{"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/2020/08/05/2020-17041.html","cfr_references":[],"citation":"85 FR 47389","comment_url":null,"comments_close_on":"2020-09-04","correction_of":null,"corrections":[],"dates":"Submit written comments (including recommendations) on the collection of information by September 4, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0424"],"dockets":[{"supporting_documents":[{"title":"Regulatory Impact Assessment for Postmarketing Safety Reporting for Combination Products ","document_id":"FDA-2008-N-0424-0021"},{"title":"DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PUBLIC HEARING ON: FDA REGULATION OF  COMBINATION PRODUCTS","document_id":"FDA-2008-N-0424-0020"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-08-05","updated_at":"2023-02-28T22:50:53.533-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2008-N-0424-0038","allow_late_comments":null,"id":"FDA-2008-N-0424-0038","comment_end_date":"2020-09-05","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2008-N-0424","title":"Postmarketing Safety Reporting for Combination Products"}],"document_number":"2020-17041","effective_on":null,"end_page":47390,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/08/05/2020-17041.xml","html_url":"https://www.federalregister.gov/documents/2020/08/05/2020-17041/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-17041?publication_date=2020-08-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-08-05/2020-17041/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":235,"last_updated":"2026-08-26 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-08-05/pdf/2020-17041.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-17041.pdf?1596545130","publication_date":"2020-08-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/08/05/2020-17041.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Regulatory Impact Assessment for Postmarketing Safety Reporting for Combination Products ","document_id":"FDA-2008-N-0424-0021"},{"title":"DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PUBLIC HEARING ON: FDA REGULATION OF  COMBINATION PRODUCTS","document_id":"FDA-2008-N-0424-0020"}],"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-2008-N-0424","supporting_documents_count":2,"docket_id":"FDA-2008-N-0424","document_id":"FDA-2008-N-0424-0038","regulation_id_number":null,"title":"Postmarketing Safety Reporting for Combination Products","checked_regulationsdotgov_at":"2023-03-01T03:50:52Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":47389,"subtype":null,"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products","toc_doc":"Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:\n","topics":[],"type":"Notice","volume":85}