{"abstract":"The Food and Drug Administration (FDA, 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 and August 2016. 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 a change of a sponsor's address.","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/2016/09/30/2016-23230.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":529,"title":21},{"chapter":null,"citation_url":null,"part":558,"title":21}],"citation":"81 FR 67149","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 30, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0002"],"dockets":[],"document_number":"2016-23230","effective_on":"2016-09-30","end_page":67153,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/09/30/2016-23230.xml","html_url":"https://www.federalregister.gov/documents/2016/09/30/2016-23230/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsors-address","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-23230?publication_date=2016-09-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-09-30/2016-23230/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":459,"last_updated":"2026-07-25 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-09-30/pdf/2016-23230.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-23230.pdf?1475153133","publication_date":"2016-09-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/09/30/2016-23230.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FOI Summary sN 141-452 approved December 12 2016","document_id":"FDA-2016-N-0002-0046"},{"title":"FOI Summary sN 141-443, approved November 16, 2016","document_id":"FDA-2016-N-0002-0045"},{"title":"FOI Summary oN 141-475 approved December 29 2016","document_id":"FDA-2016-N-0002-0044"},{"title":"FOI Summary oN 141-474 approved November 10 2016","document_id":"FDA-2016-N-0002-0043"},{"title":"FOI Summary oN 141-473 approved December 16 2016","document_id":"FDA-2016-N-0002-0042"},{"title":"FOI Summary oA 200-589 approved December 21 2016","document_id":"FDA-2016-N-0002-0041"},{"title":"FOI Summary oA 200-596, approved May 24, 2016 re  New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0027"},{"title":"FOI Summary oN 141-463, approved May 17, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0026"},{"title":"FOI Summary oN 141-457, approved May 16, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0025"},{"title":"FOI Summary oN 141-439, approved May 2, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0024"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-0002","supporting_documents_count":27,"docket_id":"FDA-2016-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2016-10-20T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67149,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address","toc_doc":"Approval of New Animal Drug Applications; Change of Sponsor's Address","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}