ITACSITACS

ITACS Overview and Pilot Summary ITACS Overview and Pilot Summary October 13, 2011October 13, 2011

Food and Drug AdministrationFood and Drug AdministrationDivision of Import Operations and PolicyDivision of Import Operations and PolicySystems BranchSystems Branch

Import Trade Auxiliary Communications System

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TopicsTopics

Description of ITACSDescription of ITACS

System RequirementsSystem Requirements

Benefits to the TradeBenefits to the Trade

Benefits to FDABenefits to FDA

Future FunctionalityFuture Functionality

Walkthrough of FunctionalityWalkthrough of Functionality

Pilot SummaryPilot Summary

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ITACSITACS

Internet portal for import tradeInternet portal for import trade

–– Ability for the trade to check the status of Ability for the trade to check the status of individual entries/linesindividual entries/lines

–– Submission of entry documentation which will be Submission of entry documentation which will be linked to specific entries/lineslinked to specific entries/lines

–– Provide availability information for targeted Provide availability information for targeted shipmentsshipments

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Trade System RequirementsTrade System Requirements

Internet access Internet access -- URL to be provided on a TBD URL to be provided on a TBD basisbasis

Security Security –– CurrentCurrent–– Accounts Not RequiredAccounts Not Required–– Entry Number/Line NumberEntry Number/Line Number

Security Security –– FutureFuture–– Account management required to add Account management required to add

functionality to send Notices of FDA Action and functionality to send Notices of FDA Action and other functionality other functionality

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File size limitation issuesFile size limitation issues

Server capacityServer capacity

Document format limited to PDF for nowDocument format limited to PDF for now

Worked with CBP to receive conveyance Worked with CBP to receive conveyance arrival information for truck and air arrival information for truck and air shipmentsshipments

FDA System RequirementsFDA System Requirements

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Trade Benefits Trade Benefits –– Entry/Entry/LineLine StatusStatus

Allows a quick way to check on the status of Allows a quick way to check on the status of entries successfully transmitted to FDAentries successfully transmitted to FDA

–– CBP/FDA Interface downCBP/FDA Interface down

–– No time waiting for return phone callsNo time waiting for return phone calls

–– More specific information regarding a More specific information regarding a shipment during the admissibility processshipment during the admissibility process

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Trade Benefits Trade Benefits –– Document SubmissionDocument Submission

Entry Document SubmissionEntry Document Submission

–– No need to copy documents for FDANo need to copy documents for FDA

–– No need to fax or deliver documents to No need to fax or deliver documents to FDAFDA

–– No problems with lost document No problems with lost document submissionssubmissions

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Trade Benefits Trade Benefits –– Availability Availability InformationInformation

Shipment Availability InformationShipment Availability Information

–– No faxingNo faxing

–– No phone callsNo phone calls

–– Less confusion between trade and FDA Less confusion between trade and FDA about date and location of availabilityabout date and location of availability

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Benefits to FDA Benefits to FDA –– EntryEntry/Line/Line StatusStatus

Status of entries successfully transmitted to Status of entries successfully transmitted to FDA FDA

–– Reduces need to respond to phone calls Reduces need to respond to phone calls regarding status throughout the processregarding status throughout the process

–– Enables FDA to focus limited resources on Enables FDA to focus limited resources on expediting review of entries and focusing expediting review of entries and focusing on completion of designated shipment on completion of designated shipment examinationsexaminations

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Benefits to FDABenefits to FDA -- Entry DocumentationEntry Documentation

Entry Document SubmissionEntry Document Submission

–– No need to retain paper copies of entry No need to retain paper copies of entry documentationdocumentation

–– Fewer problems with claims regarding Fewer problems with claims regarding lost document submissionslost document submissions

–– Provides all FDA staff easy access to Provides all FDA staff easy access to documents via FDAdocuments via FDA’’s Import systems Import system

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Benefits to FDABenefits to FDA

Availability InformationAvailability Information

–– Fewer faxesFewer faxes–– Fewer phone callsFewer phone calls–– Less confusion between trade and FDA Less confusion between trade and FDA

about date and location of availabilityabout date and location of availability–– No need to log information in FDANo need to log information in FDA’’s s

Import systemImport system

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EntryEntry/Line/Line StatusesStatuses

CBP Conveyance Arrival NotificationCBP Conveyance Arrival Notification

–– Truck and AirTruck and Air

–– ““FDA entry status information is not FDA entry status information is not available pending receipt of Conveyance available pending receipt of Conveyance Arrival Notification from CBPArrival Notification from CBP””

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Future FunctionalityFuture Functionality

Transmission of Notices of FDA ActionTransmission of Notices of FDA Action

Query for FDA Firm IdentifiersQuery for FDA Firm Identifiers

Query for FDA Product CodesQuery for FDA Product Codes

Display of Laboratory TimeframesDisplay of Laboratory Timeframes

Submission of other document typesSubmission of other document types

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Future Functionality Future Functionality (cont.)(cont.)

Improved CAPTCHA legibilityImproved CAPTCHA legibility

Virus scanning of submitted documentsVirus scanning of submitted documents

Printer friendly version of Status pagePrinter friendly version of Status page

Link to FDA Import Reference materialsLink to FDA Import Reference materials

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Trade Outreach PlannedTrade Outreach Planned

Internet URL for the tradeInternet URL for the trade

EE--mail mail itacssupport@fda.hhs.govitacssupport@fda.hhs.gov

Further training before official Further training before official implementationimplementation

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Checking StatusesChecking Statuses

Enter a valid entry number (specific Enter a valid entry number (specific line numbers may be entered but are line numbers may be entered but are optional)optional)

Enter the CAPTCHA letters Enter the CAPTCHA letters

Click Click ““SubmitSubmit””

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Checking Checking Entry/LineEntry/Line StatusesStatuses

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Status: Lines Still Under ReviewStatus: Lines Still Under Review ““No public status availableNo public status available””

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Status: CBP Status: CBP ConveyanceConveyance Arrival Arrival Notification Not Received For Truck and Notification Not Received For Truck and

Air ShipmentsAir Shipments ““FDA entry status information is not available pending FDA entry status information is not available pending

receipt of Conveyance Arrival Notificationreceipt of Conveyance Arrival Notification””

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Status: Mixed for MultiStatus: Mixed for Multi--line Truck line Truck Port Entry After CBP Conveyance Port Entry After CBP Conveyance Arrival Notification ReceivedArrival Notification Received

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Status: Documents RequiredStatus: Documents Required ““Documents RequiredDocuments Required””

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Status: Sample Collected Status: Sample Collected by FDAby FDA ““Product Collected for Laboratory AnalysisProduct Collected for Laboratory Analysis””

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Status: Pending Compliance ReviewStatus: Pending Compliance Review ““Sent to Compliance for ReviewSent to Compliance for Review””

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Status: Refused LineStatus: Refused Line ““Refused Inform FDA After ExportRefused Inform FDA After Export””

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Checking Checking Entry/LineEntry/Line StatusesStatuses

Note:Note: ITACS will only display statuses ITACS will only display statuses for for ““openopen”” entries. If a final FDA entries. If a final FDA admissibility decision has been made admissibility decision has been made for all lines of an entry, the entry is for all lines of an entry, the entry is ““closedclosed”” in FDAin FDA’’s import system and s import system and you will need to check your ABI you will need to check your ABI Messaging or Notices of FDA Action for Messaging or Notices of FDA Action for the status.the status.

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Submitting DocumentsSubmitting Documents

Input an Entry NumberInput an Entry Number

Select the radio button next to:Select the radio button next to:

–– ““Submit Entry Level DocumentsSubmit Entry Level Documents”” OR OR

–– ““Submit Line Level Documents for the selected Submit Line Level Documents for the selected item(sitem(s))””

Note: If submitting lineNote: If submitting line--level documents, select the checkbox next to the lines level documents, select the checkbox next to the lines related to the document being submitted. Standard Entry Documenrelated to the document being submitted. Standard Entry Documentation (3461, tation (3461, invoice, bill of lading, packing lists) should be submitted at tinvoice, bill of lading, packing lists) should be submitted at the Entry Level.he Entry Level.

Click Click ““Take ActionTake Action””

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Submitting Submitting Entry LevelEntry Level DocumentsDocuments

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Submitting Documents Submitting Documents (cont)(cont)

Click the Click the ““BrowseBrowse”” button and locate the button and locate the PDF file you want to attachPDF file you want to attach

Click the Click the ““AttachAttach”” buttonbutton

Select the Document Type from the dropSelect the Document Type from the drop--down listdown list

Repeat as neededRepeat as needed

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Submitting Documents Submitting Documents (cont)(cont)

You may attach up to 5 files of 20 MB each, for a You may attach up to 5 files of 20 MB each, for a total of 100 MB per submissiontotal of 100 MB per submission

A document may be deleted from the list prior to A document may be deleted from the list prior to submission if it has been attached in errorsubmission if it has been attached in error

Enter the required Submitter Information (marked Enter the required Submitter Information (marked with an asterisk)with an asterisk)

When done, click either When done, click either ““Submit and FinishedSubmit and Finished”” or or ““Submit and Return to EntrySubmit and Return to Entry”” buttonbutton

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Finding Documents to SubmitFinding Documents to Submit

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Attaching Documents For SubmissionAttaching Documents For Submission

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Successful Document SubmissionSuccessful Document Submission

After submitting the documents, a After submitting the documents, a message will be displayed at the top of message will be displayed at the top of the screen the screen ““The documents were The documents were submitted successfullysubmitted successfully””..

The new ITACS Entry/Line Status will The new ITACS Entry/Line Status will also change to also change to ““Document SubmittedDocument Submitted””

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Successful Document SubmissionSuccessful Document Submission

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Document Review by FDADocument Review by FDA

When documents have been When documents have been successfully submitted, FDAsuccessfully submitted, FDA’’s Entry s Entry Review staff will see an icon which Review staff will see an icon which indicates documents are available for indicates documents are available for review and they can access and review review and they can access and review those documents onthose documents on--line.line.

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Submitting Availability Submitting Availability Information Information for FDA Examinationfor FDA Examination

InputInput an entry numberan entry number

Click the checkbox next to the Click the checkbox next to the line(sline(s) for ) for which you wish to submit availabilitywhich you wish to submit availability

Select the radio button next to Select the radio button next to ““Input Line Input Line Availability for the selected Availability for the selected item(sitem(s))””

Click on the Click on the ““Take ActionTake Action”” buttonbutton

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Submitting Availability Submitting Availability InformationInformation

((All lines or Selected lines)All lines or Selected lines)

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Submitting Availability Submitting Availability –– Three OptionsThree Options

1.1. Goods for the selected lines are available Goods for the selected lines are available at the Consignee address as filed at the Consignee address as filed

2.2. Goods for the selected lines are available Goods for the selected lines are available at the Consignee address as filed with at the Consignee address as filed with extra information as provided belowextra information as provided below

3. Provide an updated location for the 3. Provide an updated location for the selected lines selected lines

Note: If there is any question about the validity of the Note: If there is any question about the validity of the consignee firm information as stored in FDAconsignee firm information as stored in FDA’’s Import s Import system, do not use option 1 or option 2.system, do not use option 1 or option 2.

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Required and Optional Required and Optional InformationInformation

For all options, submitter information is For all options, submitter information is requiredrequiredRequired information is marked with an Required information is marked with an asteriskasteriskInformation required varies depending on Information required varies depending on the option chosenthe option chosenDo not submit availability location in Do not submit availability location in advance of the product being available for advance of the product being available for examination by FDAexamination by FDA

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Submitting Availability Submitting Availability –– Option 1Option 1

Only Submitter information is requiredOnly Submitter information is required

The consignee as filed in the entry will The consignee as filed in the entry will be indicated as the location of goodsbe indicated as the location of goods

No additional information may be No additional information may be enteredentered

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Submitting Availability Submitting Availability –– OptionOption 22

Submitter information is requiredSubmitter information is required

The consignee as filed in the entry will be The consignee as filed in the entry will be indicated as the location of goodsindicated as the location of goods

Contact Name, Contact Phone Number, Contact Name, Contact Phone Number, Warehouse/Pier Lot Number, Hours of Warehouse/Pier Lot Number, Hours of Operation and Additional Information may Operation and Additional Information may all be entered optionallyall be entered optionally

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Submitting Availability Submitting Availability –– Option 3Option 3

Submitter information is requiredSubmitter information is required

Facility Name, Contact Name, Contact Facility Name, Contact Name, Contact Phone Number, Street Address, City, Phone Number, Street Address, City, State and Zip Code are requiredState and Zip Code are required

Warehouse/Pier Lot Number, Hours of Warehouse/Pier Lot Number, Hours of Operation and Additional Information Operation and Additional Information may all be entered optionallymay all be entered optionally

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Provide a Location of Goods Provide a Location of Goods (Not at Consignee)(Not at Consignee)

““Provide an updated location for the selected linesProvide an updated location for the selected lines””

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ITACS Pilot SummaryITACS Pilot Summary

Ran from May 25 through August 22, Ran from May 25 through August 22, 20112011

Concluded with a survey of Concluded with a survey of participants to gather feedbackparticipants to gather feedback

Participants may continue to use Participants may continue to use ITACS if they wishITACS if they wish

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ITACS Pilot Summary ITACS Pilot Summary (cont.)(cont.)

Out of 20 filers selected for the Pilot, Out of 20 filers selected for the Pilot, 12 actively participated12 actively participatedParticipation was measured based on Participation was measured based on documents submitted via ITACSdocuments submitted via ITACSOut of 1406 document requests, 240 Out of 1406 document requests, 240 documents were submitted via ITACS. documents were submitted via ITACS. This was a 17.1% submission rate.This was a 17.1% submission rate.

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Filer Communications Filer Communications During PilotDuring Pilot

KickKick--off Meeting May 25, 2011off Meeting May 25, 2011Check in call June 9, 2011 Check in call June 9, 2011 –– gathered gathered feedbackfeedbackFollowFollow--up call July 18, 2011 up call July 18, 2011 ––extended Pilotextended PilotSurvey sent out September 2, 2011Survey sent out September 2, 2011

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Survey ResultsSurvey Results

On a scale of 1 to 5, rate the usefulness On a scale of 1 to 5, rate the usefulness of checking line statuses via ITACSof checking line statuses via ITACS

1 1 -- Not Not Useful Useful At AllAt All

22 3 3 -- NeutralNeutral

44 5 5 –– Very Very

UsefulUseful

7.1% 7.1% (1)(1)

0.0%0.0% 28.6% 28.6% (4)(4)

28.6% 28.6% (4)(4)

35.7% 35.7% (5)(5)

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Survey Results Survey Results (cont)(cont)

On a scale of 1 to 5, rate the usefulness On a scale of 1 to 5, rate the usefulness of submitting documents via ITACSof submitting documents via ITACS

1 1 -- Not Not Useful Useful At AllAt All

22 3 3 -- NeutralNeutral

44 5 5 –– Very Very

UsefulUseful

7.1% 7.1% (1)(1)

14.3% 14.3% (2)(2)

14.3% 14.3% (2)(2)

14.3% 14.3% (2)(2)

50% 50% (7)(7)

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Survey Results Survey Results (cont)(cont)

On a scale of 1 to 5, rate the usefulness On a scale of 1 to 5, rate the usefulness of submitting availability information via of submitting availability information via ITACSITACS

1 1 -- Not Not Useful Useful At AllAt All

22 3 3 -- NeutralNeutral

44 5 5 –– Very Very

UsefulUseful

0.0% 0.0% (0)(0)

14.3% 14.3% (2)(2)

42.9% 42.9% (6)(6)

14.3% 14.3% (2)(2)

28.6% 28.6% (4)(4)

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Survey Results Survey Results (cont)(cont)

On a scale of 1 to 5, rate the speed of On a scale of 1 to 5, rate the speed of ITACSITACS

1 1 –– Very Very SlowSlow

22 3 3 -- NeutralNeutral

44 5 5 –– Very Very FastFast

0.0% 0.0% (0)(0)

7.1% 7.1% (1)(1)

35.7% 35.7% (5)(5)

21.4% 21.4% (3)(3)

35.7% 35.7% (5)(5)

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Survey Results Survey Results (cont)(cont)

On a scale of 1 to 5, rate ITACSOn a scale of 1 to 5, rate ITACS’’ ease of ease of useuse

1 1 –– Very Very

DifficultDifficult

22 3 3 -- NeutralNeutral

44 5 5 –– Very Very EasyEasy

0.0% 0.0% (0)(0)

0.0% 0.0% (0)(0)

7.1% 7.1% (1)(1)

28.6% 28.6% (4)(4)

64.3% 64.3% (9)(9)

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Survey Results Survey Results (cont)(cont)

Would you continue using ITACS?Would you continue using ITACS?

–– Yes Yes –– 100% (13)100% (13)–– No No –– 0% (0)0% (0)

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Problems Identified Problems Identified During PilotDuring Pilot

Availability information submitted via ITACS Availability information submitted via ITACS could not be viewed by FDA staff. A change could not be viewed by FDA staff. A change to correct this is scheduled for to correct this is scheduled for implementation in late October 2011.implementation in late October 2011.

FDA staff could not easily identify FDA staff could not easily identify documents that had been submitted. documents that had been submitted. Because of this, entries were not always Because of this, entries were not always reviewed in a timely manner. A change to reviewed in a timely manner. A change to correct this is scheduled for implementation correct this is scheduled for implementation in late October 2011.in late October 2011.

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Problems Identified Problems Identified During Pilot During Pilot (cont.)(cont.)

In some cases, ITACS displayed the wrong In some cases, ITACS displayed the wrong date that documents were submitted (next date that documents were submitted (next calendar day). This is currently being calendar day). This is currently being investigated.investigated.One filer submitted documents that were One filer submitted documents that were not received by ITACS, despite receiving a not received by ITACS, despite receiving a status of status of ““Documents SubmittedDocuments Submitted””. This is . This is currently being investigated.currently being investigated.When Entry Level documents are submitted, When Entry Level documents are submitted, the status is not copied to the lines and the the status is not copied to the lines and the date of submission is not displayed.date of submission is not displayed.

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Problems Identified Problems Identified During Pilot During Pilot (cont.)(cont.)

Difficulty reading the CAPTCHA letters. Difficulty reading the CAPTCHA letters. A future release will address this A future release will address this problem.problem.

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Suggested ChangesSuggested Changes

Ability to query entries for 30 days Ability to query entries for 30 days after they have been closedafter they have been closedAbility to view the entire status history Ability to view the entire status history of a line rather than only the current of a line rather than only the current statusstatusUsers would like to receive an email Users would like to receive an email indicating that documents have been indicating that documents have been received.received.

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Suggested Changes Suggested Changes (cont.)(cont.)

Ability to upload lot information for Ability to upload lot information for multiple lines at the same time when multiple lines at the same time when submitting availability informationsubmitting availability informationAbility to receive automated messages Ability to receive automated messages when the status of a line changeswhen the status of a line changesAbility to receive detailed information Ability to receive detailed information on what documentation is being on what documentation is being requestedrequested

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Suggested Changes Suggested Changes (cont.)(cont.)

Ability to view and print Notices of Ability to view and print Notices of FDA ActionFDA ActionMore trainingMore trainingFDA Users would like to receive FDA Users would like to receive submitter email information in case submitter email information in case they have questions regarding they have questions regarding document submissiondocument submission

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Next StepsNext Steps

ITACS will not be released nationwide ITACS will not be released nationwide until all FDA Districts are using MARCS until all FDA Districts are using MARCS Imports Entry ReviewImports Entry ReviewSuggested changes will be evaluated Suggested changes will be evaluated and implemented where possible.and implemented where possible.

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FDA ContactsFDA Contacts

Please do NOT contact the Districts Please do NOT contact the Districts directly about ITACSdirectly about ITACS

To report problems or ask questions, To report problems or ask questions, please send emails to please send emails to itacssupport@fda.hhs.govitacssupport@fda.hhs.gov

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Questions?Questions?