{"abstract":"The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research and (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the date that support begins for version 3.1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG), and the date that this version update is required in certain submissions. The Agency will update 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/2022/02/15/2022-03225.html","cfr_references":[],"citation":"87 FR 8585","comment_url":"http://www.regulations.gov/commenton/FDA-2022-N-0072-0001","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Support for version 3.1.1 of the CDISC SENDIG begins February 15, 2022. The requirement for electronic submissions to be submitted using version 3.1.1 of the CDISC SENDIG begins March 15, 2023, for new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs).","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-0072"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2022-02-15","updated_at":"2023-03-01T14:10:24.238-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-0072-0001","allow_late_comments":null,"id":"FDA-2022-N-0072-0001","comment_end_date":"2023-03-16","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2022-N-0072","title":"Data Standards; Requirement Begins for Version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide"}],"document_number":"2022-03225","effective_on":null,"end_page":8586,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/02/15/2022-03225.xml","html_url":"https://www.federalregister.gov/documents/2022/02/15/2022-03225/data-standards-requirement-begins-for-version-311-of-the-clinical-data-interchange-standards","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-03225?publication_date=2022-02-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-02-15/2022-03225/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1278,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-15/pdf/2022-03225.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-03225.pdf?1644846343","publication_date":"2022-02-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/02/15/2022-03225.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-0072","supporting_documents_count":0,"docket_id":"FDA-2022-N-0072","document_id":"FDA-2022-N-0072-0001","regulation_id_number":null,"title":"Data Standards; Requirement Begins for Version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide","checked_regulationsdotgov_at":"2023-03-01T19:10:23Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2022-N-0072-0001","significant":null,"signing_date":null,"start_page":8585,"subtype":null,"title":"Data Standards; Requirement Begins for Version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide","toc_doc":"Version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide","toc_subject":"Data Standards:\n","topics":[],"type":"Notice","volume":87}