CTD Section 1.1.3 Report
Summary
Section Name:
Form FDA 3397: User Fee Cover Sheet
Section Code:
1.1.3
Module Number:
1
Description:
Form that provides information to determine whether a fee is required for review of an application, to determine the amount of fee required, and to help FDA track payments
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources