{"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) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2023. 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/2024/02/27/2024-03765.html","cfr_references":[{"chapter":null,"citation_url":null,"part":510,"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},{"chapter":null,"citation_url":null,"part":529,"title":21},{"chapter":null,"citation_url":null,"part":556,"title":21},{"chapter":null,"citation_url":null,"part":558,"title":21}],"citation":"89 FR 14407","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective February 27, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-0002"],"dockets":[{"supporting_documents":[{"title":"FOI Summary sN 038-439, approved April 10, 2023","document_id":"FDA-2023-N-0002-0029"},{"title":"FOI Summary oN 141-571, approved May 1, 2023","document_id":"FDA-2023-N-0002-0028"},{"title":"FOI Summary oN 141-562, approved May 5, 2023","document_id":"FDA-2023-N-0002-0026"},{"title":"FOI Summary oN 141-555, approved June 9, 2023","document_id":"FDA-2023-N-0002-0025"},{"title":"FOI Summary oA 200-751, approved June 22, 2023","document_id":"FDA-2023-N-0002-0024"},{"title":"FOI Summary oA 200-750, approved May 25, 2023","document_id":"FDA-2023-N-0002-0023"},{"title":"FOI Summary oA 200-748, approved May 10, 2023","document_id":"FDA-2023-N-0002-0022"},{"title":"FOI Summary Supplemental New Animal Drug Application 141-426 - Approved January 12, 2023","document_id":"FDA-2023-N-0002-0019"},{"title":"FOI Summary Supplemental Abbreviated New Animal Drug Application 200-721 - Approved January 12, 2023","document_id":"FDA-2023-N-0002-0018"},{"title":"FOI Summary Supplemental Abbreviated New Animal Drug Application 200-701 - Approved February 9, 2023","document_id":"FDA-2023-N-0002-0017"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-02-27","updated_at":"2024-02-27T09:57:44.152-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-0002-0032","allow_late_comments":null,"id":"FDA-2023-N-0002-0032","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":28,"id":"FDA-2023-N-0002","title":"NADA/ANADA Notices"}],"document_number":"2024-03765","effective_on":"2024-02-27","end_page":14412,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/02/27/2024-03765.xml","html_url":"https://www.federalregister.gov/documents/2024/02/27/2024-03765/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/2024-03765?publication_date=2024-02-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-02-27/2024-03765/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":713,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-27/pdf/2024-03765.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-03765.pdf?1708955113","publication_date":"2024-02-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/02/27/2024-03765.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FOI Summary sN 038-439, approved April 10, 2023","document_id":"FDA-2023-N-0002-0029"},{"title":"FOI Summary oN 141-571, approved May 1, 2023","document_id":"FDA-2023-N-0002-0028"},{"title":"FOI Summary oN 141-562, approved May 5, 2023","document_id":"FDA-2023-N-0002-0026"},{"title":"FOI Summary oN 141-555, approved June 9, 2023","document_id":"FDA-2023-N-0002-0025"},{"title":"FOI Summary oA 200-751, approved June 22, 2023","document_id":"FDA-2023-N-0002-0024"},{"title":"FOI Summary oA 200-750, approved May 25, 2023","document_id":"FDA-2023-N-0002-0023"},{"title":"FOI Summary oA 200-748, approved May 10, 2023","document_id":"FDA-2023-N-0002-0022"},{"title":"FOI Summary Supplemental New Animal Drug Application 141-426 - Approved January 12, 2023","document_id":"FDA-2023-N-0002-0019"},{"title":"FOI Summary Supplemental Abbreviated New Animal Drug Application 200-721 - Approved January 12, 2023","document_id":"FDA-2023-N-0002-0018"},{"title":"FOI Summary Supplemental Abbreviated New Animal Drug Application 200-701 - Approved February 9, 2023","document_id":"FDA-2023-N-0002-0017"}],"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-N-0002","supporting_documents_count":28,"docket_id":"FDA-2023-N-0002","document_id":"FDA-2023-N-0002-0032","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2024-02-28T14:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14407,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address","toc_doc":"Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address","toc_subject":"New Animal Drugs:\n","topics":["Administrative practice and procedure","Animal drugs","Animal feeds","Foods","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":89}