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.Apply for RFA RM 23 018
- 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.
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Frequently Asked Questions (FAQs)
1) What is the funding opportunity?
The opportunity is 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). It is a Request for Applications (RFA) from the National Institutes of Health (NIH) under the NIH Common Fund Human Virome Program (HVP).
2) What is the main goal of this program?
The goal is to move the field beyond current bottlenecks that make it hard to reliably detect, classify, and interpret viruses that live in and on humans (the human virome). The program aims to build broadly usable tools and 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.
3) What kind of funding mechanism is used?
This opportunity uses a cooperative agreement mechanism (U01). Under a U01, awardees should expect substantial involvement from NIH program staff in coordinating, steering, and shaping aspects of the work as the broader program develops.
4) Does this opportunity allow clinical trials?
No. The notice explicitly states "Clinical Trial Not Allowed." Applications should not propose prospective studies that assign human participants to interventions to evaluate health outcomes.
5) If clinical trials are not allowed, what types of projects fit this RFA?
The emphasis is on technology and methods development rather than clinical testing of interventions. Projects are expected to create and validate tools, models, methods, and computational approaches that enable deeper and more accurate interrogation of the human virome.
6) What problem areas is the program trying to address?
The program highlights two major needs: (1) better ways to identify and characterize viruses, including difficult-to-detect or previously unannotated viruses, and (2) stronger computational biology and bioinformatics capabilities to analyze virome data, interpret function, and connect viral signals to host and environmental factors.
7) What kinds of improvements are considered competitive?
Competitive projects typically focus 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.
8) Is this mainly for basic research, applied research, or tool-building?
The program is primarily aimed at tool-building and methods development that can generalize broadly and unlock wider discovery, rather than simply applying existing virome methods to a single cohort or a single disease area.
9) What parts of the virome research pipeline can be supported?
The scope includes tool-building across the full pipeline, from sample processing and assay design through sequencing (or other readouts) to downstream analytics, data integration, and interpretation.
10) What is the program's interest in computational methods?
The opportunity signals strong interest in computational tool development, including bioinformatics workflows, reference resources, and methods designed to address common virome challenges such as sparse reference databases, high diversity, rapid evolution, contamination/background, and distinguishing true infections or colonization from transient signals.
11) What is meant by "human virome" in this context?
In this opportunity, the human virome refers to viruses that live in and on humans. The RFA focuses on improving how these viruses are detected, classified, annotated, and interpreted, and on understanding how the virome varies across people and contexts.
12) Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and includes: 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.
13) Are there additional eligible applicant categories specifically called out?
Yes. The announcement explicitly calls out 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.
14) Can a non-U.S. (foreign) organization apply as the main applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible.
15) Are any kinds of foreign collaborations allowed?
Yes. "Foreign components" (as defined by the NIH Grants Policy Statement) are allowed. This generally means a U.S. applicant organization can include certain types of foreign collaborations or elements within NIH rules for foreign components, even though the primary applicant must be domestic.
16) What NIH program is this associated with?
This opportunity is part of the NIH Common Fund Human Virome Program (HVP).
17) What is the activity category and CFDA number?
The listing is under the Health activity category with CFDA number 93.310 and is administered by NIH.
18) What is the application deadline?
The information provided lists an original closing date of November 14, 2023.
19) What is the award ceiling?
The award ceiling is listed as 350,000 (as presented in the source information).
20) How many awards will NIH make?
The listing notes expected awards, but the number of expected awards is not provided in the information given here.
21) What should applicants expect because this is a cooperative agreement (U01)?
Because this is a U01 cooperative agreement, applicants should plan for substantial NIH program staff involvement and program-level coordination as the broader Human Virome Program develops. This can affect coordination, steering, and shaping of project activities over time.
22) Is the program focused on a specific disease area or cohort?
The emphasis is not on projects that simply apply existing virome methods to one cohort or one disease area. Instead, it is focused on innovations that can generalize and enable broader discovery across people, contexts, and research questions.
23) What types of outputs is the program trying to produce for the wider research community?
The program aims to produce broadly usable resources and enabling technologies, such as tools, methods, and computational frameworks that improve detection, characterization, functional annotation, and large-scale analysis of virome data and its relationship to host biology and environmental factors.
24) What are examples of virome-specific challenges this program wants tools to address?
The opportunity highlights challenges such as sparse reference databases, high viral diversity, rapid viral evolution, contamination/background signals, and the difficulty of distinguishing true infections or colonization from transient viral signals.
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