This grant from the NIDCD is for the purpose of supporting planning for Phase III clinical trials focused on communication disorders. The NIDCD aims to identify effective interventions for treatment or prevention. This opportunity facilitates a cooperative agreement for investigators to gather essential information and develop a comprehensive Manual of Procedures (MOP). Successful completion of this U34 planning grant is generally a prerequisite for subsequent NIDCD Phase III Clinical Trials (U01) applications. This ensures that definitive efficacy studies in communication disorders proceed with a thoroughly prepared MOP, vital for the quality and execution of future trials.
Opportunity ID: 154194
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-12-124 |
| Funding Opportunity Title: | NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) |
| 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: | Mar 16, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Feb 04, 2015 |
| Current Closing Date for Applications: | Feb 04, 2015 |
| Archive Date: | Mar 07, 2015 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments City or township governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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: | The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting robust, well-designed, and well-executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between NIDCD project collaborator and investigator for a planning grant for phase III clinical trials of definitive efficacy. NIDCD Phase III Clinical Trials in Communication Disorders (U01) applications are accepted only from successful NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) awardees, unless NIDCD program staff agrees to accept a phase III clinical trial application from an investigator who has not used an NIDCD clinical trial planning grant first. The NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) is used to gather information and prepare a Manual of Procedures (MOP) (see http://www.nidcd.nih.gov/research/clinicaltrials for an example of a complete, detailed MOP). NIDCD Phase III Clinical Trials in Communication Disorders (U01) (PAR-12-123) applications must include a complete detailed MOP in the appendix. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-12-124.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 |
|---|---|---|---|---|---|---|
| 93.173 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00106732 | May 05, 2012 | Sep 24, 2013 | View |
| 93.173 | FORMS-C | Use for due dates after 9/24/2013 | PKG00181324 | Sep 16, 2013 | Feb 04, 2015 | View |
Package 1
Mandatory forms
154194 RR_SF424_1_2-1.2.pdf
154194 PerformanceSite_1_4-1.4.pdf
154194 RR_OtherProjectInfo_1_3-1.3.pdf
154194 RR_KeyPersonExpanded_1_2-1.2.pdf
154194 PHS398_CoverPageSupplement_1_4-1.4.pdf
154194 PHS398_ResearchPlan_1_3-1.3.pdf
154194 PHS398_Checklist_1_3-1.3.pdf
Optional forms
154194 RR_SubawardBudget30-1.2.pdf
154194 PHS398_ModularBudget_1_2-1.2.pdf
154194 RR_Budget-1.1.pdf
154194 PHS_CoverLetter_1_2-1.2.pdf
Package 2
Mandatory forms
154194 RR_SF424_2_0-2.0.pdf
154194 PHS398_ResearchPlan_2_0-2.0.pdf
154194 PHS398_CoverPageSupplement_2_0-2.0.pdf
154194 RR_KeyPersonExpanded_2_0-2.0.pdf
154194 RR_OtherProjectInfo_1_3-1.3.pdf
154194 PerformanceSite_2_0-2.0.pdf
Optional forms
154194 RR_SubawardBudget30_1_3-1.3.pdf
154194 PlannedReport-1.0.pdf
154194 PHS398_CumulativeInclusionReport-1.0.pdf
154194 PHS398_ModularBudget_1_2-1.2.pdf
154194 RR_Budget_1_3-1.3.pdf
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