FDA's New ITACS for Checking Entries Allows Doc Submission by All, Etc.

On March 14, 2012, the Food and Drug Administration launched its online Import Trade Auxiliary Communications System (ITACS) which allows the trade to: (i) check the FDA status of specific entries/lines; (2) submit entry documentation and link them to specific entries/lines; and (3) submit availability information for targeted shipments. FDA has posted a presentation on ITACS, which covers its system requirements, benefits, future functionality, and a "walkthrough" of current functionality. FDA sources stated that anyone with the shipment's entry number could submit entry documents using ITACS, and noted that there were no plans to integrate ITACS with ACE.

(See ITT's Online Archives 12031902 for initial summary of the March 14 availability of ITACS.)

Key to ITACS Access is Entry Number

FDA officials state that the key to accessing and using ITACS is the entry number. Those with an entry number can query the system for status and submit entry documents and shipment availability information. The official added that no trade confidential information is provided by ITACS to those who use it. ITACS does not display any of the firms involved in the transaction. The only information displayed is the product code, product description, quantity, country of origin, and status of the line. (FDA sources note that this is even less information than is provided in the public Refusal Report that is posted on fda.gov.)

Only Entry/Line Number Needed to Use ITACS, but May Become Account-Based

Currently, no accounts are required to access and use the three ITACS functions; only an entry number or line number is needed. However, those submitting documents have to enter their name, a firm name, and a phone number.

At an October 2011 trade event¹, FDA officials had stated that the agency planned for ITACS to eventually become an account-based system. FDA now states that future account management will be required in order to add feature such as the ability for FDA to send Notices of FDA Action, among other functionality.

ITACS Interfaces with FDA's Import System, No Plans to Integrate with ACE

ITACS interfaces with FDA's Import System in order to retrieve the entry/line status information and in order for FDA staff to access the documents and availability information submitted through ITACS. FDA sources note that currently ITACS is not related in any way to U.S. Customs and Border Protection's (CBP) Automated Commercial Environment (ACE) and there are no plans to integrate it in the near future.

(FDA's OASIS is an automated system for processing and making admissibility determinations for shipments of foreign-origin FDA-regulated products seeking to enter domestic commerce.² CBP has previously noted that there is a direct interface between FDA's OASIS and CBP's legacy Automated Commercial System (ACS). CBP had also stated that all interface functionality was planned to be transferred from ACS to ACE.)

Current System Issues Involve File Size Limits, Server Capacity, Etc.

Current issues FDA has identified with ITACS system requirements involve file size limitations, server capacity, and documents currently being limited to PDF format. Additionally, FDA has worked with CBP to receive conveyance arrival information for truck and air shipments.

(Participants in the ITACS pilot, which ended in August 2011, identified various problems with the system, including that FDA compliance officers did not know that documents were waiting for them, which caused delays, and that documents were not being received by FDA. These issues have been since been resolved. See ITT's Online Archives 11101401 for summary.)

Trade Benefits Include More Detailed Entry Info, Less Wait Time, Etc.

Trade benefits from the ITACS include a quicker way to check on the status of entries successfully transmitted to FDA, the ability to use the ITACS when the CBP/FDA Interface is down, no wait time for return phone calls, and more specific information regarding a shipment during the admissibility process. Entry Document Submission benefits to the trade include the fact that there is no need to copy documents for FDA, no need to fax or deliver documents to FDA, and there are no problems with lost document submissions. Regarding shipment availability information, no faxing or phone calls are needed and there is less confusion between the trade and FDA about the date and location of availability.

Allows FDA to Focus Resources on Expediting Review of Entries, Etc.

Correspondingly, as ITACS reduces the need to respond to phone calls regarding status, it benefits FDA in that it allows the agency to focus limited resources on expediting review of entries and focusing on completion of designated shipment examinations. FDA also doesn't need to retain paper copies of entry documentation, it has fewer problems with claims regarding lost documents, and provides FDA staff easy access to documents via FDA's Import System.

Future Functionality to Include Query for FDA Product Code & Firm Identifiers, Etc.

FDA states that future ITACS functionality includes the following:

• Transmission of Notices of FDA Actions
• Query for FDA Firm Identifiers
• Query for FDA Product Codes
• Display of Laboratory Timeframes
• Submission of other document types
• Improved CAPTCHA legibility
• Virus scanning of submitted documents
• Providing a printer friendly version of the Status page
• Linking to FDA Import Reference materials

(See presentation for a "walkthrough" of ITACS functionality, including checking entry/line status, submitting documents, and submitting availability information for FDA examinations.)

¹A National Customs Brokers & Forwarders Association of America, Inc. (NCBFAA) meeting. (See ITT's Online Archives 11101401 for summary of FDA's remarks at this event.)

²FDA's OASIS will eventually be replaced by FDA's MARCS Imports program. Additionally, FDA's PREDICT risk-based screening system for imports will replace the electronic screening function of OASIS for import admissibility determinations and will assist entry reviewers in targeting higher-risk shipments for examination. The MARCS Imports Entry Review software is currently replacing the entry review application only from OASIS and includes the ability to view documents and shipment examination availability information transmitted to FDA via ITACS as well as the integration of PREDICT.

Do not contact the Districts directly about ITACS. To report problems or ask questions, contact itacssupport@fda.hhs.gov.

ITACS may be accessed here.