{"abstract":"The Food and Drug Administration (FDA or Agency) 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 the applicable regulations, and the guidance documents and agency forms related to Premarket Notifications of Devices.","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/2026/03/19/2026-05329.html","cfr_references":[],"citation":"91 FR 13310","comment_url":null,"comments_close_on":"2026-05-18","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the collection of information must be submitted by May 18, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-1849"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-03-19","updated_at":"2026-05-19T20:03:44.166-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-1849-0001","allow_late_comments":false,"id":"FDA-2026-N-1849-0001","comment_end_date":"2026-05-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-1849","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission"}],"document_number":"2026-05329","effective_on":null,"end_page":13313,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/03/19/2026-05329.xml","html_url":"https://www.federalregister.gov/documents/2026/03/19/2026-05329/agency-information-collection-activities-proposed-collection-comment-request-premarket-notifications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-05329?publication_date=2026-03-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-03-19/2026-05329/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":2583,"last_updated":"2026-05-25 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-19/pdf/2026-05329.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05329.pdf?1773837908","publication_date":"2026-03-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/03/19/2026-05329.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-1849","supporting_documents_count":0,"docket_id":"FDA-2026-N-1849","document_id":"FDA-2026-N-1849-0001","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission","checked_regulationsdotgov_at":"2026-05-20T00:03:43Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13310,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission","toc_doc":"Premarket Notifications Submission","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals","topics":[],"type":"Notice","volume":91}