{"abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 24, 2026, to open 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.","action":"Notice; request for information; establishment of a public docket; extension 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/2026/07/21/2026-14672.html","cfr_references":[],"citation":"91 FR 45820","comment_url":null,"comments_close_on":"2026-08-24","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the notice published on June 24, 2026 (91 FR 37996). Either electronic or written comments, data, or information must be received by August 24, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-4699"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-07-21","updated_at":"2026-07-21T09:58:07.729-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-4699-0012","allow_late_comments":false,"id":"FDA-2026-N-4699-0012","comment_end_date":null,"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":"2026-14672","effective_on":null,"end_page":45821,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/07/21/2026-14672.xml","html_url":"https://www.federalregister.gov/documents/2026/07/21/2026-14672/expedited-investigational-new-drug-pilot-program-request-for-information-extension-of-the-comment","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-14672?publication_date=2026-07-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-07-21/2026-14672/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":4337,"last_updated":"2026-09-20 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-21/pdf/2026-14672.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14672.pdf?1784551514","publication_date":"2026-07-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/07/21/2026-14672.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-2026-N-4699","supporting_documents_count":0,"docket_id":"FDA-2026-N-4699","document_id":"FDA-2026-N-4699-0012","regulation_id_number":null,"title":"Expedited IND Pilot Program; Request for Information","checked_regulationsdotgov_at":"2026-07-22T16:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45820,"subtype":null,"title":"Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period","toc_doc":"Expedited Investigational New Drug Pilot Program; Extension of the Comment Period","toc_subject":"Request for Information","topics":[],"type":"Notice","volume":91}