[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: 21CFR1.280]



[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]