The National Heart, Lung, and Blood Institute (NHLBI) is offering this grant to support planning activities for late-phase (Phase II and beyond) investigator-initiated clinical trials. This grant is for studies addressing critical clinical questions aligned with NHLBI’s mission, specifically those requiring innovative or non-traditional clinical trial designs and statistical analysis plans. The funding aims to facilitate the development of feasible and well-designed single or multi-site trials. Grantees will utilize consultative services from the Innovative Clinical Trials Resource (ICTR), ensuring robust planning and design. This initiative fosters novel approaches in heart, lung, and blood research.
Opportunity ID: 293884
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-18-008 |
| Funding Opportunity Title: | Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (U34) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 17, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jan 12, 2018 |
| Current Closing Date for Applications: | Jan 12, 2018 |
| Archive Date: | Feb 17, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $125,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Public and State controlled institutions of higher education Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district 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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this FOA is to provide support for planning activities for late phase (phase II and beyond) single-site or multi-site investigator-initiated clinical trials that address critical clinical questions within the mission of the National Heart, Lung, and Blood Institute (NHLBI) and that require non-traditional clinical trial designs with the opportunity for statistical novelty and/or innovation. The FOA will support the development of feasible and well-designed clinical trials utilizing consultative services provided by the Innovative Clinical Trials Resource (ICTR) (N01). |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-008.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-D | Use for due dates on or after May 25, 2016 | PKG00232595 | Sep 19, 2017 | Jan 12, 2018 | View |
Package 1
Mandatory forms
293884 RR_SF424_2_0-2.0.pdf
293884 PHS398_CoverPageSupplement_3_0-3.0.pdf
293884 RR_OtherProjectInfo_1_3-1.3.pdf
293884 PerformanceSite_2_0-2.0.pdf
293884 RR_KeyPersonExpanded_2_0-2.0.pdf
293884 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
293884 RR_Budget_1_3-1.3.pdf
293884 RR_SubawardBudget30_1_3-1.3.pdf
293884 PHS398_ModularBudget_1_2-1.2.pdf
293884 PHS_Inclusion_Enrollment_Report-1.0.pdf
293884 PHS_AssignmentRequestForm-1.0.pdf
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