--- kind: "section" citation: "21 C.F.R. § 1.280" title: "21" number: "1.280" heading: "How must you submit prior notice?" url: "https://uscodex.org/cfr/21/1.280" --- # §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)](#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. ## Notes ### Amendments [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] ### Source Source: 73 FR 66402, Nov. 7, 2008, unless otherwise noted. ### Authority Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271. ### Source Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted. ### Amendments [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]