The National Institute of Dental and Craniofacial Research (NIDCR) is offering this grant to support investigator-initiated Phase I, II, III, or IV clinical trials and biomarker evaluation studies. This NIDCR cooperative agreement (U01) focuses on research requiring prospective collection of clinical outcomes and specimens in dental and craniofacial health. Applicants must typically have received an NIDCR Clinical Trial Planning (R34) award, though exceptions may be considered. A unique application is required for each study, demanding a final draft protocol, Manual of Procedures, and other supporting materials like the Investigators Brochure. All submitted documents must adhere to NIH, FDA, and OHRP requirements, ensuring compliance and ethical standards for human research.
Opportunity ID: 123213
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-11-339 |
| Funding Opportunity Title: | NIDCR Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (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: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 16, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jan 07, 2015 |
| Current Closing Date for Applications: | Jan 07, 2015 |
| Archive Date: | Feb 07, 2015 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Native American tribal governments (Federally recognized) City or township governments County governments Special district governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Small businesses Private institutions of higher education Nonprofits having 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) State governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits that do not have 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: | This FOA issued by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health, will support investigator-initiated Phase I, II, III or IV clinical trial cooperative agreement applications or biomarker evaluation studies that require prospective collection of clinical outcomes and clinical specimens. All applicants must have received an NIDCR Clinical Trial Planning (R34) award to plan the proposed cooperative agreement study (see PAR-11-338 for information about NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grants). NIDCR may consider an exception. A unique application is required for each proposed study, and must include a final draft of the study protocol, a Manual of Procedures and other supporting materials such as the Investigators Brochure. These documents must meet all National Institutes of Health (NIH), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) requirements. All awards will be made as cooperative agreements. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-11-339.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 |
|---|---|---|---|---|---|---|
| 93.121 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00078831 | Oct 18, 2011 | Sep 24, 2013 | View |
| 93.121 | FORMS-C | Use for due dates after 9/24/2013 | PKG00180684 | Sep 08, 2013 | Jan 07, 2015 | View |
Package 1
Mandatory forms
123213 RR_SF424_1_2-1.2.pdf
123213 PerformanceSite_1_4-1.4.pdf
123213 RR_OtherProjectInfo_1_3-1.3.pdf
123213 RR_KeyPersonExpanded_1_2-1.2.pdf
123213 PHS398_CoverPageSupplement_1_4-1.4.pdf
123213 PHS398_ResearchPlan_1_3-1.3.pdf
123213 PHS398_Checklist_1_3-1.3.pdf
Optional forms
123213 RR_SubawardBudget30-1.2.pdf
123213 PHS398_ModularBudget_1_2-1.2.pdf
123213 RR_Budget-1.1.pdf
123213 PHS_CoverLetter_1_2-1.2.pdf
Package 2
Mandatory forms
123213 RR_SF424_2_0-2.0.pdf
123213 PHS398_ResearchPlan_2_0-2.0.pdf
123213 PHS398_CoverPageSupplement_2_0-2.0.pdf
123213 RR_KeyPersonExpanded_2_0-2.0.pdf
123213 RR_OtherProjectInfo_1_3-1.3.pdf
123213 PerformanceSite_2_0-2.0.pdf
Optional forms
123213 RR_SubawardBudget30_1_3-1.3.pdf
123213 PlannedReport-1.0.pdf
123213 PHS398_CumulativeInclusionReport-1.0.pdf
123213 PHS398_ModularBudget_1_2-1.2.pdf
123213 RR_Budget_1_3-1.3.pdf
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