The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project is offering this grant to improve health and quality-of-life for individuals with Down syndrome. This grant is for the purpose of supporting the development of clinical trials to treat critical and co-occurring health conditions in this population. It utilizes an Exploratory/Developmental Phased Innovation (R61/R33) grant mechanism. The R61 phase provides up to two years for preliminary/planning studies, with a possible transition to the R33 phase for up to three years of clinical trial support. The total project period cannot exceed five years. Proposed research aims must be milestone-driven, with measurable R61 milestones required.
Opportunity ID: 339232
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-OD-22-010 |
| Funding Opportunity Title: | Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Education Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.173 — Research Related to Deafness and Communication Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 05, 2022 |
| Last Updated Date: | Apr 05, 2022 |
| Original Closing Date for Applications: | Jul 01, 2024 |
| Current Closing Date for Applications: | Jul 01, 2024 |
| Archive Date: | Aug 06, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses County governments Independent school districts City or township governments Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal governments (Federally recognized) Private institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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. This Funding Opportunity Announcement (FOA) 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 FOA may not exceed five years. This FOA 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 FOA requires measurable R61 milestones. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-22-010.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 339232 Full Announcement-RFA-OD-22-010 -> RFA-OD-22-010-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00273086 | May 30, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278403 | Nov 14, 2022 | Jul 01, 2024 | View |
Package 1
Mandatory forms
339232 RR_SF424_5_0-5.0.pdf
339232 PHS398_CoverPageSupplement_5_0-5.0.pdf
339232 RR_OtherProjectInfo_1_4-1.4.pdf
339232 PerformanceSite_4_0-4.0.pdf
339232 RR_KeyPersonExpanded_4_0-4.0.pdf
339232 RR_Budget_3_0-3.0.pdf
339232 PHS398_ResearchPlan_4_0-4.0.pdf
339232 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
339232 RR_SubawardBudget30_3_0-3.0.pdf
339232 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
339232 RR_SF424_5_0-5.0.pdf
339232 PHS398_CoverPageSupplement_5_0-5.0.pdf
339232 RR_OtherProjectInfo_1_4-1.4.pdf
339232 PerformanceSite_4_0-4.0.pdf
339232 RR_KeyPersonExpanded_4_0-4.0.pdf
339232 RR_Budget_3_0-3.0.pdf
339232 PHS398_ResearchPlan_5_0-5.0.pdf
339232 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
339232 RR_SubawardBudget30_3_0-3.0.pdf
339232 PHS_AssignmentRequestForm_3_0-3.0.pdf
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