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The NIH INCLUDE Project Grant for Down Syndrome Research aims to enhance the health and quality of life for individuals with Down syndrome. This grant opportunity supports clinical projects focused on addressing the clinical trial readiness in Down syndrome. Researchers can propose projects that advance the progress of candidate therapeutics or diagnostics, develop biomarkers, trial methods, and recruitment strategies, and define the presentation of co-occurring conditions in individuals with Down syndrome. The goal is to accelerate the movement of potential treatments towards clinical trials, ultimately improving outcomes for individuals with Down syndrome. Closing date for applications is July 01, 2024.
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Opportunity ID: 339250
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General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-OD-22-007 |
| Funding Opportunity Title:: | INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed) |
| 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:: | $275,000 |
| Award Floor:: | $ |
Eligibility
| Eligible Applicants:: | Nonprofits having a 501(c)(3) status with the IRS, other than 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) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in Down syndrome. This initiative seeks applications that are intended to facilitate Down syndrome research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for Down syndrome and its co-occurring conditions, and to increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with Down syndrome to enable the design of future clinical trials. |
| 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: | PKG00273093 |
| 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] PHS 398 Research Plan [V4.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
Research & Related Budget [V3.0] R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS 398 Modular Budget [V1.2] 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: | PKG00278186 |
| Opening Date: | Nov 08, 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] PHS 398 Research Plan [V5.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
Research & Related Budget [V3.0] R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS 398 Modular Budget [V1.2] 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 | PKG00273093 | 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 | PKG00278186 | Nov 08, 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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