Code of Federal Regulations Title 21. Food and Drugs § 21.1.280 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 the items listed in the previous sentence, must be submitted using the Latin (Roman) alphabet. Unless paragraph (c) of this section applies, you must submit prior notice through:

(b) If a customhouse broker's or self-filer's system is not working or if the ABI/ACE/ITDS interface is not working, prior notice must be submitted through the FDA PNSI.

(c) If FDA determines that FDA PNSI or the Operational and Administration System for Import Support (OASIS) is not working, FDA will post prominent notification and instructions at https://www.access.fda.gov—see log-in page. FDA will accept prior notice submissions in the format it deems appropriate during the system(s) outage.