{"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 2019. 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 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/2020/04/01/2020-06688.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"500","title":21},{"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":"526","title":21},{"chapter":null,"citation_url":null,"part":"556","title":21},{"chapter":null,"citation_url":null,"part":"558","title":21}],"citation":"85 FR 18114","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 30, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-0002"],"dockets":[],"document_number":"2020-06688","effective_on":"2020-03-30","end_page":18125,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/04/01/2020-06688.xml","html_url":"https://www.federalregister.gov/documents/2020/04/01/2020-06688/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/2020-06688?publication_date=2020-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-04-01/2020-06688/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":1460,"last_updated":"2026-08-23 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-04-01/pdf/2020-06688.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-06688.pdf?1585572348","publication_date":"2020-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/04/01/2020-06688.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FOI Summary oA 200-651, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0029"},{"title":"FOI Summary oA 200-650, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0028"},{"title":"FOI Summary oA 200-649, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0027"},{"title":"FOI Summary oA 200-648, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0026"},{"title":"FOI Summary oA 200-647, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0025"},{"title":"FOI Summary oA 200-646, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0024"},{"title":"FOI Summary oA 200-645, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0023"},{"title":"FOI Summary oA 200-644, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0022"},{"title":"FOI Summary oA 200-643, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0021"},{"title":"FOI Summary oA 200-642, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address","document_id":"FDA-2019-N-0002-0020"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-0002","supporting_documents_count":25,"docket_id":"FDA-2019-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2020-04-03T03:30:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":18114,"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 Sponsors' Name and Addresses","toc_doc":null,"toc_subject":null,"topics":["Animal drugs","Cancer","Foods","Incorporation by reference","Labeling","Packaging and containers","Polychlorinated biphenyls (PCB's)"],"type":"Rule","volume":85}