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

HHS-NIH11 RFA-OD-27-005
Posted: May 13, 2026 12:00:00 AM EDT
Closes: 06/15/2028
Views: 90

Funding Information

Estimated Total Funding
$3,000,000
Expected Number of Awards
4

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.

Synopsis

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:
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments City or township governments Others (see text field entitled "Additional Information on Eligibility" for clarification) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) State governments Native American tribal governments (Federally recognized) Private institutions of higher education Small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Independent school districts
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.

Funding Activity Categories

Health

CFDA Numbers

  • 93.173 - Research Related to Deafness and Communication Disorders
  • 93.233 - National Center on Sleep Disorders Research
  • 93.310 - Trans-NIH Research Support
  • 93.350 - National Center for Advancing Translational Sciences
  • 93.395 - Cancer Treatment Research
  • 93.837 - Cardiovascular Diseases Research
  • 93.838 - Lung Diseases Research
  • 93.839 - Blood Diseases and Resources Research
  • 93.840 - Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
  • 93.846 - Arthritis, Musculoskeletal and Skin Diseases Research
  • 93.847 - Diabetes, Digestive, and Kidney Diseases Extramural Research
  • 93.865 - Child Health and Human Development Extramural Research
  • 93.866 - Aging Research

Contact Information

Agency: National Institutes of Health
Contact: National Institutes of Health
Email: DownSyndromeINCLUDE@mail.nih.gov
Phone: 301-402-2541
The INCLUDE Project
DownSyndromeINCLUDE@mail.nih.gov

Additional Information

Document Type: synopsis
Opportunity Category: Discretionary
Version: 1
Last Updated: May 13, 2026 09:50:52 AM EDT

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