{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #251 entitled \"Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease.\" This draft guidance, when finalized, will set forth FDA's policy regarding heritable intentional genomic alterations (IGAs) in animals of food- producing species, such as swine and rabbits, that are intended to be marketed for use as models of human or animal disease in biomedical research under contained and controlled conditions. The draft guidance describes the conditions under which we generally may not expect developers of IGAs in animal models of disease to submit an application to FDA's Center for Veterinary Medicine (CVM) or to get our approval before marketing their animals following CVM's prior review of risk factor data.","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/2025/01/07/2024-31530.html","cfr_references":[],"citation":"90 FR 1144","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either electronic or written comments on the draft guidance by March 10, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2024-D-4778"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-01-07T12:56:41.461-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-4778-0001","allow_late_comments":false,"id":"FDA-2024-D-4778-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-4778","title":"Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability"}],"document_number":"2024-31530","effective_on":null,"end_page":1145,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/07/2024-31530.xml","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31530/heritable-intentional-genomic-alterations-in-animals-of-food-producing-species-for-use-as-models-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31530?publication_date=2025-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-07/2024-31530/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":385,"last_updated":"2026-10-24 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31530.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31530.pdf?1736171121","publication_date":"2025-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/07/2024-31530.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-4778","supporting_documents_count":0,"docket_id":"FDA-2024-D-4778","document_id":"FDA-2024-D-4778-0001","regulation_id_number":null,"title":"Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-01-08T17:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1144,"subtype":null,"title":"Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability","toc_doc":"Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}