Federal Register Notice: FDA is making available final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: “`The eCTD Backbone Files Specification for Module 1, version 2.0” (which includes the U.S. regional document type definition, version 3.0) and “Comprehensive Table of Contents Headings and Hierarchy, version 2.0.” Supporting technical files are also being made available on the agency Web site. These documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information. To view this notice, click here.