009

The National Institutes of Health (NIH), through the Common Fund, is offering a cooperative agreement opportunity to support the Human Virome Program with a focus on building new and better ways to study the human virome. The central goal is to more completely identify and characterize the viruses associated with humans and to develop the tools, experimental systems, and computational approaches needed to understand how the virome varies across people and contexts, how it interacts with host factors, and how it may influence health and disease. This funding opportunity is designed to push the field past current bottlenecks that make viruses especially difficult to detect, classify, and interpret, even in an era of powerful sequencing and large-scale data analysis.

The emphasis of this Notice of Funding Opportunity (NOFO) is technology and method development rather than clinical testing. Applicants are being asked to create innovative tools, models, and methods that address the major technical challenges in virome research. In practice, that includes improving how viruses are found in complex samples, how viral genomes are assembled and annotated, how viral diversity is measured, and how viral function is inferred. The NOFO also explicitly calls for computational and bioinformatics tool development to strengthen human virome analysis, reflecting the reality that many virome reads remain unclassified and that reference databases, annotation standards, and analysis pipelines still lag behind what is needed for robust and reproducible interpretation.

This opportunity uses the U01 mechanism, which is a cooperative agreement. That structure typically means substantial NIH programmatic involvement compared with a standard research grant, with an expectation of active coordination and partnership between awardees and NIH staff to meet program goals. The NOFO is labeled "Clinical Trial Not Allowed," signaling that the funded work should not involve clinical trial activities as defined by NIH policy. The program is therefore aimed at foundational capabilities: tool creation, enabling platforms, computational frameworks, and experimental models that can later be applied to health and disease research, rather than interventional clinical studies.

A notable required component of the application is a Plan for Enhancing Diverse Perspectives (PEDP). This plan will be reviewed as part of the scientific and technical peer review process, meaning it is not a superficial administrative attachment but a scored or otherwise substantively considered element. In general terms, the PEDP expectation is that teams describe how they will broaden the range of perspectives, backgrounds, expertise, and potentially community or stakeholder inputs that shape the research, which can strengthen creativity, rigor, and relevance, especially in a program trying to map variation in the human virome across different host and environmental contexts.

Eligibility is broad across public and private sectors. Eligible applicants include state, county, city, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations. The NOFO also highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed when they meet the NIH Grants Policy Statement definition, which can enable specific international collaborations or resources under a U.S.-led application.

Key administrative details from the listing include the funding opportunity title "Human Virome Program: Developing novel and innovative tools to interrogate and annotate the human virome (U01 Clinical Trial Not Allowed)," the opportunity number RFA-RM-24-009, and classification as a discretionary funding opportunity in the health area under CFDA 93.310. The sponsoring agency is the NIH. The original closing date is February 27, 2025. The listed award ceiling is $350,000. The posting (creation) date in the provided source data is October 23, 2024. The number of expected awards is not specified in the supplied text.

Overall, this NOFO is best read as a targeted call to build next-generation virome capabilities: better wet-lab and computational methods to detect and interpret viruses, better models and analytical frameworks to understand what those viruses are doing, and better annotation and bioinformatics infrastructure so the field can move from "we found sequences" to "we can reliably identify, compare, and understand viral constituents and functions" across human populations and conditions.

• 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 2024-10-23.
• Applicants must submit their applications by 2025-02-27. (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.

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