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

National Institutes of Health · Opportunity number RFA-OD-27-005

View the official notice on Grants.gov
608 days left (deadline Jun 15, 2028)

Details summarized from the official notice as of Oct 16, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.

Independent platform. Not affiliated with or endorsed by any government agency. Data from public federal sources.

Key facts

Opportunity numberRFA-OD-27-005
AgencyNational Institutes of Health
Department of Health and Human Services
Assistance listing (ALN, formerly CFDA)93.395, 93.866, 93.839, 93.838, 93.846, 93.840, 93.173, 93.310, 93.847, 93.837, 93.233, 93.350, 93.865
PostedMay 13, 2026
DeadlineJun 15, 2028
Expected number of awards4
Estimated total program funding$3,000,000
Cost sharing or matching requiredNo
Funding typeGrant
CategoryHealth
Last updated hereOct 16, 2026

Summary from the notice

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

The official notice lists these applicant types as eligible:

  • City or township governments
  • Independent school districts
  • County governments
  • Private colleges and universities
  • Special district governments
  • Public and state colleges and universities
  • Public and Indian housing authorities
  • Nonprofits without 501(c)(3) status (other than colleges)
  • State governments
  • Federally recognized tribal governments
  • Nonprofits with 501(c)(3) status (other than colleges)
  • Small businesses
  • For-profit organizations other than small businesses
  • Other Native American tribal organizations
  • Others named in the notice (see the eligibility text)

Who should take a closer look

  • Small businesses
  • Nonprofits
  • Colleges and universities
  • State governments
  • Local governments
  • Tribal governments and organizations
  • Larger for-profit companies

Not listed as eligible

  • Individuals

Unless the eligibility text in the notice names you, this opportunity is probably not for you.

Eligibility details from the notice

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.

Registrations you will likely need

Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.

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