{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) draft guidance for industry entitled \"SUPAC: Manufacturing Equipment Addendum.\" This revised draft document combines and supersedes \"SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,\" published on January 1, 1999; and \"SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,\" published as a draft on December 1, 1998. FDA has now revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.","action":"Notice.","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/2013/04/01/2013-07432.html","cfr_references":[],"citation":"78 FR 19495","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance and on any other part of the SUPAC guidance series, submit either electronic or written comments on the draft guidance by July 1, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0295"],"dockets":[],"document_number":"2013-07432","effective_on":null,"end_page":19495,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/04/01/2013-07432.xml","html_url":"https://www.federalregister.gov/documents/2013/04/01/2013-07432/draft-guidance-for-industry-on-scale-up-and-post-approval-changes-manufacturing-equipment-addendum","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-07432?publication_date=2013-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-04-01/2013-07432/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1786,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-04-01/pdf/2013-07432.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-07432.pdf?1364561365","publication_date":"2013-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/04/01/2013-07432.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0295","supporting_documents_count":0,"docket_id":"FDA-2013-D-0295","regulation_id_number":null,"title":"Draft Guidance for Industry on SUPAC: Manufacturing Equipment Addendum; Availability of Form FDA 3331-Automated Pilot Program","checked_regulationsdotgov_at":"2013-05-26T05:00:46Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19495,"subtype":null,"title":"Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum; Availability","toc_doc":"Scale-Up and Post-Approval Changes, Manufacturing Equipment Addendum","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}