{"abstract":"The Food and Drug Administration (FDA) 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 November and December 2015. FDA is also 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 changes of sponsorship of applications that occurred in November and December 2015.","action":"Final rule; technical amendment.","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/2016/03/30/2016-07135.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":528,"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":"81 FR 17604","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":["https://www.federalregister.gov/api/v1/documents/C1-2016-07135"],"dates":"This rule is effective March 30, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0002"],"dockets":[],"document_number":"2016-07135","effective_on":"2016-03-30","end_page":17610,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/03/30/2016-07135.xml","html_url":"https://www.federalregister.gov/documents/2016/03/30/2016-07135/new-animal-drugs-approval-of-new-animal-drug-applications-changes-of-sponsorship","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-07135?publication_date=2016-03-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-03-30/2016-07135/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":1447,"last_updated":"2026-08-23 18:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-03-30/pdf/2016-07135.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-07135.pdf?1459271777","publication_date":"2016-03-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/03/30/2016-07135.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FONSI for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0069"},{"title":"FONSI for  oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0068"},{"title":"FOI Summary for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0067"},{"title":"FOI Summary for sN 141-258, approved December 2, 2015","document_id":"FDA-2015-N-0002-0066"},{"title":"FOI Summary for oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0065"},{"title":"EA for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0064"},{"title":"EA for oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0063"},{"title":"Finding of No Significant Impact (FONSI) for SAFE-GUARD AQUASOL\n(fenbendazole oral suspension) in\nChickens","document_id":"FDA-2015-N-0002-0056"},{"title":"FREEDOM OF INFORMATION SUMMARY  NADA 141-442 LUTALYSE HighCon Injection Dinoprost Tromethamine Injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers","document_id":"FDA-2015-N-0002-0055"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-449 SAFE-GUARD AquaSol Fenbendazole oral suspension Broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens","document_id":"FDA-2015-N-0002-0054"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0002","supporting_documents_count":51,"docket_id":"FDA-2015-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2016-04-19T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17604,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","toc_doc":"Approval of New Animal Drug Applications; Changes of Sponsorship","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Foods","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}