{"abstract":"The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG- DART) and version 1.6 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and the dates when such new standard and version update will be required in certain submissions. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes. An additional note is added to the Catalog clarifying the requirements for the submission of a simplified trial summary dataset to determine a study start date at the point of submission at the electronic gateway.","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/2021/03/05/2021-04609.html","cfr_references":[],"citation":"86 FR 12951","comment_url":"http://www.regulations.gov/commenton/FDA-2020-N-2354-0001","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Support for version 1.1 of the CDISC SENDIG-DART and version 1.6 of the CDISC SDTM will begin on March 15, 2021. The requirement for electronic submissions to be submitted using version 1.1 of the CDISC SENDIG-DART will begin March 15, 2023, for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs), and March 15, 2024, for certain investigational new drug applications (INDs). The requirement for electronic submissions to be submitted using version 1.6 of the CDISC SDTM will begin on March 15, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-2354"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2021-03-05","updated_at":"2023-03-01T14:10:17.016-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-2354-0001","allow_late_comments":null,"id":"FDA-2020-N-2354-0001","comment_end_date":"2023-03-16","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2020-N-2354","title":"Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model. Clarification to the FDA Data Standards"}],"document_number":"2021-04609","effective_on":null,"end_page":12952,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/03/05/2021-04609.xml","html_url":"https://www.federalregister.gov/documents/2021/03/05/2021-04609/data-standards-requirement-begins-for-the-clinical-data-interchange-standards-consortium-version-11","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-04609?publication_date=2021-03-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-03-05/2021-04609/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1752,"last_updated":"2026-10-25 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-05/pdf/2021-04609.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-04609.pdf?1614865551","publication_date":"2021-03-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/03/05/2021-04609.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-2354","supporting_documents_count":0,"docket_id":"FDA-2020-N-2354","document_id":"FDA-2020-N-2354-0001","regulation_id_number":null,"title":"Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model. Clarification to the FDA Data Standards","checked_regulationsdotgov_at":"2023-03-01T19:10:16Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2020-N-2354-0001","significant":null,"signing_date":null,"start_page":12951,"subtype":null,"title":"Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model; Clarification to Food and Drug Administration Data Standards","toc_doc":"Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model","toc_subject":"Clarification to Food and Drug Administration Data Standards:\n","topics":[],"type":"Notice","volume":86}