{"abstract":"The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide--Animal Rule Version 1.0 (SENDIG-AR v1.0) on March 26, 2024, and this standard will be required in submissions to CBER for studies that start after March 15, 2027. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect this change.","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/2024/03/26/2024-06294.html","cfr_references":[],"citation":"89 FR 20987","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-1221-0001","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Support for version CDISC SENDIG-AR v1.0 begins March 26, 2024. The requirement for electronic submissions using CDISC SENDIG-AR v1.0 begins for studies that start after March 15, 2027, for new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs). Submit either electronic or written comments at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-1221"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-03-26","updated_at":"2024-09-03T16:49:32.443-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-1221-0001","allow_late_comments":true,"id":"FDA-2024-N-1221-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-1221","title":"Electronic Submissions Data Standards Support and Requirement for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide – Animal Rule Version 1.0 (SENDIG-AR v1.0)"}],"document_number":"2024-06294","effective_on":null,"end_page":20988,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/26/2024-06294.xml","html_url":"https://www.federalregister.gov/documents/2024/03/26/2024-06294/electronic-submissions-data-standards-support-and-requirement-for-the-clinical-data-interchange","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-06294?publication_date=2024-03-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-26/2024-06294/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":271,"last_updated":"2026-06-23 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-26/pdf/2024-06294.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-06294.pdf?1711370722","publication_date":"2024-03-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/26/2024-06294.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-2024-N-1221","supporting_documents_count":0,"docket_id":"FDA-2024-N-1221","document_id":"FDA-2024-N-1221-0001","regulation_id_number":null,"title":"Electronic Submissions Data Standards Support and Requirement for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide – Animal Rule Version 1.0 (SENDIG-AR v1.0)","checked_regulationsdotgov_at":"2024-03-27T16:00:20Z"},"regulations_dot_gov_url":"https://www.regulations.gov/commenton/FDA-2024-N-1221-0001","significant":null,"signing_date":null,"start_page":20987,"subtype":null,"title":"Electronic Submissions: Data Standards; Support and Requirement for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0","toc_doc":"Data Standards; Support and Requirement for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0","toc_subject":"Electronic Submissions:\n","topics":[],"type":"Notice","volume":89}