{"abstract":"The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled \"Informed Consent Information Sheet.\" A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information.","action":"Notice; reopening of the comment period.","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/2014/09/26/2014-22951.html","cfr_references":[],"citation":"79 FR 57940","comment_url":null,"comments_close_on":"2014-10-27","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by October 27, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-D-0031"],"dockets":[],"document_number":"2014-22951","effective_on":null,"end_page":57940,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/09/26/2014-22951.xml","html_url":"https://www.federalregister.gov/documents/2014/09/26/2014-22951/draft-informed-consent-information-sheet-guidance-for-institutional-review-boards-clinical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-22951?publication_date=2014-09-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-09-26/2014-22951/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":485,"last_updated":"2026-09-22 04:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-09-26/pdf/2014-22951.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-22951.pdf?1411649067","publication_date":"2014-09-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/09/26/2014-22951.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Waiver of IRB Requirements for Drug and Biological Products Stuides","document_id":"FDA-2006-D-0031-0004"},{"title":"FDA Institutional Review Board Inspections","document_id":"FDA-2006-D-0031-0003"},{"title":"Information Sheet Guidance For IRBs,Clinical Investigators, and Sponsors","document_id":"FDA-2006-D-0031-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2006-D-0031","supporting_documents_count":3,"docket_id":"FDA-2006-D-0031","regulation_id_number":null,"title":"Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents","checked_regulationsdotgov_at":"2014-10-28T05:01:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57940,"subtype":null,"title":"Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period","toc_doc":"Institutional Review Boards, Clinical Investigators, and Sponsors","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":79}