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FDA

ACE: CBP updates PGA Filing Status document

Tuesday, April 25th, 2017

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.

ACE PGA Filing Status Apr 2017 update (1)

 

Importers: This could be the cause of your FDA rejects

Monday, April 24th, 2017

From CSMS #17-000227:fda1

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

 

 

 

 

 

Food importers: Are you ready for new FSVP requirements on May 30?

Wednesday, April 19th, 2017

produce

 

 

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.

 

ACE: New and updated PGA info posted on CBP.gov

Tuesday, March 14th, 2017

pgasseal_aceCBP 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, 2017fda1
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.
Webinar Recording | Transcript | Presentation | Technical Guides

 

 

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

LA trade professionals: Attend WITOC’s State of the Trade 2017 event

Tuesday, January 31st, 2017
Screen Shot 2017-01-30 at 3.16.41 PM 

Join Women In Trade — Orange County for its annual – The State of Trade – Symposium and Luncheon. Hear leading industry members and top local government officials provide a recap of 2016 and a look ahead of what to expect for 2017.

There will be speakers from CBP, FDA and CPSC that will present important industry updates that will affect all in 2017.

The lunchtime topic will feature a discussion of the different ways imports and exports will be affected by the 115th Congress and President-elect Trump.   Increase duties?  Tear up/renegotiate free trade agreements?  Border tax?  Trade war?  All will be discussed!

 

 

SPEAKERS:
Heather Litman, Trade Attorney
(Program Moderator)
Grunfeld, Desiderio, Leibowitz, Silverman & Klestadt
 
U.S. Customs and Border Protection
Anne Maricich, Assistant Director, Trade – Los Angeles Field Office
U.S. Consumer Product Safety Commission
Stacy Prosperi, Compliance Investigator, Office of Import Surveillance, Western Region
Food and Drug Administration
Dan Solis - Director of Import Operations LA District
EVENT DETAILS:
Date: February 15, 2017
Venue: Avenue of the Arts Hotel
3350 Avenue of the Arts
Costa Mesa, CA 92626
Cost:  Symposium - $120 Members ; $135 Non-Members
          Luncheon Only - $65 members ; $80 Non-Members
Registration after Feb.10, 2017, add $10 – No Cancellations or Refunds after Feb.13, 2017
register-now-button-pilll-red-hi

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

Thursday, January 26th, 2017

fda1

 

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.)

 

FDA/CBP webinar on FDA supplemental guidance for ACE on 12/13

Thursday, December 8th, 2016

FDA-Logo

 

 

FDA and CBP will host a webinar on Tuesday, December 13, 2016 at 2:30 pm Eastern Time.  The purpose of the webinar is to review updates to FDA’s Supplemental Guidance for ACE Version 2.5 and the related PGA Samples.  The link to the FDA Supplemental Guide and Samples will be posted to cbp.gov and a “Supplemental CSMS” will be issued with that link as soon as possible.

 

To participate in this webinar:

Join by phone

  • Local: 1-301-796-7777
  • toll free: 1-855-828-1770
  • Cisco Unified Meeting Place meeting ID: 745 429 430

Or click here and join by phone once you are on WebEx

 

ACE: CustomNow’s Nic Adams on FDA’s new final rule on import entry

Tuesday, December 6th, 2016

fdalogo

 

The FDA just published a Final Rule in the Federal Register regarding requirements for the submission of information to the ACE.

It is now mandated that select data elements be submitted into ACE at the time of entry for FDA-regulated articles to include foods, human and animal drugs, medical devices, biological products, human cells, tissues, and cellular and tissue-based products (HCT/Ps), radiation-emitting electronic products, cosmetics, and tobacco products.

Nic Adams, Vice President of Client Services of CustomsNow, with over 30 years of strong customs compliance and global supply chain industry experience, adds the following commentary:

Nic Adams

Nic Adams

  • Much of the new rule is codifying the way things are today.  But it also shows the interplay between the FDA, who many would say did a ‘data grab’ with FDA message set, and the trade.  And, it clarifies the changes from the old process and the new.  Many are pretty exciting for us that have been battling/frustrated with the FDA for many, many years.
  • The fact that FDA is moving to a risk-based system is something the trade has been clamoring for over many years.  And to let the system make the determination in the majority of instances vs an FDA employee speeds things up greatly.
    • The average time for an FDA-reviewer to manually review and issue a “May Proceed” determination in ACS from August 27 to October 22, 2015, was about 28 hours and that has been reduced to under 2 hours in ACE
  • FDA rejected comments that it should make Device Listing Numbers (LSTs) publicly available, and decline to make the requested revisions to the requirement to submit the LST (i.e., permit the use of “UNK” instead of the LST).  This is problematic because importers often do not have access to this information at the time of entry.  But it appears that FDA erred on the side of keeping LSTS confidential: “The confidentiality of LSTs serves important public health interests and helps to prevent the importation of substandard, mislabeled, and counterfeit medical devices.”
  • It’s quite surprising that no one commented on radiation emitting devices.  I would have also requested that the registration information be made available to the public, but FDA probably would have used the same argument as they did with LSTs.
  • FDA has revised § 1.90 to allow FDA to provide notice of sampling directly rather than through the “collector of customs” which will normally happen through a secure electronic system.  No more waiting for your detention notice to show up in the mail!  Very nice.