ITACS

January 2017

Food and Drug Administration

Division of Compliance Systems

Import Compliance Systems Branch

Import Trade Auxiliary Communications System

Overview and Walkthrough of Functionality 
Topics

• Description of ITACS

• System Requirements

• Benefits to the Trade and FDA

• Walkthrough of Functionality

2
ITACS – Web Users

ITACS currently provides web users with 4 functions:

 the ability to check the status of FDA-regulated entries and 

lines

 the ability to submit entry documentation electronically

 the ability to electronically submit the location of goods 

availability for those lines targeted for FDA exam

 the ability to check the estimated laboratory analysis 

completion dates

No login accounts are necessary to access these functions. All 

that is needed is a valid Customs entry number that has been 

successfully transmitted to FDA. 

3
ITACS – Account Users

ITACS Account Management allows users to: 

 Receive Notices of FDA Action via email*

 Retrieve Notices of FDA Action as downloads from within 

ITACS

 View the details of specific information requests, which are 

currently delivered via hard copy Notices of FDA Action

 Will also allow for future enhancements requested by the 

Import Trade Community which require user verification

*Receipt of Notices of FDA Action via email is optional and will 

take the place of paper Notices if chosen. Account users will be 

able to retrieve Notices by downloading them from within 

ITACS regardless of whether they opt to receive them via email 

or regular mail. 4
ITACS – Account Users

 To view the ITACS Account Management PP visit: 

http://www.fda.gov/forindustry/importprogram/entryprocess/

importsystems/ucm480953.htm

Details:

 Background and Overview of ITACS Account Management

 Creating a New Account

 Retrieving Notices of FDA Action from ITACS

 Managing your Account, Users and Groups

5
Trade System Requirements

 ITACS Internet access - https://itacs.fda.gov

 Security – Web User

– Accounts Not Required

– Only Entry Number/Line Number needed

– Limited functionality available

 Security – ITACS Account User

– Approved ITACS Account required to receive Notices of 

FDA Action and Specific Information requests via email 

and/or to download them from within ITACS.

 FURLS account access: https://www.access.fda.gov/oaa

6
FDA System Requirements

 File size limitation increased to 5 files of 50 MB each, 

for a total of 250 MB per submission

 Server storage capacity

 Variety of document types accepted including PDF, 

Word and Excel

 Receipt of conveyance arrival information from CBP 

for truck and air shipments

 Virus scanning of submitted documents

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Benefits – Entry/Line Status

 Allows a quick way to check on the status of entries 

successfully transmitted to FDA

– CBP/FDA Interface down

– No time waiting for return phone calls

– More specific information regarding a shipment during the 

admissibility process

– Displays expected Laboratory Time Frames for sampled 

lines

– Ability To Query Closed Entries

– Enables FDA to focus resources on expediting review of 

entries and completion of designated shipment 

examinations

8
Benefits - Document Submission

 Entry Document Submission

– No need to copy documents for FDA

– No need to fax or deliver documents to FDA

– No problems with lost document submissions

– Documented date and time of document upload

– No need to for FDA to retain paper copies of entry 

documentation

– Provides all FDA staff easy access to documents via FDA’s 

Import systems (OASIS & ER)

9
Benefits – Availability Information

 Shipment Availability Information

– No faxing

– No phone calls

– Less confusion between trade and FDA about date 

and location of availability

– Documented date and time of submission of 

information

10
Benefits – ITACS Accounts

 ITACS Accounts

– Faster receipt of Notices of FDA Action either via e-mail or 

via download within ITACS

– No need to wait for hard copy mailed Notices

– Receipt of requests for specific information sent via email 

or via download within ITACS

11
Checking Entry/Line Statuses
Checking Statuses

• Enter a valid entry number (specific line 

numbers may be entered but are optional)

• Enter the CAPTCHA letters 

• Click “Submit”

13
Checking Entry/Line Statuses

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Status: Lines Still Under Review

“No public status available”

15

Indicates that FDA has not yet taken an action 

and the line is pending review
Status: CBP Conveyance Arrival Notification Not Received For 

Truck and Air Shipments

“FDA entry status information is not available pending receipt of Conveyance Arrival 

Notification”

16

• Applies to Truck and Air Shipments

• Entry/Line status will not be displayed until electronic arrival 

notification has been received from Customs
Status: Mixed for Multi-line Entry

17
Status: Documents Required

“Documents Required”

18
Status: Pending Compliance Review

“Pending Review By FDA Compliance Staff”

19
Status: Refused Line

“Refused Inform FDA Before Export”

20
Status: Sample Collected by FDA

“FDA Sample Collected”

21
Status: Sample Collected by FDA

Viewing Laboratory Timeframes for Sampled Lines

22

When a sample has been collected and the 

analysis is in progress, an estimated 

completion date may be viewed.

Select a line using the checkbox, then select 

“View Expected Lab Completion Date” and 

click “Take Action”
Status: Sample Collected by FDA

Viewing Laboratory Timeframes for Sampled Lines
Status: Sample Collected by FDA

Viewing Laboratory Timeframes for Sampled Lines

Example of Expected Lab Work Completion Date
Status: Sample Collected by FDA

Viewing Laboratory Timeframes for Sampled Lines

No Sample Collected

No Sample Collection Assigned/Performed
Status: Sample Collected by FDA

Viewing Laboratory Timeframes for Sampled Lines

Lab Completion Date Not Yet Available

Expected Lab Completion Date Not Yet Available. Please 

Check Back Later.
Checking Entry/Line Statuses

Printer Friendly Results

Status results can be exported to a PDF file 

for printing or record keeping.

Click on the “Export as PDF for print” link
Checking Entry/Line Statuses

Printer Friendly Results

Example PDF
Checking Entry/Line Statuses

• Note: ITACS will display the status for closed 

entries. However; if the entry has been closed 

by FDA you will not be able to upload 

documents or submit availability information.

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Submitting Documents
Submitting Documents

• Input an Entry Number

• Select the radio button next to:

– “Submit Entry Level Documents” OR 

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

Note: If submitting line-level documents, select the checkbox next to 

the lines related to the document being submitted. Standard Entry 

Documentation (3461, invoice, bill of lading, packing lists) should be 

submitted at the Entry Level.

• Click “Take Action”

31
Submitting Entry Level Documents

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Submitting Documents (cont)

• Click the “Browse” button and locate the file you want to 

attach

• A document may be deleted from the list prior to 

submission if it has been attached in error

• Select the Document Type from the drop-down list

• Enter the required Submitter Information (marked with 

an asterisk)

• When done, click either “Submit and Finished” or 

“Submit and Return to Entry” button

• Repeat as needed

• You may attach up to 5 files of 50 MB each, for a total of 

250 MB per submission

33
Finding Documents to Submit

34
Finding Documents to Submit

35

Choose one
After Document Submission

• Immediately after submitting the documents, a 

message will be displayed at the top of the screen “If 

you selected to receive email notification you will 

receive an email upon completion of the virus scan 

and successful upload. If you have not opted to 

receive email notification please check back later to 

review the status of your submission” 

36
After Document Submission

37
After Document Submission

• With the implementation of virus scanning, 

document uploads may take up to fifteen minutes to 

complete.

• Users may select the checkbox “Receive a 

confirmation of submission by email”. This email will 

notify the user whether the document(s) passed or 

failed the virus scan.

• If the virus scan is successful, the ITACS status will 

update to “Document Submitted” and the ITACS 

Status date will reflect the date of submission.

38
Successful Document Submission

Example Email

39
Successful Document Submission

“Document Submitted” Status

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Document Review by FDA

• When documents have been successfully 

submitted, FDA’s Entry Review staff will see an 

icon which indicates documents are available 

for review and they can access and review 

those documents on-line.

41
Submitting Availability
Submitting Availability Information for FDA 

Examination

• Query the entry number

• Click the checkbox next to the line(s) for which 

you wish to submit availability

• Select the radio button next to “Input Line 

Availability for the selected item(s)”

• Click on the “Take Action” button

43
Submitting Availability Information

(All lines or Selected lines)

44
Submitting Availability – Three Options

1. Goods for the selected lines are available at 

the Consignee address as filed 

2. Goods for the selected lines are available at 

the Consignee address as filed with extra 

information as provided below

3. Provide an updated location for the selected 

lines 

Note: If there is any question about the validity of the consignee 

firm information as stored in FDA’s Import system, do not use 

option 1 or option 2.

45
Required and Optional Information

• For all options, submitter information is required

• Required information is marked with an asterisk

• Information required varies depending on the option 

chosen

• Do not submit availability location in advance of the 

product being available for examination by FDA

46
Submitting Availability – Option 1

• Only Submitter information is required

• The consignee as filed in the entry will be 

indicated as the location of goods

• No additional information may be entered

47
Submitting Availability – Option 2

• Submitter information is required

• The consignee as filed in the entry will be 

indicated as the location of goods

• Contact Name, Contact Phone Number, 

Warehouse/Pier Lot Number, Hours of 

Operation and Additional Information may all be 

entered optionally

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Submitting Availability – Option 3

• Submitter information is required

• Facility Name, Contact Name, Contact 

Phone Number, Street Address, City, State 

and Zip Code are required

• Warehouse/Pier Lot Number, Hours of 

Operation and Additional Information 

may all be entered optionally

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Provide a Location of Goods 

(Not at Consignee)

“Provide an updated location for the selected lines”

50
Submitting Availability

• After filling out all required information and 

clicking “Submit”, the Confirm Input Line 

Availability screen is presented.

• Verify all information is correct then click 

either “Submit and Return to Entry” or 

“Submit and Finished”.
Verify Availability Information Before Submitting

Choose one
After Availability Information is Submitted
Line(s) Not Eligible for Availability 

Submission

• Availability Information may only be 

submitted for entries where at least one line 

has been designated for physical exam/sample 

by FDA.

• If no lines have been designated, the message 

“Selected lines are not eligible for submission 

of availability at this time” will be displayed.

54
Line(s) Not Eligible for Availability 

Submission

55

Selected lines are not eligible for submission of availability at this time. 
Retrieving Notices of FDA Action from ITACS

*ITACS Account Management Required

No CAPTCHA Code required when 

logged into your account

Indicates that you are logged in and the User Name 

for the account. Also provides links to modify your 

account and manage users if a Firm or Group Admin
Retrieving Notices of FDA Action from ITACS

*ITACS Account Management Required

To retrieve Notices choose 

‘Retrieve Notices of FDA Action’ 

radio button and click TAKE 

ACTION.
Retrieving Notices of FDA Action from ITACS

*ITACS Account Management Required

Available Notices of FDA Action 

will be listed at the bottom of the 

page. Click on the PDF icons to 

open and view the Notices.
Emailed Notices of FDA Action

Example Email

Example email received by the account holder with the 

Notice of FDA Action attached. 
Retrieving Information Requests from ITACS

Click the link to show the 

information request.
Retrieving Information Requests from ITACS

The Information 

Request will be 

displayed in a pop 

up box. 

Requests also available 

to download as pdf 

under Retrieve Notices 

of FDA Action.
Helpful Links

 Found at the bottom of every page and 

provides some links to helpful information.
ITACS Banner

 Can be placed on any ITACS page in red, bold 

font to notify users of issues or updates.
ITACS Link

Access ITACS directly at: 

https://itacs.fda.gov 

To view the ITACS for Industry page visit: 

http://www.fda.gov/forindustry/importpr ogram/entryprocess/importsystems/ucm

480953.htm

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FDA Contacts

• Do NOT contact the field Divisions directly for 

ITACS technical assistance.

• To report problems, ask questions, or to 

suggest additional functionality please send 

emails to itacssupport@fda.hhs.gov .

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