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NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)

Type: Posted • Opportunity: PAR-24-116

Description

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early 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. 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 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on 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 engage the same target; or study the impact of the natural product in a target population that is more responsive. 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 R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will

Overview

Category of Funding
Health
Funding Instruments
Grant
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 2/1/24 the National Institutes of Health posted grant opportunity PAR-24-116 for NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required). The grant will be issued under grant program 93.213 Research and Training in Complementary and Integrative Health.

Timing

Posted Date
Feb. 1, 2024, 12:00 a.m. EST
Closing Date
Nov. 13, 2026, 12:00 a.m. EST Due in 994 Days
Last Updated
Feb. 1, 2024, 11:12 a.m. EST
Version
1
Archive Date
Dec. 19, 2026

Eligibility

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

Award Sizing

Ceiling
$1,050,000
Floor
Not Listed
Estimated Program Funding
Not Provided
Estimated Number of Grants
Not Listed

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-24-116.html

Documents

Posted documents for PAR-24-116

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