{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled \"Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2).\" This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of genotoxicity testing of veterinary drug residues.","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/2026/09/02/2026-17928.html","cfr_references":[],"citation":"91 FR 56454","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 2, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2000-D-0598"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-02","updated_at":"2026-09-02T09:57:09.848-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2000-D-0598-0018","allow_late_comments":false,"id":"FDA-2000-D-0598-0018","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2000-D-0598","title":"Genotoxicity Studies (VICH GL23)"}],"document_number":"2026-17928","effective_on":null,"end_page":56455,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/02/2026-17928.xml","html_url":"https://www.federalregister.gov/documents/2026/09/02/2026-17928/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-17928?publication_date=2026-09-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-02/2026-17928/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":184,"last_updated":"2026-10-24 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17928.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17928.pdf?1788266710","publication_date":"2026-09-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/02/2026-17928.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2000-D-0598","supporting_documents_count":0,"docket_id":"FDA-2000-D-0598","document_id":"FDA-2000-D-0598-0018","regulation_id_number":null,"title":"Genotoxicity Studies (VICH GL23)","checked_regulationsdotgov_at":"2026-09-03T17:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56454,"subtype":null,"title":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability","toc_doc":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing; Revision 2","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}