{"abstract":"The Food and Drug Administration (FDA) is reopening the comment period for the document that announced a public meeting in the Federal Register of May 11, 2016. In the document, FDA invited public comment as the Agency considers a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. FDA will hold a Webinar for stakeholders on September 6, 2016. This Webinar is intended to be a followup to the June 10, 2016, public meeting on this topic and to provide stakeholders with a status update on the process of FDA and industry discussions that began in July 2016.","action":"Notice of public meeting; reopening of comment period; stakeholder meeting.","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/2016/08/08/2016-18717.html","cfr_references":[],"citation":"81 FR 52444","comment_url":null,"comments_close_on":"2016-10-06","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by October 6, 2016. FDA will hold a Webinar for stakeholders on Tuesday, September 6, 2016, from 10:30 a.m. to 12 p.m. EDT.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1092"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2016-08-08","updated_at":"2023-03-01T03:15:08.176-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-1092-0014","allow_late_comments":null,"id":"FDA-2016-N-1092-0014","comment_end_date":"2016-10-07","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-N-1092","title":"Over-the-Counter Monograph User Fees"}],"document_number":"2016-18717","effective_on":null,"end_page":52445,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/08/2016-18717.xml","html_url":"https://www.federalregister.gov/documents/2016/08/08/2016-18717/over-the-counter-monograph-user-fees-reopening-of-comment-period-stakeholder-meeting","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-18717?publication_date=2016-08-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-08/2016-18717/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1142,"last_updated":"2026-09-21 22:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-08/pdf/2016-18717.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-18717.pdf?1470401140","publication_date":"2016-08-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/08/2016-18717.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-1092","supporting_documents_count":0,"docket_id":"FDA-2016-N-1092","document_id":"FDA-2016-N-1092-0014","regulation_id_number":null,"title":"Over-the-Counter Monograph User Fees","checked_regulationsdotgov_at":"2023-03-01T08:15:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52444,"subtype":null,"title":"Over-the-Counter Monograph User Fees: Reopening of Comment Period; Stakeholder Meeting","toc_doc":"Stakeholders; Over-the-Counter Monograph User Fees: Reopening of Comment Period","toc_subject":"Meetings:","topics":[],"type":"Notice","volume":81}