National Institutes of Health · United States

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

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National Institutes of Health expects to make 4 awards, from a total budget of $3 million. Applications close on 15 Jun 2028. Eligible applicant types include native American tribal governments (Federally recognized), small businesses, city or township governments and 12 more.

Deadline: 15 Jun 2028 (in 578 days)
Grant amount: ≈ $750,000 per award (estimate: total ÷ 4 awards)
Total budget: $3 million
Funding rate: No mandatory cost sharing stated; funding percentage not stated
Total budget: $3 million
Expected awards: 4
Cost sharing: Not required
Likely applicant types: Public bodies, SMEs / start-ups, Companies, Non-profits, Universities & research From source categories or programme rules; the call decides.
Funder: National Institutes of Health
Reference: RFA-OD-27-005
Assistance listing: 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
Last checked: 13 Nov 2026

Open the official call ↗ Add deadline to calendar

About this call

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.

Who can apply

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

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.

Applicant categories are a starting point. The official call decides eligibility.

Topics

Health

How to apply

Read the full notice of funding opportunity (NOFO) linked from the official page: eligibility, cost sharing and evaluation criteria.
Make sure your organisation has an active SAM.gov registration and Unique Entity ID (UEI); registration can take several weeks.
For NIH: the organisation and the principal investigator also need eRA Commons accounts; applications are usually submitted through Grants.gov (for example with ASSIST).
Prepare the required forms, narrative, budget and attachments exactly as the NOFO specifies.
Submit before the deadline and keep the tracking number. Check for amendments before you submit.

From the call text

Who can apply: Not stated in the call text we hold — check the official page
Company stage: Not stated in the call text we hold — check the official page
Single applicant or consortium: Not stated in the call text we hold — check the official page
Where applicants must be based: Not stated in the call text we hold — check the official page
Where to apply: Not stated in the call text we hold — check the official page

Contact

National Institutes of Health · DownSyndromeINCLUDE@mail.nih.gov · 301-402-2541

Where these facts come from

Fact	Value	How we know	Taken from the source
Deadline	15 June 2028	official data field	15 Nov 2026
Amount per applicant	Unknown — not stated in the source we hold	unknown	—
Total budget	$3 million	official data field	15 Nov 2026
Funding rate	No mandatory cost sharing stated; funding percentage not stated	read from the official text	15 Nov 2026
Who can apply	Native American tribal governments (Federally recognized); Small businesses; City or township governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); Nonprofits that do…	official data field	15 Nov 2026
Where to apply	Unknown — not stated in the source we hold	unknown	—

Official sources

Official call page

Facts on this page come from the funder’s official data, taken on 13 Nov 2026. The funder's own documents, including later amendments, always take precedence.