Import Trade Auxiliary Communication System (ITACS) – FDA

  • Import Trade Auxiliary Communication System (ITACS) – FDA

    Posted by Paul Gordon on October 25, 2022 at 1:36 pm

    The FDA has deployed the Import Trade Auxiliary Communication System (ITACS) for use by the import trade community. This system was implemented in order to improve communication between the FDA and the import trade community.  ITACS basic functionality provides the import trade community the ability to electronically: check the status of FDA-regulated entries and lines, submit entry documentation, submit the location of goods availability for those lines targeted for examination by the FDA, and check the estimated laboratory analysis completion dates for lines which have been sampled.

    What are the benefits of ITACS?

    Benefits of ITACS to the trade include the ability to receive more detailed entry statuses than what is currently transmitted to filers via Customs’ Automated Broker Interface (ABI) reducing the need for phone calls inquiring about the status of entries and eliminating the need to email, mail or fax entry documentation and goods availability to the FDA.  Additionally, ITACS mitigates the problem of lost documents.

    ITACS Account Management functionality enables the electronic distribution of Notices of FDA Action via email and as downloads from within ITACS. It also allows account holders to view the details of specific information requests, versus delivery of hard copy Notices of FDA Action. ITACS Account Management functionality may be used by customs brokers (entry filers), importers of record, and consignees with an approved ITACS account. To be granted an account, a firm must have been a party to a previously transmitted FDA entry. ITACS accounts are limited to one individual per firm at the corporate level. This person should be a high ranking individual within the firm as they will have the responsibility to create and manage ITACS accounts for other users within their firm.

    Functions of ITACS:

    New ITACS for Importers to Check Status of Entries, Submit Documents

    The Food and Drug Administration is announcing the Import Trade Auxiliary Communication System (ITACS) for use by the import trade community to improve communication with FDA.

     

    Trade benefits include the ability to receive more detailed entry statuses than what is currently transmitted to filers via the U.S. Customs and Border Protection (CBP) Automated Broker Interface (ABI), reducing the need for phone calls inquiring about the status of entries, eliminating the need to mail or fax entry documentation and goods availability to FDA as well as problems with lost documents.

    ITACS Account Functionality

     

    ITACS account management functionality will be available to Importers of Record, Filers, and/or Consignees which have been associated with at least one previous FDA entry.  ITACS accounts will be limited to one individual per firm at the corporate level. That person will have the responsibility to create and manage ITACS accounts for other users within the same firm, regardless of their location.  ITACS accounts will be requested via the FDA Unified Registration and Listing System (FURLS).

    Paul Gordon replied 1 year, 11 months ago 1 Member · 0 Replies
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