FDA Says Few Checked Entry Status in ITACS Pilot but Still Moving Forward

(ITACS is an Internet portal that allows individuals with an entry number to check the FDA status of specific entries/lines, submit documents and link them to specific entries/lines, and provide availability information for targeted shipments. No trade confidential information is provided.)

Only 12 of 20 Filers Actively Participated, Only 17% Submitted Docs

The officials were disappointed that only 12 of the 20 filers selected for the pilot actively participated. They were also disappointed with the level of document submission under the pilot, which indicated that only 17% of the pilot participants used that capability.

FDA to Fix Problems with Delays in Document Review, Lost Docs

The participants identified some shortcomings and concerns with ITACS. For example, FDA compliance officers did not know that documents were waiting for them in the system, which caused delays. In addition, one pilot participant submitted information and received a receipt, but the document was not received by ITACS.

FDA is looking into the problem of the lost document and will resolve this issue before expanding ITACS to other users. It is also fixing the problem of compliance officers not knowing documents are available. The next update of the MARCS Entry Review application, which FDA personnel use to view documents submitted via ITACS, will include an icon indicating the presence of documents for an entry and/or line. This update is scheduled for implementation in late October 2011, but will only benefit pilot participants, who are encouraged to continue using ITACS.

Overall Response Positive, FDA Hopeful ITACS Will Benefit both Trade & Agency

Despite the problems, the overall feedback from the pilot was positive, and FDA believes that with better training and improvements to the system, the ITACS system will benefit both FDA and the trade.

FDA states that the benefits to the trade will include:

• providing a quick way to check the status of entries successfully transmitted to FDA, which is especially helpful when the CBP/FDA interface is down;
• not having to call FDA or wait for return calls on status inquiries;
• getting more specific information on status such as “Notify FDA of Location for FDA Examination,” “May Proceed without FDA Examination,” “Documents Required,” “Sent to Compliance for Review,” “Refused -- Inform FDA After Export,” or “Refused - Inform FDA Before Export;”
• not needing to fax or deliver documents to FDA;
• less confusion for all parties about the date and location of availability of goods.

FDA Working Toward Full Implementation after Fixes & Full Roll out of MARCS/PREDICT

Therefore, the next step will be to fix the remaining problems and work toward full implementation of ITACS. However, this will not take place until after MARCS Import Entry Review (which includes the screening tool PREDICT) is rolled out to all remaining districts, which is expected by the end of the year.

Will Eventually be Account Based, Until then only Entry Number Needed to Use

The speakers explained that FDA’s plan is for ITACS to eventually be an account based system, but for now, anyone with a valid entry number can use all three of the system’s functions. However, FDA explained that those submitting documents have to enter their name, a firm name, and a phone number, and that no trade confidential information is provided by ITACS to those who use it.

FDA is following up on a suggestion that it also require the submitter’s email so others may contact submitters that way as well if they have questions.

Also Plan to Add FDA Product Code Query, Display Lab Timeframes, Etc.

Other FDA plans for future ITACS functionality include:

• Transmission of notices of FDA action;
• Query for FDA firm identifiers;
• Query for FDA product codes;
• Display of lab timeframes;
• Submission of other document types (besides pdf files);
• Improving CAPTCHA legibility (the security code that ensures users are not spammers);
• Virus scanning for submitted documents;
• Providing a printer friendly version of the status page; and
• Linking FDA reference materials to ITACS to make it a “one stop shop.”

(Note that U.S. Customs and Border Protection (CBP) has stated that there is currently a direct interface between FDA's OASIS system and CBP's ACS system, and that all current interface functionality is planned to be transferred from ACS to ACE. According to FDA, MARCS Imports will eventually replace all of OASIS, and MARCS Entry Review and PREDICT are part of MARCS Imports. MARCS Entry Review is replacing the legacy entry review screens from OASIS, and PREDICT is replacing the entry screening function of OASIS for import admissibility determinations.)

¹National Customs Brokers & Forwarders Association of America, Inc.

Email questions on ITACS to itacssupport@fda.hhs.gov