Opportunity ID: 357669

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-25-029
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: Dec 11, 2024
Last Updated Date: May 21, 2025
Original Closing Date for Applications: Sep 11, 2025
Current Closing Date for Applications: Jan 11, 2026
Archive Date: Feb 10, 2026
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: State governments
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 organizations (other than Federally recognized tribal governments)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Special district governments
Native American tribal governments (Federally recognized)
Private institutions of higher education
City or township governments
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
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 Notice of Funding Opportunity (NOFO) 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 NOFO 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 NOFO will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO that encourages applications for a collaborating Data Coordinating Center (PAR-22-193). 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: https://grants.nih.gov/grants/guide/pa-files/PAR-25-029.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH Grants Information

grantsinfo@nih.gov
Email:grantsinfo@nih.gov

Version History

Version Modification Description Updated Date
Update close date per NOT-HL-25-012. May 21, 2025
Dec 11, 2024

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-25-029
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: Dec 11, 2024
Last Updated Date: May 21, 2025
Original Closing Date for Applications: Sep 11, 2025
Current Closing Date for Applications: Jan 11, 2026
Archive Date: Feb 10, 2026
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: State governments
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 organizations (other than Federally recognized tribal governments)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Special district governments
Native American tribal governments (Federally recognized)
Private institutions of higher education
City or township governments
Independent school districts
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
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 Notice of Funding Opportunity (NOFO) 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 NOFO 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 NOFO will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO that encourages applications for a collaborating Data Coordinating Center (PAR-22-193). 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: https://grants.nih.gov/grants/guide/pa-files/PAR-25-029.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH Grants Information

grantsinfo@nih.gov
Email:grantsinfo@nih.gov

DISPLAYING: Synopsis 1

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-25-029
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: Dec 11, 2024
Last Updated Date: Dec 11, 2024
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: Independent school districts
City or township governments
Public and State controlled institutions of higher education
State governments
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Special district governments
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Small businesses
Public housing authorities/Indian housing authorities
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 Notice of Funding Opportunity (NOFO) 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 NOFO 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 NOFO will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO that encourages applications for a collaborating Data Coordinating Center (PAR-22-193). 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: https://grants.nih.gov/grants/guide/pa-files/PAR-25-029.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH Grants Information
grantsinfo@nih.gov
Email:grantsinfo@nih.gov

Folder 357669 Full Announcement-PAR-25-029 -> PAR-25-029-Full-Announcement.pdf

Packages

Agency Contact Information: NIH Grants Information
grantsinfo@nih.gov
Email: grantsinfo@nih.gov
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
FORMS-I Use for due dates on or after January 25, 2025 PKG00289596 Jan 11, 2025 Jan 11, 2026 View

Package 1

Mandatory forms

357669 RR_SF424_5_0-5.0.pdf

357669 PHS398_CoverPageSupplement_5_0-5.0.pdf

357669 RR_OtherProjectInfo_1_4-1.4.pdf

357669 PerformanceSite_4_0-4.0.pdf

357669 RR_KeyPersonExpanded_4_0-4.0.pdf

357669 RR_Budget10_3_0-3.0.pdf

357669 PHS398_ResearchPlan_5_0-5.0.pdf

357669 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

357669 RR_SubawardBudget10_30_3_0-3.0.pdf

357669 PHS_AssignmentRequestForm_4_0-4.0.pdf

2025-07-13T15:35:27-05:00

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