{"abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","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/2025/06/25/2025-11605.html","cfr_references":[],"citation":"90 FR 27029","comment_url":null,"comments_close_on":"2025-07-25","correction_of":null,"corrections":[],"dates":"Submit written comments (including recommendations) on the collection of information by July 25, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-5468"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2025-06-25","updated_at":"2025-07-26T01:56:13.901-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-5468-0005","allow_late_comments":false,"id":"FDA-2024-N-5468-0005","comment_end_date":"2025-07-26","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":"2025-11605","effective_on":null,"end_page":27037,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/25/2025-11605.xml","html_url":"https://www.federalregister.gov/documents/2025/06/25/2025-11605/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-11605?publication_date=2025-06-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-25/2025-11605/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":1046,"last_updated":"2026-06-17 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-25/pdf/2025-11605.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11605.pdf?1750769110","publication_date":"2025-06-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/25/2025-11605.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":4,"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-5468-0005","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":"2025-07-27T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27029,"subtype":null,"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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}