{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled \"Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions.\" The draft guidance document and BIMO Technical Conformance Guide provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by FDA's Center for Biologics Evaluation and Research (CBER) in the planning of, and by FDA's Office of Regulatory Affairs (ORA) in the conduct of, BIMO inspections. The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by CBER, as well as certain supplemental applications containing new clinical study reports. This draft guidance, when finalized, will provide additional information regarding the format to be used for electronic submission of BLA and NDA content for the planning and conduct of CBER BIMO inspections, using the electronic Common Technical Document.","action":"Notice of availability.","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/2024/06/05/2024-12354.html","cfr_references":[],"citation":"89 FR 48168","comment_url":null,"comments_close_on":"2024-08-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-2221"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-06-05","updated_at":"2024-09-03T17:03:47.096-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2221-0001","allow_late_comments":false,"id":"FDA-2024-D-2221-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2221","title":"Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability"}],"document_number":"2024-12354","effective_on":null,"end_page":48170,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/06/05/2024-12354.xml","html_url":"https://www.federalregister.gov/documents/2024/06/05/2024-12354/standardized-format-for-electronic-submission-for-marketing-applications-content-for-the-planning-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-12354?publication_date=2024-06-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-06-05/2024-12354/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":460,"last_updated":"2026-09-21 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-05/pdf/2024-12354.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-12354.pdf?1717505124","publication_date":"2024-06-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/06/05/2024-12354.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-D-2221","supporting_documents_count":0,"docket_id":"FDA-2024-D-2221","document_id":"FDA-2024-D-2221-0001","regulation_id_number":null,"title":"Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-06-06T14:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48168,"subtype":null,"title":"Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability","toc_doc":"Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}