Notice of Intent to Publish Notice of Funding Opportunity Announcements for a Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project
Notice Number:

Key Dates

Release Date:
June 02, 2023
Estimated Publication Date of Notice of Funding Opportunity :
July 01, 2023
First Estimated Application Due Date:
November 01, 2023
Earliest Estimated Award Date:
July 01, 2024
Earliest Estimated Start Date:
July 01, 2024
Related Announcements
  • June 2, 2023 - Notice of Intent to Publish Notice of Funding Opportunity Announcements for a Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the INCLUDE Project. See Notice NOT-OD-23-134. 
  • June 2, 2023 - Notice of Intent to Publish Notice of Funding Opportunity Announcements for a Federated Biobanking resource for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project. See Notice NOT-OD-23-136
Issued by

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


This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The NIH INCLUDE Project seeks to improve health and quality-of-life for individuals with Down syndrome. The National Institutes of Health, Office of the Director, with other NIH Institutes and Centers (ICs) (NICHD, NHLBI, NIA, NIDCD, NIMH etc.), intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for a Down Syndrome Clinical Cohort Coordinating Center (DS-4C).

The DS-4C will be responsible for overall project coordination and outreach, support development of new cohorts of people with Down syndrome, and curate the metadata from the new cohorts. A companion NOFO (NOT-OD-23-134) will support the Cohort Research Sites (DS-CRS). A related NOFO (NOT-OD-23-136) will support a federated biobanking system for the INCLUDE Project.

The DS-4C will be a cooperative program committed to support the Down syndrome cohort development program. The DS-4C will provide overall management and oversight for the DS cohort development program, including coordination and communication across all subsections and cores of the program; most importantly, it will lead the effort to outreach to a broader DS community to increase Diversity, Equity, Inclusion and Accessibility (DEIA) within the DS cohort.

The DS-4C is expected to work closely with the INCLUDE data repository maintained by the INCLUDE Data Coordinating Center (DCC).

Research Initiative Details

This NOFO will utilize the U54 activity code. The NOFO is expected to be published in Summer 2023 with an expected application due date in Fall 2023. Details of the planned NOFO are provided below.

The 4C’s responsibilities will cover four areas:

  1. The Administrative Core will oversee study operations, research skills development, and oversee capitation to the Research Sites for deep phenotyping costs
  2. The Outreach Core will oversee communication with the broader DS community to increase DEIA for DS cohort recruitment, and support a call center to follow participant outcomes, in conjunction with the Research Sites;
  3. The Cohort Core will develop and coordinate the implementation of a common protocol by the Research Sites and oversee their data collection and quality approaches, and coordination of biospecimen and biorepository activities; and
  4. The Data Management Core will ingest, aggregate, integrate, harmonize, and curate data from the Research Sites, and work with the INCLUDE DCC to rapidly share these data through the INCLUDE Data Hub to facilitate use by the broad research community.

The total timeline for the DS-4C proposed in response to this NOFO may not exceed five years.  The DS-4C will work cooperatively with Down syndrome Cohort Research Sites (DS-CRS) that will be funded through a U01 Specialized Center mechanism.

In addition, investigators proposing collaborative transdisciplinary investigations combining expertise in fields such as biochemistry, bioengineering, computational biology, molecular biology, health services, neuroscience, pharmacology, computer and data sciences, bioinformatics as well as bioethics will be encouraged to apply for this opportunity.

This NOFO will require a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application.

Applicants are strongly encouraged to contact INCLUDE staff to discuss the scientific scope and feasibility of the proposal. The period of time from the estimated NOFO publication date until the estimated first application due date is designed to allow ample time for this discussion. If applying to this NOFO, the applicant is expected to work collaboratively with the respective team 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:

Sujata Bardhan, Ph.D, M.S
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-047

Huiqing Li, Ph.D. 
National Heart, Lung, and Blood Institute (NHLBI) 
Telephone: 301-435-0554