This grant is for supporting investigator-initiated low risk clinical trials focused on diagnosing, preventing, or treating communication disorders, aligning with the NIDCD’s mission. The National Institute on Deafness and Other Communication Disorders (NIDCD) seeks to identify effective interventions through well-designed studies. Eligible trials must adhere to specific criteria: they must meet budget limits, not require FDA oversight, not aim to formally establish efficacy, and pose low physical or psychological risks. This funding opportunity also includes support for Basic Science Experimental Studies involving Humans (BESH) that qualify as low risk clinical trials but also meet basic research definitions. Applicants are advised to propose only one clinical trial per application. High-risk trials are directed to a separate cooperative agreement.
Opportunity ID: 330355
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-063 |
| Funding Opportunity Title: | NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | Jan 07, 2024 |
| Current Closing Date for Applications: | Jan 07, 2024 |
| Archive Date: | Feb 12, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Independent school districts County governments Small businesses State governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities City or township governments 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 For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments 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 NIDCD is committed to identifying effective interventions for the diagnosis, prevention, or treatment of communication disorders by supporting well-designed and well-executed clinical trials. This funding opportunity announcement (FOA) supports investigator initiated low risk clinical trials addressing the mission and research interests of NIDCD. Clinical trials must meet ALL the following criteria: meet the budget limits of this FOA, not require FDA oversight, are not intended to formally establish efficacy and have low risks to potentially cause physical or psychological harm. This FOA also supports low risk trials determined to be Basic Science Experimental Studies involving Humans (BESH). These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. It is advisable that only one clinical trial be proposed in each NIDCD Clinical Trials in Communication Disorders R01 application. High risk clinical trials not meeting all the criteria above are referred companion U01 FOA PAR-21-XXX, NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-21-063.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 330355 Full Announcement-PAR-21-063 -> PAR-21-063-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 | PKG00264451 | Jan 05, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00269767 | Oct 28, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277731 | Nov 01, 2022 | Jan 07, 2024 | View |
Package 1
Mandatory forms
330355 RR_SF424_2_0-2.0.pdf
330355 PHS398_CoverPageSupplement_5_0-5.0.pdf
330355 RR_OtherProjectInfo_1_4-1.4.pdf
330355 PerformanceSite_2_0-2.0.pdf
330355 RR_KeyPersonExpanded_2_0-2.0.pdf
330355 PHS398_ResearchPlan_4_0-4.0.pdf
330355 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
330355 RR_Budget_1_4-1.4.pdf
330355 RR_SubawardBudget30_1_4-1.4.pdf
330355 PHS398_ModularBudget_1_2-1.2.pdf
330355 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
330355 RR_SF424_5_0-5.0.pdf
330355 PHS398_CoverPageSupplement_5_0-5.0.pdf
330355 RR_OtherProjectInfo_1_4-1.4.pdf
330355 PerformanceSite_4_0-4.0.pdf
330355 RR_KeyPersonExpanded_4_0-4.0.pdf
330355 PHS398_ResearchPlan_4_0-4.0.pdf
330355 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
330355 RR_Budget_3_0-3.0.pdf
330355 RR_SubawardBudget30_3_0-3.0.pdf
330355 PHS398_ModularBudget_1_2-1.2.pdf
330355 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
330355 RR_SF424_5_0-5.0.pdf
330355 PHS398_CoverPageSupplement_5_0-5.0.pdf
330355 RR_OtherProjectInfo_1_4-1.4.pdf
330355 PerformanceSite_4_0-4.0.pdf
330355 RR_KeyPersonExpanded_4_0-4.0.pdf
330355 PHS398_ResearchPlan_5_0-5.0.pdf
330355 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
330355 RR_Budget_3_0-3.0.pdf
330355 RR_SubawardBudget30_3_0-3.0.pdf
330355 PHS398_ModularBudget_1_2-1.2.pdf
330355 PHS_AssignmentRequestForm_3_0-3.0.pdf
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