Federal Register Notice: FDA is making available on its Web site revised final versions of the following four 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 2.2 (which includes the U.S. regional document type definition (DTD), version 3.2); “The Comprehensive Table of Contents Headings and Hierarchy,” version 2.2; “Specifications for eCTD Validation Criteria,'' version 3.0; and “Example Submissions using eCTD Backbone Files Specification for Module 1,” version 1.2. Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by 6/2014, and will give 30 days’ advance notice to industry. To view this notice, click here.