{"abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.","action":"Notice.","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/2006/05/19/E6-7617.html","cfr_references":[],"citation":"71 FR 29158","comment_url":null,"comments_close_on":"2006-07-18","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the collection of information by July 18, 2006.","disposition_notes":null,"docket_ids":["Docket No. 2006N-0185"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2006-05-19","updated_at":"2025-06-17T12:57:24.425-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2006-N-0365-0001","allow_late_comments":false,"id":"FDA-2006-N-0365-0001","comment_end_date":"2006-07-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2006-N-0365","title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable"}],"document_number":"E6-7617","effective_on":null,"end_page":29159,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2006/05/19/E6-7617.xml","html_url":"https://www.federalregister.gov/documents/2006/05/19/E6-7617/agency-information-collection-activities-proposed-collection-comment-request-guidance-on-informed","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E6-7617?publication_date=2006-05-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2006-05-19/E6-7617/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":4,"last_updated":"2026-04-10 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-05-19/pdf/E6-7617.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2006-05-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2006/05/19/E6-7617.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-2006-N-0365","supporting_documents_count":0,"docket_id":"FDA-2006-N-0365","document_id":"FDA-2006-N-0365-0001","regulation_id_number":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable","checked_regulationsdotgov_at":"2025-06-18T19:55:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":29158,"subtype":null,"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable","toc_doc":"Agency information collection activities; proposals, submissions, and approvals","toc_subject":null,"topics":[],"type":"Notice","volume":71}