For Industry

ITACS

Import Trade Auxiliary Communication System (ITACS)

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 FDA and the import trade community. The presentations provide overviews of basic ITACS functionality and the new ITACS Account Management functionality, and a walkthrough of how to use both.

ITACS basic functionality provides the import trade community with four 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 and the ability to check the estimated laboratory analysis completion dates for lines which have been sampled.

Benefits 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 FDA and no problems with 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, which are currently delivered via hard copy Notices of FDA Action. ITACS Account Management functionality may be used by 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.

Benefits of ITACS accounts include faster receipt of Notices of FDA Action via email or download from within ITACS, no need to maintain paper copies of Notices of FDA Action as they will continue to be available in ITACS even after an entry is closed and faster receipt of requests for specific information by email or ITACS.

ITACS basic functionality may be accessed at  https://itacs.fda.gov.

ITACS accounts can be requested via the FDA Unified Registration and Listing System (FURLS) at  https://www.access.fda.gov/oaa.

 

Announcement: The Division of Import Operations has launched a new and revamped website. The site provides easy access to up to date and comprehensive information on most importation issues including personal importation and commodity specific requirements. There are answers to virtually all FDA import questions such as quick access to common entry errors, and there is contact information to reach real people locally and in headquarters. The Imports site is part of the overall FDA website, FDA.GOV. We encourage all to book mark the link: http://www.fda.gov/ForIndustry/ImportProgram/default.htm.

Page Last Updated: 10/25/2017
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