NOT-AT-24-023: Notice of Intent to Publish a Notice of Funding Opportunity for Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)

Notice of Intent to Publish a Notice of Funding Opportunity for Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)

Notice Number:

NOT-AT-24-023

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 - Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required). See NOFO PAR-20-219.

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 Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 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 U24 activity code. Details of the planned NOFO are provided below.  

Research Initiative Details

This Notice of Funding Opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi-site clinical trial (Phase Ill and beyond) application submitted under the companion UG3/UH3 application. The DCC application must be specific to the collaborating Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC 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.nih.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