{"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 January, February, and March 2018. 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 reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name, and to make technical amendments to improve the accuracy 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/2018/09/28/2018-21146.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":"83 FR 48940","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 28, 2018, except for amendatory instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR 520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR 522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR 558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-0002"],"dockets":[],"document_number":"2018-21146","effective_on":"2018-09-28","end_page":48950,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/09/28/2018-21146.xml","html_url":"https://www.federalregister.gov/documents/2018/09/28/2018-21146/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/2018-21146?publication_date=2018-09-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-09-28/2018-21146/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":1031,"last_updated":"2026-07-25 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-09-28/pdf/2018-21146.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-21146.pdf?1538052327","publication_date":"2018-09-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/09/28/2018-21146.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-0002","supporting_documents_count":0,"docket_id":"FDA-2018-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2018-10-18T10:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48940,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name","toc_doc":"Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Foods","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":83}