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 third installment of the Q&A will deal with the FDA pilot and 5-day review period.

 

FDA Pilot:

Q. If we sign up for the pilot, do all our FDA entries need to be filed in the pilot?

A. You may file entries in ACE at your own pace, while continuing to file other entries in ACS until the dates set forth by CBP.

Q. When will the FDA PGA pilot be complete?

A. At this time, the FDA pilot is ongoing until further notice.

Q. Will it still be in pilot up until 2/28, or will the pilot be complete before then so that FDA can be filed as normal without being in pilot?

A. The FDA ACE pilot will continue until further notice from CBP and FDA.

Q. Are all the fields which are mandatory for the pilot also going to be mandatory in production?

A. The mandatory, and conditional when indicated, data elements outlined in FDA’s Supplemental Guide are the information FDA requires for ACE (production) entries.  



5 Day Review Period:

Q. Will the 5-day lockdown by CBP be a permanent procedure?

A. FDA and CBP will not allow any changes to FDA entry data, when the articles are within five-days of arrival in the U.S.  In future phases, FDA, in consultation with CBP and the other PGAs, may consider a different lockdown policy.  

Q. Currently we have to cancel and re-submit entries if FDA information wasn't submitted or the information submitted is grossly incorrect. In the new system, will we be able to re-submit the entry to FDA after the 5 day review period or will we have to cancel?

A. Updates to entries will not be permitted if the cargo is within five-days of arrival in the U.S.  If changes need to be made, the entry will need to be cancelled and re-submitted.

Q. Will the 5-day window be mandatory even if the filer keys in the entry and crosses the same day, i.e. within a few hours, which happens all the time at my border crossing in the port of Detroit?

A. The five-day window means that any entry submitted within the time frame of five-days prior to arrival may not be edited. If border entries are transmitted the same day (or same hour), the same rules apply: the entry data may not be edited once the entry is accepted by CBP and FDA.

Updates to the entry data are only allowed if the goods are outside of the five-day window. (Example: an update may be made if data is transmitted seven days prior to arrival. Once the timeframe hits the five days prior to arrival, CBP sends the data to FDA and no further edits can be made. Border entries submitted the same day are included in the five-day lock down).