Entry_Review_Fact_Sheet_3-28-17_clean.doc

The Import Entry Review System is an FDA application that works directly with Customs and Border Protection’s ACE system to bring FDA regulated entry/lines over to FDA for review.

The application is used internally to make initial admissibility decisions, create field work assignments, and view entry/line documentation. OASIS was the application previously used to screen import entries until 2010 when the Import Entry Review System began to come online.

The Entry Review application allows FDA employees to effectively process entries in an efficient manner by integrating other FDA applications and tools such as PREDICT and ITACS. For more information on PREDICT and ITACS, please see the links in the “Helpful Links” section below.

The application has the added functionality to quickly request additional specific information from the filer when the information transmitted in an entry/line is insufficient to make an admissibility decision. Filers have the ability to upload the requested documents through ITACS, which can be viewed directly within the Import Entry Review System, speeding up review times and reducing paper usage. With the additional information, the entry reviewer can quickly update data elements and rescreen the entry line with the new data, as needed.

After reviewing the entry/line details and supplemental documentation (if needed), the entry reviewer can then issue a May Proceed or setup a work assignment. Once the Entry Reviewer sets up additional work on the entry/line, the entry/line goes into the OASIS application to be further worked on by a Field Investigator or Compliance officer.

IMPORTS�FACT SHEET March 28, 2017

Helpful Links

� HYPERLINK "http://inside.fda.gov:9003/downloads/ORA/OfficeofRegionalOperations/OfficeofEnforcement/DivisionofImportOperationsandPolicy/UCM316013.pdf" ��PREDICT FACT SHEET�

� HYPERLINK "http://inside.fda.gov:9003/downloads/ORA/OfficeofRegionalOperations/OfficeofEnforcement/DivisionofImportOperationsandPolicy/UCM316014.pdf" ��ITACS FACT SHEET�

� HYPERLINK "http://www.fda.gov/downloads/internationalprograms/newsevents/ucm392664.pdf" ��Import Program Overview�