{"abstract":"The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments that appeared in the Federal Register of March 3, 2026. In the notice, FDA requested comments on the Agency's series of guidances for industry on scale-up and postapproval changes for specific dosage forms. The Agency is taking this action to allow interested persons additional time to submit comments.","action":"Notice; request for information and comments; reopening of the comment period.","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/2026/06/11/2026-11690.html","cfr_references":[],"citation":"91 FR 35483","comment_url":null,"comments_close_on":"2026-07-13","correction_of":null,"corrections":[],"dates":"FDA is reopening the comment period on the request for information and comments published on March 3, 2026 (91 FR 10397). Either electronic or written comments must be submitted by July 13, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-0809"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-06-11","updated_at":"2026-06-11T10:01:09.497-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-0809-0040","allow_late_comments":false,"id":"FDA-2026-N-0809-0040","comment_end_date":"2026-03-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-0809","title":"Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments."}],"document_number":"2026-11690","effective_on":null,"end_page":35484,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/11/2026-11690.xml","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11690/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-11690?publication_date=2026-06-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-11/2026-11690/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1918,"last_updated":"2026-06-13 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11690.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11690.pdf?1781095514","publication_date":"2026-06-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/11/2026-11690.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-N-0809","supporting_documents_count":0,"docket_id":"FDA-2026-N-0809","document_id":"FDA-2026-N-0809-0040","regulation_id_number":null,"title":"Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments.","checked_regulationsdotgov_at":"2026-06-12T16:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35483,"subtype":null,"title":"Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period","toc_doc":"Recommendations on Scale-Up and Postapproval Changes","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}