{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #143) entitled \"Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms\" (VICH GL30). 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 purpose of this VICH guidance document is to describe the controlled lists of terms critical to completing the controlled data fields as identified in the guidance entitled \"Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine\" (GFI #188), available on the FDA Web site at: http://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm.","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/2014/10/09/2014-24152.html","cfr_references":[],"citation":"79 FR 61081","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2002-D-0268 (formerly Docket No. 2002D-0005)"],"dockets":[],"document_number":"2014-24152","effective_on":null,"end_page":61082,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/10/09/2014-24152.xml","html_url":"https://www.federalregister.gov/documents/2014/10/09/2014-24152/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-24152?publication_date=2014-10-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-10-09/2014-24152/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":120,"last_updated":"2026-09-21 18:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-10-09/pdf/2014-24152.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-24152.pdf?1412772250","publication_date":"2014-10-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/10/09/2014-24152.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Draft Guidance re Pharmacovigilance of Veterinary Medicinal Products Controlled List of Terms","document_id":"FDA-2002-D-0268-0007"},{"title":"Draft Guidance re Pharmacovigilance of Veterinary Medicinal Products Controlled List of Terms","document_id":"FDA-2002-D-0268-0006"},{"title":"Draft Guidance re Pharmacovigilance of Veterinary Medicinal Products Controlled List of Terms","document_id":"FDA-2002-D-0268-0005"},{"title":"Draft Guidance Document re Pharmacovigilance of Veterinary Medicinal Products Controlled List of Terms","document_id":"FDA-2002-D-0268-0004"},{"title":"Appendix A re  Pharmacovigilance of Veterinary Medicinal Products Controlled List of Terms","document_id":"FDA-2002-D-0268-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2002-D-0268","supporting_documents_count":5,"docket_id":"FDA-2002-D-0268","regulation_id_number":null,"title":"Pharmacovigilance of Veterinary Medicinal Products","checked_regulationsdotgov_at":"2015-01-12T19:44:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61081,"subtype":null,"title":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL30); Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms; Availability","toc_doc":"Pharmacovigilance of Veterinary Medicinal ProductsControlled List of Terms","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":79}