{"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 2020. 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/2021/03/08/2021-04453.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":"86 FR 13181","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 8, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-0002"],"dockets":[],"document_number":"2021-04453","effective_on":"2021-03-08","end_page":13191,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/03/08/2021-04453.xml","html_url":"https://www.federalregister.gov/documents/2021/03/08/2021-04453/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-04453?publication_date=2021-03-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-03-08/2021-04453/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":2374,"last_updated":"2026-04-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-08/pdf/2021-04453.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-04453.pdf?1614951926","publication_date":"2021-03-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/03/08/2021-04453.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FOI Summary sN 132-872 approved March 24 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0046"},{"title":"FOI Summary sA 200-466 approved February 8 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0045"},{"title":"FOI Summary oN 141-540 Approved February 26 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0044"},{"title":"FOI Summary oN 141-530 approved March 15 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0041"},{"title":"FOI Summary oA 200-684 approved February 1 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0037"},{"title":"FOI Summary oA 200-683 approved February 1 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0036"},{"title":"FOI Summary oA 200-676 approved January 12 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0033"},{"title":"FOI Summary oA 200-675 approved January 12 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0032"},{"title":"FOI Summary cN 200 506 approved February 16 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0028"},{"title":"FOI Summary cN 141 544 approved January 14 2021 re New Animal Drugs; Approval of New Animal Drug Applications","document_id":"FDA-2020-N-0002-0027"}],"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-2020-N-0002","supporting_documents_count":42,"docket_id":"FDA-2020-N-0002","document_id":"FDA-2020-N-0002-0011","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2021-03-09T04:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13181,"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","Animal feeds","Confidential business information","Foods","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":86}