{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Guidance for Industry: Providing Submissions in Electronic Format--Postmarketing Safety Reports for Vaccines\" dated July 2014. The draft guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). FDA recently published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help applicants required to submit postmarketing safety reports comply with the final rule. The draft guidance, when finalized, also will supersede the document entitled \"Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)\" dated September 1998.","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/2014/07/18/2014-16931.html","cfr_references":[],"citation":"79 FR 42022","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 16, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0903"],"dockets":[],"document_number":"2014-16931","effective_on":null,"end_page":42023,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/07/18/2014-16931.xml","html_url":"https://www.federalregister.gov/documents/2014/07/18/2014-16931/draft-guidance-for-industry-providing-submissions-in-electronic-format-postmarketing-safety-reports","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-16931?publication_date=2014-07-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-07-18/2014-16931/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":235,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-07-18/pdf/2014-16931.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-16931.pdf?1405601399","publication_date":"2014-07-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/07/18/2014-16931.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-0903","supporting_documents_count":0,"docket_id":"FDA-2014-D-0903","regulation_id_number":null,"title":"Providing Submissions in Electronic Format – Postmarketing Safety Reports for Vaccines","checked_regulationsdotgov_at":"2014-09-17T05:01:00Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42022,"subtype":null,"title":"Draft Guidance for Industry: Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Availability","toc_doc":"Providing Submissions in Electronic Format; Postmarketing Safety Reports for Vaccines","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}