Briefing Slides for Importers and Entry Filers

Transcription

1 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,

2 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) 2

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

4 OASIS Operational 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 4

5 Workload: Import entry lines, in millions (excluding mail and baggage) Millions FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 Lines

6 Electronic Transactions Import Entry Lines Entry filer FDA district entry reviewer Firms, product code FDA review message Customs May proceed message foods others No OASIS PN screening food PREDICT 801(a) screening Review? foods Yes Prior Notice Center OK? No Yes 6

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

8 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.) 1 of 2 8

9 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 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 9

10 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 10

11 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. 2 of 2 11

12 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 12

13 Hit rates Field Exams Sample Analyses FY 2006 (OASIS) PREDICT pilot test FY 2006 (OASIS) PREDICT pilot test 13

14 Violation Significance Index Field Exams Sample Analyses FY 2006 (OASIS) PREDICT pilot test FY 2006 (OASIS) PREDICT pilot test 14

15 Effective rates Automated may proceed FY 2006 Control PREDICT 94.3% 60.9% 5.7% 39.1% "May proceed" Held for review "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. 15

16 Timeline FY FY 2008 FY 2009 FY 2010 July 2005 Sept 2007 Jan 2008 Oct 2008 Mar 2009 July 2009 Oct 2009 PHASE 1 Iterative prototype development Pilot test Pilot test evaluation PHASE 2 detail: Scale up Development of automated database look ups Expansion to full product set with limited rule set PHASE 2 Migration to production environment Simulation testing MARCS Imports v.1.0 UAT Performance evaluation PHASE 3 Operation and expansion to additional rules Project becomes program NOTE: Timeline is not to scale. 16

17 MID Customs 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 s risk score will be substantially elevated. The long-term solution is to replace the MID with a unique, reproducible identifier such as DUNS. 17

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

19 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 19

20 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 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. 20

21 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 ). 21

22 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. 22

23 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. 23

24 ITACS Import 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 24

25 ITACS screenshot examples Entry line status Document submission Availability of product for inspection 25

26 Entry line status 26

27 Document submission 27

28 Availability of product for inspection 28

29 Questions? 29