[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.279]

[Page 27]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
                 Subpart I_Prior Notice of Imported Food
 
Sec.  1.279  When must prior notice be submitted to FDA?

    (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, you may not submit prior notice more than 
5 calendar days before the anticipated date of arrival of the food at 
the anticipated port 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 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 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 Prior Notice 
System Interface (FDA PN System Interface) when the article arrives in 
the United States and must be provided to CBP or FDA upon arrival.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]