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ACE (Automated Commercial Environment)

FDA entry reject? Could be a food facility registration issue…

Wednesday, February 15th, 2017

rejected

If your entry was subject to an FDA reject, perhaps the food facility involved was not properly registered.

Per CSMS #17-000078:

FDA invalidated food facility registrations that failed to renew during the 2016 biennial registration period. In addition, food facility registration were invalidated for failure of confirmation by a US Agent and/or foreign manufacturer (registered by a third party) as required under the FDA Food Safety Modernization Act (FSMA), Section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350D] and in accordance with 21 CFR 1.231(a)(5) and (b)(7). (Please see related CSMS message 16-001052). [And see our related blog post]

  • If you are receiving an entry rejection for an invalid registration, you will need to confirm the status of the registration with the manufacturer. The manufacturer may check the status of their registration by logging into their FURLS Food Facility Registration Module account to verify the status of the individual registration.
  • Registrations that have been invalidated cannot be renewed and a new registration will have to be created. The US Agent or the owner must confirm the receipt of the registration within 30 days for it to be valid in the FDA reference database.
  • Failure to have a valid registered manufacturer can cause a shipment delay greater than 24 hours, therefore it is not recommended to file a prior notice if the registration is pending or use a facility registration that was invalidated due to failure to renew or confirmed by the US Agent/Owner.

ACE information: For this reject the sub-reason code 112 is sent back in the SO transaction for entries, SO71 record. For Stand-Alone prior notice filings, in the PO transaction the code 112 is in the PO71 record.

  • Contact FURLS Registration Help Desk at FURLS@fda.gov or 800-216-7331 to verify the current status of the your Food Facility Registration. Please expect long wait times for phone calls.
  • Contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries to determine the rejection reason.
  • Contact Division of Food Defense Targeting at prior.notice@fda.hhs.gov or 866-521-2297 for assistance with valid food registrations verified by FURLS Registration Desk that may be rejecting improperly.

Three new FDA import updates

Friday, February 10th, 2017

FDA has been and continues to be a very active PGA when it comes to ACE matters:fda1

 

1.  Submission of FDA data in ACE

As discussed in a previous blog post, CBP and FDA are working to implement changes related to FDA’s Final Rule on Submission of Food and Drug Administration Import Data in ACE  and corresponding Supplemental Guide. The first deployment occurred on January 5, 2017, and a second is to occur today.

2.  Common FDA rejects in ACE
In an effort to keep the trade community aware of how ACE is progressing for FDA transmissions, FDA has identified the most common FDA (bucket 2) rejects.• Invalid Product Code• Invalid Food Facility Registration Number• Mismatch between Food Facility Registration and Manufacturer

• Invalid state/zip code combination

• Foreign Consignee

• Duplicate Entry

• Missing or incomplete entity address

For specific information related to the various FDA error codes, please refer to FDA’s Error Guide.

3.  FDA Requirements Change for Medical Devices, IUC 081.005

The requirements for transmitting medical device constituent parts for drug-device IND combination products, Intended Use Code 081.005 have been changed.

The following Affirmations of Compliance for IUC 081.005 are now conditional: DEV, DFE, LST. These Affirmations of Compliance are in addition to DA and IND, which are already indicated as conditional. This change will be reflected in the next version of FDA’s Supplemental Guide

 

For questions on any of the foregoing, contact FDA ACE Support

ACE_Support@fda.hhs.gov or 877-345-1101 or 571-620-7320

ATF imports? Big change for submission of PGA information

Monday, February 6th, 2017

atf-logo

 

From CSMS #17-000056:

Effective immediately, importers filing ATF information electronically through ACE are required to use the PGA Message Set. DIS images of ATF Forms, including Form 6 and 6A, will no longer be accepted. When the PGA message set is filed correctly, the importer will received an automatic “May Proceed” from ATF, and if there are no further issues, the shipment will be released. Please note, original paper ATF Forms 6 and 6A may also be submitted to the ports of entry. For further information about PGA forms and filing procedures, visit CBP’s webpage on this topic.

ACE: Free FDA webinar 1/31 to review Supplemental Guide 2.5

Thursday, January 26th, 2017

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FDA and CBP will be hosting a webinar on Tuesday, January 31, 2017 from 1:00 pm – 3:00 pm Eastern Time to review updates to FDA’s Supplemental Guidance for ACE Version 2.5 and the related PGA Samples.  FDA will go over updates to the Implementation Guide that will go into Production on Thursday, February 9, 2017.  FDA will also address the trade’s questions during the webinar.

registernow

 

(Note: Registrants will also be able to submit questions in advance via the registration link.)

 

CBP advises to disable auto-complete functionality for ACE Portal passwords

Tuesday, January 24th, 2017

From US Customs’ January 2017 ACE Monthly Trade Update:

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Everything you need to know about PMS in ACE

Monday, January 23rd, 2017

From US Customs’ January 2017 ACE Monthly Trade Update:

Below are the preliminary (11th workday) and final (15th workday) dates for Periodic Monthly Statement (PMS). The latest date in which the “Preliminary” PMS can be requested to generate is the 11th workday of the month.

However, some companies do request their preliminary PMS to generate before the 11th workday. “Final” is the due date for the preliminary PMS. This date is also when ACE sends the Periodic Daily Statement (PDS) payment authorization message (PN Transaction) for the PMS to the Pay.gov website.

Screen Shot 2017-01-20 at 9.33.05 AM

US Customs published Cargo Systems Messaging Service (CSMS) message #17-000009 to announce the postponement of the January 14, 2017 ACE deployment. A new date will be announced in the near future.

Effective with the rescheduled date for this deployment, the final PMS will be generated to the trade community in two or three business days instead of the current one day issuance in ACE and Automated Commercial System (ACS). In ACE, the final PMS has to date been generated the day after CBP sent the PN authorization message to Pay.gov and not when the payment was transferred to CBP.

Additionally, please keep in mind that ACE Reports may not generate quickly on days when preliminary and final PMSs are generated. CBP suggests that you run and/or schedule your PMS reports during non-peak business hours and/or on days when they are not due.

For more information concerning statement processing, please review the Statements in ACE Information Notice, the Periodic Monthly Statement User Guide posted on the “ACE and Automated Systems” and “ACE Portal Training Resources” pages of CBP.gov/ACE. Questions concerning participation in Periodic Monthly Statement should be directed to the CBP Revenue Division. Users can send an email to periodicstatement@cbp.dhs.gov or contact the ACE Periodic Monthly Statement Payment Help Desk at 317-614-4545.

ACE reporting: CBP publishes updates for protest filers and more

Tuesday, January 17th, 2017

seal_aceWith the postponement of the deployment of ACE post-entry functionality, shippers now have some time to familiarize themselves with US Customs’ recent update of ACE reporting capabilities.

Specifically, the ACE Reports Team has recently deployed a new ACE Reports Workspace for Protest Filer Accounts and published new and updated ACE Reports documentation available in the “View ACE Reports Training Resources” page of the ACE Reports tool. The new report workspace and reference materials have been deployed to enhance user understanding of ACE Reports and support new enhancement made to the ACE Secure Data Portal. The new and updated items include:

  • New Protest Filer Workspace – The new Protest Filer workspace provides users access to the newly developed Protest Data Universe and the ES-403 Protest Details Report.
  • New ACE Reports Catalog for Trade Version 2016 -10 – This document provides a comprehensive inventory of all public “canned” reports currently available in ACE Reports.
  • Updated ACE Reports User Guide for Trade Version 1.1 (November 2016) – This user guide describes the steps to follow for viewing, modifying, and creating reports using the updated ACE Reports interface.

To access the new Protest Filer Workspace and review the ACE reports reference materials posted on the “View ACE Reports Training Resources” page, navigate to the “Home” tab from the ACE Reports tool. For more information on running ACE Reports, please see our series of ACE Reports Quick Training Videos on the “ACE Reports Training and User Guides” page of CBP.gov/ACE for step-by-step instructions on getting started with ACE Reports.

Breaking news! CBP postpones deployment of Jan 14 ACE post-entry functionality

Wednesday, January 11th, 2017

seal_ace

 

From CSMS #17-000009:

 

Notice Regarding ACE – Postponement of the January 14 deployment
  • This notice is with regard to the U.S. Customs and Border Protection, Automated Commercial Environment (ACE).
  • The January 14, 2017, deployment of post release capabilities including  liquidation (with the exception of the electronic posting of the Notices of Liquidation on CBP.gov), drawback, reconciliation, duty deferral, collections, statements and the Automated Surety Interface will be postponed.  However, pursuant to the Final Rule published on December 12, 2016, CBP will post the Notices of Liquidation on CBP.gov effective January 14, 2017, as planned.
  • In consideration of stakeholder feedback and the complexity of the ongoing integration testing, CBP is providing additional time to prepare for the final core ACE deployment and ensure a smooth transition of liquidation, drawback, reconciliation, duty deferral, collections, statements and Automated Surety Interface capabilities in ACE. CBP will provide updated information and a new deployment date in the near future.
Office of Trade Relations, Office of the Commissioner
U.S. Customs and Border Protection

ACE: Recon “blanket flagging” to be discontinued on Jan 14

Tuesday, January 10th, 2017

 

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Attention recon filers!  Effective January 14, US Customs will no longer apply ‘Blanket Reconciliation Flagging’ to entry summaries.  CBP has left it up to the importers and their brokers.  As a result, all reconciliation flagging must be done on an entry-by-entry basis.

Failure to do so will require importers to submit 520(d)s, post-summary corrections or prior disclosures to correct issues that are otherwise handled by reconciliation.

By way of background, CBP announced in the December 12, 2016, Federal Register that:

 

  • CBP is streamlining the process for blanket flagging underlying entries for reconciliation.
  • Under the existing process, importers provided CBP a request asking that CBP input and apply a blanket flag to all underlying entries filed by the importer for a specific time period. Importers also identified the specific issue(s) for which they requested that CBP input and apply the requested blanket flag.
  • This document announces that effective January 14, 2017, importers no longer will submit requests asking that CBP apply a blanket flag on their behalf. Instead, importers may input and apply a blanket flag themselves. Importers who use blanket flagging must continue to identify the issue(s) they are flagging.

Importers that currently benefit from blanket flagging on their recon entries should work with their customs brokers to ensure entries are flagged in accordance with the importer’s requirements.  If self-filing*, importers should ensure that their ABI software providers’ systems are programmed accordingly.

Please note that reconciliation flags are applicable ONLY to entry summary types 01, 02 and 06

 * CustomsNow self-filing clients have the ability to manage their recon flags at either the “blanket” level, or even at the Part/SKU level, a fantastic option. Learn more.

ACE: Update on PGA integration for exports

Monday, January 9th, 2017

While much of the fanfare around ACE has been on the import side, US Customs continues to work with the PGAs to complete full integration in ACE for exports. Below is a table listing all the agencies that have export data requirements, methods used to receive data in ACE, pilot availability and the required export data:


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For additional information on the integration of the PGAs for exports, please navigate to the “ACE Features” page of CBP.gov/ACE and click on the “PGA Integration” tab to review the ACE PGA Forms List – Export document.