This NIDDK grant supports the crucial implementation planning phase for investigator-initiated, multi-center clinical studies. As the initial step in a two-part process, the U34 cooperative agreement enables early peer review of the study rationale and assessment of its design and protocol. It provides funding for developing essential study documents, such as a manual of operations, and other critical elements required for study conduct. Completion of the U34 is a prerequisite for applying for the U01 cooperative agreement, which funds the actual multi-center study. Applicants are strongly encouraged to consult with NIDDK staff prior to submission.
Opportunity ID: 237375
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-268 |
| Funding Opportunity Title: | NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (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 2 |
| Posted Date: | Jul 09, 2013 |
| Last Updated Date: | Dec 11, 2014 |
| Original Closing Date for Applications: | Feb 14, 2017 |
| Current Closing Date for Applications: | Dec 12, 2014 |
| Archive Date: | Jan 11, 2015 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $225,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Independent school districts Public and State controlled institutions of higher education Special district governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) 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 For profit organizations other than small businesses Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments 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; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); 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 not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | NIDDK supports investigator-initiated, multi-center (three or more sites) clinical studies exclusively through a two-part process that includes an implementation planning cooperative agreement (U34). The U34 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 is a prerequisite for submission of a multi-center clinical study cooperative agreement (U01) application, which will support the actual conduct of the study. Consultation with NIDDK staff is strongly encouraged prior to the submission of the U34 application. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-268.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 |
|---|---|---|
| This PAR has been reissued as PAR-15-068. | Dec 11, 2014 | |
| Dec 11, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-268 |
| Funding Opportunity Title: | NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (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 2 |
| Posted Date: | Jul 09, 2013 |
| Last Updated Date: | Dec 11, 2014 |
| Original Closing Date for Applications: | Feb 14, 2017 |
| Current Closing Date for Applications: | Dec 12, 2014 |
| Archive Date: | Jan 11, 2015 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $225,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Independent school districts Public and State controlled institutions of higher education Special district governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) 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 For profit organizations other than small businesses Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments 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; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); 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 not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | NIDDK supports investigator-initiated, multi-center (three or more sites) clinical studies exclusively through a two-part process that includes an implementation planning cooperative agreement (U34). The U34 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 is a prerequisite for submission of a multi-center clinical study cooperative agreement (U01) application, which will support the actual conduct of the study. Consultation with NIDDK staff is strongly encouraged prior to the submission of the U34 application. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-268.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-13-268 |
| Funding Opportunity Title: | NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (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: | Dec 11, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 14, 2017 |
| Archive Date: | Mar 17, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $225,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Private institutions of higher education Special district governments Independent school districts State governments County governments |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); 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 not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | NIDDK supports investigator-initiated, multi-center (three or more sites) clinical studies exclusively through a two-part process that includes an implementation planning cooperative agreement (U34). The U34 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 is a prerequisite for submission of a multi-center clinical study cooperative agreement (U01) application, which will support the actual conduct of the study. Consultation with NIDDK staff is strongly encouraged prior to the submission of the U34 application. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-268.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 |
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 | FORMS-C | Use for due dates after 9/24/2013 | PKG00180573 | Mar 15, 2014 | Dec 12, 2014 | View |
Package 1
Mandatory forms
237375 RR_SF424_2_0-2.0.pdf
237375 PHS398_ResearchPlan_2_0-2.0.pdf
237375 PHS398_CoverPageSupplement_2_0-2.0.pdf
237375 RR_KeyPersonExpanded_2_0-2.0.pdf
237375 RR_OtherProjectInfo_1_3-1.3.pdf
237375 PerformanceSite_2_0-2.0.pdf
Optional forms
237375 RR_SubawardBudget30_1_3-1.3.pdf
237375 PlannedReport-1.0.pdf
237375 PHS398_CumulativeInclusionReport-1.0.pdf
237375 PHS398_ModularBudget_1_2-1.2.pdf
237375 RR_Budget_1_3-1.3.pdf
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