CTD Section 1.12.14 Report
Summary
Section Name:
Environmental analysis
Section Code:
1.12.14
Module Number:
1
Description:
All applications requesting agency action must be accompanied by an environmental analysis or a claim of categorical exclusion
Submission Timing
Required in initial IND and marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources