§ 1.280. How must you submit prior notice?
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/us/cfr/t21/s§ 1.280A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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:
(1)The U.S. Customs and Border Protection
(CBP)Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS); or
(2)The FDA Prior Notice System Interface (FDA PNSI) at https://www.access.fda.gov/.
(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. [73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017; 85 FR 50782, Aug. 18, 2020; 90 FR 46055, Sept. 25, 2025]
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§ 1.280
How must you submit prior notice?
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