FDA to Launch PREDICT in New York

January 7, 2010

U.S. Food and Drug Administration (FDA) officials have announced that the rollout of the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) will begin next week in New York.  The nationwide rollout of PREDICT, which was originally scheduled to begin in late September 2009 and was delayed until January, is scheduled to begin on January 11, 2010 in New York.  The rollout will occur one district at a time.  The rollout will first consist of training and then implementation.

FDA anticipates that PREDICT will replace the admissibility screening portion of FDA's OASIS system for processing import entries.  It is a rule-based expert system to assess information from multiple sources and determine which shipments carry the highest risk.  PREDICT will assist entry reviewers in targeting higher-risk shipments for examination.  PREDICT will also expedite the clearance of lower-risk cargo, but only if accurate and complete data are provided by importers and entry filers.

FDA sources have also confirmed that field staff are having issues with the Import Trade Auxiliary Communications System (ITACS).  ITACS is an internet portal for entry filers to check the FDA status of individual entries/lines, submit documents and link them to specific entries/lines, and provide availability information for targeted shipments.  Submitted documents will be readily available to entry reviewers.  FDA is making changes to the system and anticipates beginning beta testing in the near future.  However, FDA officials have confirmed that ITACS will not be rolled out with PREDICT as previously expected.