itacs pilot slidesfuture functionality ... consignee firm information as stored in fda’s import...
Post on 16-Oct-2020
0 Views
Preview:
TRANSCRIPT
ITACS
March 2012 Food and Drug Administration Division of Import Operations and Policy Systems Branch
Import Trade Auxiliary Communications System
Overview and Walkthrough of Functionality
2
Topics
Description of ITACS
System Requirements
Benefits to the Trade
Benefits to FDA
Future Functionality
Walkthrough of Functionality
3
ITACS
Internet portal for import trade – Ability for the trade to check the status of
individual entries/lines
– Submission of entry documentation which will be linked to specific entries/lines
– Provide availability information for targeted shipments
4
Trade System Requirements
Internet access - URL to be provided on a TBD
basis Security – Current
– Accounts Not Required – Entry Number/Line Number
Security – Future
– Account management required to add functionality to send Notices of FDA Action and other functionality
5
File size limitation issues Server capacity Document format limited to PDF for now
Worked with CBP to receive conveyance
arrival information for truck and air shipments
FDA System Requirements
6
Trade 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
7
Trade 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
8
Trade Benefits – Availability Information
Shipment Availability Information – No faxing
– No phone calls
– Less confusion between trade and FDA
about date and location of availability
9
Benefits to FDA – Entry/Line Status
Status of entries successfully transmitted to FDA – Reduces need to respond to phone calls
regarding status throughout the process
– Enables FDA to focus limited resources on expediting review of entries and focusing on completion of designated shipment examinations
10
Benefits to FDA - Entry Documentation
Entry Document Submission – No need to retain paper copies of entry
documentation – Fewer problems with claims regarding
lost document submissions – Provides all FDA staff easy access to
documents via FDA’s Import system
11
Benefits to FDA
Availability Information – Fewer faxes – Fewer phone calls – Less confusion between trade and FDA
about date and location of availability – No need to log information in FDA’s
Import system
12
Entry/Line Statuses
CBP Conveyance Arrival Notification – Truck and Air
– “FDA entry status information is not
available pending receipt of Conveyance Arrival Notification from CBP”
13
Future Functionality
Transmission of Notices of FDA Action
Query for FDA Firm Identifiers
Query for FDA Product Codes
Display of Laboratory Timeframes
Submission of other document types
14
Future Functionality (cont.)
Improved CAPTCHA legibility
Virus scanning of submitted documents
Printer friendly version of Status page
Link to FDA Import Reference materials
15
Checking Statuses
Enter a valid entry number (specific line numbers may be entered but are optional)
Enter the CAPTCHA letters
Click “Submit”
16
Checking Entry/Line Statuses
17
Status: Lines Still Under Review “No public status available”
18
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”
19
Status: Mixed for Multi-line Truck Port Entry After CBP Conveyance Arrival Notification Received
20
Status: Documents Required “Documents Required”
21
Status: Sample Collected by FDA “Product Collected for Laboratory Analysis”
22
Status: Pending Compliance Review “Sent to Compliance for Review”
23
Status: Refused Line “Refused Inform FDA After Export”
24
Checking Entry/Line Statuses
Note: ITACS will only display statuses for “open” entries. If a final FDA admissibility decision has been made for all lines of an entry, the entry is “closed” in FDA’s import system and you will need to check your ABI Messaging or Notices of FDA Action for the status.
25
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” Note: Only submit documents for your local ports during the Pilot. Do not submit them for remote filings.
26
Submitting Entry Level Documents
27
Submitting Documents (cont)
Click the “Browse” button and locate the PDF file you want to attach
Click the “Attach” button
Select the Document Type from the drop-down list
Repeat as needed
28
Submitting Documents (cont)
You may attach up to 5 files of 20 MB each, for a total of 100 MB per submission
A document may be deleted from the list prior to submission if it has been attached in error
Enter the required Submitter Information (marked with an asterisk)
When done, click either “Submit and Finished” or “Submit and Return to Entry” button
29
Finding Documents to Submit
30
Attaching Documents For Submission
31
Successful Document Submission
After submitting the documents, a message will be displayed at the top of the screen “The documents were submitted successfully”.
The new ITACS Entry/Line Status will also change to “Document Submitted”
32
Successful Document Submission
33
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.
34
Submitting Availability Information for FDA Examination
Input an 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
35
Submitting Availability Information
(All lines or Selected lines)
36
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.
37
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
38
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
39
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
40
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
41
Provide a Location of Goods (Not at Consignee)
“Provide an updated location for the selected lines”
42
ITACS Link
https://itacs.fda.gov
43
FDA Contacts
Do NOT contact the Districts directly about ITACS
To report problems or ask questions, please send emails to itacssupport@fda.hhs.gov
44
Questions?
top related