{"abstract":"The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.","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/2015/12/22/2015-32000.html","cfr_references":[{"chapter":null,"citation_url":null,"part":558,"title":21}],"citation":"80 FR 79474","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 22, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0002"],"dockets":[],"document_number":"2015-32000","effective_on":"2015-12-22","end_page":79476,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/12/22/2015-32000.xml","html_url":"https://www.federalregister.gov/documents/2015/12/22/2015-32000/new-animal-drugs-for-use-in-animal-feeds-bacitracin-methylenedisalicylate","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-32000?publication_date=2015-12-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-12-22/2015-32000/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":598,"last_updated":"2026-08-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-12-22/pdf/2015-32000.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-32000.pdf?1450705531","publication_date":"2015-12-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/12/22/2015-32000.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":"2016-01-11T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":79474,"subtype":null,"title":"New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate","toc_doc":"Bacitracin Methylenedisalicylate","toc_subject":"New Animal Drugs for Use in Animal Feeds:","topics":["Animal drugs"],"type":"Rule","volume":80}