{"abstract":"The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also 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. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.","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/2015/05/22/2015-12228.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}],"citation":"80 FR 29842","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 23, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-N-0040 (formerly Docket No. 2006N-0221)"],"dockets":[{"supporting_documents":[{"title":"Reference 77-14 Relationship between Bacterial Load, Species Virulence, and Transfusion Reaction with Transfusion re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use","document_id":"FDA-2006-N-0040-0101"},{"title":"Reference 77-13 Public Conference  Secondary Bacterial Screening of Platelet Components re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use","document_id":"FDA-2006-N-0040-0100"},{"title":"Reference 77-12 U.S. Centers for Disease Control and Prevention, Hepatitis C Fact Sheet re Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use","document_id":"FDA-2006-N-0040-0099"},{"title":"Reference 77-11 Regulatory Impact Analysis Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C virus infections re Requirements for Blood and Blood 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Components Intended for Transfusion or for Further Manufacturing Use"}],"document_number":"2015-12228","effective_on":"2016-05-23","end_page":29906,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/05/22/2015-12228.xml","html_url":"https://www.federalregister.gov/documents/2015/05/22/2015-12228/requirements-for-blood-and-blood-components-intended-for-transfusion-or-for-further-manufacturing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-12228?publication_date=2015-05-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-05-22/2015-12228/mods.xml","not_received_for_publication":null,"page_length":65,"page_views":{"count":24533,"last_updated":"2026-07-26 08:15:03 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