Opportunity Information: Apply for PAR 22 062
The National Institutes of Health (NIH) is offering an R21 exploratory/developmental research grant opportunity titled "Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R21 Clinical Trial Not Allowed)" under funding opportunity number PAR-22-062. This announcement supports early-stage, basic research projects aimed at figuring out exactly how the human microbiome can either suppress or strengthen immune responses that matter for cancer prevention and anti-tumor activity. The emphasis is on mechanism-driven work that can reveal actionable biology, including the discovery of novel molecular targets that could eventually inform cancer prevention strategies.
Projects submitted to this FOA are expected to focus on how the host interacts with specific microbes, defined microbial communities (consortia), and/or microbially derived metabolites, and how those interactions shape immune pathways linked to tumor formation. The research can address cancers that arise in the context of chronic inflammation (inflammation-associated tumors) as well as cancers that occur without an obvious inflammatory precursor (sporadic tumors). The goal is not simply to describe which microbes correlate with outcomes, but to pin down cause-and-effect relationships and the underlying immune mechanisms that explain how microbial factors modulate anti-tumor immunity or tumor-promoting inflammation.
A notable requirement in the scope is attention to practical biological variables that can change outcomes when "beneficial" microbes are introduced or manipulated. Applications are expected to rigorously consider dose or concentration, timing, and duration of administration or exposure, since these parameters can strongly influence whether a microbial intervention helps, does nothing, or potentially harms. In other words, proposals should not treat the microbiome as a static feature; they should build in a clear rationale for when, how much, and for how long microbes or microbial products are being tested, and how those choices relate to immune responses and cancer-relevant endpoints.
This FOA uses the NIH R21 mechanism, which is designed for exploratory, higher-risk concepts that can open new directions or generate key proof-of-principle evidence, rather than large, mature programs. The funding instrument is a grant, and the opportunity falls under the broad activity areas of education and health, with CFDA numbers 93.393 and 93.396 listed in the source information. The award ceiling is stated as $275,000, indicating the maximum support level expected under this announcement. The opportunity is listed as discretionary funding.
Clinical trials are explicitly not allowed under this FOA, meaning applicants should propose basic and preclinical research rather than interventional studies in human participants intended to evaluate health outcomes. Work can still be "human microbiome" focused in terms of relevance and use of human-derived data or materials, but the proposed study design must stay within the non-clinical-trial boundaries of the announcement.
Eligibility is broad and includes many types of U.S.-based and certain non-U.S. organizations. Eligible applicants include state, county, city/township, and 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as 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, non-domestic (non-U.S.) entities (foreign organizations), Indian/Native American tribal governments other than federally recognized entities, and U.S. territories or possessions.
Key administrative details from the listing include an original closing date of 2025-01-07 and a creation date of 2021-11-03. Overall, this opportunity is best suited for teams proposing well-justified, mechanistic studies that link specific microbes or microbial metabolites to defined immune pathways that influence cancer initiation or prevention, while carefully accounting for critical exposure variables like dose, timing, and duration and staying within the non-clinical-trial scope.Apply for PAR 22 062
- 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 (R21 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.)
- Each selected applicant is eligible to receive up to $275,000.00 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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FAQs: NIH R21 Grant - Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (PAR-22-062)
What is the title of this NIH funding opportunity?
The funding opportunity is titled "Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R21 Clinical Trial Not Allowed)."
What is the funding opportunity number?
The funding opportunity number is PAR-22-062.
Which agency is offering this grant?
This opportunity is offered by the National Institutes of Health (NIH).
What grant mechanism is being used?
This opportunity uses the NIH R21 exploratory/developmental research grant mechanism, which is intended for exploratory, higher-risk projects that can open new research directions or generate proof-of-principle evidence.
What is the main scientific focus of this FOA?
The focus is early-stage, mechanism-driven basic research to determine how the human microbiome can suppress or strengthen immune responses that are relevant to cancer prevention and anti-tumor activity.
What kinds of outcomes is this FOA trying to enable?
The FOA aims to support research that reveals actionable biology, including identification of novel molecular targets that could ultimately inform cancer prevention strategies.
Is this opportunity meant for descriptive microbiome association studies?
No. The emphasis is not on simply describing which microbes correlate with outcomes. Applications are expected to establish cause-and-effect relationships and identify underlying immune mechanisms explaining how microbial factors modulate anti-tumor immunity or tumor-promoting inflammation.
What types of microbiome-related factors can projects focus on?
Projects are expected to focus on host interactions with specific microbes, defined microbial communities (consortia), and/or microbially derived metabolites, and how these interactions shape immune pathways linked to tumor formation.
What immune and cancer contexts are within scope?
The FOA allows research on cancers that arise in the context of chronic inflammation (inflammation-associated tumors) as well as cancers that occur without an obvious inflammatory precursor (sporadic tumors).
What does "mechanism-driven" mean in the context of this FOA?
Within the description provided, "mechanism-driven" refers to studies that go beyond correlations and instead define immune pathways and causal mechanisms by which microbes or microbial metabolites influence anti-tumor immunity or tumor-promoting inflammation.
Are applicants expected to consider practical biological variables when introducing or manipulating microbes?
Yes. Applications are expected to rigorously consider biological variables such as dose or concentration, timing, and duration of administration or exposure, because these parameters can influence whether a microbial intervention helps, has no effect, or causes harm.
Why are dose, timing, and duration emphasized?
The FOA notes that outcomes can change substantially depending on how much is administered (dose/concentration), when it is administered (timing), and how long exposure or administration occurs (duration). Proposals should not treat the microbiome as static and should justify these parameters in relation to immune responses and cancer-relevant endpoints.
Are clinical trials allowed under this FOA?
No. Clinical trials are explicitly not allowed under this FOA.
What does "Clinical Trial Not Allowed" mean for proposed study designs?
It means applicants should propose basic and preclinical research rather than interventional studies in human participants intended to evaluate health outcomes.
Can research still be focused on the human microbiome even though clinical trials are not allowed?
Yes. The FOA indicates work can still be human microbiome focused in terms of relevance and use of human-derived data or materials, as long as the proposed design stays within the non-clinical-trial boundaries.
What is the funding instrument type?
The funding instrument is a grant.
What is the maximum award amount stated in the listing?
The award ceiling is stated as $275,000, indicating the maximum support level expected under this announcement.
Is this considered discretionary funding?
Yes. The opportunity is listed as discretionary funding.
Which broad activity areas are associated with this opportunity?
The opportunity is listed under the broad activity areas of education and health.
What CFDA numbers are associated with this listing?
The CFDA numbers provided are 93.393 and 93.396.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based and certain non-U.S. organizations. Eligible applicants include state, county, city/township, and 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Are foreign (non-U.S.) organizations eligible?
Yes. The FOA highlights non-domestic (non-U.S.) entities (foreign organizations) as an eligible applicant category.
Are U.S. territories or possessions included as eligible applicants?
Yes. U.S. territories or possessions are listed among the eligible categories.
Are minority-serving institutions and specific institution types highlighted as eligible?
Yes. The FOA highlights categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, and faith-based or community-based organizations, among others.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are included in the highlighted eligible applicant categories.
What is the original closing date listed for this opportunity?
The listing shows an original closing date of 2025-01-07.
What is the creation date shown in the listing?
The listing shows a creation date of 2021-11-03.
What kinds of projects are a good fit for this R21 opportunity?
This opportunity is best suited for teams proposing well-justified, mechanistic studies linking specific microbes or microbial metabolites to defined immune pathways that influence cancer initiation or prevention, while carefully accounting for exposure variables like dose, timing, and duration and staying within the non-clinical-trial scope.
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