[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: 21CFR1.280]

[Page 27-28]
 
                        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.  1.280  How must you submit prior notice?

    (a) You must submit the prior notice electronically to FDA. You must 
submit all prior notice information in the English language, except that 
an individual's name, the name of a company, and the name of a street 
may be submitted in a foreign language. All information, including these 
items, must be submitted using the Latin (Roman) alphabet. Unless 
paragraphs (c) and (d) of this section apply, you must submit prior 
notice through:

[[Page 28]]

    (1) The CBP Automated Broker Interface of the Automated Commercial 
System (ABI/ACS); or
    (2) The FDA PN System Interface at http://www.access.fda.gov. You 
must submit prior notice through the FDA PN System Interface for 
articles of food imported or offered for import by international mail, 
other transaction types that cannot be made through ABI/ACS, and 
articles of food that have been refused under section 801(m)(1) of the 
act and this subpart.
    (b) If a custom broker's or self-filer's system is not working or if 
the ABI/ACS interface is not working, prior notice must be submitted 
through the FDA PN System Interface.
    (c) If FDA determines that FDA PN System Interface is not working, 
FDA will issue notification at http://www.access.fda.gov or http://
www.cfsan.fda.gov/furls/fisstat.html, whichever FDA determines is 
available. Once FDA issues this notification, if you intended to use the 
FDA PN System Interface to submit a prior notice, you must submit prior 
notice information by e-mail or by fax to FDA. The location for receipt 
of submission by e-mail or fax will be listed at http://
www.access.fda.gov or http://www.cfsan.fda.gov/furls/fisstat.html, 
whichever FDA determines is available.
    (d) If FDA determines that the Operational and Administration System 
for Import Support (OASIS) is not working, FDA will issue notification 
at http://www.cfsan.fda.gov/fulrs/fisstat.html, on the FDA Web site at 
http://www.fda.gov, and through messages in ABI/ACS. Once FDA issues 
this notification, all prior notices must be submitted to FDA by e-mail 
or by fax. The location for receipt of submission by e-mail or fax will 
be listed at http://www.access.fda.gov or http://www.cfsan.fda.gov/
furls;fisstat.html, whichever FDA determines is available.
    (e) Prior notice information will only be accepted at the listed e-
mail or fax locations if FDA determines that the FDA PN System Interface 
or OASIS is not working.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2003; 69 FR 8330, Feb. 
24, 2004]