{"abstract":"The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the FDA Data Standards Catalog. FDA will continue its support of the newer SDTM Version 1.3 and Version 1.4, which have been listed in the FDA Data Standards Catalog since December 2012 and August 2015, respectively. FDA support for SDTM Version 1.2 will end for studies that start 12 months after March 15, 2018.","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/2017/09/01/2017-18566.html","cfr_references":[],"citation":"82 FR 41624","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-4302"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2017-09-01","updated_at":"2023-03-01T13:30:08.101-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-N-4302-0001","allow_late_comments":null,"id":"FDA-2017-N-4302-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-N-4302","title":"Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1"}],"document_number":"2017-18566","effective_on":null,"end_page":41625,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/09/01/2017-18566.xml","html_url":"https://www.federalregister.gov/documents/2017/09/01/2017-18566/electronic-study-data-submission-data-standards-support-end-date-for-study-data-tabulation-model","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-18566?publication_date=2017-09-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-09-01/2017-18566/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":281,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-09-01/pdf/2017-18566.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-18566.pdf?1504183556","publication_date":"2017-09-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/09/01/2017-18566.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-2017-N-4302","supporting_documents_count":0,"docket_id":"FDA-2017-N-4302","document_id":"FDA-2017-N-4302-0001","regulation_id_number":null,"title":"Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1","checked_regulationsdotgov_at":"2023-03-01T18:30:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":41624,"subtype":null,"title":"Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1","toc_doc":"Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}