Notice of Intent to Publish a Funding Opportunity Announcement for Multisite Clinical Trials: Leveraging Network Infrastructure to Advance Research and Outcomes for Women, Children, Pregnant and Lactating Individuals and/or Persons with Disabilities
Notice Number:

Key Dates

Release Date:
July 26, 2022
Estimated Publication Date of Funding Opportunity Announcement:
November 18, 2022
First Estimated Application Due Date:
June 05, 2023
Earliest Estimated Award Date:
January 22, 2024
Earliest Estimated Start Date:
April 01, 2024
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 multisite clinical research projects to be conducted using NICHD-supported clinical research network infrastructure.

The goal of this FOA is to operationalize the previously reported NICHD guiding principles for multisite clinical trials delineated in Notice NOT-HD-19-034:

  • To enhance the rigor and reproducibility of clinical trial protocols
  • To promote greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators
  • To facilitate data sharing and access to biospecimens to efficiently expand research capacity for all investigators
  • To facilitate greater involvement of diverse populations in multisite clinical trials.

To operationalize these principles, multisite clinical trials conducted via the participating NICHD-supported clinical research networks will now be submitted as investigator-initiated grant applications by any qualified investigator in the extramural community or by participating Network Clinical Center investigators through this FOA and will be reviewed by a NIH-convened peer review panel. It is the intent of this initiative to utilize the NICHD clinical research network infrastructure in a manner that will promote the funding and support of the best science in a timely, equitable and cost-effective manner.

This FOA will support large scale, multisite clinical trials and observational studies that will leverage participating NICHD Networks (listed below). It is anticipated that additional Networks will be progressively added to this initiative. Single center, animal studies, basic science and basic experimental studies involving humans are beyond the scope of this initiative and will not be considered responsive.

The scientific scope of this FOA is focused on specific areas of the NICHD mission and Strategic Plan, and the corresponding Networks that support those areas of study as depicted below. Thus, applications submitted in response to this FOA should address topics that align with one of the following Networks and their corresponding science:

if an investigator is considering another NICHD Network or area of science not directly aligned with the networks, please discuss with the NICHD scientific program contact.

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 the Fall 2022 with the first expected application due date in the Spring 2023.

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into the above areas of science to begin to consider applying for this new FOA; collaborative efforts combining expertise in various scientific areas are encouraged. Multisite research on diseases and conditions related to the mission of the specific Network is encouraged with the intent to inform and improve the care and outcomes for infants, children, adolescents, women, pregnant and lactating individuals and/or persons with disabilities. Although multisite observational studies will be accepted, priority will be given to clinical trials that hold the promise to inform and advance care.

Through a rigorous pre-application process, the scientific scope and feasibility of the projects will be assessed by the NICHD and the respective clinical Network operational components. The period of time from the estimated FOA publication date until the estimated first application due date is designed to allow ample time for this pre-application process. If approved through this process, the trial investigator will work collaboratively with the respective Network to jointly prepare a grant application in response to this funding opportunity that will undergo NIH peer review.

Funding Information


Estimated Total Funding


Expected Number of Awards
Estimated Award Ceiling


Primary Assistance Listing Number(s)


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)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
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
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 


Please direct all inquiries to:

Robert Tamburro, MD, MSc

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