{"abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled \"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information\" that appeared in the Federal Register of April 29, 2026. In the notice, FDA requested comments to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.","action":"Request for information; extension of 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/2026/05/28/2026-10602.html","cfr_references":[],"citation":"91 FR 31725","comment_url":null,"comments_close_on":"2026-06-29","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the request for information published April 29, 2026 (91 FR 23100). Either electronic or written comments must be submitted by June 29, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-4390"],"dockets":[],"document_number":"2026-10602","effective_on":null,"end_page":31726,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/28/2026-10602.xml","html_url":"https://www.federalregister.gov/documents/2026/05/28/2026-10602/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-10602?publication_date=2026-05-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-28/2026-10602/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":587,"last_updated":"2026-05-31 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-28/pdf/2026-10602.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10602.pdf?1779885915","publication_date":"2026-05-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/28/2026-10602.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2026-05-28T05:36:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31725,"subtype":null,"title":"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period","toc_doc":"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program","toc_subject":"Request for Information","topics":[],"type":"Notice","volume":91}