{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #243 entitled \"Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods\" (VICH GL56). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists. Use of veterinary drug products in honeybee production is considered as a minor use in minor species in most jurisdictions.","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/2017/01/05/2016-31998.html","cfr_references":[],"citation":"82 FR 1342","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 6, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-4461"],"dockets":[],"document_number":"2016-31998","effective_on":null,"end_page":1343,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/01/05/2016-31998.xml","html_url":"https://www.federalregister.gov/documents/2017/01/05/2016-31998/draft-guidance-for-industry-study-design-recommendations-for-residue-studies-in-honey-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-31998?publication_date=2017-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-01-05/2016-31998/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":183,"last_updated":"2026-10-25 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-01-05/pdf/2016-31998.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-31998.pdf?1483537576","publication_date":"2017-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/01/05/2016-31998.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-2016-D-4461","supporting_documents_count":0,"docket_id":"FDA-2016-D-4461","regulation_id_number":null,"title":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species:  Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods; Availability","checked_regulationsdotgov_at":"2017-01-25T06:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1342,"subtype":null,"title":"Draft Guidance for Industry: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods; Availability","toc_doc":"Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}