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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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Presentation on theme: "1 PREDICT and ITACS FDA Office of Regulatory Affairs Office of Regional Operations Office of Regional Operations Division of Import Operations & Policy."— Presentation transcript:

1 1 PREDICT and ITACS FDA Office of Regulatory Affairs Office of Regional Operations Office of Regional Operations Division of Import Operations & Policy Systems Branch June 2, 2009 Briefing for AAEI Annual Conference

2 2 Topics PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) Entry data quality, and why it really will matter with PREDICT Entry data quality, and why it really will matter with PREDICT ITACS (Import Trade Auxiliary Communications System) ITACS (Import Trade Auxiliary Communications System)

3 3 PREDICT Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting Purpose:Improve import screening and targeting to Prevent the entry of adulterated, misbranded, or otherwise violative goodsPrevent the entry of adulterated, misbranded, or otherwise violative goods Expedite the entry of non-violative goodsExpedite the entry of non-violative goods Method:Replace the admissibility screening portion of FDA’s legacy electronic system for processing import entries.

4 4 OASIS Operational and Administrative System for Import Support Legacy system operating 24/7 FDA-wide since 1998 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 The only system in the Federal government which exchanges import admissibility data with U.S. Customs & Border Protection in real time Provides -- Provides -- –Electronic screening of entry lines –Workflow management for entry reviewers, inspectors, and compliance officers –Generation of notices regarding admissibility decisions

5 5 Workload:Import entry lines, in millions (excluding mail and baggage)

6 6 foods Firms, product code Entry filer Customs OASIS Electronic Transactions Import 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

7 7 FDA district entry reviewer Entry filer Initial action? Field exam Sample, analyze Compliance Officer “May proceed” message Results? Compliance action Detain w/o physical exam Detain Release with comment Release Good Documents requested by FDA Bad IB release ???

8 8 PREDICT method 1 of 2 Use automated data mining and pattern discovery Use automated data mining and pattern discovery Utilize open-source intelligence 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.) Provide automated queries of Center databases where relevant (i.e., registration and listing, marketing approval status, low-acid canned food scheduled processes, etc.)

9 9 PREDICT 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 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

10 10 Examples of source data for PREDICT screening rules Results of field exams and sample analyses of previous entries Results of field exams and sample analyses of previous entries Results of facility inspections, foreign and domestic Results of facility inspections, foreign and domestic Ratings of inherent product risks Ratings of inherent product risks Accuracy of product and facility coding by entry filers Accuracy of product and facility coding by entry filers 1 of 2

11 11 Examples of source data for PREDICT screening rules Data anomalies within the current entry 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) 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. Open source intelligence pertaining to the manufacturer, foreign locale, product, etc. 2 of 2

12 12 Pilot test Began June 4, 2007 Began June 4, 2007 Covered 32,696 lines of seafood entering at five ports within Los Angeles District 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” 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 presented with line scores and background information in PREDICT application Reviewers used OASIS to enter their decisions and workflow assignments Reviewers used OASIS to enter their decisions and workflow assignments

13 13 “Hit rates” Field Exams Sample Analyses

14 14 Violation Significance Index Field Exams Sample Analyses

15 15 Effective rates – Automated “may proceed” FY 2006 ControlPREDICT 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.

16 16 Timeline July 2005 Sept 2007 Jan 2008 Oct 2008 Mar 2009 Oct 2009 Pilot test Project becomes program PHASE 3 Operation and expansion to additional rules PHASE 2 Migration to production environment PHASE 1 Iterative prototype development FY FY 2008FY 2009FY 2010 Pilot test evaluation 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. Performance evaluation July 2009 Simulation testing

17 17 MID Customs’ manufacturer identification Receiving inconsistent MIDs for the same foreign facility is a serious data quality issue for FDA. Receiving inconsistent MIDs for the same foreign facility is a serious data quality issue for FDA. Current record: 75 different MIDs for one facility Current record: 75 different MIDs for one facility Typical case: 6 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. 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. The long-term solution is to replace the MID with a unique, reproducible identifier such as DUNS.

18 18 Entry reviewer workload Entry lines not given a “may proceed” by PREDICT go to an entry reviewer for manual processing. “In” box

19 19 Affirmations of compliance Affirmations of compliance are data elements submitted voluntarily to FDA to expedite the entry review process. For example: 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

20 20 Without PREDICT: Affirmations of compliance OASIS cannot utilize affirmations of compliance to do automated lookups in Center databases for marketing status. 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”). OASIS sends nearly all entry lines for low- acid canned foods and for medical products to entry reviewers (no system “may proceeds”).

21 21 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. 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. If an automated lookup fails, the entry line will be forwarded to a reviewer for manual processing.

22 22 Importers and Filers When PREDICT comes online, the quality of the data you submit to FDA will count more than ever. 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. 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. 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. 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. Higher risk scores increase the likelihood of examination and/or sampling by FDA.

23 23 ITACS Import Trade Auxiliary Communications System Internet portal for entry filers to 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 Submitted documents will be readily available to entry reviewers To be pilot tested in Los Angeles concurrently with PREDICT beta testing To be pilot tested in Los Angeles concurrently with PREDICT beta testing

24 24 ITACS screenshot examples Entry line status Entry line status Document submission Document submission Availability of product for inspection Availability of product for inspection

25 25 Entry line status

26 26 Document submission

27 27 Availability of product for inspection

28 28 Questions?


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