Predict and itacs
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PREDICT and ITACS. Briefing Slides for Importers and Entry Filers. FDA Office of Regulatory Affairs Office of Regional Operations Division of Import Operations & Policy Systems Branch. Revised June 23, 2009. Topics.

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Predict and itacs

PREDICT and ITACS

Briefing Slides for Importers and Entry Filers

FDA Office of Regulatory Affairs

Office of Regional Operations

Division of Import Operations & Policy

Systems Branch

Revised June 23, 2009


Topics

Topics

  • PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting)

  • Entry data quality, and why it really will matter with PREDICT

  • ITACS (Import Trade Auxiliary Communications System)


Predict predictive risk based evaluation for dynamic import compliance targeting

PREDICTPredictive Risk-based Evaluation for Dynamic Import Compliance Targeting

Purpose:Improve import screening and targeting to

  • Prevent the entry of adulterated, misbranded, or otherwise violative goods

  • Expedite the entry of non-violative goods

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


Oasis operational and administrative system for import support

OASISOperational and Administrative System for Import Support

  • Legacy system operating 24/7 FDA-wide since 1998

  • The only system in the Federal government which exchanges import admissibility data with U.S. Customs & Border Protection in real time

  • Provides --

    • Electronic screening of entry lines

    • Workflow management for entry reviewers, inspectors, and compliance officers

    • Generation of notices regarding admissibility decisions


Workload import entry lines in millions excluding mail and baggage

Workload:Import entry lines, in millions(excluding mail and baggage)


Predict and itacs

Electronic Transactions

Import Entry Lines

OASIS

Prior Notice Center

PN screening – food

Customs

Entry filer

foods

Firms,

product

code

foods

others

PREDICT

801(a) screening

Yes

OK?

No

“FDA review”

message

“May proceed”

message

FDA district entry reviewer

Review?

No

Yes


Predict and itacs

Field exam

FDA district entry reviewer

Initial action?

???

Good

Results?

Bad

Documents

requested

by FDA

Sample, analyze

“May proceed”

message

Detain w/o

physical exam

Detain

Compliance

action

Release with

comment

Compliance Officer

Release

Entry filer

IB release


Predict method

PREDICT method

  • Use automated data mining and pattern discovery

  • Utilize open-source intelligence

  • Provide automated queries of Center databases where relevant (i.e., registration and listing, marketing approval status, low-acid canned food scheduled processes, etc.)

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Predict method1

PREDICT method

  • Improve the “hit” rate for exams and samples by –

    • Scoring each entry line on the basis of risk factors and surveillance requirements

    • Increase the number of automated, real-time, risk-based “may proceed” decisions, thereby giving entry reviewers more time to evaluate higher-risk lines

    • For those lines not given an automated “may proceed,” providing reviewers with the line scores and the reasons for those scores

2 of 2


Examples of source data for predict screening rules

Examples of source data for PREDICT screening rules

  • Results of field exams and sample analyses of previous entries

  • Results of facility inspections, foreign and domestic

  • Ratings of inherent product risks

  • Accuracy of product and facility coding by entry filers and importers

1 of 2


Examples of source data for predict screening rules1

Examples of source data for PREDICT screening rules

  • Data anomalies within the current entry

  • Admissibility 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.

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Pilot test

Pilot test

  • Began June 4, 2007

  • Covered 32,696 lines of seafood entering at five ports within Los Angeles District

  • Limited electronic interface with OASIS allowed PREDICT to screen and to issue “may proceeds”

  • Reviewers presented with line scores and background information in PREDICT application

  • Reviewers used OASIS to enter their decisions and workflow assignments


Hit rates

“Hit rates”

Field Exams

Sample Analyses


Violation significance index

Violation Significance Index

Field Exams

Sample Analyses


Effective rates automated may proceed

Effective rates –Automated “may proceed”

FY 2006 Control

PREDICT

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.


Timeline

Project

becomes

program

Simulation

testing

Performance

evaluation

MARCS Imports

v.1.0 UAT

Pilot test

evaluation

Timeline

FY 2005 - 2007

FY 2008

FY 2009

FY 2010

Oct

2008

Mar

2009

July

2009

Jan

2008

Sept

2007

July

2005

Oct

2009

PHASE 1 Iterative prototype development

Pilot test

PHASE 2 Migration to

production environment

PHASE 3

Operation and

expansion to

additional rules

  • PHASE 2 detail:

  • Scale up

  • Development of automated database look ups

  • Expansion to full product set with limited rule set

NOTE:Timeline is not to scale.


Mid customs manufacturer identification

MIDCustoms’ 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 facility

  • Typical case: 6 different MIDs for one facility

  • Submitting 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.


Entry reviewer workload

Entry reviewer workload

Entry lines not given a “may proceed” by PREDICT go to an entry reviewer for manual processing.

“In” box


Affirmations of compliance

Affirmations of compliance

  • Affirmations of compliance are data elements submitted voluntarily to FDA to expedite the entry review process. For example:

    • New drug application number

    • Device “510(k) clearance” number

    • National drug code (NDC)

    • Radiological health product report accession number


Medical devices

Medical devices

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

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

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


Without predict affirmations of compliance

Without 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”).


With predict affirmations of compliance

With 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.


Importers and filers

Importers and Filers

  • When 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 subsequent entry lines (importers and filers).

  • Higher risk scores increase the likelihood of examination and/or sampling by FDA.

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


Itacs import trade auxiliary communications system

ITACSImport Trade Auxiliary Communications System

  • Internet portal for entry filers to

    • Check the status of individual entries/lines

    • Submit documents and link them to specific entries/lines

    • Provide availability information for targeted shipments

  • Submitted documents will be readily available to entry reviewers

  • To be pilot tested in Los Angeles concurrently with PREDICT beta testing


Itacs screenshot examples

ITACS screenshot examples

  • Entry line status

  • Document submission

  • Availability of product for inspection


Entry line status

Entry line status


Document submission

Document submission


Availability of product for inspection

Availability of product for inspection


Questions

Questions?


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