Opportunity Information: Apply for PAR 22 061
The National Institutes of Health (NIH) is offering an R01 grant opportunity titled "Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R01 Clinical Trial Not Allowed)" (PAR-22-061). The goal of this funding announcement is to support basic, mechanistic research that explains how the human microbiome can either strengthen or weaken anti-tumor immune responses, and how those microbiome-driven effects might be leveraged to identify new molecular targets for cancer prevention. The emphasis is on understanding cause-and-effect biology rather than running human intervention trials, since clinical trials are explicitly not allowed under this announcement.
Proposed projects are expected to drill into the mechanisms linking specific microbes (individual species or defined microbial consortia) and/or their metabolites to immune pathways that influence tumor development. A central theme is host-microbe interaction: how the immune system senses and responds to particular microbes, how microbial products shape immune cell function, and how these interactions either promote protective anti-tumor immunity or contribute to immune states that enable cancer. The announcement specifically calls out research relevant to both inflammation-associated cancers and sporadic tumor formation, meaning it can support work on cancer arising from chronic inflammatory environments as well as cancers that develop without an obvious inflammatory precursor, as long as microbiome-immune mechanisms are clearly central.
A notable point in the scientific scope is the expectation that applicants will rigorously address parameters that often determine whether a beneficial microbe (or microbiome-based approach) actually works. The FOA highlights concentration (dose), timing (when exposure or administration occurs), and duration (how long it is given or persists) as variables that can change the effect of administered beneficial microbes. Applications that involve introducing or modulating beneficial microbes should therefore treat these variables as core experimental factors rather than afterthoughts, with careful design to test how each parameter impacts immune outcomes relevant to tumor prevention or control.
From an administrative standpoint, this is a discretionary NIH grant using the R01 funding instrument, and it falls under CFDA numbers 93.393 and 93.396. The opportunity was created on November 3, 2021, and lists an original closing date of January 7, 2025. While an award ceiling and expected number of awards are not specified in the provided source data, the R01 mechanism typically supports substantial, multi-year research programs where applicants are expected to propose a strong rationale, solid preliminary or supporting evidence when appropriate, and a clear plan for mechanistic discovery.
Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status, excluding higher education institutions when applicable); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, non-domestic (non-U.S.) entities/foreign organizations, Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions. This wide eligibility reflects an intent to draw in multidisciplinary microbiome, immunology, and cancer biology expertise from diverse institutional settings.
Overall, the opportunity is designed for researchers who can connect the dots between microbiome composition or function and immune mechanisms that influence cancer risk or early tumor development, with an eye toward identifying actionable molecular targets for prevention strategies. Competitive applications will typically be those that move beyond correlation, carefully define microbial players or metabolites of interest, map the immune pathways they affect, and demonstrate a thoughtful approach to variables like dose, timing, and duration when manipulating microbes or their products in experimental systems, all while staying within the bounds of non-clinical-trial research.Apply for PAR 22 061
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R01 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): 93.393, 93.396.
- This funding opportunity was created on 2021-11-03.
- Applicants must submit their applications by 2025-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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)
What is the name of this NIH funding opportunity?
The opportunity is titled "Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R01 Clinical Trial Not Allowed)" (PAR-22-061).
What NIH grant mechanism is being used?
This funding announcement uses the NIH R01 research project grant mechanism.
What is the overall goal of PAR-22-061?
The goal is to support basic, mechanistic research that explains how the human microbiome can strengthen or weaken anti-tumor immune responses, and how microbiome-driven effects might be leveraged to identify new molecular targets for cancer prevention.
Are clinical trials allowed under this FOA?
No. Clinical trials are explicitly not allowed under this announcement. The emphasis is on mechanistic, cause-and-effect biology rather than human intervention trials.
What kinds of research questions fit best with this announcement?
Projects are expected to focus on mechanisms linking specific microbes (individual species or defined microbial consortia) and/or microbial metabolites to immune pathways that influence tumor development, prevention, or control. A strong fit involves mapping how host-microbe interactions shape immune responses relevant to cancer.
Does the FOA emphasize correlation studies or causal/mechanistic studies?
The emphasis is on causal and mechanistic studies (cause-and-effect biology), rather than observational correlations between microbiome patterns and cancer outcomes.
What is meant by "host-microbe interaction" in this context?
It refers to how the immune system senses and responds to particular microbes, how microbial products shape immune cell function, and how these interactions either promote protective anti-tumor immunity or contribute to immune states that enable cancer.
Can proposed studies focus on microbial metabolites rather than whole microbes?
Yes. The scope includes mechanisms tied to specific microbes and/or their metabolites, as long as the work clearly links microbiome-derived factors to immune pathways relevant to tumor development or prevention.
Is the announcement limited to a specific cancer type?
The provided information does not specify a single cancer type. It highlights relevance to both inflammation-associated cancers and sporadic tumor formation, provided microbiome-immune mechanisms are central.
What is the difference between inflammation-associated cancers and sporadic tumor formation in the FOA scope?
Inflammation-associated cancers arise in the context of chronic inflammatory environments, while sporadic tumors develop without an obvious inflammatory precursor. This FOA can support mechanistic microbiome-immune studies relevant to either context.
If a project introduces or modulates beneficial microbes, what experimental variables does NIH expect applicants to address?
The FOA specifically calls out concentration (dose), timing (when exposure or administration occurs), and duration (how long it is given or persists) as key parameters that can determine whether a beneficial microbe or microbiome-based approach works. Applications are expected to treat these as core experimental factors.
Why are dose, timing, and duration highlighted as important?
Because changes in how much is administered, when it is administered, and how long it persists can change the immune effects of beneficial microbes and therefore alter outcomes relevant to tumor prevention or control.
What type of research is NIH trying to advance with this FOA?
Basic, mechanistic discovery research that identifies and explains microbiome-driven immune effects on tumor development and that can point to actionable molecular targets for cancer prevention strategies.
What kinds of applicants are eligible to apply?
Eligibility is broad and includes many U.S. and non-U.S. organizations. Examples include state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status, as applicable); for-profit organizations (other than small businesses); small businesses; and other entities.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA explicitly includes non-domestic (non-U.S.) entities/foreign organizations among the eligible applicant categories.
Are minority-serving institutions and tribal colleges specifically mentioned as eligible?
Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, TCCUs, and other tribal organizations, including Indian/Native American Tribal Governments other than federally recognized.
Are faith-based or community-based organizations eligible to apply?
Yes. Faith-based or community-based organizations are explicitly listed among the eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly listed as eligible.
Are eligible federal agencies included as potential applicants?
Yes. Eligible federal agencies are explicitly mentioned among the eligible applicant categories.
What CFDA numbers are associated with this opportunity?
The opportunity is listed under CFDA numbers 93.393 and 93.396.
When was this opportunity created?
The opportunity was created on November 3, 2021.
What is the original closing date listed for this FOA?
The provided information lists an original closing date of January 7, 2025.
Is there an award ceiling specified in the provided information?
No. The provided source data does not specify an award ceiling.
Is the expected number of awards specified in the provided information?
No. The provided source data does not specify the expected number of awards.
What level of project scope is generally implied by an R01?
While exact budgets and project periods are not provided here, the R01 mechanism typically supports substantial, multi-year research programs. Applicants are generally expected to present a strong rationale, supporting evidence when appropriate, and a clear plan for mechanistic discovery.
What would make an application more competitive based on the FOA description?
Competitive applications are typically those that move beyond correlation, clearly define microbial players or metabolites of interest, map the immune pathways they affect, and include a thoughtful, rigorous approach to key variables like dose, timing, and duration when manipulating microbes or their products in experimental systems, while staying within the non-clinical-trial boundary.
Does this FOA focus more on cancer treatment or cancer prevention?
The stated aim includes identifying new molecular targets for cancer prevention, and it emphasizes microbiome-immune mechanisms influencing cancer risk or early tumor development. It also references immune pathways that influence tumor development and potential prevention or control, within mechanistic (non-clinical-trial) research.
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