Update from FDA’s December 10 ACE webinar

Following is a brief overview of the December 10, 2015 webinar on the Food and Drug Administration (FDA) and ACE for Drugs, Devices and Biologics.

  • All FDA filings must be processed through ACE beginning February 28, 2016 (in addition to NHTSA and APHIS (Lacey)).

FDA ACE

 

 

 

 

 

 

 

Process Overview

  • The process will be very similar to current state.  CBP will check for syntax errors and reject the entry if missing or invalid data.  Once it is accepted, FDA will use its PREDICT system to check for admissibility.  However, filers will not receive their determination message until 5 days before ETA.  Filers can make changes if more than 5 days prior to ETA.
  • There was some discussion of upcoming policy changes that would allow a filer to revise a submission within the 5 day window.  FDA is also considering requiring submission for FD0 flagged HTSs.
  • FDA will continue to use the ITACS system for document collection/review until the DIS system has line-level functionality.

FDA/ACE Pilot Status

  • To date, 1,000 entries subject to FDA requirements have been filed in the FDA ACE Pilot.  FDA is still on-boarding new participants, and is working with filers and importers to ensure they understand what data is required by commodity.  They can be found in the FDA Supplemental Guide, which breaks down the requirements by commodity.
  • Four parties will always be required and possibly more depending on commodity:
MF Manufacturer of goods
DEQ Shipper
FD1 FDA Import (Importer of Record)
DP Delivered To Party
  • Federal Establishment Identifier (FEI) numbers and Data Universal Numbering System (DUNS) numbers are encouraged in lieu of Name/Address and can expedite release.
    • DUNS numbers can be found here.
    • FEI numbers can be found here.
  • To participate in pilot e-mail ACE_Support@fda.hhs.gov or call FDA’s Division of Import Operations at: 301-796-0356.

 

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