{"abstract":"The Food and Drug Administration (FDA) is proposing to revise the general biological product standards by updating the hepatitis B virus (HBV) and human immunodeficiency virus (HIV) testing requirements, by adding testing requirements for hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), and by adding requirements for licensed supplemental (i.e., additional, more specific) testing when a donation is found to be repeatedly reactive for any of the required screening tests for evidence of infection due to communicable disease agents. The agency is also proposing to require manufacturers of test kits approved for use in testing donations of human blood and blood components for evidence of infection due to communicable disease agents to use reference panels, when available, to verify the acceptable sensitivity and specificity of each lot. FDA is taking this action as part of the agency's ``Blood Initiative'' in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood and blood products, including plasma derivatives. This proposed rule is intended to help protect the safety and ensure the quality of the nation's blood supply and to promote consistency in the industry. DATES: Submit written comments on the proposed rule by November 17, 1999. Submit written comments on the information collection provisions by September 20, 1999. The agency is proposing that any final rule that may issue based upon this proposed rule become effective 180 days after its date of publication in the Federal Register.","action":"Proposed rule.","agencies":[{"raw_name":"Requirements for Testing Human Blood Donors for Evidence of Infection"},{"raw_name":"Due to Communicable Disease Agents and Requirements for Blood, Blood"},{"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/1999/08/19/99-21296.html","cfr_references":[{"chapter":null,"citation_url":null,"part":600,"title":21},{"chapter":null,"citation_url":null,"part":607,"title":21},{"chapter":null,"citation_url":null,"part":610,"title":21},{"chapter":null,"citation_url":null,"part":640,"title":21},{"chapter":null,"citation_url":null,"part":660,"title":21}],"citation":"64 FR 45340","comment_url":null,"comments_close_on":"1999-11-17","correction_of":null,"corrections":[],"dates":"Submit written comments on the proposed rule by November 17, 1999. Submit written comments on the information collection provisions by September 20, 1999. The agency is proposing that any final rule that may issue based upon this proposed rule become effective 180 days after its date of publication in the Federal Register.","disposition_notes":null,"docket_ids":["Docket No. 98N-0581"],"dockets":[],"document_number":"99-21296","effective_on":null,"end_page":45355,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/08/19/99-21296/requirements-for-testing-human-blood-donors-for-evidence-of-infection-due-to-communicable-disease","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-21296?publication_date=1999-08-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-08-19/99-21296/mods.xml","not_received_for_publication":null,"page_length":16,"page_views":{"count":81,"last_updated":"2026-10-24 00:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-08-19/pdf/99-21296.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-08-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/08/19/99-21296.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T08:33:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45340,"subtype":null,"title":"Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents","toc_doc":null,"toc_subject":null,"topics":[],"type":"Proposed Rule","volume":64}