{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum.'' This draft guidance is intended to provide insight and recommendations to pharmaceutical sponsors of new drug applications (NDA's) and abbreviated new drug applications (ANDA's) who wish to change equipment during the postapproval period.","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/1998/04/28/98-11197.html","cfr_references":[],"citation":"63 FR 23291","comment_url":null,"comments_close_on":"1998-06-29","correction_of":null,"corrections":[],"dates":"Written comments may be submitted on the draft guidance document by June 29, 1998. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 95D-0349"],"dockets":[],"document_number":"98-11197","effective_on":null,"end_page":23292,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/04/28/98-11197/draft-guidance-for-industry-on-supac-irmr-immediate-release-and-modified-release-solid-oral-dosage","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-11197?publication_date=1998-04-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-04-28/98-11197/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":52,"last_updated":"2026-04-03 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-04-28/pdf/98-11197.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-04-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/04/28/98-11197.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T03:58:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23291,"subtype":null,"title":"Draft Guidance for Industry on SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":63}