{"abstract":"The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.","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/2017/02/24/2017-03596.html","cfr_references":[{"chapter":null,"citation_url":null,"part":558,"title":21}],"citation":"82 FR 11510","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective February 24, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0002"],"dockets":[],"document_number":"2017-03596","effective_on":"2017-02-24","end_page":11513,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/02/24/2017-03596.xml","html_url":"https://www.federalregister.gov/documents/2017/02/24/2017-03596/new-animal-drugs-for-use-in-animal-feed-approval-of-new-animal-drug-applications-withdrawal-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-03596?publication_date=2017-02-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-02-24/2017-03596/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":580,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-02-24/pdf/2017-03596.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-03596.pdf?1487857544","publication_date":"2017-02-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/02/24/2017-03596.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":"2017-03-16T06:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11510,"subtype":null,"title":"New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications","toc_doc":"Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications","toc_subject":"New Animal Drugs:","topics":["Animal drugs","Animal feeds"],"type":"Rule","volume":82}