{"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 October, November, and December 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.","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/2023/03/20/2023-05465.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},{"chapter":null,"citation_url":null,"part":"526","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":"88 FR 16543","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 20, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-0002"],"dockets":[{"supporting_documents":[{"title":"FONSI sN 141-450 approved December 2 2022","document_id":"FDA-2022-N-0002-0049"},{"title":"FOI Summary sN 141-529 approved December 2 2022","document_id":"FDA-2022-N-0002-0048"},{"title":"FOI Summary sA 200-377 approved December 2 2022","document_id":"FDA-2022-N-0002-0045"},{"title":"FOI Summary oN 141-566 approved December 8 2022","document_id":"FDA-2022-N-0002-0043"},{"title":"FOI Summary oN 141-559 approved December 20 2022","document_id":"FDA-2022-N-0002-0042"},{"title":"FOI Summary oA 200-730 approved November 4 2022","document_id":"FDA-2022-N-0002-0041"},{"title":"EAsN 141-450 approved December 23 2022","document_id":"FDA-2022-N-0002-0040"},{"title":"FONSI sN 141-348 approved July 18, 2022","document_id":"FDA-2022-N-0002-0038"},{"title":"FOI Summary sN 141-348 approved July 18, 2022","document_id":"FDA-2022-N-0002-0034"},{"title":"FOI Summary oN 141-565 approved August 11, 2022","document_id":"FDA-2022-N-0002-0032"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-03-20","updated_at":"2023-03-20T09:56:18.061-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-0002-0050","allow_late_comments":null,"id":"FDA-2022-N-0002-0050","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":46,"id":"FDA-2022-N-0002","title":"NADA/ANADA Notices"}],"document_number":"2023-05465","effective_on":"2023-03-20","end_page":16550,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/03/20/2023-05465.xml","html_url":"https://www.federalregister.gov/documents/2023/03/20/2023-05465/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-05465?publication_date=2023-03-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-03-20/2023-05465/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":1270,"last_updated":"2026-07-28 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-20/pdf/2023-05465.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-05465.pdf?1679057118","publication_date":"2023-03-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/03/20/2023-05465.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FONSI sN 141-450 approved December 2 2022","document_id":"FDA-2022-N-0002-0049"},{"title":"FOI Summary sN 141-529 approved December 2 2022","document_id":"FDA-2022-N-0002-0048"},{"title":"FOI Summary sA 200-377 approved December 2 2022","document_id":"FDA-2022-N-0002-0045"},{"title":"FOI Summary oN 141-566 approved December 8 2022","document_id":"FDA-2022-N-0002-0043"},{"title":"FOI Summary oN 141-559 approved December 20 2022","document_id":"FDA-2022-N-0002-0042"},{"title":"FOI Summary oA 200-730 approved November 4 2022","document_id":"FDA-2022-N-0002-0041"},{"title":"EAsN 141-450 approved December 23 2022","document_id":"FDA-2022-N-0002-0040"},{"title":"FONSI sN 141-348 approved July 18, 2022","document_id":"FDA-2022-N-0002-0038"},{"title":"FOI Summary sN 141-348 approved July 18, 2022","document_id":"FDA-2022-N-0002-0034"},{"title":"FOI Summary oN 141-565 approved August 11, 2022","document_id":"FDA-2022-N-0002-0032"}],"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-N-0002","supporting_documents_count":46,"docket_id":"FDA-2022-N-0002","document_id":"FDA-2022-N-0002-0050","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2023-03-21T13:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16543,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor","toc_doc":"New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor","toc_subject":null,"topics":["Administrative practice and procedure","Animal drugs","Confidential business information","Dairy products","Foods","Labeling","Meat and meat products","Reporting and recordkeeping requirements"],"type":"Rule","volume":88}