{"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 Forward Compatibility 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/2026/10/16/2026-21197.html","cfr_references":[],"citation":"91 FR 65752","comment_url":"http://www.regulations.gov/commenton/FDA-2018-D-1216-0028","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"FDA support for Forward Compatibility for eCTD v4.0 electronic submissions begins October 16, 2026. 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":"2026-10-16","updated_at":"2026-10-16T09:56:49.226-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1216-0028","allow_late_comments":true,"id":"FDA-2018-D-1216-0028","comment_end_date":null,"regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2018-D-1216","title":"CDER Level 2 Technical Specifications Guidances"}],"document_number":"2026-21197","effective_on":null,"end_page":65753,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/10/16/2026-21197.xml","html_url":"https://www.federalregister.gov/documents/2026/10/16/2026-21197/electronic-common-technical-document-ectd-data-standards-supporting-forward-compatibility-for-ectd","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-21197?publication_date=2026-10-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-10-16/2026-21197/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":721,"last_updated":"2026-11-05 18:15:03 -0500"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-16/pdf/2026-21197.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-21197.pdf?1792068329","publication_date":"2026-10-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/10/16/2026-21197.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-1216-0028","regulation_id_number":null,"title":"CDER Level 2 Technical Specifications Guidances","checked_regulationsdotgov_at":"2026-11-05T05:05:21Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2018-D-1216-0028","significant":null,"signing_date":null,"start_page":65752,"subtype":null,"title":"Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0","toc_doc":"Supporting Forward Compatibility for eCTD 4.0","toc_subject":"Electronic Common Technical Document; Data Standards","topics":[],"type":"Notice","volume":91}