{"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 July, August, and September 2017. 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 address, 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/2018/03/30/2018-06358.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 13632","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-0002"],"dockets":[],"document_number":"2018-06358","effective_on":"2018-03-30","end_page":13637,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/03/30/2018-06358.xml","html_url":"https://www.federalregister.gov/documents/2018/03/30/2018-06358/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/2018-06358?publication_date=2018-03-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-03-30/2018-06358/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":592,"last_updated":"2026-07-27 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-03-30/pdf/2018-06358.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-06358.pdf?1522327521","publication_date":"2018-03-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/03/30/2018-06358.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FONSI oN 141-450 Approved July 21 2017","document_id":"FDA-2017-N-0002-0018"},{"title":"FOI Summary sN-141-333 Approved September 28 2017","document_id":"FDA-2017-N-0002-0017"},{"title":"FOI Summary sN 141-336 Approved July 19 2017","document_id":"FDA-2017-N-0002-0016"},{"title":"FOI Summary oN 141-450 Approved July 21 2017","document_id":"FDA-2017-N-0002-0015"},{"title":"FOI Summary oA 200-621 Approved July 14 2017","document_id":"FDA-2017-N-0002-0014"},{"title":"FOI Summary oA 200-620 Approved July 14 2017","document_id":"FDA-2017-N-0002-0013"},{"title":"EA oN 141-450 Approved July 21 2017","document_id":"FDA-2017-N-0002-0012"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-0002","supporting_documents_count":7,"docket_id":"FDA-2017-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2018-04-19T10:00:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13632,"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 and Address","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 and Address","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Foods","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":83}