{"abstract":"The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2013. FDA is also informing the public of the availability of summaries on the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.","action":"Final rule.","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/2013/11/05/2013-26473.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":558,"title":21}],"citation":"78 FR 66263","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective November 5, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0002"],"dockets":[],"document_number":"2013-26473","effective_on":"2013-11-05","end_page":66265,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/11/05/2013-26473.xml","html_url":"https://www.federalregister.gov/documents/2013/11/05/2013-26473/new-animal-drugs-afoxolaner-carprofen-ceftiofur-hydrochloride-monensin","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-26473?publication_date=2013-11-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-11-05/2013-26473/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1731,"last_updated":"2026-07-26 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-11-05/pdf/2013-26473.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-26473.pdf?1383572978","publication_date":"2013-11-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/11/05/2013-26473.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FREEDOM OF INFORMATION SUMMARY NADA 130-185\nAMPROL 25% and FLAVOMYCIN Amprolium and Bambermycins","document_id":"FDA-2013-N-0002-0055"},{"title":"FREEDOM OF INFORMATION SUMMARY Application Number 141-422\nPACCAL VET-CA1 Paclitaxel for injection Powder for Injection Dog","document_id":"FDA-2013-N-0002-0054"},{"title":"FREEDOM OF INFORMATION SUMMARY  NADA141-420 TILDREN\ntiludronate disodium Powder for injection Horse","document_id":"FDA-2013-N-0002-0053"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-361\nPULMOTIL AC Tilmicosin Phosphate Aqueous Concentrate\nSwine","document_id":"FDA-2013-N-0002-0052"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-246 AQUAFLOR\nFlorfenicol","document_id":"FDA-2013-N-0002-0051"},{"title":"Freedom of Information Summary NADA 141-288 EXCENEL RTU EZ Ceftiofur Hydrochloride","document_id":"FDA-2013-N-0002-0037"},{"title":"Freedom of Information Summary NADA 095-735 RUMENSIN 90 Monensin","document_id":"FDA-2013-N-0002-0036"},{"title":"Freedom of Information Summary NADA 141-406 NEXGARD Afoxolaner Chewable Tablet","document_id":"FDA-2013-N-0002-0035"},{"title":"Freedom of Information Summary ANADA 200-548 ACTOGAIN 45 Ractopamine Hydrochloride Cattle fed in confinement for slaughter","document_id":"FDA-2013-N-0002-0033"},{"title":"Freedom of Information Summary ANADA 200-542 ENGAIN 9 and ENGAIN 5 Ractopamine Hydrochloride Finishing Swine","document_id":"FDA-2013-N-0002-0032"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0002","supporting_documents_count":26,"docket_id":"FDA-2013-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2013-11-25T06:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66263,"subtype":null,"title":"New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin","toc_doc":"Afoxolaner, Carprofen, Ceftiofur Hydrochloride, Monensin","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":78}