FDA Prior Notice — Food Import Submission

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Section 1 — Submitter Information

Person or entity submitting the prior notice to FDA

Prior notice may be submitted by the importer, owner, ultimate consignee, customs broker, or other authorized agent. The submitter is responsible for accuracy of all information.

Submitter Full Name *

Company / Organization *

Title / Role *

Email *

Phone *

Fax (optional)

Street Address *

City *

State

ZIP / Postal

Country *

FDA Prior Notice Confirmation Number (if amending existing PN)

Submission Type *

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Section 2 — Product Information

Add one row per product — matches official FDA Prior Notice form

Per the official FDA Prior Notice form, list each food article separately with its own row. If the manufacturer is the same as the shipper, leave the Manufacturer column blank for that product.

Product Description	FDA Product Code	Country of Origin	No. of Cases	Net Weight / Case	Manufacturer Name, Address & FDA Reg # (blank if same as shipper)

Has any product listed above ever been refused entry to another country?

Yes No

If yes, list the product number and countries of refusal:

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Section 3 — Manufacturer & Shipper Details

Information about the foreign producer and the entity shipping the food

— Manufacturer / Producer —

Manufacturer Name *

FDA Foreign Facility Reg. Number (if registered)

Manufacturer Street Address *

City *

State / Province

Postal Code

Country *

Manufacturer Contact Name

Manufacturer Email

Manufacturer Phone

— Shipper (if different from manufacturer) —

Shipper Name

Shipper Reference / Tracking Number

Shipper Address

Shipper City

Shipper Country

Shipper Phone

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Section 4 — Carrier & Mode of Transport

How and by whom the food is being transported to the U.S.

Mode of Transport *

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Sea (Vessel)

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Air

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Truck (Land)

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Rail

Carrier Name *

Vessel / Flight / Vehicle Number *

Bill of Lading / AWB Number

Container Number (sea only)

Seal Number (sea only)

Country of Departure *

Departure Date *

Estimated Time of Arrival (ETA) *

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Section 5 — Port of Entry & Arrival Details

Where the food shipment will arrive in the United States

⚠️ Timing requirement: Prior notice must be submitted no more than 5 days before arrival and no less than 2 hours before arrival for food arriving by land (4 hours for air, 8 hours for sea).

Port of Entry *

Other Port of Entry (if not listed above)

CBP Entry Number (if available)

FDA District (if known)

Anticipated Arrival Date *

Anticipated Arrival Time *

Time Zone

— Where will product be stored upon arrival in the USA? —

Leave blank if same as Consignee / Importer address above

Warehouse Name

FDA Registration # (11 digits)

Physical Address

City

State

ZIP Code

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Section 6 — Importer of Record

U.S. entity responsible for the imported food at time of entry

Importer of Record Name *

FDA Facility Registration Number (if applicable)

DUNS Number

EIN / Tax ID

CBP Importer Number

Street Address *

City *

State *

ZIP Code *

Country

Contact Name *

Contact Email *

Contact Phone *

Ultimate Consignee (if different from importer)

Consignee Address

Customs Broker Name (if used)

Customs Broker License Number

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Section 7 — Certification & Submission

Review and certify the accuracy of your Prior Notice data

Certification Statement: By submitting this form, the submitter certifies that all information provided is accurate and complete to the best of their knowledge. Submission of false or misleading information to the FDA may result in refusal of admission of the article of food, civil monetary penalties, or criminal prosecution under 18 U.S.C. §1001 and 21 U.S.C. §350(c). Regovant LLC will use this information to prepare and submit the Prior Notice through FDA's Prior Notice System Interface (PNSI) or ABI/ACE on your behalf.

📜 Terms & Conditions

Regovant LLC provides Prior Notice submission services to assist importers in meeting their obligations under Section 801(m) of the FD&C Act and 21 CFR Part 1, Subpart I. By submitting this data collection form, you authorize Regovant LLC to prepare and transmit Prior Notice information to the FDA on your behalf. You remain solely responsible for the accuracy of information provided. Regovant LLC is not liable for delays, holds, or refusal of entry resulting from inaccurate or incomplete information. All data will be retained for a minimum of 2 years per FDA recordkeeping requirements. Submission of this form does not constitute legal advice.

I certify that all information in this Prior Notice data collection is true, accurate, and complete to the best of my knowledge, and I authorize Regovant LLC to submit this information to FDA on my behalf.

Printed Name *

Title *

Signature (type full name) *

Date *

Email for Confirmation *

Prior Notice of Imported Food

Section 1 — Submitter Information

Section 2 — Product Information

Section 3 — Manufacturer & Shipper Details

Section 4 — Carrier & Mode of Transport

Section 5 — Port of Entry & Arrival Details

Section 6 — Importer of Record

Section 7 — Certification & Submission

Prior Notice Submitted