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Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions

hospital-facility · Food and Drug Administration · Rule · Published 2025-09-25 · Effective 2025-10-27 · 90 FR 46045

Document

Document number
2025-18655
Federal Register citation
90 FR 46045
CFR reference
21 CFR 1
Type
Rule
Action
Final rule.
Category
hospital-facility
Sub-agency
Food and Drug Administration
Publication date
2025-09-25
Effective date
2025-10-27
HHS docket
Docket No. FDA-2011-N-0179

Abstract

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.

Source

Authoritative
Federal Register document
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