Import Trade Auxiliary Communication System (ITACS)
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. The presentations, listed in ITACS Resources below, 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 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.
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 the FDA. Additionally, ITACS mitigates the problem of lost documents. Note that review of documents submitted to FDA via ITACS is prioritized over review of documents submitted to FDA via other means.
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. 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. Note that an ITACS account is not required to import FDA regulated goods. To be granted an ITACS account a firm must have been a party to a previously transmitted, non-disclaimed FDA entry.
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.
Questions, comments and suggestions for improvements may be sent to email@example.com
ITACS accounts can be requested via the FDA Unified Registration and Listing System (FURLS) at https://www.access.fda.gov/oaa.
Visit FDA's Import Program Web Page: This site (link) 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. We encourage all to book mark the link.