{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.\" This draft guidance provides recommendations to applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nonprescription drug products on documenting minor labeling changes in the next annual report and provides examples of minor labeling changes that may be submitted in an annual report. The recommendations in this draft guidance address the types of minor labeling changes that may be appropriate to submit in an annual report to ensure that consumers have timely access to the most current labeling for a nonprescription drug product to ensure the product's safe and effective use. We anticipate that these recommendations may assist industry in understanding the circumstances in which it would be appropriate to document minor changes in the applicant's next annual report rather than submitting a prior approval supplement or \"changes being effected\" supplement, thereby reducing burden on industry and FDA.","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/2024/03/13/2024-05293.html","cfr_references":[],"citation":"89 FR 18418","comment_url":null,"comments_close_on":"2024-05-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by May 13, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-5616"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-03-13T09:56:16.362-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-5616-0001","allow_late_comments":null,"id":"FDA-2023-D-5616-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-5616","title":"Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products; Draft Guidance for Industry; Availability"}],"document_number":"2024-05293","effective_on":null,"end_page":18420,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/13/2024-05293.xml","html_url":"https://www.federalregister.gov/documents/2024/03/13/2024-05293/annual-reportable-labeling-changes-for-new-drug-applications-and-abbreviated-new-drug-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-05293?publication_date=2024-03-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-13/2024-05293/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1371,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-13/pdf/2024-05293.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-05293.pdf?1710247520","publication_date":"2024-03-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/13/2024-05293.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-2023-D-5616","supporting_documents_count":0,"docket_id":"FDA-2023-D-5616","document_id":"FDA-2023-D-5616-0001","regulation_id_number":null,"title":"Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-03-14T13:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":18418,"subtype":null,"title":"Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products; Draft Guidance for Industry; Availability","toc_doc":"Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}