{"abstract":"The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.","action":"Final rule.","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/2004/11/24/04-25798.html","cfr_references":[{"chapter":null,"citation_url":null,"part":16,"title":21},{"chapter":null,"citation_url":null,"part":1270,"title":21},{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"69 FR 68612","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 25, 2005.","disposition_notes":null,"docket_ids":["Docket No. 1997N-484P"],"dockets":[],"document_number":"04-25798","effective_on":"2005-05-25","end_page":68688,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/11/24/04-25798.xml","html_url":"https://www.federalregister.gov/documents/2004/11/24/04-25798/current-good-tissue-practice-for-human-cell-tissue-and-cellular-and-tissue-based-product","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-25798?publication_date=2004-11-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-11-24/04-25798/mods.xml","not_received_for_publication":null,"page_length":77,"page_views":{"count":4505,"last_updated":"2026-07-26 12:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-11-24/pdf/04-25798.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-11-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/11/24/04-25798.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T14:09:45Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":68612,"subtype":null,"title":"Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement","toc_doc":"Human cellular and tissue-based products manufacturers; current good tissue practice; inspection and enforcement","toc_subject":"Biological products:","topics":[],"type":"Rule","volume":69}