United States Food & Drug United States Food & Drug AdministrationAdministrationDivision of Import Operations and PolicyDivision of Import Operations and Policy

Presentation to:National Customs Brokers & Forwarders Association of America January 21, 2010

FDA Filer EvaluationsFDA Filer EvaluationsAn Overview of Current FDA An Overview of Current FDA ProceduresProcedures

John E. VerbetenJohn E. Verbeten301-594-3853301-594-3853john.verbeten@fda.hhs.govjohn.verbeten@fda.hhs.gov

Division of Import Division of Import Operations and PolicyOperations and Policy

CDR Domenic J. Veneziano, DirectorCDR Domenic J. Veneziano, Director

– Ted Poplawski, Special AssistantTed Poplawski, Special Assistant

– Operations & Policy BranchOperations & Policy Branch John E. Verbeten, DirectorJohn E. Verbeten, Director

– Systems BranchSystems Branch Kelle Fry, Acting DirectorKelle Fry, Acting Director

FDA Filer EvaluationsFDA Filer Evaluations

Current FDA Filer Evaluation Current FDA Filer Evaluation Procedure was originally drafted Procedure was originally drafted in 1994in 1994

There is a revision under internal There is a revision under internal reviewreview– Today’s presentation deals only with Today’s presentation deals only with

FDA’s current procedureFDA’s current procedure

FDA Filer Evaluation FDA Filer Evaluation ProcedureProcedure

Purpose: To evaluate the filer’s Purpose: To evaluate the filer’s ability to transmit accurate entry ability to transmit accurate entry data data

Goal: To ensure FDA receives Goal: To ensure FDA receives accurate entry dataaccurate entry data

Filer EvaluationsFiler Evaluations

2 stages of filer evaluations2 stages of filer evaluations– Dual PhaseDual Phase– PaperlessPaperless

Filer EvaluationsFiler EvaluationsDual PhaseDual Phase

Dual Phase is a constant Dual Phase is a constant evaluation phaseevaluation phase

While in Dual PhaseWhile in Dual Phase– Electronic Releases don’t countElectronic Releases don’t count– FDA Release not official until shown FDA Release not official until shown

on entry docson entry docs

Filer EvaluationsFiler EvaluationsDual PhaseDual Phase

Dual PhaseDual Phase– Filer required to submit entry docs Filer required to submit entry docs

to FDA for ALL entries flagged FD1, to FDA for ALL entries flagged FD1, FD2, FD3 or FD4FD2, FD3 or FD4

– This includes disclaimed entriesThis includes disclaimed entries

Filer EvaluationsFiler EvaluationsDual PhaseDual Phase

Dual PhaseDual Phase– Districts evaluate the electronic data Districts evaluate the electronic data

against the entry docs for ALL Dual against the entry docs for ALL Dual Phase entries for correctnessPhase entries for correctness

– After 3 weeks and 50 entries, After 3 weeks and 50 entries, calculate the filer’s error ratecalculate the filer’s error rate

– Less than 10% error rate = Less than 10% error rate = paperless filerpaperless filer

Filer EvaluationsFiler EvaluationsPaperless StatusPaperless Status

Once a filer is in Paperless statusOnce a filer is in Paperless status– No longer has to submit docs for No longer has to submit docs for

every entryevery entry Evaluate at least every 9 monthsEvaluate at least every 9 months

– Review limited to:Review limited to: System May ProceedsSystem May Proceeds FDA May ProceedsFDA May Proceeds DisclaimsDisclaims

Filer EvaluationsFiler EvaluationsAlternate Evaluation ScheduleAlternate Evaluation Schedule

Based on FDA-regulated Based on FDA-regulated lines/yearlines/year1-100 lines/year: every 4 years 1-100 lines/year: every 4 years

101-1,000 lines/year: every 2 years 101-1,000 lines/year: every 2 years

1,001-10,000 lines/year: every year 1,001-10,000 lines/year: every year

10,001+ lines/year: twice yearly10,001+ lines/year: twice yearly

Filer EvaluationsFiler EvaluationsEvaluation ProcessEvaluation Process

FDA selects entries for evaluationFDA selects entries for evaluation System May ProceedsSystem May Proceeds FDA May ProceedsFDA May Proceeds DisclaimsDisclaims

Number of entries evaluated is a Number of entries evaluated is a function of FDA entries transmittedfunction of FDA entries transmitted

FDA schedules evaluation with the filerFDA schedules evaluation with the filer Filer provides entry documents for Filer provides entry documents for

selected entriesselected entries

Filer EvaluationsFiler EvaluationsRemote FilersRemote Filers

Entries are evaluated as if filed by Entries are evaluated as if filed by the local office. Example:the local office. Example:– Filer with offices in Chicago, New Filer with offices in Chicago, New

York, and PhiladelphiaYork, and Philadelphia– Entries through the Port of Chicago:Entries through the Port of Chicago:

Evaluated by FDA’s Chicago officeEvaluated by FDA’s Chicago office Reflect in the filer’s Chicago office error Reflect in the filer’s Chicago office error

raterate Regardless of filer office locationRegardless of filer office location

Filer Evaluations - Filer Evaluations - ErrorsErrors Incorrectly Disclaimed Products Incorrectly Disclaimed Products Incorrect Country of Origin Incorrect Country of Origin Incorrect FDA Product Code Incorrect FDA Product Code Incorrect FDA Manufacturer Incorrect FDA Manufacturer Incorrect FDA ShipperIncorrect FDA Shipper Incorrect Affirmation* Incorrect Affirmation* Quantity and Value*Quantity and Value*

*If Submitted*If Submitted

Filer Evaluations - Filer Evaluations - Errors Errors DisclaimsDisclaims

Limited to tariffs with FD1 or FD3 Limited to tariffs with FD1 or FD3 FlagFlag– Is the product regulated by FDA?Is the product regulated by FDA?

– If the product is FDA regulatedIf the product is FDA regulated Submit entry information to FDASubmit entry information to FDA

– If the product is not FDA regulatedIf the product is not FDA regulated The line may be disclaimedThe line may be disclaimed

Filer Evaluations - Filer Evaluations - Errors Errors Disclaims/FD FlagsDisclaims/FD Flags

FD0 – Regulated by FDA: FDA does not want FD0 – Regulated by FDA: FDA does not want entry informationentry information

FD1 – May or may not be regulated by FDA: If FD1 – May or may not be regulated by FDA: If yes, submit entry information; if no, yes, submit entry information; if no, disclaimdisclaim

FD2 – Regulated by FDA: Submit entry FD2 – Regulated by FDA: Submit entry informationinformation

FD3 – May or not be a food product: If yes, FD3 – May or not be a food product: If yes, submit PN and entry information; if no, submit PN and entry information; if no, disclaimdisclaim

FD4 – Food product: Submit PN and entry FD4 – Food product: Submit PN and entry informationinformation

Filer Evaluations – Filer Evaluations – ErrorsErrorsCountry of OriginCountry of Origin Country of Origin generally matches Country of Origin generally matches

the country of declared manufacturerthe country of declared manufacturer In limited cases, they may differ. Ex: In limited cases, they may differ. Ex:

– Produce grown in IsraelProduce grown in Israel– Packing house in NetherlandsPacking house in Netherlands

Country of origin = IsraelCountry of origin = Israel Declared manufacturer = NetherlandsDeclared manufacturer = Netherlands VERY limited circumstancesVERY limited circumstances

Filer Evaluations – Filer Evaluations – ErrorsErrorsManufacturer & ShipperManufacturer & Shipper Definitions of “FDA Manufacturer” and Definitions of “FDA Manufacturer” and

“FDA Shipper”“FDA Shipper”– Manufacturer: site-specific location where Manufacturer: site-specific location where

the product is manufactured, produced, or the product is manufactured, produced, or growngrown

– Shipper: shipper of the product identified Shipper: shipper of the product identified on freight bills or bills of ladingon freight bills or bills of lading

http://www.fda.gov/ForIndustry/ImportProgram/http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077797.htmucm077797.htm

Filer Evaluations – Filer Evaluations – ErrorsErrorsProduct CodeProduct Code Use FDA Product Code BuilderUse FDA Product Code Builder

– http://www.accessdata.fda.gov/SCRIhttp://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTMPTS/ORA/PCB/PCB.HTM

– Use the tutorialUse the tutorial– Ask your local FDA office if you have Ask your local FDA office if you have

questions about a product codequestions about a product code

Filer Evaluations – Filer Evaluations – ErrorsErrorsAffirmations of ComplianceAffirmations of Compliance Voluntary SubmissionVoluntary Submission Codes to indicate compliance with Codes to indicate compliance with

specific requirementsspecific requirements If provided, are expected to be If provided, are expected to be

correctcorrect

– Failure to provide can slow the FDA Failure to provide can slow the FDA entry processentry process

Filer Evaluations – Filer Evaluations – ErrorsErrorsQuantity and ValueQuantity and Value Voluntary SubmissionVoluntary Submission If provided, are expected to be If provided, are expected to be

correctcorrect

– Failure to provide can slow the FDA Failure to provide can slow the FDA entry processentry process

Filer Evaluations - Filer Evaluations - OutcomesOutcomes FDA District provides results in FDA District provides results in

writing to the filer:writing to the filer:– Filer’s error rateFiler’s error rate– Entries with errorsEntries with errors– CorrectionsCorrections

Error Rate:Error Rate:<= 10%: Pass<= 10%: Pass>10% : Fail>10% : Fail

Filer EvaluationsFiler EvaluationsOutcomesOutcomes

Failure:Failure:– Filer put on increased evaluation cycleFiler put on increased evaluation cycle– More entries are reviewedMore entries are reviewed

– Repeated failures can lead to return to Repeated failures can lead to return to Dual PhaseDual Phase

– FDA’s can and does work with CBP for FDA’s can and does work with CBP for Broker Penalties for repeat failuresBroker Penalties for repeat failures

Filer EvaluationsFiler EvaluationsCooperation with CBPCooperation with CBP

– 19USC1641(b)(4) -- Exercise 19USC1641(b)(4) -- Exercise responsible supervision and control responsible supervision and control over Customs businessover Customs business

– Also see 19CFR111.28Also see 19CFR111.28– Can be and has been linked to filer Can be and has been linked to filer

error rateserror rates

Filer EvaluationsFiler EvaluationsCooperation with CBPCooperation with CBP

Actions taken against an entry Actions taken against an entry filer will be for a lack of ‘due filer will be for a lack of ‘due diligence’diligence’

When FDA goes to CBP asking for When FDA goes to CBP asking for a penalty against a filer, FDA will a penalty against a filer, FDA will show the filer ‘should have known show the filer ‘should have known better’better’

Filer EvaluationsFiler Evaluations

FDA is limited in what we count FDA is limited in what we count as an error for an evaluationas an error for an evaluation

ButBut

If we find other things, we let CBP If we find other things, we let CBP know about itknow about it

Filer EvaluationsFiler EvaluationsClosingClosing

The goal is for FDA to receive accurate The goal is for FDA to receive accurate and reliable entry data:and reliable entry data:– Allows FDA to make the best admissibility Allows FDA to make the best admissibility

determination possibledetermination possible– Accurate and reliable data furthers the Accurate and reliable data furthers the

protection of public health and safetyprotection of public health and safety– Accurate and reliable data can make FDA’s Accurate and reliable data can make FDA’s

admissibility process quickeradmissibility process quicker– Inaccurate and unreliable data can make Inaccurate and unreliable data can make

FDA’s admissibility process take longerFDA’s admissibility process take longer

Questions?Questions?