{"abstract":"The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled \"Considerations for Including Tissue Biopsies in Clinical Trials.\" This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).","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/2025/01/07/2024-31536.html","cfr_references":[],"citation":"90 FR 1173","comment_url":null,"comments_close_on":"2025-03-10","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 10, 2025. to ensure that the Agency and OHRP consider your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2024-D-2402"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-01-07T21:56:21.811-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2402-0001","allow_late_comments":false,"id":"FDA-2024-D-2402-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2402","title":"Considerations for Including Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability"}],"document_number":"2024-31536","effective_on":null,"end_page":1175,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/07/2024-31536.xml","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31536/considerations-for-including-tissue-biopsies-in-clinical-trials-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31536?publication_date=2025-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-07/2024-31536/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":590,"last_updated":"2026-10-24 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31536.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31536.pdf?1736171121","publication_date":"2025-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/07/2024-31536.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-2024-D-2402","supporting_documents_count":0,"docket_id":"FDA-2024-D-2402","document_id":"FDA-2024-D-2402-0001","regulation_id_number":null,"title":"Considerations for Including Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability","checked_regulationsdotgov_at":"2025-01-09T02:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1173,"subtype":null,"title":"Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability","toc_doc":"Considerations for including Tissue Biopsies in Clinical Trials","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}