{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled \"Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer's Goods from DWPE.\" The draft guidance, when finalized, will provide recommendations for collecting a representative sample for products subject to DWPE under an import alert due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. When finalized, the draft guidance will also help foreign manufacturers and other processors of fish and fishery products subject to DWPE introduce evidence to FDA to support a request to have products removed from DWPE.","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/2024/02/12/2024-02838.html","cfr_references":[],"citation":"89 FR 9852","comment_url":null,"comments_close_on":"2024-04-12","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 12, 2024 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-5303"],"dockets":[{"supporting_documents":[{"title":"Reference 1 2019-754 Sampling Memo DWPE Seafood Guidance","document_id":"FDA-2023-D-5303-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-02-12","updated_at":"2024-02-12T09:57:48.004-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-5303-0001","allow_late_comments":null,"id":"FDA-2023-D-5303-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2023-D-5303","title":"Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE: Guidance for Industry; Draft Guidance for Industry; Availability"}],"document_number":"2024-02838","effective_on":null,"end_page":9854,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/02/12/2024-02838.xml","html_url":"https://www.federalregister.gov/documents/2024/02/12/2024-02838/recommendations-for-collecting-representative-samples-for-food-testing-used-as-evidence-for-release","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-02838?publication_date=2024-02-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-02-12/2024-02838/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":451,"last_updated":"2026-07-28 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-12/pdf/2024-02838.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-02838.pdf?1707486333","publication_date":"2024-02-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/02/12/2024-02838.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 2019-754 Sampling Memo DWPE Seafood Guidance","document_id":"FDA-2023-D-5303-0003"}],"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-2023-D-5303","supporting_documents_count":1,"docket_id":"FDA-2023-D-5303","document_id":"FDA-2023-D-5303-0001","regulation_id_number":null,"title":"Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE: Guidance for Industry; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-02-13T17:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9852,"subtype":null,"title":"Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Availability","toc_doc":"Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention without Physical Examination; etc.","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}