predict and itacs

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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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PREDICT and ITACS. Briefing for AAEI Annual Conference. FDA Office of Regulatory Affairs Office of Regional Operations Division of Import Operations & Policy Systems Branch. June 2, 2009. Topics. PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) - PowerPoint PPT Presentation

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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

ITACS (Import Trade Auxiliary ITACS (Import Trade Auxiliary Communications System)Communications System)

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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 misbranded, or otherwise violative goodsgoods

• Expedite the entry of non-violative Expedite the entry of non-violative goodsgoods

MethodMethod:: Replace the admissibility screening Replace the admissibility screening portion of FDA’s legacy electronic system portion of FDA’s legacy electronic system for processing import entries.for 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)

0

2

4

6

8

10

12

14

16

18Millions

Lines 9372423 11823054 13696343 14978003 15955943 17209441

FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008

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foodsFirms,product

code

Entry filer

CustomsOASIS

Electronic TransactionsImport Entry

Lines

Review?No

FDA district entry

reviewerYes

Prior Notice Center

OK?Yes No“May proceed”

message“FDA review”

message

PN screening – food

801(a) screening

PREDICT

others

foods

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FDA district entry

reviewer

Entry filer

Initial action?

Field exam

Sample, analyze

Compliance Officer

“May proceed”message

Results?

Complianceaction

Detain w/ophysical exam

Detain

Release withcomment

Release

Good

Documentsrequested

by FDA

Bad

IB release

???

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PREDICT methodPREDICT method

1 of 2

Use automated data mining and pattern Use automated data mining and pattern discoverydiscovery

Utilize open-source intelligenceUtilize open-source intelligence Provide automated queries of Center databases Provide automated queries of Center databases

where relevant (i.e., registration and listing, where relevant (i.e., registration and listing, marketing approval status, low-acid canned marketing approval status, low-acid canned food scheduled processes, etc.)food scheduled processes, etc.)

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PREDICT methodPREDICT method

2 of 2

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 filers1 of 2

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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.

2 of 2

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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

FY 2006 (OASIS)PREDICT pilot test

FY 2006 (OASIS)PREDICT pilot test

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Effective rates –Effective rates –Automated “may proceed”Automated “may proceed”

FY 2006 Control PREDICT

5.7%

94.3%

"May proceed" Held for review

39.1%

60.9%

"May proceed" Held for review

The 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.

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TimelineTimelineJuly

2005Sept2007

Jan2008

Oct2008

Mar2009

Oct2009

Pilot test

Projectbecomesprogram

PHASE 3Operation and expansion toadditional rules

PHASE 2 Migration to production environment

PHASE 1 Iterative prototype development

FY 2005 - 2007 FY 2008 FY 2009 FY 2010

Pilot testevaluation

PHASE 2 detail:•Scale up•Development of automated database look ups•Expansion to full product set with limited rule set

MARCS Imports v.1.0 UAT

NOTE: Timeline is not to scale.

Performanceevaluation

July2009

Simulationtesting

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MIDMIDCustoms’ manufacturer identificationCustoms’ manufacturer identification

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 accession Radiological health product report accession

numbernumber

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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 ever.data you submit to FDA will count more than 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.

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ITACSITACSImport Trade Auxiliary Communications Import Trade Auxiliary Communications SystemSystem

Internet portal for entry filers toInternet portal for entry filers to– Check the status of individual entries/lines Check the status of individual entries/lines – Submit documents and link them to specific Submit documents and link them to specific

entries/linesentries/lines– Provide availability information for targeted Provide availability information for targeted

shipmentsshipments Submitted documents will be readily available to Submitted documents will be readily available to

entry reviewersentry reviewers To be pilot tested in Los Angeles concurrently To be pilot tested in Los Angeles concurrently

with PREDICT beta testingwith PREDICT beta testing

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ITACS screenshot examplesITACS screenshot examples

Entry line statusEntry line status Document submissionDocument submission Availability of product for Availability of product for

inspectioninspection

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Entry line statusEntry line status

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Document submissionDocument submission

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Availability of product for inspectionAvailability of product for inspection

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Questions?Questions?