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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@[email protected]
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?