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OpenResearch announcementOpportunity RFA-OD-27-005

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

National Institutes of Health · Department of Health and Human Services

At a glance

INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required) is an open federal grant opportunity from the National Institutes of Health (Department of Health and Human Services). Applications are due June 15, 2028. Total estimated funding is $3M across about 4 awards. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 more. Cost sharing is not required. It is funded under Assistance Listing 93.173 (Research Related to Deafness and Communication Disorders) and 12 other listings.

Summary assembled from the official notice's fields. The official notice governs.

Key facts

  1. May 13, 2026Posted
  2. Jun 15, 2028Application deadlinenext date
  3. Sep 1, 2026 (est.)Est. award date
  4. Aug 14, 2028Archived
Posted
May 13, 2026
Close date
Jun 15, 2028
Archive date
Aug 14, 2028
Est. award date
Sep 1, 2026
Award floor
Not specified
Award ceiling
Not specified
Est. total funding
$3,000,000
Implied average award
$750,000 calculated
Expected awards
4
Cost sharing
Not required
Funding instrument
Grant
Opportunity category
Discretionary

Typical awards for this program (SAM.gov listing for ALN 93.173, not this notice): Project Grants: FY23 - Ranged from $100 to $3.235,000; Average was $403,000.

Implied average = estimated total funding ÷ expected number of awards, calculated by GrantsJunction. Actual awards vary.

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public colleges & universities
  • Federally recognized tribal governments
  • Public & Indian housing authorities
  • Native American tribal organizations
  • 501(c)(3) nonprofits
  • Nonprofits without 501(c)(3) status
  • Private colleges & universities
  • For-profit organizations (not small businesses)
  • Small businesses
  • Others (see notice)

Additional information on eligibility (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.

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

Full announcement & documents

The full announcement has the complete rules — page limits, required attachments, evaluation criteria and any letter-of-intent dates. Files download directly from Grants.gov.

How to apply

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Assistance Listings

What is an ALN?

Reported obligations under ALN 93.173

Historical data · not a prediction
FY24$422M
FY25$423M
FY26$427M est.
Source: SAM.gov Assistance Listing 93.173. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

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

Quick answers

When is the deadline for this opportunity?

According to the official notice, applications are due June 15, 2028. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for this opportunity?

The official notice lists these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How much funding is available through this opportunity?

Per the notice, total estimated program funding is $3,000,000 and the agency expects to make about 4 awards.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity RFA-OD-27-005), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.