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The National Institutes of Health (NIH) is offering grants through the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project to enhance healthcare for individuals with Down syndrome. This grant supports the development of clinical trials targeting critical health issues in this population. The funding allows for a two-year preliminary phase (R61) for planning and developmental studies, with the potential to transition to a three-year clinical trial phase (R33). Researchers must set measurable milestones in their proposals, and the total project period cannot exceed five years. Applications are accepted until July 1, 2024.
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Opportunity ID: 339232
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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:: | |
| Category of Funding Activity:: | Education |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 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:: | Native American tribal organizations (other than Federally recognized tribal governments) |
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 | Apr 05, 2022 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | |
| Competition ID: | FORMS-G |
| Competition Title: | Use for due dates on or before January 24, 2023 |
| Opportunity Package ID: | PKG00273086 |
| Opening Date: | May 30, 2022 |
| Closing Date: | Jan 24, 2023 |
| Agency Contact Information:: | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] Research & Related Budget [V3.0] PHS 398 Research Plan [V4.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS Assignment Request Form [V3.0] |
Package No: 2
| Assistance Listings: | |
| Competition ID: | FORMS-H |
| Competition Title: | Use for due dates on or after January 25, 2023 |
| Opportunity Package ID: | PKG00278403 |
| Opening Date: | Nov 14, 2022 |
| Closing Date: | Jul 01, 2024 |
| Agency Contact Information:: | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] Research & Related Budget [V3.0] PHS 398 Research Plan [V5.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS Assignment Request Form [V3.0] |
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Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00273086 | May 30, 2022 | Jan 24, 2023 | View | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ | Organization Applicants |
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| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278403 | Nov 14, 2022 | Jul 01, 2024 | View | eRA Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ | Organization Applicants |
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