Presentation on theme: "PREDICT and ITACS Briefing for AAEI Annual Conference"— Presentation transcript:
1PREDICT and ITACS Briefing for AAEI Annual Conference FDA Office of Regulatory AffairsOffice of Regional OperationsDivision of Import Operations & PolicySystems BranchJune 2, 2009
2TopicsPREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting)Entry data quality, and why it really will matter with PREDICTITACS (Import Trade Auxiliary Communications System)
3PREDICT Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting Purpose: Improve import screening and targeting toPrevent the entry of adulterated, misbranded, or otherwise violative goodsExpedite the entry of non-violative goodsMethod: Replace the admissibility screening portion of FDA’s legacy electronic system for processing import entries.
4OASIS Operational and Administrative System for Import Support Legacy system operating 24/7 FDA-wide since 1998The only system in the Federal government which exchanges import admissibility data with U.S. Customs & Border Protection in real timeProvides --Electronic screening of entry linesWorkflow management for entry reviewers, inspectors, and compliance officersGeneration of notices regarding admissibility decisions
5Workload: Import entry lines, in millions (excluding mail and baggage)
6Electronic Transactions FDA district entry reviewer Import Entry LinesOASISPN screening – foodPrior Notice CenterCustomsEntry filerfoodsFirms,productcodefoodsothersPREDICT801(a) screeningYesOK?No“FDA review”message“May proceed”messageFDA district entry reviewerReview?NoYes
7FDA district entry reviewer Field examFDA district entry reviewerInitial action????GoodResults?BadDocumentsrequestedby FDASample, analyze“May proceed”messageDetain w/ophysical examDetainComplianceactionRelease withcommentCompliance OfficerReleaseEntry filerIB release
8PREDICT method Use automated data mining and pattern discovery Utilize open-source intelligenceProvide automated queries of Center databases where relevant (i.e., registration and listing, marketing approval status, low-acid canned food scheduled processes, etc.)1 of 2
9PREDICT method Improve the “hit” rate for exams and samples by – Scoring each entry line on the basis of risk factors and surveillance requirementsIncrease the number of automated, real-time, risk-based “may proceed” decisions, thereby giving entry reviewers more time to evaluate higher-risk linesFor those lines not given an automated “may proceed,” providing reviewers with the line scores and the reasons for those scores2 of 2
10Examples of source data for PREDICT screening rules Results of field exams and sample analyses of previous entriesResults of facility inspections, foreign and domesticRatings of inherent product risksAccuracy of product and facility coding by entry filers1 of 2
11Examples of source data for PREDICT screening rules Data anomalies within the current entryAdmissibility history with respect to the manufacturer, exporter, importer, and consignee for the current product (at industry and more specific levels)Open source intelligence pertaining to the manufacturer, foreign locale, product, etc.2 of 2
12Pilot testBegan June 4, 2007Covered 32,696 lines of seafood entering at five ports within Los Angeles DistrictLimited electronic interface with OASIS allowed PREDICT to screen and to issue “may proceeds”Reviewers presented with line scores and background information in PREDICT applicationReviewers used OASIS to enter their decisions and workflow assignments
14Violation Significance Index Field ExamsSample Analyses
15Effective rates – Automated “may proceed” FY 2006 ControlPREDICTThe effective rate is lower than the individual line rate because of a business rule which requires that if any one line of an entry does not receive a “may proceed,” all lines will be held.
16Timeline NOTE: Timeline is not to scale. FY 2005 - 2007 FY 2008 July2005Sept2007Jan2008Oct2008Mar2009July2009Oct2009SimulationtestingPHASE 1 Iterative prototype developmentPilot testPilot testevaluationMARCS Importsv.1.0 UATPerformanceevaluationPHASE 2 Migration toproduction environmentPHASE 3Operation andexpansion toadditional rulesPHASE 2 detail:Scale upDevelopment of automated database look upsExpansion to full product set with limited rule setProjectbecomesprogramNOTE: Timeline is not to scale.
17MID Customs’ manufacturer identification Receiving inconsistent MIDs for the same foreign facility is a serious data quality issue for FDA.Current record: 75 different MIDs for one facilityTypical case: 6 different MIDs for one facilitySubmitting a different MID for an established, site-specific facility will cause PREDICT to view the facility as new, and the entry line’s risk score will be substantially elevated.The long-term solution is to replace the MID with a unique, reproducible identifier such as DUNS.
18Entry reviewer workload Entry lines not given a “may proceed” by PREDICT go to an entry reviewer for manual processing.“In” box
19Affirmations of compliance Affirmations of compliance are data elements submitted voluntarily to FDA to expedite the entry review process. For example:New drug application numberDevice “510(k) clearance” numberNational drug code (NDC)Radiological health product report accession number
20Without PREDICT: Affirmations of compliance OASIS cannot utilize affirmations of compliance to do automated lookups in Center databases for marketing status.OASIS sends nearly all entry lines for low-acid canned foods and for medical products to entry reviewers (no system “may proceeds”).
21With PREDICT: Affirmations of compliance With accurate and complete affirmations of compliance (NDA, ANDA, PMA, 510(k), NDC numbers, etc.), PREDICT can do the automated lookups for marketing status.If an automated lookup fails, the entry line will be forwarded to a reviewer for manual processing.
22Importers and FilersWhen PREDICT comes online, the quality of the data you submit to FDA will count more than ever.Importers need to work closely with filers to ensure data quality.Poor data quality or missing data will increase the risk scores for your entry lines.Filers’ data error rates will be available to the public through the Freedom of Information Act.Higher risk scores increase the likelihood of examination and/or sampling by FDA.
23ITACS Import Trade Auxiliary Communications System Internet portal for entry filers toCheck the status of individual entries/linesSubmit documents and link them to specific entries/linesProvide availability information for targeted shipmentsSubmitted documents will be readily available to entry reviewersTo be pilot tested in Los Angeles concurrently with PREDICT beta testing
24ITACS screenshot examples Entry line statusDocument submissionAvailability of product for inspection