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The document explains how inconsistent and incomplete 2008–2014 data made analysis difficult, leading EPA to require standardized enhanced quarterly reporting. It describes the one-year pilot with selected registrants for 2016 Q1–Q4, feedback collection via webinars and Q&A calls, Excel-based data submission, vendor compatibility, and planned tiered statistical and narrative case review.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/spot-on-enhanced-reporting-pilot-template-development-synopsis/357893/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/spot-on-enhanced-reporting-pilot-template-development-synopsis/357893.png","ImageObject",442,249,{"name":88,"@type":89},"Stanley","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-27","2026-09-23",true,{"@type":98,"interactionType":99,"userInteractionCount":8},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What prompted EPA to develop the Spot-on enhanced reporting template?","Question",{"text":108,"@type":109},"EPA identified deficiencies in 2008–2014 enhanced incident data that made analysis difficult, including inconsistent formatting, missing incident fields, unreadable formats, and incomplete or inconsistent sales and incident information.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Who participated in the pilot program and what period did it cover?",{"text":113,"@type":109},"Up to nine registrants were invited for CY2016, and five volunteered. The pilot used the template for one year and required submission of incidents and sales data for 2016 Q1 and Q2, continuing through Q3 and Q4 with additional feedback.",{"name":115,"@type":106,"acceptedAnswer":116},"How will EPA analyze future enhanced reporting data after the pilot?",{"text":117,"@type":109},"EPA will perform descriptive analysis, and if appropriate, evaluate potential signals using statistical analysis and detailed review of incident case narratives, using a tiered approach based on data quality, completeness, and strength.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},357893,1791725515,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":8,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":73},2336477405376,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","# UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON,D.C.20460\n\nOFFICE OF CHEMICAL SAFETY ANDPOLLUTION PREVENTION  \nMEMORANDUM  \nDate:October 10,2017  \nSUBJECT:Spot-On Enhanced Reporting Pilot Template Development SynopsisFROM:Shanna Recore,Industrial Hygienist从ha aaeAaron Niman,Environmental Health ScientistDan2Toxicology and Epidemiology BranchHealth Effects Division(7509P)THROUGH:David J.Miller,Acting Branch ChiefToxicology and Epidemiology BranchmaHealth Effects Division(7509P)  \nD.a4.217  \nTO:Catherine Aubee,Branch ChiefJulie Breeden-Alemi,DVMInvertebrate and Vertebrate Branch IRegistration Division(7505P)  \n## I.    ACTION REQUESTED\n\nRegistration Division's Invertebrate and Vertebrate Branch I requested that Health EffectsDivision finalize the Spot-on Enhanced Reporting template.This template was developed tostandardize submission of enhanced reporting data on both sales data and adverse event incidentsacross spot-on registrants.The remainder of the memorandum provides background on thedevelopment of the template and an overview of the framework that will be used to analyzeenhanced reporting data required as a condition of registration.  \n## II.    BACKGROUND\n\nIn 2008-2009,an increase in the number of reports of pet incidents involving Spot-on flea andtick control products were reported to EPA's Incident Data System(IDS).In response,EPArequired Spot-on registrants to submit enhanced incident reports for 2008 incidents to bereviewed by EPA.An analysis of this enhanced data was conducted in 2009 and released in2010.As a result of the 2010 analysis,EPA implemented several mitigation measures includinga requirement that registrants continue to perform enhanced quarterly incident reporting to EPA.EPA recently compiled some of the enhanced incident reports for the years 2008 to 2014 into anelectronic format to perform statistical analysis.In reviewing the data,EPA found a number ofdeficiencies that made it difficult to analyze the data and evaluate potential risks that might beassociated with Spot-on products and the effects that earlier mitigation actions may have had.These deficiencies included:  \n● Inconsistent formatting both between companies and within a company over time;  \n● Missing incident information in the data file (e.g.,missing EPA Reg.Nos.;missing datafields);  \n● No data for some quarters/years;  \n● Not all companies submitted data;  \n● Some data formats were unreadable by statistical software;  \n● Incomplete sales data or sales data inconsistent with incident counts;and  \n● Sales data deficiencies,inconsistencies,or ambiguities.  \nPage 2 of 5  \n## III.   PILOT\n\nDue to the deficiencies identified in its review of the 2008-2014 data,EPA developed asubmission template in order to better standardize submissions of enhanced reporting data onboth sales data and adverse event incidents across registrants.Such standardized submissionformats willconsiderably improve the ability of EPA to review the data using state-of-the-science pharmacovigilance methods.EPA decided to first pilot the submission templates andreporting program over the course of a year.A public webinar was held on June 7,2017,tointroduce the proposed pilot program,ask for volunteers,and discuss anticipated statisticalanalysis.²Up to nine spot -on registrants were asked to participate in the pilot program for CY2016.Five registrants volunteered to participate in the pilot,use the template for one year,andprovide feedback.The objective of the pilot was to:  \n● Test the standard template that will facilitate submission and analysis of enhancedincident reporting;  \n● Obtain feedback from pilot participants and other interested stakeholders regarding thefeasibility and usability of the template to inform meaningful analyses of the data;and  \n·Use information from the pilot to modify the template based on registrant feedback andEPA experience.  \nAs part of this pilot,the five registrants agreed to submit Spot-on product incidents and salesdata for 2016Q","cbCaibuSrA0WKRen","https://ap.wps.com/l/cbCaibuSrA0WKRen","pdf",853909,6,"English","# I. ACTION REQUESTED\n# II. BACKGROUND\n# III. PILOT\n# IV. ANALYSIS","[{\"question\":\"What prompted EPA to develop the Spot-on enhanced reporting template?\",\"answer\":\"EPA identified deficiencies in 2008–2014 enhanced incident data that made analysis difficult, including inconsistent formatting, missing incident fields, unreadable formats, and incomplete or inconsistent sales and incident information.\"},{\"question\":\"Who participated in the pilot program and what period did it cover?\",\"answer\":\"Up to nine registrants were invited for CY2016, and five volunteered. The pilot used the template for one year and required submission of incidents and sales data for 2016 Q1 and Q2, continuing through Q3 and Q4 with additional feedback.\"},{\"question\":\"How will EPA analyze future enhanced reporting data after the pilot?\",\"answer\":\"EPA will perform descriptive analysis, and if appropriate, evaluate potential signals using statistical analysis and detailed review of incident case narratives, using a tiered approach based on data quality, completeness, and strength.\"}]","Spot-On Enhanced Reporting Pilot Template Development Synopsis | PDF",1790132205]