NIDDK is offering this grant for investigator-initiated, multi-center clinical studies through an implementation planning cooperative agreement (U34). This grant aims to support the development and planning of proposed clinical studies by providing early peer review, assessing study design, and supporting the creation of essential study documents. Completion of the U34 is a requirement for submitting a multi-center clinical study cooperative agreement (U01) application. Applicants are encouraged to consult with NIDDK staff before applying. Closing date: Dec 12, 2014.
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:: | |
| Category of Funding Activity:: | Food and Nutrition |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 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:: | Public housing authorities/Indian housing authorities |
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 2 | This PAR has been reissued as PAR-15-068. | Dec 11, 2014 |
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.847 |
| Competition ID: | FORMS-C |
| Competition Title: | Use for due dates after 9/24/2013 |
| Opportunity Package ID: | PKG00180573 |
| Opening Date: | Mar 15, 2014 |
| Closing Date: | Dec 12, 2014 |
| Agency Contact Information:: | eRA Commons Help Desk |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V2.0] PHS 398 Research Plan [V2.0] PHS 398 Cover Page Supplement [V2.0] Research and Related Senior/Key Person Profile (Expanded) [V2.0] Research And Related Other Project Information [V1.3] Project/Performance Site Location(s) [V2.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.3] Planned Enrollment Report [V1.0] PHS 398 Cumulative Inclusion Enrollment Report [V1.0] PHS 398 Modular Budget [V1.2] Research & Related Budget [V1.3] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.847 | FORMS-C | Use for due dates after 9/24/2013 | PKG00180573 | Mar 15, 2014 | Dec 12, 2014 | View | eRA Commons Help Desk | Organization Applicants |