{"abstract":"The Food and Drug Administration (FDA or we) is announcing a stay of portions of the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled \"Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an IND.\" We are republishing the guidance with the portions that are being stayed clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to this stay.","action":"Notice of administrative stay of action.","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/2015/10/30/2015-27729.html","cfr_references":[],"citation":"80 FR 66907","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This stay is effective October 30, 2015 Submit either electronic or written comments on FDA guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0503"],"dockets":[],"document_number":"2015-27729","effective_on":"2015-10-30","end_page":66909,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/10/30/2015-27729.xml","html_url":"https://www.federalregister.gov/documents/2015/10/30/2015-27729/investigational-new-drug-applications-determining-whether-human-research-studies-can-be-conducted","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-27729?publication_date=2015-10-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-10-30/2015-27729/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":4861,"last_updated":"2026-08-23 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-10-30/pdf/2015-27729.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-27729.pdf?1446122819","publication_date":"2015-10-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/10/30/2015-27729.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-2010-D-0503","supporting_documents_count":0,"docket_id":"FDA-2010-D-0503","regulation_id_number":null,"title":"Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND","checked_regulationsdotgov_at":"2015-11-19T06:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66907,"subtype":null,"title":"Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance","toc_doc":"Investigational New Drug ApplicationsDetermining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}