The National Institute of Health is offering Phased Awards for INCLUDE to support the development of clinical trials treating critical health conditions in individuals with Down syndrome. The grant allows for up to five years of funding, with a two-year R61 phase for preliminary studies and a possible transition to a four-year R33 phase for expanded clinical trial support. Applicants must adhere to milestone-driven research aims and provide measurable R61 milestones. Deadline for application submission is on November 3, 2021.
Opportunity ID: 323065
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-OD-20-003 |
| 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: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 13, 2019 |
| Last Updated Date: | Dec 13, 2019 |
| Original Closing Date for Applications: | Nov 03, 2021 |
| Current Closing Date for Applications: | Nov 03, 2021 |
| Archive Date: | Dec 09, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education State governments City or township governments County governments Independent school districts Public housing authorities/Indian housing authorities Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education For profit organizations other than small businesses |
| 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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 of up to four years of expanded clinical trial support (R33), 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-20-003.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00260355 | Jan 14, 2020 | Jan 24, 2022 | View | |
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00257129 | Jan 14, 2020 | May 24, 2020 | View |
Package 1
Mandatory forms
323065 RR_SF424_2_0-2.0.pdf
323065 PHS398_CoverPageSupplement_5_0-5.0.pdf
323065 RR_OtherProjectInfo_1_4-1.4.pdf
323065 PerformanceSite_2_0-2.0.pdf
323065 RR_KeyPersonExpanded_2_0-2.0.pdf
323065 RR_Budget_1_4-1.4.pdf
323065 PHS398_ResearchPlan_4_0-4.0.pdf
323065 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
323065 RR_SubawardBudget30_1_4-1.4.pdf
323065 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
323065 RR_SF424_2_0-2.0.pdf
323065 PHS398_CoverPageSupplement_4_0-4.0.pdf
323065 RR_OtherProjectInfo_1_4-1.4.pdf
323065 PerformanceSite_2_0-2.0.pdf
323065 RR_KeyPersonExpanded_2_0-2.0.pdf
323065 RR_Budget_1_4-1.4.pdf
323065 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
323065 RR_SubawardBudget30_1_4-1.4.pdf
323065 PHS_AssignmentRequestForm_2_0-2.0.pdf
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