{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The final guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. The recommendations in the guidance endeavor to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles. The final guidance replaces the draft guidance entitled \"S12 Nonclinical Biodistribution Considerations for Gene Therapy Products\" issued on September 9, 2021.","action":"Notice of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/2023/05/01/2023-09179.html","cfr_references":[],"citation":"88 FR 26562","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 1, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-D-0875"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-05-01T11:56:06.360-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-0875-0009","allow_late_comments":null,"id":"FDA-2021-D-0875-0009","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-D-0875","title":"S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Draft Guidance for Industry; Availability"}],"document_number":"2023-09179","effective_on":null,"end_page":26563,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/05/01/2023-09179.xml","html_url":"https://www.federalregister.gov/documents/2023/05/01/2023-09179/s12-nonclinical-biodistribution-considerations-for-gene-therapy-products-international-council-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-09179?publication_date=2023-05-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-05-01/2023-09179/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":463,"last_updated":"2026-08-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-01/pdf/2023-09179.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-09179.pdf?1682685935","publication_date":"2023-05-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/05/01/2023-09179.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-2021-D-0875","supporting_documents_count":0,"docket_id":"FDA-2021-D-0875","document_id":"FDA-2021-D-0875-0009","regulation_id_number":null,"title":"S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-05-02T14:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26562,"subtype":null,"title":"S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}