| Title: | NOTIFICATION OF FDA CENTRALIZED ENTRY REVIEW PILOT |
|---|---|
| Date: | 2013-06-18 |
| To: | abi |
| Links: | previous, original, next |
FDA is issuing this communication to notify all users that FDA will be conducting a Centralized Entry Review Pilot that will run from August 12, 2013 through November 4, 2013. FDA has decided to limit the scope of this initial pilot to ports of entry that primarily serve as courier hubs.
This pilot will include the following ports of entry: 1195, 2095, 2775, 2776, 2791, 2792, 2795, 2870, 2895, 3071, 3195, 3196, 4196, 4197, 4198, 4670, 4671, 4771, 4772, 4773, 4778, 5295, 5296, 5297, and 5298.
In an effort to improve efficiency and review of entries, FDA expects that 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 or directed to itacssupport@fda.hhs.gov
Entry filers who will be filing through one of the identified port codes, between August 12, 2013 through November 4, 2013, and who have pilot entry questions, will be able to email the pilot entry reviewers at CERpilot@fda.hhs.gov.
FDA will provide additional details including contact points and pilot hours of operation as the start date for the Centralized Entry Review Pilot nears.