Nutrition for Precision Health, powered by the All of Us Research Program: Microbiome and Metagenomics Center (U24 Clinical Trial Not Allowed) | RFA RM 21 003

Opportunity Information: Apply for RFA RM 21 003

This funding opportunity (RFA-RM-21-003) is a National Institutes of Health (NIH) cooperative agreement (U24; clinical trial not allowed) under CFDA 93.310 that supports the creation or designation of one or more Microbiome and Metagenomics Centers (MMCs) to participate in the Nutrition for Precision Health initiative, which is powered by the All of Us Research Program. The central purpose is to add a dedicated, consortium-scale capability for generating and analyzing microbiome-related data that can be integrated with the broader Nutrition for Precision Health study data. In practical terms, the MMC is meant to function as a core resource for the consortium, providing standardized laboratory and analytical workflows so microbiome results are comparable across participants and usable for downstream precision nutrition research.

The scientific and operational focus of the MMC is analysis of stool specimens collected as part of the Nutrition for Precision Health study. The FOA specifically highlights three major types of work: microbiome profiling, metagenomics, and metatranscriptomics. Microbiome work typically refers to characterizing microbial communities present in the samples, while metagenomics focuses on sequencing and analyzing the collective genetic material of those communities to infer functional potential (for example, metabolic pathways that could influence nutrient processing). Metatranscriptomics extends this further by examining RNA expression patterns to understand which microbial genes are actively being expressed at the time of sampling, providing a more dynamic view of microbiome activity that may relate to dietary intake, host metabolism, and other health-related phenotypes captured in the parent study.

Because the award mechanism is a cooperative agreement, the expectation is not simply to run an isolated lab service, but to operate as an active partner within an NIH-led consortium structure. Cooperative agreements usually involve substantial programmatic involvement from NIH, meaning awardees often coordinate closely with NIH staff and other consortium components on issues like protocol harmonization, quality control standards, data pipelines, timelines, reporting, and integration with other study cores. The “clinical trial not allowed” designation clarifies that the MMC’s work should not be structured as an interventional clinical trial; rather, it is positioned as a research support and data generation/analysis center contributing to an ongoing observational or consortium-driven study framework.

Eligibility is broad and includes many common domestic applicant categories: 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 tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/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 explicitly calls out additional eligible applicant types 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions. At the same time, it states that non-domestic (non-U.S.) entities (foreign organizations/foreign institutions) are not eligible to apply as applicant organizations. However, non-domestic components of U.S. organizations may participate, and foreign components (as defined in the NIH Grants Policy Statement) are allowed, which generally means a U.S. applicant can include certain foreign activities or collaborations if properly justified and consistent with NIH policy.

Key administrative details included in the source information are that NIH is the sponsoring agency; the opportunity category is discretionary; the award instrument is a cooperative agreement (U24); and the original application closing date listed is April 6, 2021 (with a creation date of January 21, 2021). The award ceiling and expected number of awards are not specified in the provided text. Overall, the FOA is aimed at building a centralized, high-quality microbiome and multi-omics capability for stool samples that can support the Nutrition for Precision Health consortium’s broader goal of understanding how nutrition-related factors interact with biology to enable more precise, individualized approaches to health.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Nutrition for Precision Health, powered by the All of Us Research Program: Microbiome and Metagenomics Center (U24 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 2021-01-21.
• Applicants must submit their applications by 2021-04-06. (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.

Apply for RFA RM 21 003

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