{"abstract":"The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.","action":"Final rule.","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/2014/06/10/2014-13480.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":329,"title":21},{"chapter":null,"citation_url":null,"part":600,"title":21}],"citation":"79 FR 33072","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 10, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0334"],"dockets":[],"document_number":"2014-13480","effective_on":"2015-06-10","end_page":33092,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/06/10/2014-13480.xml","html_url":"https://www.federalregister.gov/documents/2014/06/10/2014-13480/postmarketing-safety-reports-for-human-drug-and-biological-products-electronic-submission","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-13480?publication_date=2014-06-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-06-10/2014-13480/mods.xml","not_received_for_publication":null,"page_length":21,"page_views":{"count":13066,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-06-10/pdf/2014-13480.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-13480.pdf?1402318457","publication_date":"2014-06-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/06/10/2014-13480.txt","regulation_id_number_info":{"9010-AF96":null},"regulation_id_numbers":["9010-AF96"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-06-30T06:02:56Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33072,"subtype":null,"title":"Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements","toc_doc":"Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements","toc_subject":null,"topics":["Administrative practice and procedure","Biologics","Confidential business information","Drugs","Labeling","Medical devices","Over-the-counter drugs","Reporting and recordkeeping requirements"],"type":"Rule","volume":79}