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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Frequently Asked Questions (FAQs)

What is the funding opportunity?

The opportunity is titled "Human Virome Program: Characterization of functional interactions between viruses and human and microbial hosts (U01 Clinical Trial Not Allowed)." It is a National Institutes of Health (NIH) Request for Applications (RFA) under the NIH Common Fund Human Virome Program (HVP).

What is the opportunity number?

The opportunity number is RFA-RM-23-017.

Which NIH program is this part of?

This RFA is part of the NIH Common Fund Human Virome Program (HVP), which aims to deeply map and understand the human virome and build the foundation (tools, models, and methods) needed to study the virome at scale.

What is the main purpose of the Human Virome Program (HVP)?

The central purpose is to map and understand the human virome (the full collection of viruses that reside in and on the human body) and to create practical, broadly usable foundations for virome research. These foundations include new tools, experimental and computational models, and improved methods that enable large-scale study of how the virome varies across people and environments and how it relates to host factors, the microbiome, health, and disease.

What is the scientific focus of this particular RFA?

This notice emphasizes functional biology rather than simple cataloging of viruses. The focus is on characterizing functional interactions among resident viruses, human tissues (the host), and microbial communities (the microbiota/microbiome), including mechanisms that shape viral behavior and host and microbial biology.

What does "moving beyond cataloging" mean in the context of this opportunity?

It means the project goals should not stop at identifying which viruses are present. Instead, applications are expected to address how viruses functionally interact with human tissues and microbial communities, including mechanisms and consequences of those interactions.

What overarching biological relationships are applicants expected to study?

Applications are expected to study the three-way relationship between the virome, the human host, and the microbiota, including how each component influences the others.

What is tissue tropism, and why is it important here?

Tissue tropism refers to where resident viruses live in the body (which tissues or cell types they inhabit). This RFA expects applicants to address tissue tropism and to identify which tissues or cell types may serve as reservoirs for resident viruses over time.

What does the RFA mean by "reservoirs" for resident viruses?

Reservoirs are tissues or cell types that may harbor viruses over time, supporting persistence, latency, or the potential for reactivation depending on local conditions and host factors.

What types of functional interactions are within scope?

The notice describes functional interactions as mechanisms by which viruses influence host biology and microbial communities, and how host and microbial factors shape viral behavior. Examples mentioned include how resident viruses persist, how they modulate immune responses, how they alter microbial ecology, and how local tissue environments constrain or enable viral replication, latency, or reactivation.

What kinds of contextual factors does the RFA highlight as important to consider?

The RFA highlights virome variation alongside host genetics, immune status, microbiome composition, and other contextual factors (including variation across people and environments).

What is the award mechanism?

The mechanism is a U01 cooperative agreement.

What is a U01 cooperative agreement, and how is it different from a standard research grant?

A cooperative agreement typically includes substantial NIH programmatic involvement during the project. This can involve coordinated milestones, steering committees, data-sharing expectations, and other collaborative structures common in large NIH Common Fund initiatives.

Does NIH expect collaboration and coordination across projects?

Yes. Because this is a Common Fund initiative using a cooperative agreement mechanism, applicants should expect coordinated, collaborative structures and expectations such as milestones and data-sharing approaches intended to support a broader program.

What is the activity area for this opportunity?

The activity area is health.

What is the CFDA number associated with this listing?

The listing is associated with CFDA number 93.310.

What does "Clinical Trial Not Allowed" mean for applicants?

It means applicants should not propose studies that meet NIH's definition of a clinical trial, such as prospectively assigning human participants to interventions to evaluate effects on health-related biomedical outcomes. Projects must be designed to remain within NIH non-clinical-trial boundaries for this mechanism.

Are human samples or human observational research allowed?

The information provided indicates that human samples and observational human research may still be possible depending on design, as long as the work does not meet NIH's definition of a clinical trial and stays within the non-clinical-trial boundaries required for this opportunity.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

When was this opportunity created?

The creation date listed is 2023-09-13.

What is the application closing date?

The original closing date listed for applications is 2023-11-15.

What is the maximum award amount?

The award ceiling is stated as $750,000, indicating the maximum amount anticipated per award in the notice summary.

How many awards will NIH make?

The expected number of awards is not specified in the provided information.

Who is eligible to apply?

Eligibility is broad and includes many 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."

Are minority-serving institutions and other highlighted institution types eligible?

Yes. The notice explicitly highlights eligibility for institution types including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), among others.

Are faith-based or community-based organizations eligible?

Yes. The notice explicitly includes faith-based or community-based organizations among eligible applicants.

Are U.S. territories or possessions eligible to apply?

Yes. The notice explicitly includes U.S. territories or possessions among eligible applicants.

Are foreign (non-U.S.) organizations eligible to apply as the applicant organization?

No. Non-domestic (non-U.S.) entities (foreign organizations or foreign institutions) are not eligible to apply as the applicant organization.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are not eligible to apply.

Are foreign components allowed in the project?

Yes. Foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include well-justified foreign collaborations or performance sites as components of the project, subject to NIH rules and approvals.

What is the intent behind allowing foreign components but not foreign applicants?

The structure preserves domestic leadership and accountability for the award while still allowing international scientific collaboration when it is necessary and appropriate.

What kinds of outputs are likely emphasized because this is a Common Fund initiative?

Applicants should generally expect emphasis on producing broadly usable resources for the research community, such as data, assays, analytic pipelines, reference materials, or model systems, and on making outputs accessible to support future virome research.

What types of research capabilities is the program trying to build?

The program aims to build tools and experimental and computational models, along with improved methods, that enable scalable study of the virome, including how it varies across people and environments and how it relates to host and microbiome factors.

What is the overall goal of the opportunity in plain terms?

The overall goal is to help research teams identify where resident viruses are found in the body, determine potential reservoirs, and connect those findings to real biological function by studying interactions among viruses, human tissues, and microbial communities, with outputs designed to enable broader progress in the field.

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