{"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 effective date for Electronic Common Technical Document (eCTD) validations referenced in FDA's \"Technical Rejection Criteria for Study Data\" (TRC).","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/2021/07/29/2021-16187.html","cfr_references":[],"citation":"86 FR 40855","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The eCTD validations will become applicable on September 15, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1216"],"dockets":[],"document_number":"2021-16187","effective_on":null,"end_page":40856,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/07/29/2021-16187.xml","html_url":"https://www.federalregister.gov/documents/2021/07/29/2021-16187/electronic-study-data-submission-data-standards-technical-rejection-criteria-for-study-data","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-16187?publication_date=2021-07-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-07-29/2021-16187/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":966,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-07-29/pdf/2021-16187.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-16187.pdf?1627476334","publication_date":"2021-07-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/07/29/2021-16187.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-2018-D-1216","supporting_documents_count":0,"docket_id":"FDA-2018-D-1216","document_id":"FDA-2018-D-1216-0018","regulation_id_number":null,"title":"CDER Level 2 Technical Specifications Guidances","checked_regulationsdotgov_at":"2021-07-30T03:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40855,"subtype":null,"title":"Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date","toc_doc":"Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date","toc_subject":null,"topics":[],"type":"Notice","volume":86}