The National Heart, Lung, and Blood Institute (NHLBI) is offering a grant for investigator-initiated phase I clinical trials focusing on diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The grant supports single or multisite trials that align with the NHLBI research mission and NIH clinical trial definition. Applicants are encouraged to consult the NHLBI website for research priorities. The grant follows a milestone-driven approach, allowing initial phase activities like stability studies and site training. Collaboration with experts in biostatistics, clinical trial design, and manufacturing is recommended. Prospective applicants should contact NHLBI staff for guidance due to the trial’s complexity.
Opportunity ID: 301098
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-684 |
| Funding Opportunity Title: | NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | Feb 27, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jan 07, 2021 |
| Current Closing Date for Applications: | Jan 07, 2021 |
| Archive Date: | Feb 12, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,515,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments For profit organizations other than small businesses 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 County governments Native American tribal governments (Federally recognized) City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Special district governments 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); 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 objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite. Applications submitted to this FOA must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website: http://www.nhlbi.nih.gov. This FOA will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training. It is anticipated that applications will present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes the plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to form a team with expertise in biostatistics, clinical trial design, and coordination as well as product manufacturing and formulation as appropriate. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application due to the complex nature of conducting a clinical trial. Staff will be able to assist applicants in meeting the objectives of this FOA. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-684.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-E | Use for due dates on or before May 24, 2020 | PKG00238624 | May 04, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00260066 | May 04, 2018 | Jan 07, 2021 | View |
Package 1
Mandatory forms
301098 RR_SF424_2_0-2.0.pdf
301098 PHS398_CoverPageSupplement_4_0-4.0.pdf
301098 RR_OtherProjectInfo_1_4-1.4.pdf
301098 PerformanceSite_2_0-2.0.pdf
301098 RR_KeyPersonExpanded_2_0-2.0.pdf
301098 RR_Budget_1_4-1.4.pdf
301098 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
301098 RR_SubawardBudget30_1_4-1.4.pdf
301098 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
301098 RR_SF424_2_0-2.0.pdf
301098 PHS398_CoverPageSupplement_5_0-5.0.pdf
301098 RR_OtherProjectInfo_1_4-1.4.pdf
301098 PerformanceSite_2_0-2.0.pdf
301098 RR_KeyPersonExpanded_2_0-2.0.pdf
301098 RR_Budget_1_4-1.4.pdf
301098 PHS398_ResearchPlan_4_0-4.0.pdf
301098 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
301098 RR_SubawardBudget30_1_4-1.4.pdf
301098 PHS_AssignmentRequestForm_3_0-3.0.pdf
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