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.
Response Date	Jun 15, 2028 12:00:00 AM EDT
Posting Date	May 13, 2026 12:00:00 AM EDT
Archive Date	Aug 14, 2028 12:00:00 AM EDT
Award Ceiling	N/a
Award Floor	N/a
Cost Sharing	No

Eligibility

Eligible Applicants

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

Additional Info on Eligibility:

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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	N/a
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

• 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