{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled \"Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4).\" The draft guidance adds three additional questions.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.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2022/09/13/2022-19724.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1","title":21}],"citation":"87 FR 55932","comment_url":null,"comments_close_on":"2022-11-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 14, 2022 to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0179"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-09-14","updated_at":"2023-02-27T20:20:08.174-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2011-N-0179-0030","allow_late_comments":null,"id":"FDA-2011-N-0179-0030","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2011-N-0179","title":"Information Required in Prior Notice of Imported Food"}],"document_number":"2022-19724","effective_on":null,"end_page":55934,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/09/13/2022-19724.xml","html_url":"https://www.federalregister.gov/documents/2022/09/13/2022-19724/prior-notice-of-imported-food-questions-and-answers-edition-4-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-19724?publication_date=2022-09-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-09-13/2022-19724/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1021,"last_updated":"2026-07-27 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-13/pdf/2022-19724.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-19724.pdf?1662986736","publication_date":"2022-09-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/09/13/2022-19724.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AI75/prior-notice-adding-requirement-to-submit-mail-tracking-number-for-articles-of-food-arriving-by-inte","title":"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"},"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0179","supporting_documents_count":0,"docket_id":"FDA-2011-N-0179","document_id":"FDA-2011-N-0179-0030","regulation_id_number":"0910-AI75","title":"Information Required in Prior Notice of Imported Food","checked_regulationsdotgov_at":"2023-02-28T01:20:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55932,"subtype":null,"title":"Prior Notice of Imported Food Questions and Answers (Edition 4); Draft Guidance for Industry; Availability","toc_doc":"Prior Notice of Imported Food Questions and Answers (Edition 4)","toc_subject":"Guidance:\n","topics":[],"type":"Proposed Rule","volume":87}