Integration Point and U.S. Customs and Border Protection (CBP) have joined together to present a series of webcasts to help the trade prepare for the Partner Government Agency (PGA) integration deadlines in 2016.

On Thursday, December 10, 2015, we hosted the first webcast in the CBP PGA series, “FDA and ACE for Drugs, Devices, and Biologics.” You can view the on-demand webcast here.

During the webcast, some questions were unanswered due to time constraints. The complete Q&A will be grouped by topic and posted in the following order:

This fourth installment of the Q&A will deal with foreign-trade zones (FTZs) and other systems.

 

FTZ:

Q. I am an FTZ operator that is filing weekly entry.  I have heard that FDA may be collecting data at time of entry summary and cargo release.  Is that true?  When will the FDA requirements for PGA be finalized for zones?

A. For the purposes of weekly estimates offered for import from a foreign trade zone (FTZ), FDA will continue to process the weekly entry estimate filed at the time of cargo release, as in the current ACS environment.  In future phases, FDA may receive electronic data from the entry summary for audit purposes.  

Q. On a weekly 3461estimate for a zone, I don’t have all of the information that is required by FDA as I will be producing and packaging the product throughout the week.  What should I enter on my estimate?

A. As indicated in the FDA Supplemental Guide, "IF reporting only one level of packaging, show the total quantity for the line and report that as level 1." Thus, should the responsible parties only have an estimated piece count for the weekly estimate, the Packaging could be transmitted as XX PCS for XX pieces in PG26.


Other Systems:

Q. Will ITACS go away with ACE?

A. No, ITACS should be used to provide further verification or information when requested by FDA.  Once DIS incorporates line-level functionality, FDA expects to work with CBP to transition to DIS so that any additional documentation only needs to be submitted one time to 1USG.

Q. With ACE implementation, will PREDICT be decommissioned?

A. No, FDA will continue to process/screen data as it does today using OASIS and PREDICT.

Q. When is DIS expected to have line level functionality?

A. Currently CBP has not provided a date as to when such functionality will be available.