{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on issues related to communications by manufacturers, packers, and distributors, including their representatives (collectively \"firms\"), regarding FDA-regulated drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively, \"medical products\"). FDA is engaged in a comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA's policy development in this area. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.","action":"Notification of public hearing; request for comments.","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/2016/09/01/2016-21062.html","cfr_references":[{"chapter":null,"citation_url":null,"part":15,"title":21}],"citation":"81 FR 60299","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The public hearing will be held on November 9 and 10, 2016, from 9 a.m. to 5 p.m. The meeting may be extended or end early depending on the level of public participation. Persons seeking to attend or present at the public hearing must register by October 19, 2016. Electronic or written comments will be accepted after the public hearing until January 9, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1149"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":42,"comment_start_date":"2016-09-01","updated_at":"2023-03-01T13:24:41.886-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-1149-0001","allow_late_comments":null,"id":"FDA-2016-N-1149-0001","comment_end_date":"2017-04-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-N-1149","title":"Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products"}],"document_number":"2016-21062","effective_on":null,"end_page":60304,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/09/01/2016-21062.xml","html_url":"https://www.federalregister.gov/documents/2016/09/01/2016-21062/manufacturer-communications-regarding-unapproved-uses-of-approved-or-cleared-medical-products-public","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-21062?publication_date=2016-09-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-09-01/2016-21062/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":6436,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-09-01/pdf/2016-21062.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-21062.pdf?1472647551","publication_date":"2016-09-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/09/01/2016-21062.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":42,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-1149","supporting_documents_count":0,"docket_id":"FDA-2016-N-1149","document_id":"FDA-2016-N-1149-0001","regulation_id_number":null,"title":"Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products","checked_regulationsdotgov_at":"2023-03-01T18:24:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60299,"subtype":null,"title":"Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments","toc_doc":"Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing","toc_subject":null,"topics":[],"type":"Proposed Rule","volume":81}