This NIDDK grant, the Multi-Center Clinical Study Implementation Planning Grant (U34), is for facilitating the initial planning and development phase of investigator-initiated, multi-center clinical studies involving three or more sites. Its primary purpose is to allow early peer review of the study’s rationale, assess the proposed design and protocol, and provide essential support for developing necessary operational documents, such as a manual of operations. The U34 mechanism ensures all crucial elements for a robust clinical study are in place before progression. Successfully completing the deliverables from this U34 grant is a mandatory prerequisite for applying for the subsequent U01 cooperative agreement, which funds the actual conduct of the study. Pre-approval from NIDDK is required before submitting a U34 application.
Opportunity ID: 54650
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-10-197 |
| Funding Opportunity Title: | NIDDK Multi-Center Clinical Study Implementation Planning Grants (U34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 18, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 28, 2013 |
| Current Closing Date for Applications: | Jun 28, 2013 |
| Archive Date: | Jul 29, 2013 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Independent school districts Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Small businesses Public housing authorities/Indian housing authorities State governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County 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. NIDDK supports investigator-initiated, multi-center (three or more sites) clinical studies exclusively through a two-part process that includes an implementation planning (U34) grant. The U34 planning grant is designed to: (1) permit early peer review of the rationale for the proposed clinical study; (2) permit assessment of the design and protocol of the proposed study; (3) provide support for the development of documents needed for the conduct of the study, including a manual of operations and (4) support the development of other essential elements required for the conduct of a clinical study. Completion of the required products of a U34 grant is a prerequisite for submission of a multi-center clinical study cooperative agreement (U01) application, which will support the actual conduct of the study. Pre-approval from NIDDK will be required for submission of an U34 application. Mechanism of Support. This FOA will utilize the U34 grant mechanism. Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, 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 mechanism numbers, quality, duration, and costs of the applications received. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-10-197.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 |
|---|---|---|---|---|---|---|
| 93.847 | ADOBE-FORMS-B | Use for submissions intended for due dates of January 25, 2010 and beyond | PKG00018748 | Jul 10, 2010 | Nov 05, 2010 | View |
| 93.847 | ADOBE-FORMS-B1 | Supersedes ADOBE-FORMS-B | PKG00022415 | Nov 05, 2010 | Jun 28, 2013 | View |
Package 1
Mandatory forms
54650 RR_SF424_1_2-1.2.pdf
54650 PerformanceSite_1_3-1.3.pdf
54650 RR_OtherProjectInfo_1_2-1.2.pdf
54650 RR_KeyPersonExpanded_1_2-1.2.pdf
54650 PHS398_CoverPageSupplement_1_4-1.4.pdf
54650 PHS398_ResearchPlan_1_3-1.3.pdf
54650 PHS398_Checklist_1_3-1.3.pdf
Optional forms
54650 PHS_CoverLetter_1_2-1.2.pdf
54650 PHS398_ModularBudget-1.1.pdf
54650 RR_Budget-1.1.pdf
54650 RR_SubawardBudget-1.2.pdf
Package 2
Mandatory forms
54650 RR_SF424_1_2-1.2.pdf
54650 RR_OtherProjectInfo_1_3-1.3.pdf
54650 RR_KeyPersonExpanded_1_2-1.2.pdf
54650 PerformanceSite_1_4-1.4.pdf
54650 PHS398_ResearchPlan_1_3-1.3.pdf
54650 PHS398_CoverPageSupplement_1_4-1.4.pdf
54650 PHS398_Checklist_1_3-1.3.pdf
Optional forms
54650 RR_Budget-1.1.pdf
54650 RR_SubawardBudget-1.2.pdf
54650 PHS_CoverLetter_1_2-1.2.pdf
54650 PHS398_ModularBudget-1.1.pdf
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