{"abstract":"The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled \"New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.\" The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.","action":"Proposed rule; supplemental 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/2016/10/28/2016-26043.html","cfr_references":[{"chapter":null,"citation_url":null,"part":514,"title":21},{"chapter":null,"citation_url":null,"part":556,"title":21}],"citation":"81 FR 74962","comment_url":null,"comments_close_on":"2016-12-27","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this proposed rule by December 27, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-1067"],"dockets":[{"supporting_documents":[{"title":"Reference 2 - FDA, ``Draft Guidance for Industry #232: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) re New Animal Drugs; Updating Tolerances for Residues of New ","document_id":"FDA-2012-N-1067-0010"},{"title":"Reference 1 -  International Programme on Chemical Safety, ``Environmental Health Criteria 240, Principals and Methods for the Risk Assessmet  of Chemicals in Food,'' 2009 re New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food","document_id":"FDA-2012-N-1067-0009"}],"agency_name":"FDA","documents":[{"comment_count":7,"comment_start_date":"2016-10-28","updated_at":"2023-02-28T15:54:53.016-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2012-N-1067-0008","allow_late_comments":null,"id":"FDA-2012-N-1067-0008","comment_end_date":"2016-12-28","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2012-N-1067","title":"New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food"}],"document_number":"2016-26043","effective_on":null,"end_page":74966,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/10/28/2016-26043.xml","html_url":"https://www.federalregister.gov/documents/2016/10/28/2016-26043/new-animal-drugs-updating-tolerances-for-residues-of-new-animal-drugs-in-food","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-26043?publication_date=2016-10-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-10-28/2016-26043/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":934,"last_updated":"2026-09-22 10:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-28/pdf/2016-26043.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-26043.pdf?1477572338","publication_date":"2016-10-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/10/28/2016-26043.txt","regulation_id_number_info":{"0910-AG17":{"issue":"201904","html_url":"https://www.federalregister.gov/regulations/0910-AG17/new-animal-drugs-updating-tolerances-for-residues-of-new-animal-drugs-in-food","title":"New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0910-AG17&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AG17"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 2 - FDA, ``Draft Guidance for Industry #232: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) re New Animal Drugs; Updating Tolerances for Residues of New ","document_id":"FDA-2012-N-1067-0010"},{"title":"Reference 1 -  International Programme on Chemical Safety, ``Environmental Health Criteria 240, Principals and Methods for the Risk Assessmet  of Chemicals in Food,'' 2009 re New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food","document_id":"FDA-2012-N-1067-0009"}],"comments_count":7,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-1067","supporting_documents_count":2,"docket_id":"FDA-2012-N-1067","document_id":"FDA-2012-N-1067-0008","regulation_id_number":null,"title":"New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food","checked_regulationsdotgov_at":"2023-02-28T20:54:52Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":74962,"subtype":null,"title":"New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food","toc_doc":"Updating Tolerances for Residues of New Animal Drugs in Food","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Confidential business information","Foods","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":81}