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FDA Proposal of amendment prior notice regulations


Nov 07, 2023

The Food and Drug Administration (FDA) is proposing to amend its prior notice regulations by adding the following requirements after certain notices of refusal or hold have been issued (''post-refusal'' and ''post-hold'' submission):

- the prior notice for articles of food arriving by international mail shall include the name of the mail service and a mail tracking number

- the prior notice and food facility registration information is to be submitted within a certain timeframe

The proposal includes also 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, if finalized, will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.

Either electronic or written comments on the proposed rule must be submitted by January 30, 2024

For further information (in English), click on the Link

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