{"abstract":"The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT[sol]P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The agency is amending the current good manufacturing practice (CGMP) and quality system (QS) regulations that apply to HCT[sol]Ps regulated as drugs, medical devices, and/or biological products to clarify the role of the new donor-eligibility regulations in relation to existing CGMP regulations. By preventing the transmission of communicable disease by the wide spectrum of HCT[sol]Ps that are marketed now or may be marketed in the future, the agency's action will improve protection of the public health and increase public confidence in new technologies.","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/2004/05/25/04-11245.html","cfr_references":[{"chapter":null,"citation_url":null,"part":210,"title":21},{"chapter":null,"citation_url":null,"part":211,"title":21},{"chapter":null,"citation_url":null,"part":820,"title":21},{"chapter":null,"citation_url":null,"part":1271,"title":21}],"citation":"69 FR 29786","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 25, 2005. This rule is applicable to cells and tissues recovered on or after May 25, 2005.","disposition_notes":null,"docket_ids":["Docket No. 1997N-0484S"],"dockets":[],"document_number":"04-11245","effective_on":"2005-05-25","end_page":29834,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/05/25/04-11245.xml","html_url":"https://www.federalregister.gov/documents/2004/05/25/04-11245/eligibility-determination-for-donors-of-human-cells-tissues-and-cellular-and-tissue-based-products","images":{"ER25MY04.000":{"large":"https://img.federalregister.gov/ER25MY04.000/ER25MY04.000_large.png","medium":"https://img.federalregister.gov/ER25MY04.000/ER25MY04.000_medium.png","original_size":"https://img.federalregister.gov/ER25MY04.000/ER25MY04.000_original_size.png"}},"images_metadata":{"ER25MY04.000":{"large":{"identifier":"ER25MY04.000","content_type":"image/png","size":4650,"width":209,"sha":"854e26f883e88a6c577066fa51f4f76d","url":"https://img.federalregister.gov/ER25MY04.000/ER25MY04.000_large.png","height":235},"medium":{"identifier":"ER25MY04.000","content_type":"image/png","size":1882,"width":98,"sha":"e69410718b1ab4bedb78c592b94b55a7","url":"https://img.federalregister.gov/ER25MY04.000/ER25MY04.000_medium.png","height":110},"original_size":{"identifier":"ER25MY04.000","content_type":"image/png","size":7503,"width":740,"sha":"f23ef27f82db7badcdf014b841c15cb7","url":"https://img.federalregister.gov/ER25MY04.000/ER25MY04.000_original_size.png","height":832}}},"json_url":"https://www.federalregister.gov/api/v1/documents/04-11245?publication_date=2004-05-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-05-25/04-11245/mods.xml","not_received_for_publication":null,"page_length":49,"page_views":{"count":3645,"last_updated":"2026-09-21 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-05-25/pdf/04-11245.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-05-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/05/25/04-11245.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T12:22:01Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":29786,"subtype":null,"title":"Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products","toc_doc":"Human cells, tissues, and cellular and tissue-based products; donors eligibility determination","toc_subject":"Human drugs, medical devices, and biological products:","topics":["Communicable diseases","Drugs","HIV/AIDS","Labeling","Laboratories","Medical devices","Packaging and containers","Prescription drugs","Reporting and recordkeeping requirements","Warehouses"],"type":"Rule","volume":69}