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United States Food & Drug Administration Division of Import Operations and Policy. FDA Filer Evaluations An Overview of Current FDA Procedures. John E. Verbeten 301-594-3853 john.verbeten@fda.hhs.gov.

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united states food drug administration division of import operations and policy

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

division of import operations and policy
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
fda filer evaluations
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
fda filer evaluation procedure
FDA Filer Evaluation Procedure
  • Purpose: To evaluate the filer’s ability to transmit accurate entry data
  • Goal: To ensure FDA receives accurate entry data
filer evaluations
Filer Evaluations
  • 2 stages of filer evaluations
    • Dual Phase
    • Paperless
filer evaluations dual phase
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
filer evaluations dual phase7
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
filer evaluations dual phase8
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
filer evaluations paperless status
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
filer evaluations alternate evaluation schedule
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

filer evaluations evaluation process
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
filer evaluations remote filers
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
filer evaluations errors
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

filer evaluations errors disclaims
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
filer evaluations errors disclaims fd flags
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

filer evaluations errors country of origin
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
filer evaluations errors manufacturer shipper
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

filer evaluations errors product code
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
filer evaluations errors affirmations of compliance
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
filer evaluations errors quantity and value
Filer Evaluations – ErrorsQuantity and Value
  • Voluntary Submission
  • If provided, are expected to be correct
    • Failure to provide can slow the FDA entry process
filer evaluations outcomes
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

filer evaluations outcomes22
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
filer evaluations cooperation with cbp
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
filer evaluations cooperation with cbp24
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’
filer evaluations25
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
filer evaluations closing
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