{"abstract":"The Food and Drug Administration (FDA) is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.","action":"Direct final rule; confirmation of effective date.","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/2016/07/21/2016-17186.html","cfr_references":[{"chapter":null,"citation_url":null,"part":56,"title":21}],"citation":"81 FR 47288","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date of final rule published in the Federal Register of April 4, 2016 (81 FR 19033), confirmed: August 17, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-5052"],"dockets":[],"document_number":"2016-17186","effective_on":"2016-04-04","end_page":47288,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/21/2016-17186.xml","html_url":"https://www.federalregister.gov/documents/2016/07/21/2016-17186/administrative-actions-for-noncompliance-lesser-administrative-actions-confirmation-of-effective","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-17186?publication_date=2016-07-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-21/2016-17186/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":302,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-21/pdf/2016-17186.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-17186.pdf?1469018766","publication_date":"2016-07-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/21/2016-17186.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-5052","supporting_documents_count":0,"docket_id":"FDA-2015-N-5052","regulation_id_number":null,"title":"Subpart E-Administrative Actions for Noncompliance; Lesser Administrative Actions.","checked_regulationsdotgov_at":"2016-08-10T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":47288,"subtype":null,"title":"Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date","toc_doc":"Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date","toc_subject":null,"topics":[],"type":"Rule","volume":81}