{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled \"Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.\" This guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the- counter (OTC) monograph drugs or organizations nominated by sponsors or requestors to represent their interests in a proceeding and discusses the procedures and principles for these formal meetings. This guidance finalizes the draft guidance of the same title issued on February 7, 2022. FDA is required to issue this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act).","action":"Notice of availability.","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/2026/07/14/2026-14120.html","cfr_references":[],"citation":"91 FR 43098","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 14, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-0080"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-07-14","updated_at":"2026-07-14T09:58:07.573-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0080-0007","allow_late_comments":false,"id":"FDA-2022-D-0080-0007","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-0080","title":"Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability"}],"document_number":"2026-14120","effective_on":null,"end_page":43100,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/07/14/2026-14120.xml","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14120/formal-meetings-between-fda-and-sponsors-or-requestors-of-over-the-counter-monograph-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-14120?publication_date=2026-07-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-07-14/2026-14120/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":362,"last_updated":"2026-09-22 10:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14120.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14120.pdf?1783946712","publication_date":"2026-07-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/07/14/2026-14120.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-2022-D-0080","supporting_documents_count":0,"docket_id":"FDA-2022-D-0080","document_id":"FDA-2022-D-0080-0007","regulation_id_number":null,"title":"Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-07-15T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43098,"subtype":null,"title":"Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs","toc_doc":"Formal Meetings between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}