The National Center for Complementary and Integrative Health (NCCIH) is offering this grant to encourage investigator-initiated mid-phase clinical trials focused on natural products. This grant is for studying promising nutritional regimens, botanicals, dietary supplements, and probiotics with compelling preliminary evidence. Applicants must demonstrate bioavailability and a reproducible impact on target engagement. The primary purpose is to determine optimal dose or formulation for future multi-site efficacy trials, or identify patient phenotypes (responders versus non-responders) to inform inclusion criteria. This grant supports hypothesis-based, milestone-driven clinical trials directly related to NCCIH’s research priorities and mission. It will not fund single or multi-site efficacy/effectiveness trials, nor cancer-related studies. Prior contact with NCCIH scientific staff is encouraged.
Opportunity ID: 357493
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-271 |
| Funding Opportunity Title: | NCCIH Natural Product Mid Phase Clinical Trial (R01 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: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 02, 2024 |
| Last Updated Date: | Dec 02, 2024 |
| Original Closing Date for Applications: | Nov 13, 2026 |
| Current Closing Date for Applications: | Nov 13, 2026 |
| Archive Date: | Dec 19, 2026 |
| Estimated Total Program Funding: | $350,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal 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 Private institutions of higher education Public housing authorities/Indian housing authorities Special district governments Independent school districts County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal governments (Federally recognized) 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products(i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. 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. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived. Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This NOFO will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NO |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-271.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 357493 Full Announcement-PAR-25-271 -> PAR-25-271-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 | PKG00289348 | May 23, 2025 | Nov 13, 2026 | View |
Package 1
Mandatory forms
357493 RR_SF424_5_0-5.0.pdf
357493 PHS398_CoverPageSupplement_5_0-5.0.pdf
357493 RR_OtherProjectInfo_1_4-1.4.pdf
357493 PerformanceSite_4_0-4.0.pdf
357493 RR_KeyPersonExpanded_4_0-4.0.pdf
357493 PHS398_ResearchPlan_5_0-5.0.pdf
357493 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357493 RR_Budget_3_0-3.0.pdf
357493 RR_SubawardBudget30_3_0-3.0.pdf
357493 PHS398_ModularBudget_1_2-1.2.pdf
357493 PHS_AssignmentRequestForm_4_0-4.0.pdf
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