Prior Notice of Imported Food Questions and Answers (Edition 4); Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4)." The draft guidance adds three additional questions.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 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 address the timeframe for making requests for FDA review of such a refusal or hold. FDA is also making other technical and editorial changes.