The National Institutes of Health INCLUDE Project has opened RFA-OD-27-005, INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required). The program supports development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. Responsive applications use a milestone-driven phased structure: up to two years of R61 preliminary, developmental, planning, or piloting work followed, after successful milestone completion, by up to three years of R33 clinical-trial support. The combined project period may not exceed five years.
Deadline: October 15, 2026 at 5:00 PM local time of the applicant organization. The opportunity opened September 15, 2026. Additional listed cycles include June 15, 2027 and June 15, 2028.
Funding: NIH intends to commit an estimated $3,000,000 to fund up to four awards per year in FY2027, FY2028, and FY2029. Application budgets for both the R61 and R33 phases are not capped but must reflect the actual needs of the proposed project. The combined R61/R33 project period is limited to five years, with up to two years for R61 and up to three years for R33. Cost sharing is not required.
Eligibility: Eligible organizations include public and private institutions of higher education, qualifying nonprofits, small businesses and other for-profit organizations, state and local governments, federally recognized and other eligible Tribal governments and organizations, independent school districts, housing authorities, faith-based and community-based organizations, regional organizations, eligible federal agencies, U.S. territories and possessions, and eligible foreign organizations. Foreign components are allowed, but applications involving foreign subawards or subcontracts under this NOFO are noncompliant.
Required research and submission controls: This NOFO requires a clinical trial. The Research Strategy must separately describe the R61 and R33 phases. Applications must include specific, quantifiable, scientifically justified R61 transition milestones and R33 milestones; the R33 clinical trial begins only after successful completion of the R61 phase and milestone review. Budgets should include Data Safety and Monitoring Board activities where applicable. A Data Management and Sharing Plan is required for projects generating scientific data, and INCLUDE expects broad, timely sharing of de-identified human data through NIH-designated repositories. Applicable PHS Human Subjects and Clinical Trials study records are required. Applications follow NIH Research (R) instructions and are submitted through NIH ASSIST, an institutional system-to-system solution through Grants.gov, or Grants.gov Workspace and tracked in eRA Commons.
Atlas fit: This is a high-value healthcare and clinical-research opportunity. Although for-profit organizations are structurally eligible and no match is required, a legitimate direct Dr. Miltie prime application would require a qualified clinical-trial PD/PI, substantiated trial concept, participating sites, participant recruitment and retention capability, human-subjects and IRB infrastructure, data safety monitoring, clinical operations, NIH registrations, and milestone/data-sharing readiness. Those capabilities have not been independently substantiated. Preferred posture: Partner-Led / Clinical Research Consortium, with Dr. Miltie considered for a legitimate partner, subrecipient, or vendor role where allowable, while routing to applicable state academic-health, Down syndrome, clinical-research, health-system, university, and nonprofit pathways.