This NCCIH grant is for establishing a Clinical Coordinating Center (CCC) to manage investigator-initiated, multi-site (Phase III and beyond) clinical trials on natural products. These trials will investigate botanicals, probiotics, dietary supplements, or specific nutritional compounds in NCCIH’s high-priority areas. The CCC’s role includes developing and implementing the trial, managing projects, recruiting/retaining participants, setting performance milestones, ensuring scientific conduct, and disseminating results. This cooperative agreement uses a two-phase, milestone-driven UG3/UH3 funding. A corresponding Data Coordinating Center application must be submitted concurrently for consideration.
Opportunity ID: 356904
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-312 |
| Funding Opportunity Title: | Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (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: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 30, 2024 |
| Last Updated Date: | Oct 30, 2024 |
| Original Closing Date for Applications: | Jul 14, 2026 |
| Current Closing Date for Applications: | Jul 14, 2026 |
| Archive Date: | Aug 19, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | 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 Private institutions of higher education Independent school districts City or township governments Small businesses For profit organizations other than small businesses County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for investigator-initiated, multi-site, clinical trials (Phase III and beyond) to study the effects of natural products (i.e. botanicals, probiotics, and products marketed as dietary supplements) in NCCIH designated areas of high research priority. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective of the Clinical Coordinating Center application is to provide the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this NOFO will utilize a two-phase, milestone-driven, cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center application, submitted under PAR-24-125, proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans). |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-312.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 |
|---|---|---|
Related Documents
Folder 356904 Full Announcement-PAR-24-312 -> PAR-24-312-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 | PKG00288442 | Jan 20, 2025 | Jul 14, 2026 | View |
Package 1
Mandatory forms
356904 RR_SF424_5_0-5.0.pdf
356904 PHS398_CoverPageSupplement_5_0-5.0.pdf
356904 RR_OtherProjectInfo_1_4-1.4.pdf
356904 PerformanceSite_4_0-4.0.pdf
356904 RR_KeyPersonExpanded_4_0-4.0.pdf
356904 RR_Budget10_3_0-3.0.pdf
356904 PHS398_ResearchPlan_5_0-5.0.pdf
356904 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356904 RR_SubawardBudget10_30_3_0-3.0.pdf
356904 PHS_AssignmentRequestForm_4_0-4.0.pdf
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