NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
- Posted
- February 1, 2024
- Closed
- December 1, 2024
- Award ceiling
- $350,000
- Cost sharing
- No
- Instrument
- Grant
- Assistance listing
- 93.213
- Category
- Health
- Archives
- December 31, 2024
Program funding history
Awards made under Assistance Listing 93.213 across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $115.4M
- FY2026 obligated
- $119M
- FY2027 (to date) obligated
- $0
- Awards in window
- 635
Top recipients: University of California, San Diego, The General Hospital Corporation, Yale Univ, The Spaulding Rehabilitation Hospital Corporation, University of California Irvine
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
Synopsis
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), 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. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive,
Who can apply
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Special district governments
- Public and State controlled institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- State governments
- For profit organizations other than small businesses
- Public housing authorities/Indian housing authorities
- Small businesses
- Independent school districts
- City or township governments
- Private 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)
- Native American tribal organizations (other than Federally recognized tribal governments)
- County governments
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.
The official record
Grants.gov published the official terms and dates of this opportunity; this page keeps them as they were listed.
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