On August 21st CBP sent out CSMS message no. 17-000506 on behalf of the U.S. Food & Drug Administration.
The message announced three identical webinars, to be held September 5th, 7th, and 11th which will provide information on the evolution of FDA’s Import Trade Auxiliary Communications System or ITACS system “to ensure that trade users are familiar with and understand the new ITACS Account Management functionality.”
The webinars will include the following:
- An overview of current ITACS functionality
- Background and overview of the new ITACS Account Management functionality
- Creating an ITACS Account
- Retrieving Notices of FDA Action from ITACS
- Managing your ITACS Account, Users and Groups
- Where to find ITACS and ITACS Account Management resources
If your imports are regulated by the FDA we strongly suggest that you attend one of these webinars. Click here for more detailed information and to register.
On July 18th, 2017 CBP posted the recently updated ‘Entry Types by PGA’ document. This document advises the trade which CBP entry type codes will require Partner Government Agency data, and when; either at cargo release, summary or other.
The majority of PGA’s require that their PGA Message Set be sent at the time of Entry (Cargo Release).
However, with the implementation of ACE, and based on feedback from the Trade, some flexibility has been provided for Foreign Trade Zone (FTZ) entries. For instance, with FTZ for Vehicles & Equipment regulated by the EPA, filers have the option of filing the EPA message set at the time of filing the type 06 Entry (Cargo Release) or, if utilizing the weekly entry process, they can send it at the time of transmitting the Entry Summary.
US Customs has posted an updated version of the PGA Filing Status document.
The updated version includes the status of import and export PGA pilots, the accepted electronic filing methods, and indicates those PGAs that are no longer accepting paper filings. For reference, this document also contains the relevant PGA announcements in the Federal Register, as well as agency contacts for filing questions.
From CSMS #17-000227:
CBP and FDA are in the process of updating the ACE PGA flags for FDA requirements. Specifically, the tariff numbers that had flags for ACS OGA of FD0 are getting ACE PGA requirements updates to have either no FDA flag, FD1 (FDA May Be Required) or FD2 (FDA Required).
In the meantime, following is a spreadsheet of the FDA HTS codes and their associated flags in ACE. Trade can use this as a reference in investigating any rejects they may be getting when filing entries. FD0 flags do not exist in ACE.
If you have questions about the HTS flags please contact FDAImportsInquiry@fda.hhs.gov or Ted.Poplawski@fda.hhs.gov
CBP spreadsheet >> FDA HTS codes and flags
Starting May 30, 2017, FDA will begin implementing the FDA’s Food Supplier Verification Program (FSVP).
Under new FDA regulations, US food importers for the first time must ensure that imported food for humans and animal is as safe as domestically produced food. It is up to each importer to establish their own FSVP.
In addition, as of May 30, each entry filing of food products offered for import into the U.S. must include the name, contact info, and DUNS # of the FSVP Importer.
See our previous blog post on this topic for more details and requirements.
CBP has recently posted new and updated information on ACE and Partner Government Agencies on CBP.gov.
Also posted on CBP.gov:
FDA Webinar – January 31, 2017
The purpose of this webinar was to review updates to FDA’s Supplemental Guidance for ACE Version 2.5 and the related PGA samples. FDA also addressed trade questions during the webinar.
| Technical Guides
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 email@example.com or 866-521-2297 for assistance with valid food registrations verified by FURLS Registration Desk that may be rejecting improperly.
FDA has been and continues to be a very active PGA when it comes to ACE matters:
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
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.
(Note: Registrants will also be able to submit questions in advance via the registration link.)