{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum.'' This draft guidance is intended to provide recommendations to pharmaceutical manufacturers using the Center for Drug Evaluation and Research's guidance for industry, ``SUPAC-SS Nonsterile Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation'' (SUPAC-SS).","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/1999/01/05/99-29.html","cfr_references":[],"citation":"64 FR 518","comment_url":null,"comments_close_on":"1999-03-08","correction_of":null,"corrections":[],"dates":"Written comments on the draft guidance document may be submitted by March 8, 1999. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 95D-0349"],"dockets":[],"document_number":"99-29","effective_on":null,"end_page":518,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/01/05/99-29/draft-guidance-for-industry-on-supac-ss-nonsterile-semisolid-dosage-forms-manufacturing-equipment","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-29?publication_date=1999-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-01-05/99-29/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":248,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-01-05/pdf/99-29.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/01/05/99-29.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-20T22:29:44Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":518,"subtype":null,"title":"Draft Guidance for Industry on SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":64}