{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.\" The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices during or in advance of a public health emergency. FDA is issuing this guidance to implement amendments to the FD&C Act by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages during or in advance of a public health emergency. This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2022/01/11/2022-00321.html","cfr_references":[],"citation":"87 FR 1417","comment_url":null,"comments_close_on":"2022-03-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 14, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2022-D-0053"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-01-11","updated_at":"2023-02-28T12:32:34.904-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0053-0001","allow_late_comments":null,"id":"FDA-2022-D-0053-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-0053","title":"Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2022-00321","effective_on":null,"end_page":1419,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/01/11/2022-00321.xml","html_url":"https://www.federalregister.gov/documents/2022/01/11/2022-00321/notifying-the-food-and-drug-administration-of-a-permanent-discontinuance-or-interruption-in","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-00321?publication_date=2022-01-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-01-11/2022-00321/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1229,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-01-11/pdf/2022-00321.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-00321.pdf?1641822340","publication_date":"2022-01-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/01/11/2022-00321.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2022-D-0053","supporting_documents_count":0,"docket_id":"FDA-2022-D-0053","document_id":"FDA-2022-D-0053-0001","regulation_id_number":null,"title":"Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-11-18T14:55:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1417,"subtype":null,"title":"Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Permanent Discontinuance or Interruption in Manufacturing of a Device under the Federal Food, Drug, and Cosmetic Act","toc_subject":"Guidance","topics":[],"type":"Notice","volume":87}