Register a US agent under the Bioterrorism Act

Costs

GTH is providing the Registration Service and Resident US Agent to help the food executive comply with the new dispositions of the Bioterrorism Act. GTH offers our services at a reasonable and modest cost for the food sector.

GTH Services

First Food Facility

Second And Additional Food Facilities With Same Owner

Serve as U.S. Agent and provide registration assistance

$395.00 per year per facility

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$275.00 per year per facility

Prior Notice and Record Keeping Services.

In addition to the US Agent services, GTH is offering the service to automatically fill out and submit the Prior Notice Form each time you sell your products to the USA. When you trade your products through the GTH Trading System, the Prior Notice Form can be electronically filled out and submitted to the FDA. All the information will be stored for you and made available upon request by the FDA. For more information, click here.

If you trade your products through the GTH Trading System, we will not charge you for the Prior Notice Form service and it will be part of our established trading fees. Visit our Trading Site at www.gthub.com

GTH informs you that the FDA is not charging to Register the Food Facility. GTH is charging a modest fee to act as your US Agent, providing the services as detailed below.

The services we are providing is as follows:

Registration

1. Help you fill out the Registration Form and translate it into English if necessary.
2. Electronically submit the Registration Form to the FDA.
3. Receive and store the Registration Number issued by the FDA and send you a copy for your records.
4. Make any changes or modifications to the Form as required by the FDA.
5. Maintain you informed of all changes to the Law and Regulations of the Bioterrorism Act.

Responsibility of the US Agent

1. To provide the Resident Agent information in the FDA Registration Form.
2. Assume the responsibility of the Resident Agent in the US, representing the Foreign Entity before the FDA.
3. Stay informed of any changes, modifications or notifications of the FDA.
4. Notify the Foreign Entity of any changes in the law and help you take the necessary measures to comply with the new changes.
5. Make the changes or modifications to the Original Registration Form as required.
6. Be the communications link between the FDA and the Foreign Entity.

GTH is offering a premiere service so you can have the piece-of-mind of knowing that you are complying with the norms established by the FDA. The annual cost is Tree Hundred Ninety Five US Dollars ($395.00). You have several options to pay for this service, click here to see Payment Options.

Estimated costs to appoint a US Resident Agent

Published in the US Federal Register Vol. 68, No. 22 / Monday, February 3, 2003 / Proposed Rules, Section vi. “Costs to a Foreign Entity to appoint a US Agent”, the FDA estimates that the annual costs to appoint a US Agent will be between $700.00 - $2,000.00 (Ref. 16 and 17). GTH is offering this valuable service far below what the FDA estimates other US Agents will charge.

Am I obligated to use your service?

As a serious international organization, GTH informs you that the FDA is not charging to Register. If you would like to register without the help of GTH, you can go to the FDA site to register at http://www.fda.gov/oc/bioterrorism/bioact.html. You can fill out the Registration Form Starting on October 12th, 2003. The Registration Form must be filled out in English and you will still need to appoint a US Agent to represent you in the USA.

Prior Notice

The Registration Form is the first step that needs to be taken in order to comply with the new Bioterrorism Act, and in our opinion, it is the easiest step. However, the Prior Notice Form is constant and required for each and every shipment to the USA. This Form must be correctly filled out with all the information required by the FDA or your product will be detained at the US Port.

As an additional service, GTH is offering the service to automatically fill out and submit the Prior Notification Form each time you sell your products to the USA. When you trade your products through the GTH Trading System, the Prior Notice Form can be electronically filled out and submitted to the FDA. Our Trading Systems are designed to automatically fill out the Prior Notification Forms and submit it within the time frame required by the FDA before your product reaches a US Port. All the information will be stored for you and made available upon request from the FDA. You will have access to all that information with your personal password. For more information, click here.

If you trade your products through the GTH Trading System, we will not charge you for this service and it will be part of our established trading fees.

Detention of your Product at the US Port

If there is a problem with your shipment and the FDA detains it at the Port to investigate it, the costs associated with storage, transport, inspection, administration and other related costs shall be paid by the owner of the Product, which most likely will be the exporter. If the Product is damaged in this process, there will be no claims allowed against the FDA. The FDA estimates that the majority of the time the causes for detention may be that the Prior Notice Form was not filled out correctly and will need to be investigated.