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How to fill out fda-bta prior notice form

How to fill out the FDA-BTA prior notice form:

1. Start by accessing the FDA's Prior Notice System Interface (PNSI) website.
2. Log in to the PNSI using your FDA Industry User ID and Password. If you don't have one, you will need to create an account.
3. After accessing the PNSI, select the "Create Prior Notice" option to start filling out the form.
4. You will be prompted to enter various details about the shipment, including the FDA's product code, quantity, packing type, and country of production.
5. Provide accurate information regarding the submitter and importer of the product, including their names, addresses, and contact details.
6. Specify the intended arrival information, including the expected date and port of arrival in the U.S.
7. Enter the required information about the manufacturer or shipper of the product, such as their name, address, and contact details.
8. Provide details about the product itself, including its common or usual name, brand, and complete product description.
9. Include any necessary information on the establishment where the product was manufactured, such as its name, address, and FDA registration number.
10. Upload any supporting documentation or certificates that may be required, such as FDA product codes, lab test results, or other relevant documents.
11. Once you have provided all the necessary information, review it carefully to ensure accuracy and completeness.
12. After reviewing, submit the prior notice form through the PNSI. You will receive a Confirmation Number indicating that the prior notice has been successfully submitted.

Who needs the FDA-BTA prior notice form?

1. Importers: Any person or company importing food for human or animal consumption into the United States needs to complete the FDA-BTA prior notice form.
2. Manufacturers or shippers: If you are shipping food products to the U.S., you may also be required to provide prior notice using the FDA-BTA form.
3. Submitters: Individuals or businesses submitting the prior notice on behalf of the importer or manufacturer must also fill out the FDA-BTA form.

It's crucial to ensure compliance with the FDA's prior notice requirements to avoid any delays or issues with importing food products into the United States.

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What is fda-bta prior notice form?

The FDA-BTA Prior Notice Form is a form that must be filed with the Food and Drug Administration (FDA) to provide information about shipments of food, including animal feed, that are being imported into the United States.

Who is required to file fda-bta prior notice form?

Any person or company that is the owner, consignee, or importer of the food or animal feed shipment being imported into the United States is required to file the FDA-BTA Prior Notice Form.

How to fill out fda-bta prior notice form?

To fill out the FDA-BTA Prior Notice Form, you will need to provide information such as the name and address of the importer, the country of export, the anticipated arrival information, and details about the food or animal feed being imported.

What is the purpose of fda-bta prior notice form?

The purpose of the FDA-BTA Prior Notice Form is to ensure that the FDA has advance notice of shipments of food or animal feed coming into the United States. This allows the FDA to take necessary actions to protect public health and ensure compliance with regulatory requirements.

What information must be reported on fda-bta prior notice form?

The FDA-BTA Prior Notice Form requires information such as the FDA registration numbers of the facilities involved in the production, processing, and storage of the food or animal feed, the types and quantities of the products, and details about the packaging and labeling.

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