United States Food & Drug Administration Division of Import Operations and Policy

1. United States Food & Drug AdministrationDivision of Import Operations and Policy FDA Filer EvaluationsAn Overview of Current FDA Procedures John E. Verbeten 301-594-3853 john.verbeten@fda.hhs.gov Presentation to:National Customs Brokers & Forwarders Association of America January 21, 2010

2. Division of Import Operations and Policy • CDR Domenic J. Veneziano, Director • Ted Poplawski, Special Assistant • Operations & Policy Branch • John E. Verbeten, Director • Systems Branch • Kelle Fry, Acting Director

3. FDA Filer Evaluations • Current FDA Filer Evaluation Procedure was originally drafted in 1994 • There is a revision under internal review • Today’s presentation deals only with FDA’s current procedure

4. FDA Filer Evaluation Procedure • Purpose: To evaluate the filer’s ability to transmit accurate entry data • Goal: To ensure FDA receives accurate entry data

5. Filer Evaluations • 2 stages of filer evaluations • Dual Phase • Paperless

6. Filer EvaluationsDual Phase • Dual Phase is a constant evaluation phase • While in Dual Phase • Electronic Releases don’t count • FDA Release not official until shown on entry docs

7. Filer EvaluationsDual Phase • Dual Phase • Filer required to submit entry docs to FDA for ALL entries flagged FD1, FD2, FD3 or FD4 • This includes disclaimed entries

8. Filer EvaluationsDual Phase • Dual Phase • Districts evaluate the electronic data against the entry docs for ALL Dual Phase entries for correctness • After 3 weeks and 50 entries, calculate the filer’s error rate • Less than 10% error rate = paperless filer

9. Filer EvaluationsPaperless Status • Once a filer is in Paperless status • No longer has to submit docs for every entry • Evaluate at least every 9 months • Review limited to: • System May Proceeds • FDA May Proceeds • Disclaims

10. Filer EvaluationsAlternate Evaluation Schedule • Based on FDA-regulated lines/year 1-100 lines/year: every 4 years 101-1,000 lines/year: every 2 years 1,001-10,000 lines/year: every year 10,001+ lines/year: twice yearly

11. Filer EvaluationsEvaluation Process • FDA selects entries for evaluation • System May Proceeds • FDA May Proceeds • Disclaims • Number of entries evaluated is a function of FDA entries transmitted • FDA schedules evaluation with the filer • Filer provides entry documents for selected entries

12. Filer EvaluationsRemote Filers • Entries are evaluated as if filed by the local office. Example: • Filer with offices in Chicago, New York, and Philadelphia • Entries through the Port of Chicago: • Evaluated by FDA’s Chicago office • Reflect in the filer’s Chicago office error rate • Regardless of filer office location

13. Filer Evaluations - Errors • Incorrectly Disclaimed Products • Incorrect Country of Origin • Incorrect FDA Product Code • Incorrect FDA Manufacturer • Incorrect FDA Shipper • Incorrect Affirmation* • Quantity and Value* *If Submitted

14. Filer Evaluations - Errors Disclaims • Limited to tariffs with FD1 or FD3 Flag • Is the product regulated by FDA? • If the product is FDA regulated • Submit entry information to FDA • If the product is not FDA regulated • The line may be disclaimed

15. Filer Evaluations - Errors Disclaims/FD Flags FD0 – Regulated by FDA: FDA does not want entry information FD1 – May or may not be regulated by FDA: If yes, submit entry information; if no, disclaim FD2 – Regulated by FDA: Submit entry information FD3 – May or not be a food product: If yes, submit PN and entry information; if no, disclaim FD4 – Food product: Submit PN and entry information

16. Filer Evaluations – ErrorsCountry of Origin • Country of Origin generally matches the country of declared manufacturer • In limited cases, they may differ. Ex: • Produce grown in Israel • Packing house in Netherlands • Country of origin = Israel • Declared manufacturer = Netherlands • VERY limited circumstances

17. Filer Evaluations – ErrorsManufacturer & Shipper • Definitions of “FDA Manufacturer” and “FDA Shipper” • Manufacturer: site-specific location where the product is manufactured, produced, or grown • Shipper: shipper of the product identified on freight bills or bills of lading http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077797.htm

18. Filer Evaluations – ErrorsProduct Code • Use FDA Product Code Builder • http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM • Use the tutorial • Ask your local FDA office if you have questions about a product code

19. Filer Evaluations – ErrorsAffirmations of Compliance • Voluntary Submission • Codes to indicate compliance with specific requirements • If provided, are expected to be correct • Failure to provide can slow the FDA entry process

20. Filer Evaluations – ErrorsQuantity and Value • Voluntary Submission • If provided, are expected to be correct • Failure to provide can slow the FDA entry process

21. Filer Evaluations - Outcomes • FDA District provides results in writing to the filer: • Filer’s error rate • Entries with errors • Corrections • Error Rate: <= 10%: Pass >10% : Fail

22. Filer EvaluationsOutcomes • Failure: • Filer put on increased evaluation cycle • More entries are reviewed • Repeated failures can lead to return to Dual Phase • FDA’s can and does work with CBP for Broker Penalties for repeat failures

23. Filer EvaluationsCooperation with CBP • 19USC1641(b)(4) -- Exercise responsible supervision and control over Customs business • Also see 19CFR111.28 • Can be and has been linked to filer error rates

24. Filer EvaluationsCooperation with CBP • Actions taken against an entry filer will be for a lack of ‘due diligence’ • When FDA goes to CBP asking for a penalty against a filer, FDA will show the filer ‘should have known better’

25. Filer Evaluations • FDA is limited in what we count as an error for an evaluation But • If we find other things, we let CBP know about it

26. Filer EvaluationsClosing • The goal is for FDA to receive accurate and reliable entry data: • Allows FDA to make the best admissibility determination possible • Accurate and reliable data furthers the protection of public health and safety • Accurate and reliable data can make FDA’s admissibility process quicker • Inaccurate and unreliable data can make FDA’s admissibility process take longer

27. Questions?