The NHLBI is offering this grant to support the establishment and implementation of Clinical Coordinating Centers (CCCs) for investigator-initiated, multi-site clinical trials. This grant is for research that aligns with the NHLBI’s mission, encompassing efficacy, comparative effectiveness, pragmatic, or implementation studies that meet the NIH clinical trial definition. Utilizing a bi-phasic, milestone-driven cooperative agreement, applicants must propose a comprehensive scientific and operational plan. This plan should detail project management, subject recruitment and retention strategies, performance milestones, scientific conduct, and results dissemination. A collaborating Data Coordinating Center (DCC) application must be submitted concurrently. This grant is for entities poised to lead the coordination of complex, multi-site clinical research projects.
Opportunity ID: 342124
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-192 |
| Funding Opportunity Title: | Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) |
| 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 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 10, 2025 |
| Archive Date: | Feb 09, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Native American tribal governments (Federally recognized) County governments Special district governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than 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 a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. 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 cooperative agreement mechanism of award and runs in parallel with a companion FOA that encourages applications for a collaborating Data Coordinating Center (PAR-22-NNN). The objective of the CCC 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. Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-192.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-25-029. | Dec 11, 2024 | |
| Jul 12, 2022 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-192 |
| Funding Opportunity Title: | Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) |
| 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 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 10, 2025 |
| Archive Date: | Feb 09, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Native American tribal governments (Federally recognized) County governments Special district governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than 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 a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. 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 cooperative agreement mechanism of award and runs in parallel with a companion FOA that encourages applications for a collaborating Data Coordinating Center (PAR-22-NNN). The objective of the CCC 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. Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-192.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-22-192 |
| Funding Opportunity Title: | Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) |
| 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: | 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: | City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts Public and State controlled institutions of higher education Private institutions of higher education 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 State governments County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Native American tribal governments (Federally recognized) For profit organizations other than 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) supports applications to develop and implement a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. 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 cooperative agreement mechanism of award and runs in parallel with a companion FOA that encourages applications for a collaborating Data Coordinating Center (PAR-22-NNN). The objective of the CCC 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. Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-192.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 342124 Full Announcement-PAR-22-192 -> PAR-22-192-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 | PKG00275698 | Sep 11, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00278451 | Nov 15, 2022 | Jan 10, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289209 | Nov 27, 2024 | Jan 10, 2025 | View |
Package 1
Mandatory forms
342124 RR_SF424_5_0-5.0.pdf
342124 PHS398_CoverPageSupplement_5_0-5.0.pdf
342124 RR_OtherProjectInfo_1_4-1.4.pdf
342124 PerformanceSite_4_0-4.0.pdf
342124 RR_KeyPersonExpanded_4_0-4.0.pdf
342124 RR_Budget10_3_0-3.0.pdf
342124 PHS398_ResearchPlan_4_0-4.0.pdf
342124 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342124 RR_SubawardBudget10_30_3_0-3.0.pdf
342124 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
342124 RR_SF424_5_0-5.0.pdf
342124 PHS398_CoverPageSupplement_5_0-5.0.pdf
342124 RR_OtherProjectInfo_1_4-1.4.pdf
342124 PerformanceSite_4_0-4.0.pdf
342124 RR_KeyPersonExpanded_4_0-4.0.pdf
342124 RR_Budget10_3_0-3.0.pdf
342124 PHS398_ResearchPlan_5_0-5.0.pdf
342124 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342124 RR_SubawardBudget10_30_3_0-3.0.pdf
342124 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
342124 RR_SF424_5_0-5.0.pdf
342124 PHS398_CoverPageSupplement_5_0-5.0.pdf
342124 RR_OtherProjectInfo_1_4-1.4.pdf
342124 PerformanceSite_4_0-4.0.pdf
342124 RR_KeyPersonExpanded_4_0-4.0.pdf
342124 RR_Budget10_3_0-3.0.pdf
342124 PHS398_ResearchPlan_5_0-5.0.pdf
342124 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342124 RR_SubawardBudget10_30_3_0-3.0.pdf
342124 PHS_AssignmentRequestForm_4_0-4.0.pdf
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