Human Milk as a Biological System (R01 Clinical Trial Optional) | RFA HD 22 020

Opportunity Information: Apply for RFA HD 22 020

The National Institutes of Health (NIH) funding opportunity titled "Human Milk as a Biological System (R01 Clinical Trial Optional)" (Funding Opportunity Number: RFA-HD-22-020; CFDA: 93.865) supports research projects that treat human milk not just as a nutrient source, but as a complex, dynamic biological system. The FOA is aimed at closing priority knowledge gaps about what human milk contains, how and why its composition changes, and how those components function biologically. A central theme is the use of systems biology approaches, meaning applicants are encouraged to study human milk in an integrated way across multiple interacting layers (for example, combining data on nutrients, immune factors, microbes, metabolites, genetics, and environmental influences) rather than focusing on a single component in isolation.

The scientific focus is on understanding the many factors that influence the composition and function of human milk. This includes the idea that milk varies across individuals and over time, and that it is shaped by a wide range of maternal, infant, and contextual factors. In practice, the FOA is looking for research that can explain patterns and mechanisms: how biological pathways and external exposures translate into measurable differences in milk; how milk components interact with each other; and how milk as an interconnected system may affect infant biology. Because the announcement explicitly frames human milk as a "biological system," competitive projects would typically emphasize integrative study designs, multi-omics or similarly comprehensive profiling strategies, robust computational or modeling components, and careful attention to the interactions among milk constituents and relevant biological or environmental drivers.

The award mechanism is an NIH R01 research project grant, and clinical trials are optional, meaning proposals may be purely observational or mechanistic, may include human subjects research, and may include a clinical trial if it is scientifically appropriate to answer the questions being posed. The opportunity falls under the broader NIH activity category of Health, Income Security and Social Services, reflecting its relevance to maternal and child health and to biological determinants of early-life development.

A wide range of organizations are eligible to apply. Standard 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; public housing authorities/Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status, excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also highlights additional eligible applicant types, 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); Indian/Native American Tribal Governments other than federally recognized; eligible federal agencies; faith-based or community-based organizations; U.S. territories or possessions; and non-U.S. entities (foreign organizations) as well as regional organizations. This broad eligibility suggests NIH is encouraging diverse institutional participation and research perspectives, including community-connected and international expertise where relevant.

Key administrative details provided in the source data include an original application closing date of November 29, 2021, and a listed award ceiling of $499,999. The opportunity was created on May 5, 2021, and is categorized as a discretionary grant program. The expected number of awards is not specified in the provided text, which typically means applicants would need to consult the full FOA or NIH funding plan details for any specific award count targets. Overall, the program is designed to fund rigorous, integrative studies that can advance a more complete and mechanistic understanding of human milk composition, variability, and biological function using systems-level thinking and methods.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Human Milk as a Biological System (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2021-05-05.
• Applicants must submit their applications by 2021-11-29. (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 $499,999.00 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 HD 22 020

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