[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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]