Notice Number: NOT-AT-19-018

Key Dates
Release Date: January 11, 2019

Issued by
National Center for Complementary and Integrative Health (NCCIH)

Purpose

The purpose of this Notice is to correct the instructions for submitting Other Clinical Trial-related Attachments in applications for PAR-18-828, "NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required).”

The Funding Opportunity Announcement (FOA) currently reads:

Section IV. Application and Submission Information

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments The following attachments must be included as a part of the cooperative agreement application. Attachments permit expansion of certain elements that cannot be appropriately described in the Research Strategy. All attachments listed below must be provided or the application will not be peer reviewed.

The table elements should include:

Element A: clinical trial title
Element B: applicant's role in the trial
Element C: a brief description of the trial design
Element D: planned enrollment
Element E: actual enrollment
Element F: number of sites
Element G: whether the trial(s) were completed on schedule or not
Element H: publication reference(s)

The Funding Opportunity Announcement (FOA) modified to read:

Section IV. Application and Submission Information

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments The following attachments must be included as a part of the application. Attachments permit expansion of certain elements that cannot be appropriately described in the Research Strategy. All attachments listed below must be provided or the application will not be peer reviewed.

The table elements should include:

Element A: clinical trial title
Element B: applicant's role in the trial
Element C: a brief description of the trial design
Element D: planned enrollment
Element E: actual enrollment
Element F: number of sites
Element G: whether the trial(s) were completed on schedule or not
Element H: publication reference(s)

Inquiries

Please direct all inquiries to:

Wendy Weber, ND, PhD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-402-1272
Email:Wendy.Weber@nih.gov