United States Food

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United States Food Drug AdministrationDivision
of Import Operations and Policy
FDA Filer EvaluationsAn Overview of Current FDA
Procedures
Presentation toNational Customs Brokers
Forwarders Association of America January 21,
2010

• John E. Verbeten
• 301-594-3853
• john.verbeten_at_fda.hhs.gov

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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

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FDA Filer Evaluations

• Current FDA Filer Evaluation Procedure was
  originally drafted in 1994
• There is a revision under internal review
• Todays presentation deals only with FDAs
  current procedure

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FDA Filer Evaluation Procedure

• Purpose To evaluate the filers ability to
  transmit accurate entry data
• Goal To ensure FDA receives accurate entry data

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Filer Evaluations

• 2 stages of filer evaluations
• Dual Phase
• Paperless

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Filer EvaluationsDual Phase

• Dual Phase is a constant evaluation phase
• While in Dual Phase
• Electronic Releases dont count
• FDA Release not official until shown on entry docs

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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

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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
  filers error rate
• Less than 10 error rate paperless filer

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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

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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

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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

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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 FDAs Chicago office
• Reflect in the filers Chicago office error rate
• Regardless of filer office location

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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

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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

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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

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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

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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/Admis
  sibilityDeterminationsforShipmentsofForeign-origin
  OASIS/ucm077797.htm

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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

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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

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Filer Evaluations ErrorsQuantity and Value

• Voluntary Submission
• If provided, are expected to be correct
• Failure to provide can slow the FDA entry process

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Filer Evaluations - Outcomes

• FDA District provides results in writing to the
  filer
• Filers error rate
• Entries with errors
• Corrections
• Error Rate
• lt 10 Pass
• gt10 Fail

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Filer EvaluationsOutcomes

• Failure
• Filer put on increased evaluation cycle
• More entries are reviewed
• Repeated failures can lead to return to Dual
  Phase
• FDAs can and does work with CBP for Broker
  Penalties for repeat failures

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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

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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

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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

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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 FDAs
  admissibility process quicker
• Inaccurate and unreliable data can make FDAs
  admissibility process take longer

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• Questions?