Opportunity Listing - INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)

INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)

Agency: National Institutes of Health

Assistance Listings: 93.310 -- Trans-NIH Research Support

93.350 -- National Center for Advancing Translational Sciences

93.837 -- Cardiovascular Diseases Research

93.846 -- Arthritis, Musculoskeletal and Skin Diseases Research

93.866 -- Aging Research

93.847 -- Diabetes, Digestive, and Kidney Diseases Extramural Research

93.395 -- Cancer Treatment Research

93.839 -- Blood Diseases and Resources Research

93.865 -- Child Health and Human Development Extramural Research

93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

93.838 -- Lung Diseases Research

93.173 -- Research Related to Deafness and Communication Disorders

93.233 -- National Center on Sleep Disorders Research

Last Updated: May 13, 2026

View version history on Grants.gov

Description

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. The purpose of this Notice of Funding Opportunity (NOFO) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this NOFO may...

not exceed five years. This NOFO provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition to clinical trial support (R33) of up to three years, although the total duration of the award may not exceed five years. This NOFO requires measurable R61 milestones.

Eligibility

Eligible applicants

Government

City or township governments
County governments
Special district governments
Public and Indian housing authorities
State governments
Federally recognized Native American tribal governments

Education

Independent school districts
Private institutions of higher education
Public and state institutions of higher education

Nonprofit

Nonprofits non-higher education without 501(c)(3)
Nonprofits non-higher education with 501(c)(3)
Other Native American tribal organizations

Business

Small businesses
For-profit organizations other than small businesses

Miscellaneous

Other

Additional information

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Grantor contact information

Description

The INCLUDE Project DownSyndromeINCLUDE@mail.nih.gov

Email

DownSyndromeINCLUDE@mail.nih.gov

Documents

File name	Description	Last updated
RFA-OD-27-005-Full-Announcement.html	RFA-OD-27-005-Full-Announcement.html	May 13, 2026 01:51 PM UTC

Link to additional information

Closing: June 15, 2028

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$3,000,000

Program Funding

Expected awards

$--

Award Minimum

$--

Award Maximum

Funding opportunity number:

RFA-OD-27-005

Cost sharing or matching requirement:

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

Category of Funding Activity:

Health

Category Explanation:

History

Version:

Posted date:

May 13, 2026

Archive date:

August 14, 2028