How to complete FDA Prior Notice in PNSI

One-time setup

Create an FDA Industry Systems account

Go to FDA Industry Systems, select Create New Account, and select Prior Notice System Interface as a system you need to access. Enter the account holder’s real contact information, accept the federal false-statement notice, review the details, and submit.

Save the Account ID shown after successful creation. You will need the Account ID and password for later submissions.

Access the filing system

Open PNSI and start a new submission

After signing in, select Prior Notice System Interface. On the PNSI home page, select Create New Prior Notice. Existing work appears under submissions and drafts.

PNSI uses a left navigation panel. A red exclamation mark means a section is incomplete. A green check mark means the section has the required information.

Choose carefully

Select the shipment or entry type

Select the type that matches how the goods will enter or move through the United States. PNSI may show options such as Consumption, Express Courier, Mail Commercial, Baggage, Transportation and Exportation, Immediate Transportation, Foreign Trade Zone, Warehouse, Temporary Importation under Bond, or Informal.

Consumption is commonly used when imported food will enter U.S. commerce without CBP time or use restrictions. Other movements require different types.

Match the transport plan

Enter the shipment, carrier, and arrival details

Enter the CBP Entry Identifier when one is available. For qualifying types, PNSI can generate an identifier. Then select the carrier type or mode and complete every field marked with an asterisk.

Use the first U.S. port of arrival

Enter the location, anticipated date, and anticipated time when the shipment will first reach the United States, not the final delivery location. Match carrier names, voyage or flight information, vehicle or rail identifiers, airway bill, bill of lading, or tracking information to the actual booking and selected mode.

Identify the responsible parties

Complete submitter and importer information

Choose whether you are filing for yourself or someone else. Filing for yourself can prefill the account holder’s details. If someone else is the submitter, enter that person’s business and contact information accurately.

On the Importer Details page, identify the U.S. importer for this shipment. The importer, owner, ultimate consignee, submitter, and transmitter can be different parties. Do not copy one company into every role unless that is factually correct.

One line item at a time

Add each food article and choose its FDA product code

From the Prior Notice Overview, select Add Food Article. Enter the common or usual market name and any required lot or production identifiers. If you know the FDA product code, enter it. Otherwise, use Product Code Search.

The product-code workflow narrows the item through Industry, Class, Subclass, Process Indicator Code, and Product Group. Choose the code that describes the actual product, processing, and packaging, not merely the closest name.

When to create another food article

Add separate articles when the product identity, product code, manufacturer or grower, country of production, or other article-level details differ. Repeat identical shipment parties only where PNSI allows and the fact remains true.

Describe the physical shipment

Enter quantity, packaging, and refusal information

For packaged goods, work from the outer shipping level to the base unit. Enter package count and package type for each level, then the base weight or volume. PNSI currently permits up to five packaging levels. For a true bulk shipment, enter the total amount and base unit.

Answer whether any country has refused entry to this article. If yes, identify every applicable country available in the system.

Trace the product and custody

Add the manufacturer or grower, shipper, owner, and consignee

PNSI changes the next screen according to the product code. Processed food generally requires the last facility that manufactured or processed the food. Food in its natural state generally requires the grower and growing location, if known. A consolidator can be used only in the circumstances allowed by FDA.

• Manufacturer or grower: use the actual facility and FDA Food Facility Registration number where applicable. If no number is provided, select only a valid reason and provide the required address.
• Shipper: identify the party shipping the article from the foreign country. This is not automatically the carrier.
• Owner: identify the owner of the article at the relevant time.
• Ultimate consignee: identify the U.S. party that will receive the article, subject to the selected entry type.

Final accuracy check

Review every article, then submit to FDA

Select Review after every navigation item has a green check. Check names, addresses, product codes, package counts, facility information, countries, route, port, and arrival timing against the commercial invoice, packing list, carrier booking, and broker instructions.

Select Add Article to my Prior Notice Submission, then add another food article or finish. On the Submission Summary, make any final edits and select Submit to FDA.

Do not stop at submission

Generate the PDF and send the confirmation to the carrier

Confirm that the status reads Submitted to FDA. Select Generate PDF, save the PDF with its barcode and PN Confirmation Number, and retain it with the shipment records.

• For a commercial carrier when PNSI was used, give the carrier the PN Confirmation Number.
• For international mail, place the PN Confirmation Number on the parcel.
• For food accompanying an individual when Prior Notice applies, the individual must carry the confirmation.

Tell the broker, importer, and receiving party which confirmation applies to each food article. Do not treat the number as FDA approval or release.