NOT-AT-24-022: Notice of Intent to Publish a Notice of Funding Opportunity for NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

Notice of Intent to Publish a Notice of Funding Opportunity for NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

Notice Number:

NOT-AT-24-022

Key Dates

Release Date:

September 28, 2023

Estimated Publication Date of Notice of Funding Opportunity :

December 04, 2023

First Estimated Application Due Date:

February 05, 2024

Earliest Estimated Award Date:

October 01, 2024

Earliest Estimated Start Date:

December 02, 2024

Related Announcements

May 20, 2020 - NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required). See NOFO PAR-20-218.

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

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 Phased Innovation Award (R61/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 R61/R33 activity code. Details of the planned NOFO are provided below. 

Research Initiative Details

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 three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural product’s effect (i.e., measure of mechanism of action) when used by humans on a biological signature(s). 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 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 R33 studies to determine how to optimize the impact of the natural product on the biological signature by optimizing the delivery of the natural product by examining 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 R61/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. A maximum of 5 years will be supported by the two phases of the R61/R33 award.

Funding Information

Estimated Total Funding

TBD

Expected Number of Awards

Contingent upon appropriations and the submission of a sufficient number of meritorious applications

Estimated Award Ceiling

The budget is limited to $350,000 direct costs per year in both the R61 and R33 phases. Application budgets need to reflect the actual needs of the proposed project.

Primary Assistance Listing Number(s)

93.213

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
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 