{"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 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. Technical amendments are also being made to improve the accuracy, consistency, 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/2019/08/09/2019-16884.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":558,"title":21}],"citation":"84 FR 39179","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 9, 2019, except for amendatory instructions 51 to 21 CFR 524.916 and 63 to 21 CFR 558.325, which are effective August 19, 2019, and instruction 60 to 21 CFR 558.235, which is effective September 9, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-0002"],"dockets":[],"document_number":"2019-16884","effective_on":"2019-08-09","end_page":39187,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/08/09/2019-16884.xml","html_url":"https://www.federalregister.gov/documents/2019/08/09/2019-16884/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/2019-16884?publication_date=2019-08-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-08-09/2019-16884/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":1685,"last_updated":"2026-07-27 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-08-09/pdf/2019-16884.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-16884.pdf?1565268317","publication_date":"2019-08-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/08/09/2019-16884.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":"2019-08-12T08:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":39179,"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 Sponsors' Names and Addresses","toc_doc":"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors' Names and Addresses","toc_subject":null,"topics":["Administrative practice and procedure","Animal drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":84}