{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited Safety Reports.\" This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This specific guidance discusses issues related to the electronic submission of postmarketing expedited safety reports for drug products marketed for human use with new drug applications (NDAs) and abbreviated new drug applications (ANDAs), prescription drug products marketed for human use without an approved NDA or ANDA, and therapeutic biological products marketed for human use with biologic license applications (BLAs). This guidance does not apply to vaccines. The submission of these reports in an electronic format will significantly improve the agency's efficiency in processing, archiving, and reviewing the reports.","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/2001/05/04/01-11235.html","cfr_references":[],"citation":"66 FR 22585","comment_url":null,"comments_close_on":"2001-07-03","correction_of":null,"corrections":[],"dates":"Submit written comments on the draft guidance by July 3, 2001. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 01D-0185"],"dockets":[],"document_number":"01-11235","effective_on":null,"end_page":22586,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2001/05/04/01-11235.xml","html_url":"https://www.federalregister.gov/documents/2001/05/04/01-11235/draft-guidance-for-industry-on-providing-regulatory-submissions-in-electronic-format-postmarketing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/01-11235?publication_date=2001-05-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2001-05-04/01-11235/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":35,"last_updated":"2026-08-26 00:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2001-05-04/pdf/01-11235.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2001-05-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2001/05/04/01-11235.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":22585,"subtype":null,"title":"Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Expedited Safety Reports; Availability","toc_doc":"Regulatory submissions in electronic format; postmarketing expedited safety reports","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":66}