The National Institute of Dental and Craniofacial Research (NIDCR) is offering a grant to support Phase I, II, III, or IV clinical trial cooperative agreement applications from NIDCR Clinical Trial Planning grant awardees. The grant requires submission of a final draft of the clinical trial protocol, Clinical Investigators Brochure, and Manual of Procedures. This cooperative agreement utilizes the NIH U01 award mechanism with varying funding amounts and durations based on the trial’s relevance to NIDCR’s mission, complexity, duration, and operational costs. Applications must comply with NIH, FDA, and OHRP requirements. Closing date for applications is May 07, 2011.
Opportunity ID: 43549
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-08-196 |
| Funding Opportunity Title: | NIDCR Clinical Trial Implementation 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 2 |
| Posted Date: | Dec 03, 2008 |
| Last Updated Date: | Feb 25, 2011 |
| Original Closing Date for Applications: | Sep 07, 2011 |
| Current Closing Date for Applications: | May 07, 2011 |
| Archive Date: | Jun 07, 2011 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township governments For profit organizations other than small businesses Small businesses Independent school districts County governments Special district governments Public and State controlled institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Private 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); 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: | -Purpose. 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 only from NIDCR Clinical Trial Planning (R34) grant awardees (see PAR-08-195 for information about NIDCR Clinical Trial Planning Grants) unless an exception is granted. Each clinical trial implementation application will use the PHS 398 grant application with special instructions and will include a final draft of the clinical trial protocol, the Clinical Investigators Brochure or equivalent, and a Manual of Procedures resulting from the R34 grant. 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.-Mechanism of Support. This FOA will utilize the NIH single project (U01) cooperative agreement award grant mechanism. -Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary between applications, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the relevance of the proposed trial to the NIDCR mission and strategic plan, trial complexity, anticipated duration, and associated operational trial proposed costs. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-08-196.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 |
|---|---|---|
| Modified to change Close Date to May 7, 2011 per NOT-OD-11-048 (<a href="http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-048.html">http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-048.html</a>). | Feb 25, 2011 | |
| Feb 25, 2011 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-08-196 |
| Funding Opportunity Title: | NIDCR Clinical Trial Implementation 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 2 |
| Posted Date: | Dec 03, 2008 |
| Last Updated Date: | Feb 25, 2011 |
| Original Closing Date for Applications: | Sep 07, 2011 |
| Current Closing Date for Applications: | May 07, 2011 |
| Archive Date: | Jun 07, 2011 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township governments For profit organizations other than small businesses Small businesses Independent school districts County governments Special district governments Public and State controlled institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Private 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); 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: | -Purpose. 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 only from NIDCR Clinical Trial Planning (R34) grant awardees (see PAR-08-195 for information about NIDCR Clinical Trial Planning Grants) unless an exception is granted. Each clinical trial implementation application will use the PHS 398 grant application with special instructions and will include a final draft of the clinical trial protocol, the Clinical Investigators Brochure or equivalent, and a Manual of Procedures resulting from the R34 grant. 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.-Mechanism of Support. This FOA will utilize the NIH single project (U01) cooperative agreement award grant mechanism. -Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary between applications, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the relevance of the proposed trial to the NIDCR mission and strategic plan, trial complexity, anticipated duration, and associated operational trial proposed costs. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-08-196.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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-08-196 |
| Funding Opportunity Title: | NIDCR Clinical Trial Implementation 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: | Feb 25, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 07, 2011 |
| Archive Date: | Oct 08, 2011 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities County governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Private institutions of higher education Special district governments State governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) |
| 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); 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: | -Purpose. 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 only from NIDCR Clinical Trial Planning (R34) grant awardees (see PAR-08-195 for information about NIDCR Clinical Trial Planning Grants) unless an exception is granted. Each clinical trial implementation application will use the PHS 398 grant application with special instructions and will include a final draft of the clinical trial protocol, the Clinical Investigators Brochure or equivalent, and a Manual of Procedures resulting from the R34 grant. 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. -Mechanism of Support. This FOA will utilize the NIH single project (U01) cooperative agreement award grant mechanism. -Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary between applications, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the relevance of the proposed trial to the NIDCR mission and strategic plan, trial complexity, anticipated duration, and associated operational trial proposed costs. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-08-196.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 |
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