When must prior notice be submitted to FDA?

21 C.F.R. § 1.279
in effectEffective: 2024-07-01
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(a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must be confirmed by FDA for review as follows: (1) If the article of food is arriving by land by road, no less than 2 hours before arriving at the port of arrival; (2) If the article of food is arriving by land by rail, no less than 4 hours before arriving at the port of arrival; (3) If the article of food is arriving by air, no less than 4 hours before arriving at the port of arrival; or (4) If the article of food is arriving by water, no less than 8 hours before arriving at the port of arrival. (b) Except in the case of an article of food imported or offered for import by international mail: (1) If prior notice is submitted via the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS), you may not submit prior notice more than 30-calendar days before the anticipated date of arrival. (2) If prior notice is submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than 15-calendar days before the anticipated date of arrival. (c) Notwithstanding paragraphs (a) and (b) of this section, if the article of food is arriving by international mail, you must submit the prior notice before the article of food is sent to the United States. (d) FDA will notify you that your prior notice has been confirmed for review with a reply message that contains a Prior Notice (PN) Confirmation Number. Your prior notice will be considered submitted and the prior notice time will start when FDA has confirmed your prior notice for review. (e) The PN Confirmation Number must accompany any article of food arriving by international mail. The PN Confirmation Number must appear on the Customs Declaration (e.g., CN22 or CN23 or U.S. equivalent) that accompanies the package. (f) A copy of the confirmation, including the PN Confirmation Number, must accompany any article of food that is subject to this subpart when it is carried by or otherwise accompanies an individual when arriving in the United States. The copy of the confirmation must be provided to U.S. Customs and Border Protection (CBP) or FDA upon arrival. (g) The PN Confirmation Number must accompany any article of food for which the prior notice was submitted through the FDA PNSI when the article arrives in the United States and must be provided to CBP or FDA upon arrival.

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