{"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 support for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.","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/2024/09/16/2024-20897.html","cfr_references":[],"citation":"89 FR 75545","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Support for eCTDv4.0 electronic submissions begins September 16, 2024. FDA will also continue to support eCTDv3.2.2 electronic submissions. Submit either electronic or written comments at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1216"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-09-16","updated_at":"2024-09-16T10:56:28.326-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1216-0026","allow_late_comments":false,"id":"FDA-2018-D-1216-0026","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":"2024-20897","effective_on":null,"end_page":75546,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/16/2024-20897.xml","html_url":"https://www.federalregister.gov/documents/2024/09/16/2024-20897/electronic-common-technical-document-data-standards-center-for-drug-evaluation-and-research-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-20897?publication_date=2024-09-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-16/2024-20897/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1042,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20897.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20897.pdf?1726231525","publication_date":"2024-09-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/16/2024-20897.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-1216-0026","regulation_id_number":null,"title":"CDER Level 2 Technical Specifications Guidances","checked_regulationsdotgov_at":"2024-09-17T14:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":75545,"subtype":null,"title":"Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0","toc_doc":"Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0","toc_subject":"Data Standards:\n","topics":[],"type":"Notice","volume":89}