NIH Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE

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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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