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FDA

ACE: On June 15, ACE will be the only system to process certain FDA entry types

Monday, May 16th, 2016

FDA-LogoFrom today’s Federal Register:

Effective June 15, 2016, ACE will be the sole CBP-authorized EDI system for electronic entries and entry summaries for merchandise that is subject to import requirements of the Food and Drug Administration (FDA), associated with the certain entry types listed below.

Other FDA entry types will processed solely in ACS, and the remainder will not be automated in either ACE or ACS.   CBP will publish a subsequent Federal Register Notice in the near future when the additional entry and entry summary filings will be transitioned in ACE.

ACE as the Sole CBP-Authorized EDI System for the Processing of Certain Electronic Entry and Entry Summary Filings Accompanied by FDA Data

  • 01—Consumption—Free and Dutiable
  • 03—Consumption—Antidumping/Countervailing Duty
  • 06—Consumption—Foreign Trade Zone (FTZ)
  • 11—Informal—Free and Dutiable
  • 23—Temporary Importation Bond (TIB)
  • 51—Defense Contract Administration Service Region (DCASR)
  • 52—Government—Dutiable

ACS as the Sole CBP-Authorized EDI System for the Processing of Certain Electronic Entry and Entry Summary Filings

  • Electronic entry and entry summary filings for the following entry types must continue to be filed only in ACS:
    • 02—Consumption—Quota/Visa
    • 07—Consumption—Antidumping/ Countervailing Duty and Quota/Visa Combination
    • 08—NAFTA Duty Deferral
    • 09—Reconciliation Summary
    • 12—Informal—Quota/Visa (other than textiles)
    • 21—Warehouse
    • 22—Re-Warehouse
    • 22—Re-Warehouse
    • 31—Warehouse Withdrawal— Consumption
    • 32—Warehouse Withdrawal—Quota
    • 34—Warehouse Withdrawal— Antidumping/Countervailing Duty
    • 38—Warehouse Withdrawal— Antidumping/Countervailing Duty & Quota/Visa Combination
    • 41—Direct Identification Manufacturing Drawback
    • 42—Direct Identification Unused Merchandise Drawback
    • 43—Rejected Merchandise Drawback
    • 44—Substitution Manufacturer Drawback
    • 45—Substitution Unused Merchandise Drawback
    • 46—Other Drawback
    • 61—Immediate Transportation
    • 62—Transportation and Exportation
    • 63—Immediate Exportation
    • 69—Transit (Rail only)
    • 70—Multi-Transit (Rail only)

Due to Low Shipment Volume, Filings for the Following Entry Types Will Not Be Automated in Either ACS or ACE 

  • 04—Appraisement
  • 05—Vessel—Repair
  • 24—Trade Fair
  • 25—Permanent Exhibition
  • 26—Warehouse—Foreign Trade Zone (FTZ) (Admission)
  • 33—Aircraft and Vessel Supply (For Immediate Exportation)
  • 64—Barge Movement
  • 65—Permit to Proceed
  • 66—Baggage

 

ACE Cargo Release: CBP to resolve FDA/CBP HTS dilemma this summer

Monday, March 28th, 2016

fdalogo

 

While the launch of ACE is transforming and modernizing the way the trade does business, the process is not without its hiccups.  US Customs just acknowledged a significant glitch — an inconsistency between the number of HTS codes that CBP and FDA permit in a single line in entries.  The good news is that the agencies are addressing the issue and expect resolution this summer.

 

 

Per CSMS #16-000233:

  • Cargo Release was designed in the same manner as Entry summary to allow the transmission of up to 8 HTS codes within a single CBP line. FDA cannot accept entries where within a single CBP line there is more than one HTS code with FDA data. Both CBP and FDA are aware of the issue.
  • In order to submit FDA data properly, trade must provide only one HTS code with FDA data on each CBP line. In this manner FDA can accept up to 999 CBP lines per entry. CBP and FDA will be working on this issue to enhance system capability and allow for trade to submit multiple HTS codes with FDA lines on a single CBP line. Work is currently underway to complete this functionality by mid to late Summer 2016.

ACE timeline slips!

Monday, February 8th, 2016

seal_aceIn response to continued concerns about system readiness, US Customs today announced an updated ACE transition timeline.

CBP has implemented a staggered approach to the mandatory filing of electronic entries and corresponding entry summaries in ACE, and the decommissioning of electronic entry/entry summary filing capabilities in the Automated Commercial System (ACS).

Here are the first of the upcoming deadlines, with a link to the complete transition plan — which CBP states will continue “to align with our December 2016 deadline for implementation of the Single Window via ACE.”

  • The February 28, 2016 deadline for the crossover to file all entries in ACE is now the date when CBP will start divesting ACS, and limiting support and maintenance.
  • A March 31, 2016 deadline now requires electronic entry summaries with no PGA data to be filed in ACE (entry types 01, 03, 11, 23, 51 and 52).  Also electronic entries and corresponding entry summaries (for the same entry types) with data for APHIS (Lacey) and NHTSA (unless paired with other PGA data) must be filed in ACE.

US Customs’ entire ACE transition timeline, with additional deadlines (May 28, 2016 and TBD Summer 2016) for other entry types and PGAs, may be found here.  Interestingly, CBP has specifically singled out FDA filings which”will continue to be allowed in ACS to provide more time for industry to transition to ACE.”

We will update as we learn more from Customs.

 

Update from FDA’s December 10 ACE webinar

Saturday, December 19th, 2015

Following is a brief overview of the December 10, 2015 webinar on the Food and Drug Administration (FDA) and ACE for Drugs, Devices and Biologics.

  • All FDA filings must be processed through ACE beginning February 28, 2016 (in addition to NHTSA and APHIS (Lacey)).

FDA ACE

 

 

 

 

 

 

 

Process Overview

  • The process will be very similar to current state.  CBP will check for syntax errors and reject the entry if missing or invalid data.  Once it is accepted, FDA will use its PREDICT system to check for admissibility.  However, filers will not receive their determination message until 5 days before ETA.  Filers can make changes if more than 5 days prior to ETA.
  • There was some discussion of upcoming policy changes that would allow a filer to revise a submission within the 5 day window.  FDA is also considering requiring submission for FD0 flagged HTSs.
  • FDA will continue to use the ITACS system for document collection/review until the DIS system has line-level functionality.

FDA/ACE Pilot Status

  • To date, 1,000 entries subject to FDA requirements have been filed in the FDA ACE Pilot.  FDA is still on-boarding new participants, and is working with filers and importers to ensure they understand what data is required by commodity.  They can be found in the FDA Supplemental Guide, which breaks down the requirements by commodity.
  • Four parties will always be required and possibly more depending on commodity:
MF Manufacturer of goods
DEQ Shipper
FD1 FDA Import (Importer of Record)
DP Delivered To Party
  • Federal Establishment Identifier (FEI) numbers and Data Universal Numbering System (DUNS) numbers are encouraged in lieu of Name/Address and can expedite release.
    • DUNS numbers can be found here.
    • FEI numbers can be found here.
  • To participate in pilot e-mail ACE_Support@fda.hhs.gov or call FDA’s Division of Import Operations at: 301-796-0356.

 

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ACE: Successful PGA Pilot for entries involving FDA and NHTSA

Thursday, August 27th, 2015

seal_acePer US Customs’ CSMS #15-000623:

Last week, [CBP] initiated the first Phase (I) of the PGA Pilots.  [FDA] and [NHTSA] entry data transactions were successfully transmitted, accepted and processed in [ACE].  The second Phase (II) of the PGA Pilots is scheduled to begin on September 2, 2015, with an expansion to additional ports.

In advance of the November 1, 2015 ACE mandatory filing date, CBP has also published a comprehensive overview of the schedule of PGAs and ports participating in the PGA Pilot.

Food importers: Are your foreign food facilities properly registered?

Tuesday, January 6th, 2015

produceImporting food into the US from a foreign food facility?  Make sure that facility has a valid — and renewed — registration with the US Food & Drug Administration.  Otherwise, FDA may hold the imported food at the port, or even refuse import of that food.

The Food Safety Modernization Act requires foreign (and domestic) facilities that manufacture, process, pack or hold food for human or animal consumption in the US to register with FDA.  These facilities must renew their registrations with FDA, every other year, by December 31 of each even-numbered year.  If a facility failed to register or renew by December 31, 2014, FDA may issue a hold for any food to be imported into the US.

FDA’s advice, per CSMS #15-000002:

“FDA encourages import brokers who file prior notices for food shipments after January 1, 2015 take proactive action and contact clients with high-volume food shipments, inquire about the renewal status of foreign manufacturing facilities associated to their shipment, and confirm any new registration numbers. Prior notices after January 1, 2015 must have a valid facility registration number. Doing so could greatly mitigate any prior notice shipment delays related to invalid or canceled registration.”

 

 

LA/LB Seaport’s new rules for FDA refused merchandise

Tuesday, December 16th, 2014

fdalogoUS Customs’ Los Angeles Field Office has released a Public Bulletin announcing revised port procedures for disposition of merchandise refused by FDA, which will be overseen by the newly created Federal Destruction and Redelivery Team (Team FDR).  Key points are as follows:

  • All merchandise refused by the FDA must be exported or destroyed under CBP and FDA supervision within 90 days of the refusal date.
  • Instead of receiving a separate CBPF 4647 and the Notice of FDA Action (Refusal), the importer will now receive a new combined “Refusal Redelivery Notice” (RRN).
  • The RRN is the Notice of Refusal stamped by CBP to indicated redelivery.  A cover sheet with port specific instructions for exportation or destruction of FDA refused merchandise will be included.

The Public Bulletin also details the specific procedures for merchandise for exportation as well as merchandise for destruction (for both seaport shipments and air shipments).

The Public Bulletin can be found here:  LA15-005 (Updated) Los Angeles Field Office Procedures for CBP-FDA Refused Merchandise

 

 

Medical device importers — new AofC qualifiers for De Novo applications

Wednesday, September 3rd, 2014

fdalogoThe Food and Drug Administration (FDA) has begun using a new numbering system for medical device De Novo applications.

Accordingly, the appropriate qualifier for the Affirmation of Compliance (AofC) code PMN will either be K or DEN, followed by 6 digits.

On a related note, previously-granted De Novo applications with 510(k) numbers have been reassigned DEN numbers as well.

Full details are available in US Customs’ CSMS #14-000482.

Also, for a general background, see FDA’s August 2014 draft guidance on the De Novo classification process.

CBP launches Trusted Trader program test

Thursday, June 26th, 2014


handshake

US Customs has launched a test of its Trusted Trader initiative, “a new program that will streamline the process through which importers can establish to CBP that they strive to secure their supply chains and strengthen their internal controls for compliance with … existing [customs] laws.”

Working in conjunction with the CPSC and FDA, CBP plans to use the Trusted Trader program to unify the current C-TPAT and ISA programs.  (Non-participating companies will still have the option to participate exclusively in C-TPAT and apply to the ISA program).  In addition, the Trusted Trader program will leverage the expertise of Customs’s CEEs “to manage trusted trader accounts from an industry perspective.”

CBP lists numerous benefits of the Trusted Trader program, including:

  • All the incentives provided by the C-TPAT and ISA programs
  • Reduced FDA targeting/examination risk score
  • Potential for penalty offsets in penalty mitigation decisions
  • Additional benefits if participating in Reconciliation Prototype program
  • Exemptions from on-site visits from Drawback Specialists
  • And much more

The Trusted Trader test is expected to last for 18 months, and the application process is now open.

See last week’s Federal Register announcement for more details.

Attend next week’s Annual State of the LA/LB Port & CBP Update

Thursday, January 2nd, 2014

owit_oc_logo_smOn January 9, Women in Trade – Orange County is hosting the Annual State of the Los Angeles/Long Beach Seaport event with a panel of the following speakers from US Customs LA/LB officials:

  • Todd Owen – Director, Field Operations
  • Carlos Martel – Port Director LA/LB Seaport
  • Elva Muneton – Assistant Port Director, Trade

Also participating in the roundtable will be:

  • Dan Solis, Director of LA District of Import Operations, FDA
  • Hank Tapy, Director, Western Region, Office of Import Surveillance & Inspection, CPSC

Discussion topics will include:

  • Headlines of 2013 — Year in Review
  • Current Updates for Trade Compliance
  • Forecast of Trade Issues, Challenges & Priorities for 2014
  • Expected Operational Changes at National and Port Locations
  • Risk Assessment Methodologies
  • New CPCS and FDA Regulations and Standards
  • Import/Export Exams, Investigations and Inspections
  • Centers of Excellence & Expertise (CEE)

Register for this event to be held in Newport Beach.