The NIDCD department is inviting researchers to apply for a cooperative agreement to conduct clinical trials focused on identifying effective interventions for communication disorders. This grant is specifically for clinical trials that require FDA oversight, have high annual costs, aim to establish efficacy, or pose higher risks. The goal is to support well-designed trials that have the potential to benefit from close interaction and guidance. Researchers can propose only one clinical trial per application. Low-risk trials that do not meet the specific criteria are encouraged to apply to the companion grant opportunity. Closing date: Oct 21, 2020.
Opportunity ID: 298674
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-340 |
| 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: | Nov 13, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Oct 21, 2020 |
| Current Closing Date for Applications: | Oct 21, 2020 |
| Archive Date: | Nov 26, 2020 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments County governments Public housing authorities/Indian housing authorities Private institutions of higher education Small businesses City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Independent school districts For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) 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 not 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. 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. Low risk clinical trials not meeting any of the criteria above are referred to the companion NIDCD Clinical Trials in Communication Disorders (R01-Clinical Trial Required) PA-18-334 |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-340.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-E | Use for due dates on or before May 24, 2020 | PKG00236265 | Jan 22, 2018 | May 24, 2020 | View | |
| FORMS-D | FORMS-D package posted in error – you must use the FORMS-E package for this opportunity. | PKG00236175 | Nov 16, 2017 | Nov 17, 2017 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00259515 | Jan 22, 2018 | Oct 21, 2020 | View |
Package 1
Mandatory forms
298674 RR_SF424_2_0-2.0.pdf
298674 PHS398_CoverPageSupplement_4_0-4.0.pdf
298674 RR_OtherProjectInfo_1_4-1.4.pdf
298674 PerformanceSite_2_0-2.0.pdf
298674 RR_KeyPersonExpanded_2_0-2.0.pdf
298674 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
298674 RR_Budget_1_4-1.4.pdf
298674 RR_SubawardBudget30_1_4-1.4.pdf
298674 PHS398_ModularBudget_1_2-1.2.pdf
298674 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
298674 RR_SF424_2_0-2.0.pdf
298674 PHS398_CoverPageSupplement_3_0-3.0.pdf
298674 RR_OtherProjectInfo_1_3-1.3.pdf
298674 PerformanceSite_2_0-2.0.pdf
298674 RR_KeyPersonExpanded_2_0-2.0.pdf
298674 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
298674 RR_Budget_1_3-1.3.pdf
298674 RR_SubawardBudget30_1_3-1.3.pdf
298674 PHS398_ModularBudget_1_2-1.2.pdf
298674 PHS_Inclusion_Enrollment_Report-1.0.pdf
298674 PHS_AssignmentRequestForm-1.0.pdf
Package 3
Mandatory forms
298674 RR_SF424_2_0-2.0.pdf
298674 PHS398_CoverPageSupplement_5_0-5.0.pdf
298674 RR_OtherProjectInfo_1_4-1.4.pdf
298674 PerformanceSite_2_0-2.0.pdf
298674 RR_KeyPersonExpanded_2_0-2.0.pdf
298674 PHS398_ResearchPlan_4_0-4.0.pdf
298674 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
298674 RR_Budget_1_4-1.4.pdf
298674 RR_SubawardBudget30_1_4-1.4.pdf
298674 PHS398_ModularBudget_1_2-1.2.pdf
298674 PHS_AssignmentRequestForm_3_0-3.0.pdf
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