Notice of Intent to Publish a Notice of Funding Opportunity for Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
Notice Number:
NOT-AT-24-021

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 - Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required). See NOFO PAR-20-215.  
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 a Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 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 Winter2024.    

This NOFO will utilize the UG3/UH3 activity code. Details of the planned NOFO are provided below.   

Research Initiative Details

This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for investigator-initiated, multi-site, clinical trials (Phase III and beyond) to study the effects of natural products in NCCIH designated areas of high research priority. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective of the Clinical Coordinating Center is to provide the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. The Clinical Coordinating Center is expected to be responsible for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this NOFO will utilize a two-phase, milestone-driven, cooperative agreement (UG3/UH3) funding mechanism.  

In addition, an accompanying Data Coordinating Center application proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nig.gov/about/plans).   

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

Application budgets are not limited but need to reflect the actual needs of the proposed project. 

The combined budgets of the CCC and DCC will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied (https://nccih.nih.gov/grants/policies/over500k-clinical-trials).  

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: 

Wendy Weber, N.D., Ph.D., M.P.H.  
National Center for Complementary and Integrative Health  
Telephone: 301-402-1272  
Email: Wendy.Weber@nih.gov