{"abstract":"The Food and Drug Administration (FDA or we) is amending the biologics regulation to improve clarity and revise an incorrect citation. This action is being taken to ensure the accuracy and clarity of the biologics regulation.","action":"Final rule; technical amendment.","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/2021/09/07/2021-19220.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"610","title":21}],"citation":"86 FR 49922","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is September 7, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0011"],"dockets":[],"document_number":"2021-19220","effective_on":null,"end_page":49922,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/09/07/2021-19220.xml","html_url":"https://www.federalregister.gov/documents/2021/09/07/2021-19220/revision-to-restrictions-on-shipment-or-use-for-human-blood-and-blood-components-exceptions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-19220?publication_date=2021-09-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-09-07/2021-19220/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":421,"last_updated":"2026-08-23 18:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-09-07/pdf/2021-19220.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-19220.pdf?1630673135","publication_date":"2021-09-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/09/07/2021-19220.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2021-N-0011","supporting_documents_count":0,"docket_id":"FDA-2021-N-0011","document_id":"FDA-2021-N-0011-0001","regulation_id_number":null,"title":"Technical Amendment (Unrelated to existing docket number)","checked_regulationsdotgov_at":"2021-09-08T03:30:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49922,"subtype":null,"title":"Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment","toc_doc":"Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment","toc_subject":null,"topics":["Biologics","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":86}