{"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 April, May, and June 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 make technical amendments 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/2018/12/18/2018-27238.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":556,"title":21},{"chapter":null,"citation_url":null,"part":558,"title":21}],"citation":"83 FR 64738","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 18, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-0002"],"dockets":[],"document_number":"2018-27238","effective_on":"2018-12-18","end_page":64744,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/18/2018-27238.xml","html_url":"https://www.federalregister.gov/documents/2018/12/18/2018-27238/new-animal-drugs-approval-of-new-animal-drug-applications-changes-of-sponsorship-change-of-a","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-27238?publication_date=2018-12-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-18/2018-27238/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":811,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-18/pdf/2018-27238.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-27238.pdf?1545054318","publication_date":"2018-12-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/18/2018-27238.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":"2019-01-07T11:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":64738,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address","toc_doc":"Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Foods","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":83}