{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry (GFI) #299 entitled \"Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication.\" This guidance is intended to inform new animal drug sponsors that dual labeling of a new animal drug product may include an intended use that is fully approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and an intended use that is conditionally approved under section 571 of the FD&C Act where the claim to be added to the existing product labeling is intended to treat or prevent New World screwworm myiasis.","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/2025/10/16/2025-19565.html","cfr_references":[],"citation":"90 FR 48313","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 16, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-D-4500"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-10-16","updated_at":"2025-10-16T08:55:56.875-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-4500-0001","allow_late_comments":false,"id":"FDA-2025-D-4500-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-4500","title":"Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication; Guidance for Industry; Availability"}],"document_number":"2025-19565","effective_on":null,"end_page":48314,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/10/16/2025-19565.xml","html_url":"https://www.federalregister.gov/documents/2025/10/16/2025-19565/dual-labeling-for-fully-approved-and-conditionally-approved-new-animal-drugs-with-a-new-world","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-19565?publication_date=2025-10-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-10-16/2025-19565/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":362,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-10-16/pdf/2025-19565.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19565.pdf?1760532306","publication_date":"2025-10-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/10/16/2025-19565.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-2025-D-4500","supporting_documents_count":0,"docket_id":"FDA-2025-D-4500","document_id":"FDA-2025-D-4500-0001","regulation_id_number":null,"title":"Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication; Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-10-17T15:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48313,"subtype":null,"title":"Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability","toc_doc":"Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}