{"abstract":"The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.","action":"Proposed 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/2007/11/08/E7-21565.html","cfr_references":[{"chapter":null,"citation_url":null,"part":606,"title":21},{"chapter":null,"citation_url":null,"part":610,"title":21},{"chapter":null,"citation_url":null,"part":630,"title":21},{"chapter":null,"citation_url":null,"part":640,"title":21},{"chapter":null,"citation_url":null,"part":660,"title":21},{"chapter":null,"citation_url":null,"part":820,"title":21},{"chapter":null,"citation_url":null,"part":1270,"title":21}],"citation":"72 FR 63416","comment_url":null,"comments_close_on":"2008-02-06","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the proposed rule by February 6, 2008. Submit comments regarding information collection by December 10, 2007 to OMB (see ADDRESSES). See section IV of this document for the proposed effective date of a final rule based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. 2006N-0221"],"dockets":[],"document_number":"E7-21565","effective_on":null,"end_page":63444,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/11/08/E7-21565.xml","html_url":"https://www.federalregister.gov/documents/2007/11/08/E7-21565/requirements-for-human-blood-and-blood-components-intended-for-transfusion-or-for-further","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E7-21565?publication_date=2007-11-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-11-08/E7-21565/mods.xml","not_received_for_publication":null,"page_length":29,"page_views":{"count":1845,"last_updated":"2026-10-24 00:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-11-08/pdf/E7-21565.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-11-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/11/08/E7-21565.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-13T08:23:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63416,"subtype":null,"title":"Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use","toc_doc":"Human blood and blood components intended for transfusion or further manufacturing use; requirements","toc_subject":"Biological products:","topics":["Biologics","Blood","Communicable diseases","HIV/AIDS","Labeling","Laboratories","Medical devices","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":72}