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
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
Business
- For-profit organizations other than small businesses
- Small businesses
Nonprofit
- Nonprofits non-higher education with 501(c)(3)
- Other Native American tribal organizations
- Nonprofits non-higher education without 501(c)(3)
Government
- City or township governments
- Public and Indian housing authorities
- County governments
- Special district governments
- Federally recognized Native American tribal governments
- State governments
Education
- Independent school districts
- Private institutions of higher education
- Public and state institutions of higher education
Miscellaneous
- Other
Additional information
Grantor contact information
Description
ryanl@nih.gov
Documents
No documents are currently available.
Link to additional information
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Forecasted
Estimated Post Date:
December 19, 2025
Estimated Application Due Date:
February 19, 2026
Estimated Due Date Description:
Not available
Estimated Award Date:
September 1, 2026
Estimated Project Start Date:
September 1, 2026
Fiscal Year:
2026
Award
$3,000,000
Program Funding
4
Expected awards
$100,000
Award Minimum
$--
Award Maximum
Funding opportunity number:
RFA-OD-25-021
Cost sharing or matching requirement:
Funding instrument type:
Grant
Opportunity Category:
Discretionary
Opportunity Category Explanation:
Category of Funding Activity:
Health
Category Explanation:
History
Version:
1
Forecast posted date:
September 25, 2025
Archive date:
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