Regulatory Focus™ > News Articles > FDA Pilot Project to Test New Import Communication System

FDA Pilot Project to Test New Import Communication System

Posted 22 June 2016 | By Zachary Brennan 

FDA Pilot Project to Test New Import Communication System

The Food and Drug Administration (FDA) on Wednesday said it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) and is seeking participants.

The purpose of the pilot is to test and evaluate a new ITACS account management function with user login accounts that enable FDA to distribute “Notices of FDA Action” to users electronically via email (rather than regular mail) and enable users to download such notices.

“User login accounts also allow users to view in ITACS the details of specific information requests, which are currently delivered via hard copy Notices of FDA Action,” FDA said. “Implementation of user login accounts would also allow for potential future ITACS enhancements, requested by the import trade community, that require user authentication.”

FDA is seeking participation from a small group of “Filers, Importers of Record, and Consignees, who will use the new ITACS Account Management function and provide feedback to FDA,” a notice in the Federal Register said.

ITACS currently provides the import trade community with the ability to: (1) check the status of FDA-regulated entries and lines, (2) electronically submit entry documentation, (3) electronically submit the location of goods availability for those lines targeted for FDA physical examination, and (4) check the estimated laboratory analysis completion dates. No user login accounts are necessary to access these functions; all that is necessary is a valid customs entry number that has been successfully transmitted to FDA. FDA has developed, and wishes to test, an ITACS user account management function.

Pilot participants, according to FDA, should be prepared to: (1) Attend a kickoff training session using the new functionality, (2) provide real-time feedback, and (3) participate in any follow-up meetings FDA deems necessary. Pilot participants also need to be willing to receive their Notices of FDA Action electronically in lieu of FDA distribution of paper Notices of FDA action.

The pilot is expected to kick off in a month, and those wishing to be considered for participation should send an email with the subject line “ITACS Pilot Participation Request” to itacssupport@fda.hhs.gov in the next two weeks.

The pilot project comes as FDA made the switch in February to allow companies to submit information through the Automated Commercial Environment (ACE) to FDA for an entry decision where the product falls under FDA jurisdiction.

Doug Stearn, director of FDA’s Office of Regulatory Affairs’ Office of Enforcement and Import Operations, told Focus: “Since February, the overwhelming number of brokers have begun filing in ACE.  We believe the reception has generally been very good.  FDA has begun a help desk to assist industry in ACE filings.”    

Federal Register


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