{"abstract":"The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.","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/2016/05/04/2016-10385.html","cfr_references":[{"chapter":null,"citation_url":null,"part":610,"title":21}],"citation":"81 FR 26687","comment_url":null,"comments_close_on":"2016-07-18","correction_of":null,"corrections":[],"dates":"This rule is effective September 16, 2016. Submit either electronic or written comments on this direct final rule or its companion proposed rule by July 18, 2016. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1170"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-05-04","updated_at":"2023-02-28T16:14:17.141-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-1170-0001","allow_late_comments":null,"id":"FDA-2016-N-1170-0001","comment_end_date":"2016-07-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-N-1170","title":"Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products"}],"document_number":"2016-10385","effective_on":"2016-09-16","end_page":26692,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/05/04/2016-10385.xml","html_url":"https://www.federalregister.gov/documents/2016/05/04/2016-10385/standard-preparations-limits-of-potency-and-dating-period-limitations-for-biological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-10385?publication_date=2016-05-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-05-04/2016-10385/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":1028,"last_updated":"2026-10-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-05-04/pdf/2016-10385.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-10385.pdf?1462279594","publication_date":"2016-05-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/05/04/2016-10385.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-2016-N-1170","supporting_documents_count":0,"docket_id":"FDA-2016-N-1170","document_id":"FDA-2016-N-1170-0001","regulation_id_number":null,"title":"Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products","checked_regulationsdotgov_at":"2023-02-28T21:14:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26687,"subtype":null,"title":"Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products","toc_doc":"Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products","toc_subject":null,"topics":["Biologics","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}