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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

Last Updated: September 25, 2025

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

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

Grantor contact information

Description

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Email

ryanl@nih.gov

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

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

4

Expected awards

$100,000

Award Minimum

$--

Award Maximum

Funding opportunity number:

RFA-OD-25-021

Cost sharing or matching requirement:

No

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

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Category of Funding Activity:

Health

Category Explanation:

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History

Version:

1

Forecast posted date:

September 25, 2025

Archive date:

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