{"abstract":"The Food and Drug Administration (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing that FDA will begin supporting the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of Nonclinical Data Implementation Guide--Animal Rule version 1.0 (SENDIG-AR v1.0) on March 15, 2020, and that these new standards will be required in submissions to FDA effective March 15, 2022. An update will be made to the FDA Data Standards Catalog (Catalog) 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/2020/03/11/2020-04898.html","cfr_references":[],"citation":"85 FR 14205","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-2020-N-0315"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-03-11","updated_at":"2023-03-01T14:05:30.965-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-0315-0001","allow_late_comments":null,"id":"FDA-2020-N-0315-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-N-0315","title":"Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.8 with Standard for Exchange of Nonclinical Data Implementation Guide – Animal Rule Version 1.0."}],"document_number":"2020-04898","effective_on":null,"end_page":14206,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/11/2020-04898.xml","html_url":"https://www.federalregister.gov/documents/2020/03/11/2020-04898/electronic-study-data-submission-data-standards-support-and-requirement-begin-for-study-data","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-04898?publication_date=2020-03-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-11/2020-04898/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":855,"last_updated":"2026-07-26 14:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-11/pdf/2020-04898.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-04898.pdf?1583844323","publication_date":"2020-03-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/11/2020-04898.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-2020-N-0315","supporting_documents_count":0,"docket_id":"FDA-2020-N-0315","document_id":"FDA-2020-N-0315-0001","regulation_id_number":null,"title":"Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.8 with Standard for Exchange of Nonclinical Data Implementation Guide – Animal Rule Version 1.0.","checked_regulationsdotgov_at":"2023-03-01T19:05:30Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14205,"subtype":null,"title":"Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.8 With Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}