{"abstract":"The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date that FDA will no longer support electronic submissions using the Electronic Common Technical Document (eCTD) Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01, and U.S. Regional Stylesheet Version 1.1, and will require electronic submissions to be submitted using eCTD Module 1 U.S. Regional DTD Version 3.3. The Agency will update the eCTD Submission Standards document to reflect these changes.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2020/10/16/2020-22971.html","cfr_references":[],"citation":"85 FR 65827","comment_url":null,"comments_close_on":"2022-03-01","correction_of":null,"corrections":[],"dates":"The requirement for electronic submissions to be submitted using eCTD Module 1 U.S. Regional DTD Version 3.3 will begin on March 1, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1216"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-10-16","updated_at":"2023-02-28T22:43:11.652-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1216-0017","allow_late_comments":null,"id":"FDA-2018-D-1216-0017","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1216","title":"CDER Level 2 Technical Specifications Guidances"}],"document_number":"2020-22971","effective_on":null,"end_page":65828,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/10/16/2020-22971.xml","html_url":"https://www.federalregister.gov/documents/2020/10/16/2020-22971/electronic-common-technical-document-data-standards-support-ends-for-electronic-common-technical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-22971?publication_date=2020-10-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-10-16/2020-22971/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1843,"last_updated":"2026-10-23 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-16/pdf/2020-22971.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-22971.pdf?1602765940","publication_date":"2020-10-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/10/16/2020-22971.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1216","supporting_documents_count":0,"docket_id":"FDA-2018-D-1216","document_id":"FDA-2018-D-1216-0017","regulation_id_number":null,"title":"CDER Level 2 Technical Specifications Guidances","checked_regulationsdotgov_at":"2023-03-01T03:43:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65827,"subtype":null,"title":"Electronic Common Technical Document; Data Standards; Support Ends for Electronic Common Technical Document Module 1 U.S. Regional Document Type Definition Version 2.01 and Requirement Begins for Electronic Common Technical Document Module 1 U.S. Regional Document Type Definition Version 3.3","toc_doc":"Data Standards","toc_subject":"Electronic Common Technical Document:\n","topics":[],"type":"Notice","volume":85}