{"abstract":"The Food and Drug Administration (FDA) is reopening until December 16, 2003, the comment period for the draft guidance for industry entitled \"Providing Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports.\" FDA published a notice of availability of the draft guidance in the Federal Register of June 24, 2003 (68 FR 37504). The agency is taking this action in response to a request for an extension of the comment period.","action":"Notice; reopening of the comment period.","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/2003/10/17/03-26266.html","cfr_references":[],"citation":"68 FR 59797","comment_url":null,"comments_close_on":"2003-12-16","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidance by December 16, 2003. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 2003D-0231"],"dockets":[],"document_number":"03-26266","effective_on":null,"end_page":59798,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/10/17/03-26266.xml","html_url":"https://www.federalregister.gov/documents/2003/10/17/03-26266/draft-guidance-for-industry-on-providing-regulatory-submissions-in-electronic-format-postmarketing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-26266?publication_date=2003-10-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-10-17/03-26266/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":9,"last_updated":"2026-08-23 18:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-10-17/pdf/03-26266.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-10-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/10/17/03-26266.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59797,"subtype":null,"title":"Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Periodic Adverse Drug Experience Reports; Reopening of the Comment Period","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":68}