{"abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of the FDA Electronic Submission Gateway (ESG) and the Safety Reporting Portal (the SRP) to collect adverse event reports and other safety information for FDA-regulated products.","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/2012/09/14/2012-22659.html","cfr_references":[],"citation":"77 FR 56847","comment_url":null,"comments_close_on":"2012-11-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the collection of information by November 13, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0921"],"dockets":[],"document_number":"2012-22659","effective_on":null,"end_page":56851,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/09/14/2012-22659.xml","html_url":"https://www.federalregister.gov/documents/2012/09/14/2012-22659/agency-information-collection-activities-proposed-collection-comment-request-electronic-submission","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-22659?publication_date=2012-09-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-09-14/2012-22659/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":210,"last_updated":"2026-08-25 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-09-14/pdf/2012-22659.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-22659.pdf?1347540981","publication_date":"2012-09-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/09/14/2012-22659.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-2012-N-0921","supporting_documents_count":0,"docket_id":"FDA-2012-N-0921","regulation_id_number":null,"title":"Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal","checked_regulationsdotgov_at":"2012-11-15T05:00:54Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56847,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal","toc_doc":"Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:","topics":[],"type":"Notice","volume":77}