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.Apply for RFA HD 22 020
- 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.
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Frequently Asked Questions (FAQs)
What is the title of this NIH funding opportunity?
The funding opportunity is titled "Human Milk as a Biological System (R01 Clinical Trial Optional)".
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-HD-22-020.
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.865.
What is the main purpose of this funding opportunity?
This opportunity supports research that treats human milk as a complex, dynamic biological system, not simply as a source of nutrients. The goal is to close priority knowledge gaps about what human milk contains, how and why its composition changes, and how its components function biologically.
How does the FOA define "human milk as a biological system"?
In this FOA, "human milk as a biological system" means studying milk as an interconnected and changing system with multiple interacting components (for example, nutrients, immune factors, microbes, metabolites, genetics, and environmental influences), rather than isolating a single ingredient or factor.
What kinds of research approaches are encouraged?
The FOA emphasizes systems biology approaches, encouraging integrated study designs that can connect multiple layers of data and explain how milk composition and function emerge from interacting biological pathways and external exposures.
Does the FOA encourage multi-omics or comprehensive profiling?
Yes. Competitive projects would typically emphasize multi-omics or similarly comprehensive profiling strategies, along with strong computational, modeling, or integrative analytic components to study interactions among milk constituents and relevant drivers.
What scientific questions is NIH trying to address through this opportunity?
Based on the information provided, NIH is aiming to support studies that explain:
- What human milk contains, including diverse components and factors
- How and why milk composition changes over time and across individuals
- How milk components function biologically and interact with each other
- How biological pathways and external exposures translate into measurable differences in milk
- How milk, viewed as an interconnected system, may affect infant biology
Does the FOA focus on variability in human milk?
Yes. A core theme is that human milk varies across individuals and over time, and that this variability is shaped by maternal, infant, and contextual factors.
What types of factors are considered relevant to milk composition and function?
The FOA highlights a wide range of influences, including maternal factors, infant factors, and contextual or environmental influences. It also specifically references integrating information across nutrients, immune factors, microbes, metabolites, genetics, and environmental exposures.
What is the NIH award mechanism for this opportunity?
The award mechanism is an NIH R01 research project grant.
Are clinical trials required for this FOA?
No. Clinical trials are optional. Proposals may be observational or mechanistic, may include human subjects research, and may include a clinical trial if it is scientifically appropriate to answer the proposed questions.
Is human subjects research allowed under this opportunity?
Yes. The description indicates that proposals may include human subjects research, and may also include a clinical trial if appropriate.
What is the broader NIH activity category associated with this opportunity?
The opportunity is categorized under Health, Income Security and Social Services, reflecting its relevance to maternal and child health and biological determinants of early-life development.
Who is eligible to apply?
The eligibility list is broad and includes many organization types, such as:
- 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 (with or without 501(c)(3) status, excluding institutions of higher education in those categories)
- For-profit organizations (other than small businesses)
- Small businesses
- Other entities
Are minority-serving institutions specifically listed as eligible?
Yes. The FOA explicitly highlights eligibility for several categories of institutions, including:
- Historically Black Colleges and Universities (HBCUs)
- Hispanic-serving Institutions
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Can tribal governments apply if they are not federally recognized?
Yes. In addition to federally recognized Native American tribal governments, the FOA also lists Indian/Native American Tribal Governments other than federally recognized as eligible.
Are federal agencies eligible to apply?
Yes. The FOA lists eligible federal agencies among the eligible applicant types.
Are faith-based or community-based organizations eligible?
Yes. The FOA specifically includes faith-based or community-based organizations among eligible applicants.
Are applicants from U.S. territories eligible?
Yes. The FOA includes U.S. territories or possessions as eligible applicant types.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA includes non-U.S. entities (foreign organizations) and also references regional organizations as eligible.
When was this funding opportunity created?
The opportunity was created on May 5, 2021.
What was the original application closing date?
The original application closing date listed is November 29, 2021.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $499,999.
How many awards does NIH expect to make?
The expected number of awards is not specified in the provided information. The text notes that applicants would typically need to consult the full FOA or NIH funding plan materials for award count targets.
What type of grant program is this classified as?
This opportunity is categorized as a discretionary grant program.
What types of projects seem most competitive based on the description?
Based on the description provided, the most competitive projects would typically feature integrative, systems-level designs, comprehensive profiling (such as multi-omics), strong computational or modeling components, and a clear focus on interactions among milk constituents and the biological or environmental factors that drive variation in milk.
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