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Welcome to the Frequently Asked Questions (FAQ page). Below, we have tried to answer the most common questions visitors to this our Web site may have. If you find that your question is not answered on this page, please E-mail us mail@fdaus.net or usfda@hotmail.com.
Guide to FDA Food Facility Registration
Guide to FDA Prior Notice Requirement
Food Facility Registration Questions and Answers
The Best Strategies for Food Facilities.
1) Have your own FDA US agent
It is to the best interest of food facilities to use an independent agent, like C-TECH, rather than a current import broker or business or other agent for the purpose of FDA registration. By doing this way, you will not have your export business limited to a few brokers or agents, and gain more freedom to do business with whoever you want to.
2) Avoid your current import/customs broker or business agent.
Your current import broker or business agent may not really enjoy to take on the extra duty of being your US agent for FDA purpose. US agent is required to maintain routine and emergency communications with FDA for the facilities, to arrange FDA inspections, and etc.
3) Register your facilities through C-TECH. Just give your broker your FDA registration number.
When you export your products to the US, just simply tell your custom/import brokers your FDA facility registration number. They will be able to incorporate the number into the custom form they have to file and fill out the prior notice form all together through U.S. Customs and Broder Prtection (CBP)’s Automated Broker Interface of the Automated Commercial System (ABI/ACS).
4) File your Prior-Notice through (ABI/ACS) rather than FDA PN system
Filing your Prior Notice through CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS) will save your time. If you file Prior Notice through FDA system, you will have to have the Confirmation Number of the filing to accompany your food/feed products at the U.S. Customs and Broder Prtection (CBP).
BEFORE vs. AFTER Dec. 12th--- How to file with US Customs and FDA.
Timeframe Difference for Customs Filing and Prior Notice Filing based on Transportation Type
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Before 12/12
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After 12/12
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New Task for Food Exporters
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Common Practice
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Notify CBP and then subsequently FDA upon arrival (and as long as 15 days past arrival based on the time the consumption entry may be filed with CBP)
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Notify FDA before arrival. Rules for filing with CBP are the same
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By Sea Vessel
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Importers notify CBP and FDA before their arrival.
Notify CBP well in advance of the actual shipping date, but CBP will not certify the entry until 5 days before the vessel is expected to dock.
FDA is notified of the shipment then, through CBP, as early as 5 days before the vessel's arrival.
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Notify FDA before arrival, but no earlier than 5 days, no later than 8 hours before arrival by water
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Ask custom brokers to file no earlier than 5 days, no later than 8 hours before arrival
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By Airplane
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Notify CBP of intent to import food into the US no more than 24 hours before the scheduled flight departure time, but cannot certify their cargo manifests with CBP until the airplane has taken off from the airport of the exporting country (``wheels-up'').
FDA is notified after ``wheels up'', once the import entry has been filed and certified by CBP.
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Notify FDA before arrival, but no earlier than 5 days, no later than 4 hours before arrival by air
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Ask custom brokers to file no earlier than 5 days, no later than 4 hours before arrival by air
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Ground transportation by truck or train
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CBP was not notified until arrival. (Filers can certify their entry data up to 24 hours before arrival, but CBP does not give a ``screening response'' to the entry until actual arrival.) Even though these importers likely have the orders and invoices for these products in advance, they do not currently notify CBP until the arrival of the food or thereafter.
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Notify FDA before arrival, but no earlier than 5 days, no later than 2 hours before arrival by land by road
Notify FDA before arrival, but no earlier than 5 days, no later than 4 hours before arrival by land by rail
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Ask custom brokers to file based on new rules.
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Customs Filling Procedure
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Before 12/12
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After 12/12
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New Task for Food Exporters
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Information required
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A customs broker or self-filer will enter and transmit the information currently required in a CBP entry
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A customs broker or self-filer will enter and transmit the information currently required in a CBP entry, PLUS any additional information required in prior notice.
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Register with FDA before filing. Provide Registration number and other information for PN filing.
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Validation
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ACS will validate the submission to ensure that data required by CBP and FDA is entered.
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ACS will validate the submission to ensure that data required by CBP and FDA is entered.
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PN number
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Once ACS determines a submission is valid, no Prior Notice Confirmation Number is issued
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Once ACS determines a submission is valid, the prior notice information and other data will be transmitted to OASIS for additional data checks and validations.
A Prior Notice Confirmation Number is issued if the submission is determined to be facially valid.
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Make sure a PN confirmation number issued
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IT or T&E entry, or FTZ admission
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No PN require before arrival.
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A new ABI/ACS-OASIS interface for submitting prior notice for an article of food entering the United States as an IT or T&E entry, or an FTZ admission. Prior notice will be submitted by a new transaction type that will require only the information needed for prior notice and to support messages to CBP regarding the adequacy of the prior notice.
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Adapt new rules for IT or T&E entry or FTZ admission
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If CBP entry is later filed
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No PN require before arrival.
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PN Confirmation Number for the article must be entered as an affirmation of compliance for OASIS purposes as evidence that prior notice for the product was submitted and confirmed before arrival.
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Prior Notice has to be filed before arrival regardless CBP filing. A PN confirmation number is required.
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