Key Dates
- May 20, 2020 - NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required). See NOFO PAR-20-216.
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 Mid Phase Clinical Trial Cooperative Agreement (R01 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 R01 activity code. Details of the planned NOFO are provided below.
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products. All applications submitted under this NOFO must be supported by sufficient preliminary data of bioavailability and documentation that the natural product produces a replicable and measurable impact on a biological signature (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure a biological signature in the patient population of interest or when there is a fundamental understanding of the product’s mechanism of action will this preliminary data requirement be waived.
Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. 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 NOFO will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.
Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.
Funding Information
TBD
Contingent upon appropriations and the submission of a sufficient number of meritorious applications
Application budgets are not limited, but it is strongly recommended that applications not request more than $350,000 per year in direct costs per year. A strong rationale must be provided for budgets that exceed this recommendation. Budgets should reflect the actual needs of the proposed project.
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-Chihota, 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)
