TO: ALL FILERS
FROM: FOOD & DRUG ADMINISTRATION
SUBJECT: REMINDER OF FDA CENTRALIZED
ENTRY REVIEW PILOT
FDA is issuing this communication as a reminder of the Centralized Entry Review Pilot.
As indicated in our message of 6/18/2013, FDA will be conducting a Centralized Entry Review Pilot that will run from August 12, 2013 through November 2, 2013. FDA has decided to limit the scope of this initial pilot to certain ports of entry that primarily serve as courier hubs.
This pilot will include the following ports of entry: 2095, 2791, 2792, 2795, 2870, 2895, 3195, 3196, 4670, 4671, 5295, 5296, 5297, and 5298. (List of ports updated 6/19/2013)
This pilot’s hours of operation are as follows: Monday-Friday 7:00am - 4:00am, Saturday 7:00am - 10:30pm, and Sunday 6:00am - 12:00pm. All times are Eastern Standard Time (EST).
In an effort to improve efficiency and review of entries, FDA expects entry documents requested by FDA will be submitted to FDA via electronic means. FDA’s Import Trade Auxiliary Communication System (ITACS) is designed to improve communication between FDA and the import trade community and facilitate the electronic submission of documents to FDA.
Instructions on how to use ITACS to submit documentation and information to the FDA can be found at the following link: http://www.fda.gov/ForIndustry/ImportProgram/ucm296314.htm. Questions or comments on how to submit documents, or about ITACS in general, can be directed to email@example.com
Entry filers who will be filing through one of the identified port codes, between August 12, 2013 through November 2, 2013, and who have status questions, entry questions, or who are unable to submit documents via ITACS, can communicate with the pilot entry reviewers at CERpilot@fda.hhs.gov or by phone at 1-855-831-4952.