{"abstract":"The Food and Drug Administration (FDA) is issuing a final rule to require human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products. FDA is also amending the registration and listing regulations that currently apply to human cells, tissues, and cellular and tissue-based products regulated as drugs, devices, and/or biological products. These actions are being taken to establish a unified registration and listing program for human cells, tissues, and cellular and tissue-based products.","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/2001/01/19/01-1126.html","cfr_references":[{"chapter":null,"citation_url":null,"part":207,"title":21},{"chapter":null,"citation_url":null,"part":807,"title":21},{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"66 FR 5447","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The regulation is effective April 4, 2001, except for 21 CFR 207.20(f), 807.20(d), and 1271.3(d)(2), which are effective on January 21, 2003.","disposition_notes":null,"docket_ids":["Docket No. 97N-484R"],"dockets":[],"document_number":"01-1126","effective_on":"2001-04-04","end_page":5469,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2001/01/19/01-1126.xml","html_url":"https://www.federalregister.gov/documents/2001/01/19/01-1126/human-cells-tissues-and-cellular-and-tissue-based-products-establishment-registration-and-listing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/01-1126?publication_date=2001-01-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2001-01-19/01-1126/mods.xml","not_received_for_publication":null,"page_length":23,"page_views":{"count":8289,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2001-01-19/pdf/01-1126.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2001-01-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2001/01/19/01-1126.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-02-27T17:05:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5447,"subtype":null,"title":"Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing","toc_doc":"Human cells, tissues, and cellular and tissue-based products; establishment registration and listing","toc_subject":"Biological products:","topics":["Confidential business information","Drugs","Human cells and tissue-based products","Imports","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":66}