{"abstract":"The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 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 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/2017/12/13/2017-26753.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":"82 FR 58554","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 13, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-0002"],"dockets":[],"document_number":"2017-26753","effective_on":"2017-12-13","end_page":58557,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/12/13/2017-26753.xml","html_url":"https://www.federalregister.gov/documents/2017/12/13/2017-26753/new-animal-drugs-approval-of-new-animal-drug-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-26753?publication_date=2017-12-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-12-13/2017-26753/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":641,"last_updated":"2026-08-23 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-12-13/pdf/2017-26753.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-26753.pdf?1513086324","publication_date":"2017-12-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/12/13/2017-26753.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":"2018-01-02T06:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":58554,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications","toc_doc":"Approval of New Animal Drug Applications","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":82}