The NIDCD is offering this grant to identify and support effective interventions for the treatment or prevention of communication disorders. This grant is for supporting robust, well-designed, and well-executed clinical trials through a cooperative agreement between NIDCD project collaborators and investigators. Specifically, it supports Phase I and II clinical trials focused on preliminary efficacy, as well as Phase III clinical trials aimed at definitive efficacy. For Phase III applications, a complete and detailed Manual of Procedures (MOP) must be included in the appendix. The NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) is available to assist in gathering information and preparing the required MOP.
Opportunity ID: 154193
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-12-123 |
| Funding Opportunity Title: | NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01) |
| 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: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses City or township governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts Native American tribal governments (Federally recognized) State governments Special district governments Private institutions of higher education For profit organizations other than small businesses 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) |
| 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 to support phase I and II clinical trials of preliminary efficacy and phase III clinical trials of definitive efficacy. Phase III clinical trial applications must include a complete detailed Manual of Procedures (MOP) in the appendix (see http://www.nidcd.nih.gov/research/clinicaltrials for an example of a complete, detailed MOP). The NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) (PAR-12-124) may be used to gather information and prepare the MOP. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-12-123.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 | PKG00106731 | May 04, 2012 | Sep 24, 2013 | View |
| 93.173 | FORMS-C | Use for due dates after 9/24/2013 | PKG00180690 | Sep 08, 2013 | Feb 04, 2015 | View |
Package 1
Mandatory forms
154193 RR_SF424_1_2-1.2.pdf
154193 PerformanceSite_1_4-1.4.pdf
154193 RR_OtherProjectInfo_1_3-1.3.pdf
154193 RR_KeyPersonExpanded_1_2-1.2.pdf
154193 PHS398_CoverPageSupplement_1_4-1.4.pdf
154193 PHS398_ResearchPlan_1_3-1.3.pdf
154193 PHS398_Checklist_1_3-1.3.pdf
Optional forms
154193 RR_SubawardBudget30-1.2.pdf
154193 PHS398_ModularBudget_1_2-1.2.pdf
154193 RR_Budget-1.1.pdf
154193 PHS_CoverLetter_1_2-1.2.pdf
Package 2
Mandatory forms
154193 RR_SF424_2_0-2.0.pdf
154193 PHS398_ResearchPlan_2_0-2.0.pdf
154193 PHS398_CoverPageSupplement_2_0-2.0.pdf
154193 RR_KeyPersonExpanded_2_0-2.0.pdf
154193 RR_OtherProjectInfo_1_3-1.3.pdf
154193 PerformanceSite_2_0-2.0.pdf
Optional forms
154193 RR_SubawardBudget30_1_3-1.3.pdf
154193 PlannedReport-1.0.pdf
154193 PHS398_CumulativeInclusionReport-1.0.pdf
154193 PHS398_ModularBudget_1_2-1.2.pdf
154193 RR_Budget_1_3-1.3.pdf
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