{"abstract":"The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The proposed rule would require all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.","action":"Proposed rule; request for comments.","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/2013/11/04/2013-25956.html","cfr_references":[{"chapter":null,"citation_url":null,"part":20,"title":21},{"chapter":null,"citation_url":null,"part":310,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":600,"title":21}],"citation":"78 FR 65904","comment_url":null,"comments_close_on":"2014-01-03","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the provisions of this proposed rule by January 3, 2014. Submit comments on the information collection requirements under the Paperwork Reduction Act of 1995 (the PRA) by December 4, 2013 (see the \"Paperwork Reduction Act of 1995\" section).","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0898"],"dockets":[],"document_number":"2013-25956","effective_on":null,"end_page":65923,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/11/04/2013-25956.xml","html_url":"https://www.federalregister.gov/documents/2013/11/04/2013-25956/permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-25956?publication_date=2013-11-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-11-04/2013-25956/mods.xml","not_received_for_publication":null,"page_length":20,"page_views":{"count":12152,"last_updated":"2026-09-22 18:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-11-04/pdf/2013-25956.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-25956.pdf?1383232049","publication_date":"2013-11-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/11/04/2013-25956.txt","regulation_id_number_info":{"0910-AG88":{"issue":"201504","html_url":"https://www.federalregister.gov/regulations/0910-AG88/revision-of-postmarketing-reporting-requirements-discontinuance-or-interruption-in-supply-of-certain","title":"Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201504&RIN=0910-AG88&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AG88"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2013-12-30T05:00:23Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":65904,"subtype":null,"title":"Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products","toc_doc":"Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products","toc_subject":null,"topics":["Administrative practice and procedure","Biologics","Confidential business information","Courts","Drugs","Freedom of information","Government employees","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":78}