{"abstract":"The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.","action":"Advance notice of proposed rulemaking.","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/2012/07/27/2012-18366.html","cfr_references":[{"chapter":null,"citation_url":null,"part":514,"title":21}],"citation":"77 FR 44177","comment_url":null,"comments_close_on":"2012-09-25","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments by September 25, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0447"],"dockets":[],"document_number":"2012-18366","effective_on":null,"end_page":44179,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/07/27/2012-18366.xml","html_url":"https://www.federalregister.gov/documents/2012/07/27/2012-18366/antimicrobial-animal-drug-sales-and-distribution-reporting","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-18366?publication_date=2012-07-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-07-27/2012-18366/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":299,"last_updated":"2026-07-26 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-07-27/pdf/2012-18366.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-18366.pdf?1343307341","publication_date":"2012-07-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/07/27/2012-18366.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Antimicrobial Animal Drug Sales and Distribution Reporting Final Regulatory Impact Analysis","document_id":"FDA-2012-N-0447-0110"},{"title":"Congresswoman Slaughter's Letter to FDA","document_id":"FDA-2012-N-0447-0109"},{"title":"FDA PRIA Antimicrobial Animal Drug Sales and Distribution Reporting","document_id":"FDA-2012-N-0447-0069"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG45/reports-of-distribution-and-sales-information-for-antimicrobial-active-ingredients-used-in-food-prod","title":"Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0447","supporting_documents_count":3,"docket_id":"FDA-2012-N-0447","regulation_id_number":"0910-AG45","title":"Antimicrobial Animal Drug Sales and Distribution Reporting","checked_regulationsdotgov_at":"2012-09-27T05:00:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44177,"subtype":null,"title":"Antimicrobial Animal Drug Sales and Distribution Reporting","toc_doc":"Antimicrobial Animal Drug Sales and Distribution Reporting","toc_subject":null,"topics":[],"type":"Proposed Rule","volume":77}