{"abstract":"The Food and Drug Administration (FDA or the Agency) is opening a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants. FDA is requesting information on the potential pilot program which would establish a network of qualified research institutions, such as academic medical centers (AMCs), healthcare networks (HNs), contract research organizations (CROs), regulatory advisors, and/or other research or third-party review organizations (collectively called Qualified Research Institutions, or \"QRIs\"), who would partner with sponsors to develop and review protocols for FIH clinical trials intended for a IND submission to FDA. Information provided through this public docket will help the Agency refine our approach and consider other opportunities to accelerate time to FIH clinical trials.","action":"Notice; request for information; establishment of a public docket.","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/2026/06/24/2026-12621.html","cfr_references":[],"citation":"91 FR 37996","comment_url":null,"comments_close_on":"2026-07-22","correction_of":null,"corrections":[],"dates":"Either electronic or written comments, data, or information must be received by July 22, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-4699"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":217,"comment_start_date":"2026-06-24","updated_at":"2026-08-26T01:56:43.886-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-4699-0001","allow_late_comments":false,"id":"FDA-2026-N-4699-0001","comment_end_date":"2026-08-25","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-4699","title":"Expedited IND Pilot Program; Request for Information"}],"document_number":"2026-12621","effective_on":null,"end_page":38000,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/24/2026-12621.xml","html_url":"https://www.federalregister.gov/documents/2026/06/24/2026-12621/expedited-investigational-new-drug-pilot-program-request-for-information","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-12621?publication_date=2026-06-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-24/2026-12621/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":9721,"last_updated":"2026-10-18 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12621.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12621.pdf?1782141309","publication_date":"2026-06-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/24/2026-12621.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":217,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-4699","supporting_documents_count":0,"docket_id":"FDA-2026-N-4699","document_id":"FDA-2026-N-4699-0001","regulation_id_number":null,"title":"Expedited IND Pilot Program; Request for Information","checked_regulationsdotgov_at":"2026-08-27T08:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37996,"subtype":null,"title":"Expedited Investigational New Drug Pilot Program; Request for Information","toc_doc":"Expedited Investigational New Drug Pilot Program","toc_subject":"Request for Information","topics":[],"type":"Notice","volume":91}