The National Institute on Deafness and Other Communication Disorders (NIDCD) is offering this cooperative agreement grant (U01) to fund high-impact clinical trials focused on effective interventions for communication disorders. This grant is for investigator-initiated trials that benefit from close interaction and oversight with an NIDCD Project Scientist. Eligible trials include those requiring FDA oversight, having annual direct costs of $500,000 or more (or $700,000+), formally establishing efficacy, or carrying a higher risk of harm. The NIDCD supports well-designed research to advance treatment and prevention. Only one clinical trial may be proposed per application.
Opportunity ID: 330356
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-064 |
| Funding Opportunity Title: | NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 – Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| 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: | Dec 11, 2020 |
| Last Updated Date: | Dec 11, 2020 |
| Original Closing Date for Applications: | Oct 10, 2023 |
| Current Closing Date for Applications: | Oct 10, 2023 |
| Archive Date: | Nov 15, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Special district governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Native American tribal governments (Federally recognized) |
| 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 not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting welldesigned and wellexecuted clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, has annual direct costs equal to or greater than $500,000, that is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm. Clinical trial applications exceeding the annual direct costs of $700,000 or more may also be a criteria for this FOA. These investigator-initiated clinical trials are perceived to benefit from close interaction, oversight, and guidance resulting from a cooperative agreement. Only one clinical trial may be proposed in each NIDCD Clinical Trials in Communication Disorders U01 application. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-21-064.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
Folder 330356 Full Announcement-PAR-21-064 -> PAR-21-064-Full-Announcement.pdf
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 | PKG00264452 | Jan 11, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270400 | Nov 18, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277942 | Nov 04, 2022 | Oct 10, 2023 | View |
Package 1
Mandatory forms
330356 RR_SF424_2_0-2.0.pdf
330356 PHS398_CoverPageSupplement_5_0-5.0.pdf
330356 RR_OtherProjectInfo_1_4-1.4.pdf
330356 PerformanceSite_2_0-2.0.pdf
330356 RR_KeyPersonExpanded_2_0-2.0.pdf
330356 PHS398_ResearchPlan_4_0-4.0.pdf
330356 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
330356 RR_Budget_1_4-1.4.pdf
330356 RR_SubawardBudget30_1_4-1.4.pdf
330356 PHS398_ModularBudget_1_2-1.2.pdf
330356 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
330356 RR_SF424_5_0-5.0.pdf
330356 PHS398_CoverPageSupplement_5_0-5.0.pdf
330356 RR_OtherProjectInfo_1_4-1.4.pdf
330356 PerformanceSite_4_0-4.0.pdf
330356 RR_KeyPersonExpanded_4_0-4.0.pdf
330356 PHS398_ResearchPlan_4_0-4.0.pdf
330356 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
330356 RR_Budget_3_0-3.0.pdf
330356 RR_SubawardBudget30_3_0-3.0.pdf
330356 PHS398_ModularBudget_1_2-1.2.pdf
330356 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
330356 RR_SF424_5_0-5.0.pdf
330356 PHS398_CoverPageSupplement_5_0-5.0.pdf
330356 RR_OtherProjectInfo_1_4-1.4.pdf
330356 PerformanceSite_4_0-4.0.pdf
330356 RR_KeyPersonExpanded_4_0-4.0.pdf
330356 PHS398_ResearchPlan_5_0-5.0.pdf
330356 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
330356 RR_Budget_3_0-3.0.pdf
330356 RR_SubawardBudget30_3_0-3.0.pdf
330356 PHS398_ModularBudget_1_2-1.2.pdf
330356 PHS_AssignmentRequestForm_3_0-3.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
