Opportunity

Simpler Grants.gov #RFA-OD-25-021

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

Buyer

National Institutes of Health

Posted

September 25, 2025

Respond By

February 19, 2026

Identifier

RFA-OD-25-021

NAICS

541715

This opportunity from the National Institutes of Health (NIH) seeks applications for the INCLUDE Project, focused on advancing clinical trials for individuals with Down syndrome. - Government Buyer: - National Institutes of Health (NIH) - Purpose and Scope: - Soliciting milestone-driven, phased innovation (R61/R33) grant applications - Supports development of clinical trials targeting critical and co-occurring health conditions in individuals with Down syndrome - Funding Details: - Up to four awards available - Minimum award amount: $100,000 - Total program funding: $3,000,000 - Project period: up to five years (R61 phase: up to two years; R33 phase: up to three years) - Products/Services Requested: - No specific products, OEMs, or vendors required - Focus is on research and clinical trial development - Unique Requirements: - Applicants must propose milestone-driven research - Clinical trial component is required - Place of Performance: - National Institutes of Health (NIH)

Description

The NIH INCLUDE Project aims to improve health and quality-of-life for individuals with Down syndrome by supporting exploratory and developmental phased innovation grant applications (R61/R33) to develop clinical trials targeting critical and co-occurring health conditions. The project period may not exceed five years, with up to two years for preliminary studies (R61 phase) followed by up to three years for clinical trial support (R33 phase). The research must be milestone-driven with measurable R61 milestones. The funding supports up to four awards with a minimum award amount of $100,000.

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