{"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/2018/09/12/2018-19742.html","cfr_references":[],"citation":"83 FR 46166","comment_url":null,"comments_close_on":"2018-10-12","correction_of":null,"corrections":[],"dates":"Fax written comments on the collection of information by October 12, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1960"],"dockets":[{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2014-N-1960-0033"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review;\nComment Request; MedWatch: The Food and Drug Administration Safety Information and Adverse Event\nReporting Program","document_id":"FDA-2014-N-1960-0031"},{"title":"Agency Information Collection  Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2014-N-1960-0030"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0028"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0026"},{"title":"Agency Information Collection Activities; Announcement of Office of\nManagement and Budget Approvals","document_id":"FDA-2014-N-1960-0025"},{"title":"Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; MedWatch: The\nFood and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0023"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical\nProducts Reporting Program","document_id":"FDA-2014-N-1960-0010"},{"title":"Agency Information Collection Activities; Announcement of Office of\nManagement and Budget Approval; MedWatch: The Food and Drug\nAdministration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0009"},{"title":"Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; MedWatch: The\nFood and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0002"}],"agency_name":null,"documents":[{"comment_count":1,"comment_start_date":"2018-09-12","updated_at":"2023-03-01T02:57:03.485-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-N-1960-0023","allow_late_comments":null,"id":"FDA-2014-N-1960-0023","comment_end_date":"2018-10-13","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":11,"id":"FDA-2014-N-1960","title":"MedWatch: The Food and Drug Administration Medical Products Reporting Program"}],"document_number":"2018-19742","effective_on":null,"end_page":46170,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/09/12/2018-19742.xml","html_url":"https://www.federalregister.gov/documents/2018/09/12/2018-19742/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-19742?publication_date=2018-09-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-09-12/2018-19742/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":2850,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-09-12/pdf/2018-19742.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-19742.pdf?1536669916","publication_date":"2018-09-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/09/12/2018-19742.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2014-N-1960-0033"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review;\nComment Request; MedWatch: The Food and Drug Administration Safety Information and Adverse Event\nReporting Program","document_id":"FDA-2014-N-1960-0031"},{"title":"Agency Information Collection  Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2014-N-1960-0030"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0028"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0026"},{"title":"Agency Information Collection Activities; Announcement of Office of\nManagement and Budget Approvals","document_id":"FDA-2014-N-1960-0025"},{"title":"Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; MedWatch: The\nFood and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0023"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical\nProducts Reporting Program","document_id":"FDA-2014-N-1960-0010"},{"title":"Agency Information Collection Activities; Announcement of Office of\nManagement and Budget Approval; MedWatch: The Food and Drug\nAdministration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0009"},{"title":"Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; MedWatch: The\nFood and Drug Administration Medical Products Reporting Program","document_id":"FDA-2014-N-1960-0002"}],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1960","supporting_documents_count":11,"docket_id":"FDA-2014-N-1960","document_id":"FDA-2014-N-1960-0023","regulation_id_number":null,"title":"MedWatch: The Food and Drug Administration Medical Products Reporting Program","checked_regulationsdotgov_at":"2023-03-01T07:57:02Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46166,"subtype":null,"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program","toc_doc":"MedWatch: The Food and Drug Administration Medical Products Reporting Program","toc_subject":"Agency Information Collection Activities; Proposals, Submissions, and Approvals:","topics":[],"type":"Notice","volume":83}