{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry #231 entitled \"Distributor Labeling for New Animal Drugs.\" This guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a new animal drug application or abbreviated new animal drug application in ways other than those permitted by regulation.","action":"Notice of availability.","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/2016/04/20/2016-09141.html","cfr_references":[],"citation":"81 FR 23307","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-3056"],"dockets":[],"document_number":"2016-09141","effective_on":null,"end_page":23308,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/04/20/2016-09141.xml","html_url":"https://www.federalregister.gov/documents/2016/04/20/2016-09141/distributor-labeling-for-new-animal-drugs-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-09141?publication_date=2016-04-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-04-20/2016-09141/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":133,"last_updated":"2026-09-22 06:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-04-20/pdf/2016-09141.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-09141.pdf?1461069996","publication_date":"2016-04-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/04/20/2016-09141.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-3056","supporting_documents_count":0,"docket_id":"FDA-2015-D-3056","regulation_id_number":null,"title":"Distributor Labeling for New Animal Drugs","checked_regulationsdotgov_at":"2016-05-10T06:00:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23307,"subtype":null,"title":"Distributor Labeling for New Animal Drugs; Guidance for Industry; Availability","toc_doc":"Distributor Labeling for New Animal Drugs","toc_subject":"Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":81}