{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry (GFI <greek-i>116) entitled \"Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing\" (VICH GL23(R)). This draft revised guidance is a revision of a final guidance on the same topic for which a notice of availability was published in the Federal Register of January 4, 2002, and has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In this draft revised VICH guidance the recommendation for a second test to evaluate the potential of a chemical to produce chromosomal effects is being revised. The draft revised guidance indicates that the potential of a chemical to produce chromosomal effects can be evaluated using one of the the following three tests: An in vitro chromosomal aberrations test using metaphase analysis, which detects both clastogenicity and aneugenicity; an in vitro mammalian cell micronucleus test, which detects the activity of clastogenicity and aneugenicity; or a mouse lymphoma test, which, with modification, can detect both gene mutation and chromosomal damage. This draft revised VICH guidance document is intended to facilitate the mutual acceptance of safety data necessary for the establishment of acceptable daily intakes for veterinary drug residues in human food by the relevant regulatory authorities.","action":"Notice.","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/2013/03/05/2013-05014.html","cfr_references":[],"citation":"78 FR 14306","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft revised guidance before it begins work on the final version of the revised guidance, submit either electronic or written comments on the draft revised guidance by May 6, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2000-D-0598"],"dockets":[],"document_number":"2013-05014","effective_on":null,"end_page":14308,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/03/05/2013-05014.xml","html_url":"https://www.federalregister.gov/documents/2013/03/05/2013-05014/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-05014?publication_date=2013-03-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-03-05/2013-05014/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":73,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-03-05/pdf/2013-05014.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-05014.pdf?1362405317","publication_date":"2013-03-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/03/05/2013-05014.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-2000-D-0598","supporting_documents_count":0,"docket_id":"FDA-2000-D-0598","regulation_id_number":null,"title":"Genotoxicity Studies (VICH GL23)","checked_regulationsdotgov_at":"2013-05-08T05:00:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14306,"subtype":null,"title":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on “Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing” (VICH GL23(R)); Availability","toc_doc":"Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food; Genotoxicity Testing","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}