{"abstract":"The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled \"Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.\" This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled \"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.\" The newly available draft chapter is entitled \"Chapter 15--Supply-Chain Program for Human Food Products.\"","action":"Notification 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/2018/01/25/2018-01299.html","cfr_references":[{"chapter":null,"citation_url":null,"part":117,"title":21}],"citation":"83 FR 3449","comment_url":null,"comments_close_on":"2018-05-25","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-2343"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":12,"comment_start_date":"2018-01-25","updated_at":"2023-02-28T15:08:37.399-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-D-2343-0042","allow_late_comments":null,"id":"FDA-2016-D-2343-0042","comment_end_date":"2018-05-26","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-D-2343","title":"Hazard Analysis and Risk-Based Preventive Controls for Human Food"}],"document_number":"2018-01299","effective_on":null,"end_page":3450,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/01/25/2018-01299.xml","html_url":"https://www.federalregister.gov/documents/2018/01/25/2018-01299/hazard-analysis-and-risk-based-preventive-controls-for-human-food-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-01299?publication_date=2018-01-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-01-25/2018-01299/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":4276,"last_updated":"2026-07-28 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-01-25/pdf/2018-01299.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-01299.pdf?1516801523","publication_date":"2018-01-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/01/25/2018-01299.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":12,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-2343","supporting_documents_count":0,"docket_id":"FDA-2016-D-2343","document_id":"FDA-2016-D-2343-0042","regulation_id_number":null,"title":"Hazard Analysis and Risk-Based Preventive Controls for Human Food","checked_regulationsdotgov_at":"2024-06-01T13:00:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3449,"subtype":null,"title":"Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability","toc_doc":"Hazard Analysis and Risk-Based Preventive Controls for Human Food","toc_subject":"Guidance:","topics":[],"type":"Proposed Rule","volume":83}