{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 information collection associated with FDA's adverse event reports and product experience reports 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/2025/01/17/2025-01149.html","cfr_references":[],"citation":"90 FR 5900","comment_url":null,"comments_close_on":"2025-03-18","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the collection of information must be submitted by March 18, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-5468"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2025-01-17","updated_at":"2025-03-22T01:55:50.755-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-5468-0001","allow_late_comments":false,"id":"FDA-2024-N-5468-0001","comment_end_date":"2025-03-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-5468","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; FDA’s Adverse Event and Product Experience Reporting Program"}],"document_number":"2025-01149","effective_on":null,"end_page":5909,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/17/2025-01149.xml","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01149/agency-information-collection-activities-proposed-collection-comment-request-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-01149?publication_date=2025-01-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-17/2025-01149/mods.xml","not_received_for_publication":null,"page_length":10,"page_views":{"count":911,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01149.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01149.pdf?1737035130","publication_date":"2025-01-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/17/2025-01149.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-N-5468","supporting_documents_count":0,"docket_id":"FDA-2024-N-5468","document_id":"FDA-2024-N-5468-0001","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; FDA’s Adverse Event and Product Experience Reporting Program","checked_regulationsdotgov_at":"2025-03-23T00:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5900,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program","toc_doc":"Adverse Event and Product Experience Reporting Program","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals","topics":[],"type":"Notice","volume":90}