The Department of Health and Human Services is offering the NIAMS Clinical Trials Implementation Grant (U01) to support investigator-initiated interventional clinical trials in all phases. The application process includes a U34 planning phase followed by the U01 application. However, applicants with completed pre-trial planning can directly apply for the U01 grant. The trials should be hypothesis-driven, milestone-defined, align with NIAMS research mission, and be deemed high-priority by the institute. Closing Date: Mar 01, 2016.
Opportunity ID: 275566
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-15-165 |
| Funding Opportunity Title: | NIAMS 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: | 93.846 — Arthritis, Musculoskeletal and Skin Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Mar 31, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Mar 01, 2016 |
| Current Closing Date for Applications: | Mar 01, 2016 |
| Archive Date: | Apr 01, 2016 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | 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) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Private institutions of higher education State governments County governments Public and State controlled institutions of higher education Independent school districts City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses |
| 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: | This Funding Opportunity Announcement (FOA) invites cooperative agreement (U01) applications for implementation of investigator-initiated interventional clinical trials (all phases).Applications for clinical trials submitted to the NIAMS are normally expected to go through a two-part process, which begins with a U34 planning phase (Part 1) followed by an application for the U01 (Part 2).Investigators who have completed all necessary pre-trial planning and preparation through other means may apply for a NIAMS U01 without having applied for a U34.The NIAMS expects such trials to be hypothesis driven, milestone-defined, related to the research mission of the NIAMS, and considered high-priority by the institute. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-15-165.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 |
|---|---|---|---|---|---|---|
| FORMS-C | FORMS-C | PKG00215884 | Jun 01, 2015 | Mar 01, 2016 | View | |
| FORMS-D | FORMS-D | PKG00223954 | Jun 01, 2015 | Jul 01, 2016 | View |
Package 1
Mandatory forms
275566 RR_SF424_2_0-2.0.pdf
275566 PHS398_ResearchPlan_2_0-2.0.pdf
275566 PHS398_CoverPageSupplement_2_0-2.0.pdf
275566 RR_KeyPersonExpanded_2_0-2.0.pdf
275566 RR_OtherProjectInfo_1_3-1.3.pdf
275566 PerformanceSite_2_0-2.0.pdf
Optional forms
275566 RR_SubawardBudget30_1_3-1.3.pdf
275566 PlannedReport-1.0.pdf
275566 PHS398_CumulativeInclusionReport-1.0.pdf
275566 PHS398_ModularBudget_1_2-1.2.pdf
275566 RR_Budget_1_3-1.3.pdf
Package 2
Mandatory forms
275566 RR_SF424_2_0-2.0.pdf
275566 PHS398_CoverPageSupplement_3_0-3.0.pdf
275566 RR_OtherProjectInfo_1_3-1.3.pdf
275566 PerformanceSite_2_0-2.0.pdf
275566 RR_KeyPersonExpanded_2_0-2.0.pdf
275566 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
275566 RR_Budget_1_3-1.3.pdf
275566 RR_SubawardBudget30_1_3-1.3.pdf
275566 PHS398_ModularBudget_1_2-1.2.pdf
275566 PHS_Inclusion_Enrollment_Report-1.0.pdf
275566 PHS_AssignmentRequestForm-1.0.pdf
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