{"abstract":"The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment sufficient to terminate the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule. FDA is issuing this rule 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, blood components, and Source Plasma.","action":"Direct 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/1999/08/19/99-21292.html","cfr_references":[{"chapter":null,"citation_url":null,"part":606,"title":21},{"chapter":null,"citation_url":null,"part":640,"title":21}],"citation":"64 FR 45366","comment_url":null,"comments_close_on":"1999-12-03","correction_of":null,"corrections":[],"dates":"This rule is effective February 11, 2000. Submit written comments on or before December 3, 1999. If no timely significant comments are received, the agency will publish a document in the Federal Register within 30 days after the comment period on this direct final rule ends, confirming the effective date of the final rule. If timely significant adverse comments are received, the agency will publish a document in the Federal Register withdrawing the direct final rule before its effective date.","disposition_notes":null,"docket_ids":["Docket No. 98N-0673"],"dockets":[{"supporting_documents":[{"title":"Appendix C - Guide to the preparation, use and quality assurance of blood components re: Comment from ThermoGenesis Corp.","document_id":"FDA-1998-N-0567-0015"},{"title":"Appendix B - Stitching Rode Kruis Bloedbank's-Gravenhage e.o. Factor VIII Study re: Comment from ThermoGenesis Corp.","document_id":"FDA-1998-N-0567-0014"},{"title":"Appendix A - Freezing of Plasma to Obtain Better Yield of Factor VIII :C re: Comment from ThermoGenesis Corp.","document_id":"FDA-1998-N-0567-0013"},{"title":"Background Material re Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma","document_id":"FDA-1998-N-0567-0001"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"1999-08-19","updated_at":"2024-08-21T11:56:47.389-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1998-N-0567-0003","allow_late_comments":null,"id":"FDA-1998-N-0567-0003","comment_end_date":"1999-12-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-1998-N-0567","title":"Revisions to Requirements to Blood,Blood Components & Plasma - CLOSED"}],"document_number":"99-21292","effective_on":"2000-02-11","end_page":45374,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/08/19/99-21292/revisions-to-the-requirements-applicable-to-blood-blood-components-and-source-plasma","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-21292?publication_date=1999-08-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-08-19/99-21292/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":177,"last_updated":"2026-09-20 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-08-19/pdf/99-21292.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/1999/08/19/99-21292.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Appendix C - Guide to the preparation, use and quality assurance of blood components re: Comment from ThermoGenesis Corp.","document_id":"FDA-1998-N-0567-0015"},{"title":"Appendix B - Stitching Rode Kruis Bloedbank's-Gravenhage e.o. Factor VIII Study re: Comment from ThermoGenesis Corp.","document_id":"FDA-1998-N-0567-0014"},{"title":"Appendix A - Freezing of Plasma to Obtain Better Yield of Factor VIII :C re: Comment from ThermoGenesis Corp.","document_id":"FDA-1998-N-0567-0013"},{"title":"Background Material re Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma","document_id":"FDA-1998-N-0567-0001"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1998-N-0567","supporting_documents_count":4,"docket_id":"FDA-1998-N-0567","document_id":"FDA-1998-N-0567-0003","regulation_id_number":null,"title":"Revisions to Requirements to Blood,Blood Components & Plasma - CLOSED","checked_regulationsdotgov_at":"2024-08-22T14:55:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45366,"subtype":null,"title":"Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":64}