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FDA

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.

FDA ACE entries: common errors

Thursday, July 7th, 2016

fdalogoPer US Customs CSMS #16-000557:

ALL ABI FILERS OF ACE ENTRIES

FROM: THE FOOD & DRUG ADMINISTRATION

Since the month of June FDA has seen a sharp increase in submission of ACE entries containing errors which do not result in a reject at this time, but cause issues with FDA’s automated processing and subsequent admissibility decision-making process. This message is intended to convey these common errors so filers may make any corrections to their ABI systems that will avoid them moving forward.

1. One of the most common errors is the submission of duplicate units of measure when describing the quantity of product on a single FDA line. FDA’s quantity reporting requirements have not changed with ACE and filers should continue to describe the product from largest container down to the smallest base unit. An example would be a product that ships in 100 cartons (CT), each containing 24 boxes (BX), each containing 10 packages (PK) of 12 oz. (OZ) each. It is not appropriate to send cartons, boxes, packages or ounces twice on this example line. Different packaging sizes should be transmitted as separate lines in order to accurately reflect the product’s state when making entry into the country. Instructions on transmitting quantity to FDA are attached to this CSMS message.

Further quantity examples:

  • Product: 1000 cases of mineral water, 24/12 ounce bottles in each case
    • Data pairs: 1000 CS (Case)
    • 24 BO (Bottle, Non-protected, Cyl)
    • 12 FOZ (Ounces, fluid) (Base Unit)
  • Product: 200 cartons of 100 rolls surgical gauze, 75 square yards per roll
    • Data pairs: 200 CT (Carton)
    • 100 RO (Roll)
    • 75 (SYD (Square Yards) (Base Unit)

2. FDA requires Manufacturer (MF) as a mandatory entity in PG19 for lines on entries with Product Codes that are identified as “Non-Food” (not requiring Prior Notice) and for lines on entries with Product Codes that are identified as “Food” and already having a Prior Notice Confirmation. Filers need to provide the Manufacturer entity in PG19 for these scenarios.

3. FDA limits “Affirmation of Compliance Qualifier field” in PG23 (Affirmation of Compliance) to a size of 30 characters. Filers should provide no more than 30 characters for this field in PG23. In addition, the qualifier must follow the syntax indicated in the FDA Supplemental Guide.

4. Intended Use Code: FDA requires trade to provide a valid intended use code which is listed in the FDA Supplemental Guide 2.4.1 and CBP ACE CATAIR

5. Missing/Invalid Affirmations of Compliance- AofC Codes are required based on product type (and FDA Product Code), intended use, mode of transport. There have been additions and changes to many AofCs in ACE

6. Missing/Invalid Entities

• 4-5 Entities are required for Non-PN Lines

• 7 Entities are required for PN Lines

Incorrect entity role codes for a given commodity can cause processing errors and delays. Refer to the FDA Supplemental Guide to determine which entities should be provided for a given product.

Please direct any questions to ACE_SUPPORT@FDA.HHS.GOV

FDA to give “priority processing” to ACE entries, implement production calls with trade

Tuesday, June 14th, 2016

As posted here previously, US Customs is mandating filing in ACE for select FDA entry types as of tomorrow, June 15, 2016.  In addition to establishing a 24/7 ACE support center, FDA is taking further, significant steps to assist the trade in the transition to ACE, including:

  • Institution of “production calls”
    • a meeting between the FDA, the entry filer and the entry filer’s software vendor (preferably) to walk through an entry that is being submitted via ACE
    • Production calls allow FDA and the entry filer to talk about the entry submission in real time
  • Priority processing of ACE entries
    • The average processing time for manual review and release of ACE submitted entries is 25% faster than the average processing time for manual review and release of ACS submitted entries
    • slide1When review of documents is necessary, processing time from when documents are requested to the release of ACE submitted entries is 33% faster than for ACS submitted entries, resulting in a savings of 1 ¼ days of processing time

slide1

FDA ACE support center help desk goes live tomorrow!

Monday, June 13th, 2016

fdalogo

From our friends at the NCBFAA:

The FDA has set up a 24/7 help desk — the ACE Support Center — to support implementation of ACE. This call center will address issues with ACE and will help facilitate the resolution of issues reported for ACE entries. FDA will continue to also provide e-mail support. Issues related to ACE entries can be sent to  Ace_support@fdahhs.gov.

The help desk goes live on Tuesday, June 14, 2016. It can be reached at:

  • Domestic Toll Free: 877-345-1101
  • Local/International: 571-620-7320

 

 

GAO: FDA’s PREDICT tool for food imports “working as intended”

Thursday, June 9th, 2016

fdalogoFrom the US General Accountability Office’s May 2016 Report “IMPORTED FOOD SAFETY: FDA’s Targeting Tool Has Enhanced Screening, but Further Improvements Are Possible”:

FDA officials reported that they conduct monitoring of PREDICT on an ongoing basis and that the data they collect as part of this monitoring show that PREDICT is working as intended—that is, PREDICT is focusing entry reviewers’ attention on items determined to be of higher risk. Data provided by FDA from fiscal years 2012 to 2014 confirmed that in general, PREDICT is fulfilling this role. Our analysis of these data showed that in general, the higher the PREDICT risk score, the more often entry lines were examined and the more often they were found violative.

For example, for fiscal year 2014, entry lines that received higher PREDICT scores generally were more often selected for a field examination, for a label examination, or for sampling, and entry lines with higher PREDICT scores were more often found violative.

gao fda predict report

 

 

 

 

 

 

 

 

 

The full GAO report is available here.

ACE: New CBP guidance on PGA Entry Type Codes

Monday, June 6th, 2016

seal_ace

Per CSMS #16-000439:

This following advises which CBP Entry Type Codes will require Partner Government Agency data, (i.e., the PGA Message Set) when the entry types are deployed and the PGA is ready to accept them. Below is an explanation of the legend on the attached chart detailing PGA filing requirements by entry type code, and additional clarification on the Entry Type 06 Foreign Trade Zones.

Explanation:

• The word “Yes” in the entry type line/box indicates the PGA’s data is required for, the entry type when the entry contains the (HTS) commodities, regulated by that specific PGA.

• The word “No” indicates the PGA’s data is not required for the entry type.

  • TYPE 06 – Consumption, Foreign Trade Zone (FTZ):
  • The PGA’s chose one of two options for requiring their PGA data:
    • At Cargo Release
      • Eleven (11) agencies require the PGA message set at Cargo Release, whether it is a Regular Type 06 or a Weekly Estimate:
        • ATF / AMS / APHIS / DEA / EPA / FDA / FDA / FSIS /FWS / OMC / and TTB
    • DUAL option
      • If a regular 06 entry is filed at cargo release, then the PGA data is required with the filing.
      • If a weekly estimate is filed at Cargo Release, the PGA data is required at Entry Summary, (no PGA data is to be sent with the weekly estimate).
      • Four (4) agencies opted for the dual option:
        • APHIS Lacey / CPSC / NHTSA and NMFS

Any questions can be referred to William.R.Scopa@CBP.DHS.GOV

 

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ACE: Update on status of PGA pilots

Friday, June 3rd, 2016

Here is CBP’s latest report on the status of 17 PGA pilot programs regarding ACE:

ACE PGA pilots

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.