{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #115 (VICH GL22(R)) titled \"Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).\" 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 reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food.","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/2026/09/02/2026-17927.html","cfr_references":[],"citation":"91 FR 56451","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-0784"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-02","updated_at":"2026-09-02T09:56:42.297-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2000-D-0784-0007","allow_late_comments":false,"id":"FDA-2000-D-0784-0007","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2000-D-0784","title":"Safety Studies for Veterinary Drug Residues in Human Food"}],"document_number":"2026-17927","effective_on":null,"end_page":56452,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/02/2026-17927.xml","html_url":"https://www.federalregister.gov/documents/2026/09/02/2026-17927/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-17927?publication_date=2026-09-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-02/2026-17927/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":194,"last_updated":"2026-10-23 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17927.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17927.pdf?1788266710","publication_date":"2026-09-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/02/2026-17927.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-0784","supporting_documents_count":0,"docket_id":"FDA-2000-D-0784","document_id":"FDA-2000-D-0784-0007","regulation_id_number":null,"title":"Safety Studies for Veterinary Drug Residues in Human Food","checked_regulationsdotgov_at":"2026-09-03T17:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56451,"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: Reproduction Testing (Revision 1); 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: Reproduction Testing; Revision 1","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}