Key Dates
- May 20, 2020 - NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required). See NOFO PAR-20-217.
National Center for Complementary and Integrative Health (NCCIH)
The National Center for Complementary and Integrative Health (NCCIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required).
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The NOFO is expected to be published in December 2023 with an expected application due date in Winter 2024.
This NOFO will utilize the R33 activity code. Details of the planned NOFO are provided below.
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. 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 the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature 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 the biological signature by optimizing the delivery of the natural product through examination of different doses. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same biological signature; 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 it support trials to test natural products for the treatment or prevention of cancer.
Funding Information
TBD
Contingent upon appropriations and the submission of a sufficient number of meritorious applications
The budget should reflect the actual needs of the proposed project but may not exceed a total of $1,050,000 in direct costs over the entire duration of the award. Although variations from year to year are permissible, in no case may any year be more than $525,000 in direct costs.
93.213
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Sekai Chideya, M.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-827-1916
Email: Sekai.Chideya@nih.gov
and Human Services (HHS)
