{"abstract":"The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.","action":"Final rule; technical amendments.","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/2025/05/09/2025-08137.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"510","title":21},{"chapter":null,"citation_url":null,"part":"516","title":21},{"chapter":null,"citation_url":null,"part":"520","title":21},{"chapter":null,"citation_url":null,"part":"522","title":21},{"chapter":null,"citation_url":null,"part":"524","title":21}],"citation":"90 FR 19623","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 9, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-0002"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-05-09","updated_at":"2025-05-20T13:56:46.628-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-0002-0001","allow_late_comments":false,"id":"FDA-2025-N-0002-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-0002","title":"NADA/ANADA Notices"}],"document_number":"2025-08137","effective_on":"2025-05-09","end_page":19625,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/05/09/2025-08137.xml","html_url":"https://www.federalregister.gov/documents/2025/05/09/2025-08137/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-08137?publication_date=2025-05-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-05-09/2025-08137/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":374,"last_updated":"2026-08-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-09/pdf/2025-08137.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08137.pdf?1746708318","publication_date":"2025-05-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/05/09/2025-08137.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-N-0002","supporting_documents_count":0,"docket_id":"FDA-2025-N-0002","document_id":"FDA-2025-N-0002-0001","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2025-05-22T18:55:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19623,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor","toc_doc":"Approval of New Animal Drug Applications, Withdrawal of Approval of New Animal Drug Application, Change of Sponsor; Technical Amendments","toc_subject":"New Animal Drugs","topics":["Administrative practice and procedure","Animal drugs","Confidential business information","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":90}