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FDA

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

Thursday, December 8th, 2016

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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

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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.

 

 

 

Food importers: Avoid risk and create your Foreign Supplier Verification Program (FSVP) now!

Thursday, November 17th, 2016

produceUnder 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.

Promulgated under the Food Safety Modernization Act (FSMA), the rules set parameters for foreign supplier verification programs (FSVPs) that importers must create and follow to safeguard the nation’s food supply.  Importers must have an FSVP program implemented by May 2017.

When the regulations were proposed in 2013, the FDA press release stated that

“[t]he new measures respond to the challenges of food safety in today’s global food system.  Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.”

If you fail to comply with the new rules, it could result in disruption of your supply chain, delays in entry processing, and in some cases, the exclusion of your products from the U.S. marketplace.

Act now, since there is ”little time to design, test and implement a Foreign Supplier Verification Plan,” warned the FDA’s former Director of Import Operations Domenic J. Veneziano.  He also cautioned the new regulations are broad in applicability, “and include the actual CBP importer, as well as the owner or consignee of food being offered for import, and even the U.S. agent of the importer.”  Further, Veneziano noted that the rules apply to large and smaller importers, and you should check to see if you qualify for a specific exemption from the FSVP requirements.

 

 

 

The proposed rules also call for an accreditation program for third-party auditors of imported food.

ACE: instructions below for transmitting various FDA commodities

Friday, November 11th, 2016

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Per US Customs CSMS #16-000946:

Please follow the instructions below for transmitting various FDA commodities:

  • For Medical Devices (Government Agency Program Code “DEV”) only product codes with Industry Codes 73-92 are allowed in PG02.
  • For Radiation-Emitting Products, (Government Agency Program Code RAD) only product codes with Industry Codes 94-97 are allowed in PG02.
  • For Program Code animal-use devices, (Government Agency Processing Code “ADE”) only product codes with Industry Code 68 are allowed in PG02.
  • For Cosmetics, (Government Agency Program Code “COS”) only product codes with industry code 50 or 53 are allowed in PG02.

This information will be added to the next version of FDA’s Supplemental Guide.

Please direct any FDA ACE technical questions to ACE_Support@fda.hhs.gov.

 

How is ACE doing? Pretty well, it seems

Tuesday, October 18th, 2016

Here are some analytics on the state of ACE from US Customs’ September 2016 ACE Monthly Trade Update.  Of note:

  • Nearly 100% of ACE core capabilities have been deployed, with only 12% remaining for post-release functionality.
  • 3.4 million FDA cargo release entries were transmitted.
  • There were 62,000 active trade ACE portal users, up from 12,500 in FY15.

ACE_External_Adoption_Report_September_2016

 

 

 

 

CBP leveraging new ACE data tools to improve processes, risk management

Wednesday, October 12th, 2016

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From our friends at the NCBFAA:

The ACE Business Office recently announced that the next focus of US Customs, as the remaining functionality of ACE is deployed, is how to best use the data tools that ACE provides.  The new technology will help CBP:

  • Facilitate processes
  • Promote more effective risk management
  • Keep moving towards goal of single window initiative

As for PGAs, the trade has noted that “more than 99 percent of goods inspected by some agencies are eventually let through, indicating that there’s room to improve targeting.”  However, there have already been notable improvements with FDA by having access to more import data via ACE:

  • Doubling of “may proceeds”
  • Decrease of document requests

Read the full article here.

 

CBP’s formal announcement on ACE deadline move to Oct 29

Thursday, September 8th, 2016

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In follow up to yesterday’s blog post, here is US Customs’ official announcement of the move of the October 1 ACE deadline to October 29:

U.S. Customs and Border Protection (CBP) has been assessing stakeholder readiness for the mandatory transition of post-release capabilities in ACE and has heard from key industry partners on the need for additional flexibility in this transition.  As a result, CBP is moving this date from October 1, 2016 to October 29, 2016 to allow additional time for our trade stakeholders to transition these capabilities to ACE.

This adjustment affects the mandatory filing of liquidation, drawback, reconciliation, duty deferral, collections, statements, and automated surety interface. 

All capabilities included in the October 29, 2016 transition that are planned for but not yet deployed to the Certification environment (CERT) will be operational in CERT, and all known prioritized issues will be resolved, no later than September 30, 2016.

While CBP has implemented the capability for most Partner Government Agency (PGA) data to be filed electronically in ACE, trade users may continue to file a combination of CBP electronic data and PGA paper forms where that is currently permitted. 

APHIS Lacey, NHTSA, FDA and as of 9/20/16, NMFS, data is required to be filed electronically in ACE. 

For PGA data that is not required to be filed electronically in ACE, filers may file using options currently specified as available for those PGAs.

CBP will continue to coordinate and communicate as required the conclusion of PGA pilots via public notices.

To ensure quick resolution of any issues that may arise following the October 29th deployment, CBP will stand up an operations center to support the transition to ACE for post-release capabilities for CBP users. Trade users will continue to contact their assigned Client Representative as the first line point of contact. Client Representatives will escalate trade issues as needed to the operations center.  Additional information on support during the transition will be published prior to the October 29th deployment.

The information in this notice will be posted on cbp.gov by September 8.

New ACE adoption rate report published

Monday, August 22nd, 2016

Entry release and entry summary filing numbers have begun to converge based on expanded ACE functionality.  Note high percentage of FDA filings relative to total PGA filings.  FDA has done a solid job in outreach to the trade on ACE.

External_July_ACE Adoption Rate_Final

FDA/ACE: How to get a Prior Notice confirmation number… for now

Monday, August 8th, 2016

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Per US Customs’ CSMS #16-000674:

This message is to provide an update to obtaining a standalone Prior Notice Confirmation Number for FDA.

There are currently three ways to obtain a standalone Prior Notice Confirmation Number:

  1. FDA’s Prior Notice System Interface (PNSI)
  2. The Automated Commercial System (ACS) – the WP function
  3. The Automated Commercial Environment (ACE) – the PE functionally

Filers can continue to transmit in BOTH ACS and ACE until a subsequent CSMS message is issued notifying the trade when ACS (WP) will be turned off. Following that date, ACE and the FDA PNSI will be the only systems available to provide a Prior Notice Confirmation Number.

FDA must receive prior notice before food is imported or offered for import into the United States. Advance notice of import shipments allows FDA, with the support of CBP, to target import inspections more effectively and help protect the nation’s food supply against terrorist acts and other public health emergencies.

FDA reviews response time frames in ACE

Friday, July 15th, 2016

fdalogoFrom CSMS #16-000554:

  • FDA regulated commodities go through multiple screening processes, depending on the product. From the time FDA successfully receives the entry data in its system, the screening process can vary from minutes to same business day processing, or multiple business days depending on the volume of entries/lines sent by CBP at a given time and the quality of information transmitted.
  • At the end of this screening process FDA’s system will return to CBP a message from CBP’s ACE Cargo Release Status Notification Implementation guide.
  • For commodities that require Prior Notice, the Prior Notice Confirmation Number should typically be received within 30 minutes (based on volume of entries/lines received within that window) from the time FDA successfully receives the data in their system.
  • FDA does not have a regulatory mandate regarding entry review time frames when determining admissibility of the FDA-regulated articles under 801(a.) However, FDA continues to improve the efficiency and consistency of the import admissibility process, including development of internal standards regarding entry review for an initial admissibility determination under 801(a.)
  • FDA regularly monitors its system and process performance throughout each day for anomalies.