NIH RFA · OD · R61, R33
RFA-OD-27-005: INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)
Reviewed by Dr. Meng ZhaoLast reviewed October 16, 2026Data refreshed October 16, 2026Editorial standards
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…
- NOFO number
- RFA-OD-27-005
- Type
- RFA
- Activity code
- R61R33
- Primary institute
- OD · NIH Office of the Director
- Clinical trials
- Required
- Posted
- May 13, 2026
- Opens
- Sep 15, 2026
- Expires
- Jun 16, 2028
RFA-OD-27-005 due dates
2 application due dates remain before the NOFO expires. Dates marked * are NIH standard due dates. Check the related notices below for changes NIH made after posting.
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
|---|---|---|---|---|---|
| October 15, 2026 | Not Applicable | Not Applicable | March 2027 | May 2027 | July 2027 |
| June 15, 2027 | Not Applicable | Not Applicable | November 2027 | January 2028 | April 2028 |
| June 15, 2028 | Not Applicable | Not Applicable | November 2028 | January 2029 | April 2029 |
What its predecessor RFA-OD-22-010 funded
RFA-OD-27-005 reissues RFA-OD-22-010. Until awards appear under the new number, its funding history is the best guide to who wins under this program: 5 projects and $6.1M in FY2022–FY2026.
Projects funded
5
Distinct projects, FY2022–FY2026
New awards
3
Type 1 (new project) award records
NIH funding
$6.1M
Award dollars under RFA-OD-22-010, FY2022–FY2026
Funding by fiscal year
| Fiscal year | Award records | New awards | Funding |
|---|---|---|---|
| FY2022 | 0 | 0 | $0 |
| FY2023 | 0 | 0 | $0 |
| FY2024 | 2 | 2 | $994K |
| FY2025 | 4 | 1 | $2.1M |
| FY2026 | 4 | 0 | $3.0M |
Institutions with the most funding
- Icahn School of Medicine at Mount Sinai$2.1M · 2 projects
- Colorado State University$2.0M · 2 projects
- Univ of North Carolina Chapel Hill$2.0M · 1 project
Funding institutes
- NICHD$4.0M · 7
- NIAMS$2.1M · 3
Activity codes funded
- R617 records
- R333 records
Most recent new awards
- Home Grown: A family-based lifestyle intervention to support healthy development of young children with Down syndrome (opens NIH RePORTER)
Univ of North Carolina Chapel Hill · 1R61HD118439-01 · NICHD · Notice Aug 7, 2025
$1.0MR61
- Executive Function Intervention for Young Children with Down Syndrome (opens NIH RePORTER)
Colorado State University · 1R61HD115161-01 · NICHD · Notice Jul 9, 2024
$694KR61
- Use of specific JAK inhibition on inflammatory skin and scalp diseases in Down syndrome (opens NIH RePORTER)
Icahn School of Medicine at Mount Sinai · 1R61AR084210-01 · NIAMS · Notice Jul 3, 2024
$299KR61
FY2026 closed on September 30, 2026, but NIH keeps posting that year's awards to RePORTER for several weeks. FY2026 figures reflect records available on October 16, 2026 and may rise slightly at the next refresh.
Participating institutes
9 NIH institutes and offices take applications under RFA-OD-27-005. Contact the program officer at the institute that fits your research before applying.
- OD · NIH Office of the Director
- NHLBI · National Heart, Lung, and Blood Institute
- NIA · National Institute on Aging
- NIAMS · National Institute of Arthritis and Musculoskeletal and Skin Diseases
- NICHD · Eunice Kennedy Shriver National Institute of Child Health and Human Development
- NIDCD · National Institute on Deafness and Other Communication Disorders
- NIDDK · National Institute of Diabetes and Digestive and Kidney Diseases
- NCATS · National Center for Advancing Translational Sciences
- NCI · National Cancer Institute
Related notices
NIH lists no related notices for RFA-OD-27-005 yet.
Award terms
- Application types allowed
- New The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
- Award budget
- Application budgets for the R61 phase and the R33 phase are not limited but need to reflect the actual needs of the proposed project.
- Project period
- The scope of the proposed project should determine the project period. The maximum period of the combined R61 and R33 phases is 5 years, with up to 2 years for the R61 phase and up to 3 years for the R33 phase. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
- Funds available and number of awards
- NIH intends to commit an estimated 3,000,000 to fund up to 4 awards per year in FY2027, FY2028, and FY2029.The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
Summarized from the NOFO text; the full NOFO governs eligibility, budget, and review.
Related NOFOs
- Reissue of RFA-OD-22-010.
Other open NOFOs for R61, R33
- PAR-25-158Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional)NIAAA · next due Oct 19, 2026
- PAR-25-269NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)NCCIH · next due Oct 20, 2026
- PAR-25-270NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)NCCIH · next due Oct 20, 2026
- PAR-25-225Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)NINDS · next due Oct 20, 2026
- PAR-25-024Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)NINDS · next due Oct 20, 2026
- PAR-25-059Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed)NINDS · next due Oct 20, 2026
About this page
GotGrant gathers the NOFO, its participation and change notices, and its NOSIs from the NIH Guide for Grants and Contracts, and counts funded projects from NIH RePORTER by the opportunity number each award was made under. Data refreshed October 16, 2026; the NIH Guide is the authoritative source. See our data methodology.