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    NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

    PAR-24-124

    National Institutes of Health

    Opening date 1 Feb 2024, 12:00AM

    Closing date 13 Nov 2026, 12:00AM

    Funding Opportunity Number: PAR-24-124

    Opportunity Category: Discretionary

    CFDA Number(s): 93.213 -- Research and Training in Complementary and Integrative Health

    Cost Sharing or Matching Requirement: No

    Posted Date: Feb 01, 2024 12:00:00 AM EST

    Closing Date: Nov 13, 2026 12:00:00 AM EST

    Award Ceiling: $350000

    Award Floor: none

    Eligible Applicants: County governments,Public and State controlled institutions of higher education,Native American tribal organizations (other than Federally recognized tribal governments),Private institutions of higher education,For profit organizations other than small businesses,City or township governments,Independent school districts,State governments,Others (see text field entitled "Additional Information on Eligibility" for clarification),Small businesses,Native American tribal governments (Federally recognized),Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,Public housing authorities/Indian housing authorities,Special district governments,Nonprofits that do not have a 501(c)(3) status with the IRS, other than 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.

    Agency Name: National Institutes of 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,

    Grantor Contact Information: NIH Grants Information grantsinfo@nih.gov

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