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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

Revised June 23, 2009Revised June 23, 2009

Briefing Slides for Importers and Entry Filers

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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 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)

0

2

4

6

8

10

12

14

16

18

Millions

Lines 9372423 11823054 13696343 14978003 15955943 17209441

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

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foodsFirms,

productcode

Entry filer

Customs

OASIS

Electronic TransactionsImport Entry

Lines

Review?No

FDA district entry

reviewer

Yes

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 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

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 filers and importersby entry filers and importers

1 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 Data anomalies within the current entryentry

Admissibility historyAdmissibility history with respect to with respect to the manufacturer, exporter, importer, the manufacturer, exporter, importer, and consignee for the current product and consignee for the current product (at industry and more specific levels)(at 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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TimelineTimeline

July2005

Sept2007

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 Radiological health product report accession numberaccession number

2020

Medical devicesMedical devices

Affirmation “DEV” is to be used to provide Affirmation “DEV” is to be used to provide the registration number of the the registration number of the foreign foreign shipper’sshipper’s facility. facility.

Watch for an upcoming ACS admin message Watch for an upcoming ACS admin message with additional guidance on the use of with additional guidance on the use of affirmations of compliance.affirmations of compliance.

PREDICT’s automated lookup using the DEV PREDICT’s automated lookup using the DEV affirmation will fail if the registration number affirmation will fail if the registration number furnished belongs to the importer or to the furnished belongs to the importer or to the U.S.-based specifications developer.U.S.-based specifications developer.

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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 Poor data quality or missing data will increase the risk scores for your subsequent entry lines the risk scores for your subsequent entry lines (importers and filers). (importers and filers).

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.

Data error rates will be available to the public Data error rates will be available to the public through the Freedom of Information Act.through the Freedom of Information Act.

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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 Submitted documents will be readily available to entry reviewersto entry 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?