The National Heart, Lung, and Blood Institute (NHLBI) is offering this grant to support investigator-initiated, single-site clinical trials. This grant is for studies testing efficacy, comparative effectiveness, pragmatic, or implementation research across therapeutic, behavioral, or prevention strategies. Eligible trials must align with the NHLBI’s research mission and meet the NIH clinical trial definition. Utilizing a bi-phasic, milestone-driven award, applications must present a strong scientific rationale and a comprehensive operational plan. Key elements of the plan include project management, subject recruitment and retention strategies, performance milestones, and plans for scientific conduct and results dissemination. While not mandatory, a multiple Principal Investigator model, ideally including expertise in biostatistics and clinical trial design, is highly encouraged.
Opportunity ID: 342126
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-189 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/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 2 |
| Posted Date: | Jul 12, 2022 |
| Last Updated Date: | Dec 11, 2024 |
| Original Closing Date for Applications: | Sep 11, 2025 |
| Current Closing Date for Applications: | Jan 11, 2025 |
| Archive Date: | Feb 10, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Independent school districts 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments County governments Special district governments Small businesses Public and State controlled institutions of higher education |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA applies 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.This FOA will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address 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 include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-189.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update close date per reissued NOFO PAR-25-028. | Dec 11, 2024 | |
| Jul 12, 2022 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-189 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/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 2 |
| Posted Date: | Jul 12, 2022 |
| Last Updated Date: | Dec 11, 2024 |
| Original Closing Date for Applications: | Sep 11, 2025 |
| Current Closing Date for Applications: | Jan 11, 2025 |
| Archive Date: | Feb 10, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Independent school districts 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments County governments Special district governments Small businesses Public and State controlled institutions of higher education |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA applies 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.This FOA will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address 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 include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-189.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-189 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/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: | Jul 12, 2022 |
| Last Updated Date: | Jul 12, 2022 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 11, 2025 |
| Archive Date: | Oct 17, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Small businesses County governments State governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses 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) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts Public and State controlled institutions of higher education City or township governments Native American tribal governments (Federally recognized) 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA applies 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.This FOA will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address 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 include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-189.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Related Documents
Folder 342126 Full Announcement-PAR-22-189 -> PAR-22-189-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00275810 | Sep 11, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00278371 | Nov 14, 2022 | Jan 11, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289065 | Nov 26, 2024 | Jan 11, 2025 | View |
Package 1
Mandatory forms
342126 RR_SF424_5_0-5.0.pdf
342126 PHS398_CoverPageSupplement_5_0-5.0.pdf
342126 RR_OtherProjectInfo_1_4-1.4.pdf
342126 PerformanceSite_4_0-4.0.pdf
342126 RR_KeyPersonExpanded_4_0-4.0.pdf
342126 RR_Budget_3_0-3.0.pdf
342126 PHS398_ResearchPlan_4_0-4.0.pdf
342126 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342126 RR_SubawardBudget30_3_0-3.0.pdf
342126 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
342126 RR_SF424_5_0-5.0.pdf
342126 PHS398_CoverPageSupplement_5_0-5.0.pdf
342126 RR_OtherProjectInfo_1_4-1.4.pdf
342126 PerformanceSite_4_0-4.0.pdf
342126 RR_KeyPersonExpanded_4_0-4.0.pdf
342126 RR_Budget_3_0-3.0.pdf
342126 PHS398_ResearchPlan_5_0-5.0.pdf
342126 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342126 RR_SubawardBudget30_3_0-3.0.pdf
342126 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
342126 RR_SF424_5_0-5.0.pdf
342126 PHS398_CoverPageSupplement_5_0-5.0.pdf
342126 RR_OtherProjectInfo_1_4-1.4.pdf
342126 PerformanceSite_4_0-4.0.pdf
342126 RR_KeyPersonExpanded_4_0-4.0.pdf
342126 RR_Budget10_3_0-3.0.pdf
342126 PHS398_ResearchPlan_5_0-5.0.pdf
342126 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342126 RR_SubawardBudget10_30_3_0-3.0.pdf
342126 PHS_AssignmentRequestForm_4_0-4.0.pdf
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