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

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

Award range

See source for award amount

Deadline

2028-06-15-00-00-00

Confirm exact timezone in the announcement.
Eligible applicants

City or township governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, For profit organizations other than small businesses, Public housing authorities/Indian housing authorities, Small businesses, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Special district governments, Native American tribal governments (Federally recognized), County governments, Private institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), State governments, Public and State controlled institutions of higher education, Independent school districts, Native American tribal organizations (other than Federally recognized tribal governments)

Geographic eligibility and all attachment-specific conditions require review of the original announcement.

Eligibility details

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.

Matching funds & resources

Source matching-funds field: Not Required.

Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.

About this opportunity

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.

Funding geography: Not specified — review source. A funder’s address does not establish eligibility.

Review original source ↗

Funding instrument: Grant. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.

Source fields and evidence

id: 360655
Source ↗ · id

opportunityNumber: RFA-OD-27-005
Source ↗ · opportunityNumber

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

revision: 4
Source ↗ · revision

agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails

owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode

cfdas: [{"id":433353,"opportunityId":360655,"cfdaNumber":"93.173","programTitle":"Research Related to Deafness and Communication Disorders"},{"id":433354,"opportunityId":360655,"cfdaNumber":"93.233","programTitle":"National Center on Sleep Disorders Research"},{"id":431191,"opportunityId":360655,"cfdaNumber":"93.310","programTitle":"Trans-NIH Research Support"},{"id":433343,"opportunityId":360655,"cfdaNumber":"93.350","programTitle":"National Center for Advancing Translational Sciences"},{"id":433348,"opportunityId":360655,"cfdaNumber":"93.395","programTitle":"Cancer Treatment Research"},{"id":433344,"opportunityId":360655,"cfdaNumber":"93.837","programTitle":"Cardiovascular Diseases Research"},{"id":433352,"opportunityId":360655,"cfdaNumber":"93.838","programTitle":"Lung Diseases Research"},{"id":433349,"opportunityId":360655,"cfdaNumber":"93.839","programTitle":"Blood Diseases and Resources Research"},{"id":433351,"opportunityId":360655,"cfdaNumber":"93.840","programTitle":"Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders"},{"id":433345,"opportunityId":360655,"cfdaNumber":"93.846","programTitle":"Arthritis, Musculoskeletal and Skin Diseases Research"},{"id":433347,"opportunityId":360655,"cfdaNumber":"93.847","programTitle":"Diabetes, Digestive, and Kidney Diseases Extramural Research"},{"id":433350,"opportunityId":360655,"cfdaNumber":"93.865","programTitle":"Child Health and Human Development Extramural Research"},{"id":433346,"opportunityId":360655,"cfdaNumber":"93.866","programTitle":"Aging Research"},{"id":433355,"opportunityId":360655}]
Source ↗ · cfdas

applicantTypes: [{"id":"02","description":"City or township governments"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"23","description":"Small businesses"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"04","description":"Special district governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"01","description":"County governments"},{"id":"20","description":"Private institutions of higher education"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"00","description":"State governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"05","description":"Independent school districts"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"}]
Source ↗ · applicantTypes

applicantEligibilityDesc: 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.
Source ↗ · applicantEligibilityDesc

fundingInstruments: [{"id":"G","description":"Grant"}]
Source ↗ · fundingInstruments

fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories

awardFloor: none
Source ↗ · awardFloor

awardCeiling: none
Source ↗ · awardCeiling

responseDate: Jun 15, 2028 12:00:00 AM EDT
Source ↗ · responseDate

responseDateStr: 2028-06-15-00-00-00
Source ↗ · responseDateStr

costSharing: false
Source ↗ · costSharing

lastUpdatedDate: May 13, 2026 09:50:52 AM EDT
Source ↗ · lastUpdatedDate

status: posted
Source ↗ · oppHits[id=360655].oppStatus

Source retrieved 10/15/2026 · Revision 4. Always confirm current requirements and dates with the funder. Structured source fields are checked; this is not a determination that every applicant qualifies.

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