{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled \"Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry.\" The draft document provides recommendations for next-generation sequencing (NGS)-based methods used in nonclinical studies that will likely be needed to support initiation of clinical trials of investigational human genome editing (GE) products.","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/2026/04/15/2026-07285.html","cfr_references":[],"citation":"91 FR 20173","comment_url":null,"comments_close_on":"2026-07-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 14, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-1255"],"dockets":[{"supporting_documents":[{"title":"Reference 3 - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; 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Draft Guidance for Industry; Availability","toc_doc":"Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}