1 PREDICT and ITACS PREDICT and ITACS FDA Office of Regulatory Affairs FDA Office of Regulatory Affairs Office of Regional Operations Office of Regional Operations Division of Import Operations & Division of Import Operations & Policy Policy Systems Branch Systems Branch June 2, 2009 June 2, 2009 Briefing for AAEI Annual Conference
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1 PREDICT and ITACS FDA Office of Regulatory Affairs Office of Regional Operations Office of Regional Operations Division of Import Operations & Policy.
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PREDICT and ITACSPREDICT and ITACS
FDA Office of Regulatory AffairsFDA Office of Regulatory Affairs Office of Regional OperationsOffice of Regional Operations
Division of Import Operations & PolicyDivision of Import Operations & PolicySystems BranchSystems Branch
June 2, 2009June 2, 2009
Briefing for AAEI Annual Conference
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TopicsTopics
PREDICT (Predictive Risk-based PREDICT (Predictive Risk-based Evaluation for Dynamic Import Evaluation for Dynamic Import Compliance Targeting)Compliance Targeting)
Entry data quality, and why it Entry data quality, and why it reallyreally will matter with PREDICT will matter with PREDICT
PREDICTPREDICTPredictive Risk-based Evaluation for Dynamic Predictive Risk-based Evaluation for Dynamic Import Compliance TargetingImport Compliance Targeting
PurposePurpose:: Improve import screening and targeting toImprove import screening and targeting to
• Prevent the entry of adulterated, Prevent the entry of adulterated, misbranded, or otherwise violative goodsmisbranded, or otherwise violative goods
• Expedite the entry of non-violative goodsExpedite the entry of non-violative goods
MethodMethod:: Replace the admissibility screening portion Replace the admissibility screening portion of FDA’s legacy electronic system for of FDA’s legacy electronic system for processing import entries.processing import entries.
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OASISOASISOperational and Administrative System for Import Operational and Administrative System for Import SupportSupport
Legacy system operating 24/7 FDA-wide since 1998Legacy system operating 24/7 FDA-wide since 1998 The only system in the Federal government which The only system in the Federal government which
exchanges import admissibility data with U.S. exchanges import admissibility data with U.S. Customs & Border Protection in real timeCustoms & Border Protection in real time
Provides --Provides --
– Electronic screening of entry linesElectronic screening of entry lines
– Workflow management for entry reviewers, Workflow management for entry reviewers, inspectors, and compliance officersinspectors, and compliance officers
– Generation of notices regarding admissibility Generation of notices regarding admissibility decisionsdecisions
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Workload:Workload: Import entry lines, in millionsImport entry lines, in millions(excluding mail and baggage)(excluding mail and baggage)
Provide automated queries of Center Provide automated queries of Center databases where relevant (i.e., registration databases where relevant (i.e., registration and listing, marketing approval status, low-and listing, marketing approval status, low-acid canned food scheduled processes, etc.)acid canned food scheduled processes, etc.)
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PREDICT methodPREDICT method
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Improve the “hit” rate for exams and samples by Improve the “hit” rate for exams and samples by ––
– Scoring each entry line on the basis of risk Scoring each entry line on the basis of risk factors and surveillance requirementsfactors and surveillance requirements
– Increase the number of automated, real-time, Increase the number of automated, real-time, risk-based “may proceed” decisions, thereby risk-based “may proceed” decisions, thereby giving entry reviewers more time to evaluate giving entry reviewers more time to evaluate higher-risk lineshigher-risk lines
– For those lines not given an automated “may For those lines not given an automated “may proceed,” providing reviewers with the line proceed,” providing reviewers with the line scores and the reasons for those scoresscores and the reasons for those scores
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Examples of source data for Examples of source data for PREDICT screening rulesPREDICT screening rules
Results of field exams and sample Results of field exams and sample analyses of previous entriesanalyses of previous entries
Results of facility inspections, foreign Results of facility inspections, foreign and domesticand domestic
Ratings of inherent product risksRatings of inherent product risks
AccuracyAccuracy of product and facility coding of product and facility coding by entry filersby entry filers
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Examples of source data for Examples of source data for PREDICT screening rulesPREDICT screening rules
Data anomalies within the current entryData anomalies within the current entry
Admissibility historyAdmissibility history with respect to the with respect to the manufacturer, exporter, importer, and manufacturer, exporter, importer, and consignee for the current product (at consignee for the current product (at industry and more specific levels)industry and more specific levels)
Open source intelligence pertaining to Open source intelligence pertaining to the manufacturer, foreign locale, the manufacturer, foreign locale, product, etc.product, etc.
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Pilot testPilot test
Began June 4, 2007Began June 4, 2007
Covered 32,696 lines of seafood entering at five Covered 32,696 lines of seafood entering at five ports within Los Angeles Districtports within Los Angeles District
Limited electronic interface with OASIS allowed Limited electronic interface with OASIS allowed PREDICT to screen and to issue “may proceeds”PREDICT to screen and to issue “may proceeds”
Reviewers presented with line scores and Reviewers presented with line scores and background information in PREDICT application background information in PREDICT application
Reviewers used OASIS to enter their decisions Reviewers used OASIS to enter their decisions and workflow assignmentsand workflow assignments
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““Hit rates”Hit rates”
FY 2006 (OASIS)
PREDICT pilot test
FY 2006 (OASIS)
PREDICT pilot test
Field ExamsField Exams Sample AnalysesSample Analyses
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Violation Significance IndexViolation Significance Index
Field ExamsField Exams Sample AnalysesSample Analyses
Receiving inconsistent MIDs for the same foreign Receiving inconsistent MIDs for the same foreign facility is a serious data quality issue for FDA.facility is a serious data quality issue for FDA.
Current record: 75 different MIDs for one facilityCurrent record: 75 different MIDs for one facility Typical case: 6 different MIDs for one facilityTypical case: 6 different MIDs for one facility Submitting a different MID for an established, Submitting a different MID for an established,
site-specific facility will cause PREDICT to view site-specific facility will cause PREDICT to view the facility as new, andthe facility as new, and the entry line’s risk score the entry line’s risk score will be substantially elevatedwill be substantially elevated. .
The long-term solution is to replace the MID with The long-term solution is to replace the MID with a unique, reproducible identifier such as DUNS.a unique, reproducible identifier such as DUNS.
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Entry reviewer workloadEntry reviewer workload
Entry lines not given a “may proceed” by PREDICT go to an entry reviewer for manual processing.
“In” box
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Affirmations of complianceAffirmations of compliance
Affirmations of compliance are data Affirmations of compliance are data elements submitted voluntarily to FDA elements submitted voluntarily to FDA to expedite the entry review process. to expedite the entry review process. For example:For example:– New drug application numberNew drug application number
– Device “510(k) clearance” numberDevice “510(k) clearance” number
– National drug code (NDC)National drug code (NDC)
– Radiological health product report Radiological health product report accession numberaccession number
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Without PREDICT:Without PREDICT:Affirmations of complianceAffirmations of compliance
OASIS cannot utilize affirmations of OASIS cannot utilize affirmations of compliance to do automated lookups in compliance to do automated lookups in Center databases for marketing status.Center databases for marketing status.
OASIS sends nearly all entry lines for low-OASIS sends nearly all entry lines for low-acid canned foods and for medical products acid canned foods and for medical products to entry reviewers (no system “may to entry reviewers (no system “may proceeds”).proceeds”).
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With PREDICT:With PREDICT:Affirmations of complianceAffirmations of compliance
With With accurate and completeaccurate and complete affirmations affirmations of compliance (NDA, ANDA, PMA, 510(k), of compliance (NDA, ANDA, PMA, 510(k), NDC numbers, etc.), PREDICT can do the NDC numbers, etc.), PREDICT can do the automated lookups for marketing status.automated lookups for marketing status.
If an automated lookup fails, the entry If an automated lookup fails, the entry line will be forwarded to a reviewer for line will be forwarded to a reviewer for manual processing.manual processing.
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Importers and FilersImporters and Filers
When PREDICT comes online, the quality of the When PREDICT comes online, the quality of the data you submit to FDA will count more than data you submit to FDA will count more than ever.ever.
Importers need to work closely with filers to Importers need to work closely with filers to ensure data quality.ensure data quality.
Poor data quality or missing data will increase the Poor data quality or missing data will increase the risk scores for your entry lines. risk scores for your entry lines.
Filers’ data error rates will be available to the Filers’ data error rates will be available to the public through the Freedom of Information Act.public through the Freedom of Information Act.
Higher risk scores increase the likelihood of Higher risk scores increase the likelihood of examination and/or sampling by FDA.examination and/or sampling by FDA.