{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #226 entitled \"Target Animal Safety Data Presentation and Statistical Analysis.\" The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).","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/2016/01/21/2016-01098.html","cfr_references":[],"citation":"81 FR 3429","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-2015-D-0839"],"dockets":[],"document_number":"2016-01098","effective_on":null,"end_page":3430,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/01/21/2016-01098.xml","html_url":"https://www.federalregister.gov/documents/2016/01/21/2016-01098/target-animal-safety-data-presentation-and-statistical-analysis-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-01098?publication_date=2016-01-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-01-21/2016-01098/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":207,"last_updated":"2026-08-23 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-01-21/pdf/2016-01098.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-01098.pdf?1453297595","publication_date":"2016-01-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/01/21/2016-01098.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-2015-D-0839","supporting_documents_count":0,"docket_id":"FDA-2015-D-0839","regulation_id_number":null,"title":"Target Animal Safety (TAS) Data Presentation and Statistical Analysis","checked_regulationsdotgov_at":"2016-02-10T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3429,"subtype":null,"title":"Target Animal Safety Data Presentation and Statistical Analysis; Guidance for Industry; Availability","toc_doc":"Target Animal Safety Data Presentation and Statistical Analysis","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}