Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability

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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry." The guidance document updates the current version of the guidance by including three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter or transmitter of prior notice of an FDA refusal for inadequate prior notice or hold, if the food article is from a foreign facility that is not registered and addresses the timeframe for making requests for FDA review of such refusal or hold. FDA is also making other technical editorial changes. The guidance announced in this notice finalizes the draft guidance of the same title dated September 13, 2022.