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NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
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Service Source Final Application Due Date Funding Available Match Required
Health Care Federal
HHS
11-13-2026 $350,000 No Match
Required
  • Service
  • Source
  • Final Application Due Date
  • Funding Available
  • Match Required
Status
  • Past
  • Current
  • Forecasted
  • N/A
  • $350,000
  • Award Floor
  • Award Ceiling
    • Opportunity Type Discretionary
    • CFDA

      93.213 -- Research and Training in Complementary and Integrative Health

    Description

    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,

    Eligibility
    • IHE
    • Local Government
    • Non-Profit
    • Other
    • State Government
    • Tribal Government
    Additional Eligibility Information

    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.

    Key Date(s)
    • December 02, 2024: Last Updated Date
    • December 02, 2024: Posted Date
    • November 13, 2026: Current Closing Date for Applications
    • November 13, 2026: Application Due Date
    • December 19, 2026: Application Archive Date
    Contact Information

    NIH Grants Information

    grantsinfo@nih.gov

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