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The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its prior notice regulation to add a requirement that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued ("post-refusal" and "post-hold" submission) or responses to requests for FDA review have been issued and beginning October 1, 2026, add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number. The rule will also finalize certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.
Published
Sep 25, 2025
Effective
Oct 27, 2025
Citation
90 FR 46045
Agencies
2
Full text not available in our database.
View on Federal Register →Get a plain-English explanation of what this regulation does, which agencies are responsible, and how it affects existing rules.
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Docket No. FDA-2011-N-0179
0910-AI75
21 CFR 1