21 C.F.R. § 1.280 How must you submit prior notice?
Title 21 - Food and Drugs
(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: (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.php, 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.php, 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.php, 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.php, 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]
Title 21: Food and Drugs
PART 1—GENERAL ENFORCEMENT REGULATIONS
Subpart I—Prior Notice of Imported Food
Requirements To Submit Prior Notice of Imported Food
§ 1.280 How must you submit prior notice?
