{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Container Closure Systems for Human Drugs and Biological Products.\" This document provides guiding principles for evaluating the quality of container closure systems (CCSs) used to package drugs and biological products, for human use. This includes CCSs that are also device constituent parts of combination products and CCSs used to package the drug or biological product constituent parts of combination products.","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/2026/08/14/2026-16638.html","cfr_references":[],"citation":"91 FR 52700","comment_url":null,"comments_close_on":"2026-10-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by October 13, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2026-D-7957"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-14","updated_at":"2026-08-14T10:57:55.263-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-D-7957-0001","allow_late_comments":false,"id":"FDA-2026-D-7957-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-D-7957","title":"Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability"}],"document_number":"2026-16638","effective_on":null,"end_page":52702,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/14/2026-16638.xml","html_url":"https://www.federalregister.gov/documents/2026/08/14/2026-16638/container-closure-systems-for-human-drugs-and-biological-products-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16638?publication_date=2026-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-14/2026-16638/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":15306,"last_updated":"2026-09-22 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-14/pdf/2026-16638.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16638.pdf?1786625118","publication_date":"2026-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/14/2026-16638.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-2026-D-7957","supporting_documents_count":0,"docket_id":"FDA-2026-D-7957","document_id":"FDA-2026-D-7957-0001","regulation_id_number":null,"title":"Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-08-15T18:55:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52700,"subtype":null,"title":"Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability","toc_doc":"Container Closure Systems for Human Drugs and Biological Products","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}