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Who is authorized to submit prior notice?
A prior notice for an article of food may be submitted by any
person with knowledge of the required information. This person is the
submitter. The submitter also may use another person to transmit the
required information on his/her behalf. The person who transmits the
information is the transmitter. The submitter and transmitter may be
the same person.
Excerpted from Sec. 1.278 of the Interim Final Rule.
If the article of food is sent by an individual as a personal gift (i.e., for nonbusiness
reasons) to an individual in the United States,
you may provide the name and address of the firm that appears on the
label ... instead of the name, address, and registration
number of the manufacturer. If a registration number is provided, city
and country may be provided instead of the full address;
Excerpted from Sec. 1.281 of the Interim Final Rule.
Prior Notice ... does not apply to ...
Food that was made by an individual in his/her personal
residence and sent by that individual as a personal gift (i.e., for
non-business reasons) to an individual in the United States;
Excerpted from Sec. 1.277 of the Interim Final Rule.
(See also "What foods are excluded from the prior notice
requirement?" in the Prior Notice
Fact Sheet.)
If the article of food is arriving by international mail, the prior
notice must be submitted before the food has been sent to the United
States and the parcel must be accompanied by confirmation of FDA receipt
of prior notice.
Excerpted from Sec. II. D. of the Interim Final Rule.
The PN Confirmation Number must accompany any article of food
arriving by international mail. The PN Confirmation Number must appear
on the Customs Declaration that accompanies the package.
Excerpted from Sec. 1.279 of the Interim Final Rule.
The interim final rule defines "shipper" as "the owner or
exporter of the article of food who consigns and ships the article from
a foreign country or the person who sends an article of food by
international mail to the United States."
Excerpted from Sec. II. A. of the Interim Final Rule.
When the prior notice submission has been
validated, the transmitter will receive a message showing that the
prior notice has been received by FDA for review and accepted as
facially complete. This message will include a unique PN Confirmation
Number as well as the date and time of the submission and confirmation.
The message will confirm that the prior notice is facially complete and
has been received by the FDA for review. Capability will also be
provided to get a hard copy printout of the prior notice submission and a
confirmation for verification upon arrival of the article of food, if
needed.
Excerpted from Sec. III. g. 11. of the Interim Final Rule.
How will FDA enforce this interim final rule during the comment period? FDA
will actively consider the exercise of its discretion in the enforcement of
the prior notice interim final rule while at the same time ensuring public
health protection, both during initial implementation of the interim final
rule and thereafter.
Excerpted from Fact Sheet on FDA'S New Food Bioterrorism Regulation:
Interim Final Rule -- Prior Notice of Imported Food Shipments
See also Compliance Policy Guide: Guidance for FDA and CBP Staff
When submitting Prior Notice for an item sent by international mail, the following information is required:
| Information | Transshipment, Storage and Export, Manipulation and Export |
Carried by or Accompanies an Individual | Food Not in Natural State | Food in Natural State | After Section 801(m) Refusal | |
|---|---|---|---|---|---|---|
| §1.281 paragraph(s) | (a) and (c) | (a) and (c) | (a), (b), and (c) | (a), (b), and (c) | (b) | (c) |
| Submitter | Y | Y | Y | Y | Y | Y |
| Transmitter | Y | Y | Y | Y | Y | Y |
| Entry Type | Y | Y | Y | Y | Y | Y |
| Entry Identifier | Y | Y | Y | Y | Y | Y |
| FDA Product Code | Y | Y | Y | Y | Y | Y |
| Common, usual, or market name | Y | Y | Y | Y | Y | Y |
| Estimated Quantity | Y | Y | Y | Y | Y | Y2 |
| Lot/Code # | Y | Y | Y | N | Y | Y |
| Manufacturer | Y | Y | Y | N | Y/N | Y |
| Manufacturer Registration #1 | N | Y | Y/N | N | Y/N | Y |
| Grower, if known | Y | Y | N | Y | Y | Y |
| Cty of Production | Y | Y | Y | Y | Y | Y |
| Shipper | Y | Y | Y | Y | Y | Y |
| Shipper Registration #1 | N | Y | Y | Y | Y | Y |
| Country Shipped | Y | Y | Y | Y | Y | Y |
| Port of Arrival | Y | Y | Y | Y | N | Y2 |
| Date of Arrival | Y | Y | Y | Y | N | N |
| Time of Arrival | Y | Y | Y | Y | N | N |
| Date of Shipment | N | N | N | N | Y | N |
| Importer | N | Y | Y | Y | N | Y |
| Owner | N | Y | Y | Y | N | Y |
| Ultimate Consignee | N | Y | Y | Y | N | Y |
| U. S. Recipient | N | N | N | N | Y | Y |
| Mode of Transport | Y | N | Y | Y | N | Y |
| Carrier | Y | Y | Y | Y | N | Y |
| Airbill or Bill(s) of Lading | Y | N | Y | Y | N | Y2 |
| Vessel/Voyage | Y | Y | Y | Y | N | Y2 |
| Flight # | Y | Y | Y | Y | N | Y2 |
| Trip # | Y | Y | Y | Y | N | Y2 |
| Container # | Y | N | Y | Y | N | Y2 |
| Car # | Y | N | Y | Y | N | Y2 |
| License Plate # | Y | Y | Y | Y | N | Y2 |
| HTS code | Y | Y | Y | Y | N | Y |
| Hold Location | N | N | N | N | N | Y |
1Registration numbers are required only if the firm is required to register for a facility associated with the article of food under section 415 of the FD&C Act, 21 U.S.C. 350d and 21 CFR part 1, subpart H; if registration number is provided, by city and country can be provided instead of the full address.
2After arrival, therefore, no longer anticipated or planned.
Excerpted from Sec. II.J (Table 1A) of the Interim Final Rule.
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