Notice of Intent to Publish a Funding Opportunity Announcement for Human Milk as a Biological System (R01 Clinical Trial Optional)
Notice Number:

Key Dates

Release Date:
February 02, 2021
Estimated Publication Date of Funding Opportunity Announcement:
July 26, 2021
First Estimated Application Due Date:
November 30, 2021
Earliest Estimated Award Date:
July 22, 2022
Earliest Estimated Start Date:
July 22, 2022
Related Announcements


Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on Human Milk as a Biological System.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in Summer 2021 with an expected application due date in Winter 2021.

This FOA will utilize the R01 (Clinical Trial Optional) activity code.

Research Initiative Details

Rationale. The public health community has come to appreciate that a deeper understanding of the biology of human milk is essential to address ongoing and emerging questions about infant feeding practices. The critical pieces of that understanding are that: (1) human milk is a complex biological system, a matrix of many interacting parts, that is more than the sum of those parts; and (2) human milk production needs to be studied as an ecology that consists of inputs from the mother, her breastfed baby, and their respective environments.

Human Milk as a Biological System. The purpose of this new funding opportunity is to invite applications to address priority gaps in our understanding of human milk as a biological system and to interrogate the factors that influence the composition and function of human milk using a systems biology approach.

These gaps include, but are not limited to, the following:

1. Maternal factors influencing the systems biology of human milk, including but not limited to:

  • Genetics
  • Age
  • Mammary gland biology
  • Body composition
  • Nutritional and nutritional status
  • Health status
  • Environmental exposures
  • Maternal microbiomes (GI, oral, skin)
  • Xenobiotics (e.g., therapeutic drugs, toxins)
  • Factors that may impact on the chronobiology of lactation and human milk composition
  • Hormonal regulation

2. Identifying the components of human milk (nutrients [including macro- and micronutrients], immune components, cellular components, and non-nutritive bioactive components) and defining their roles in term of:

  • Infant growth, development (physical/neurological), or other biological systems/outcomes
  • The evidence and methodologies to attest to the nature of the interactions and relationships of these components within the food matrix
  • Changes in these components over time (within a feeding, over the course of the day, over the course of lactation), and differences between milk from mothers delivering term vs. preterm infants

3. Infant factors affecting the systems biology of human milk, including but not limited to:

  • Impact of sucking (strength and duration)
  • Oral interface (infant oral microbiome and/or other bioactive components from the infant)
  • Infant gestational age, birth weight, health (illness),
  • Genetics
  • Circadian biology
  • Exposure to direct vs. expressed human milk from the infant’s own mother

4. New modeling techniques (in silico, ex vivo, in vivo, other) that allow investigators to model human milk as a biological system and interrogate the system.

It is anticipated that the science supported by this FOA will inform approaches to translation and implementation of new knowledge to support safe and efficacious infant feeding practices in the United States and globally.

Funding Information
Estimated Total Funding


Expected Number of Awards
Estimated Award Ceiling


Primary CFDA Numbers


Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
Indian/Native American Tribal Government (Federally Recognized)
County governments
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
State Government
Regional Organization

Applications are not being solicited at this time. 


Please direct all inquiries to:

Andrew A. Bremer, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-7886

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices