{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled \"Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.\" The draft guidance document provides sponsors engaged in the development of human gene therapy (GT) products incorporating ex-vivo and in vivo genome editing (GE) of human somatic cells (GE products) with FDA's recommendations on the type of prior knowledge that may be scientifically appropriate to leverage to advance product development.","action":"Notice of availability.","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/2026/06/03/2026-11054.html","cfr_references":[],"citation":"91 FR 33178","comment_url":null,"comments_close_on":"2026-09-01","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 1, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-D-1257"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-06-03","updated_at":"2026-06-04T18:32:20.368-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-D-1257-0001","allow_late_comments":false,"id":"FDA-2026-D-1257-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-D-1257","title":"Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability"}],"document_number":"2026-11054","effective_on":null,"end_page":33179,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/03/2026-11054.xml","html_url":"https://www.federalregister.gov/documents/2026/06/03/2026-11054/leveraging-prior-knowledge-in-the-development-of-human-gene-therapy-products-incorporating-genome","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-11054?publication_date=2026-06-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-03/2026-11054/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1068,"last_updated":"2026-10-10 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-03/pdf/2026-11054.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11054.pdf?1780404312","publication_date":"2026-06-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/03/2026-11054.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-D-1257","supporting_documents_count":0,"docket_id":"FDA-2026-D-1257","document_id":"FDA-2026-D-1257-0001","regulation_id_number":null,"title":"Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-06-09T16:31:49Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33178,"subtype":null,"title":"Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability","toc_doc":"Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}