{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"E11A Pediatric Extrapolation.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides a comprehensive and systematic approach to pediatric extrapolation during drug development. Notably, the guidance discusses approaches to safety extrapolation and defining extrapolation as a continuum. The guidance also includes approaches to study designs and statistical methodologies, including modeling and simulation, for developing and implementing pediatric extrapolation. The guidance is intended to provide approaches that can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. The guidance replaces the draft guidance \"E11A Pediatric Exploration\" issued on August 29, 2022.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2024/12/30/2024-31026.html","cfr_references":[],"citation":"89 FR 106515","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on December 30, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-1562"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-12-30","updated_at":"2024-12-30T11:57:38.761-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-1562-0007","allow_late_comments":false,"id":"FDA-2022-D-1562-0007","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-1562","title":"“E11A Pediatric Extrapolation; International Council for Harmonisation; Draft Guidance for Industry; Availability”"}],"document_number":"2024-31026","effective_on":null,"end_page":106516,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/12/30/2024-31026.xml","html_url":"https://www.federalregister.gov/documents/2024/12/30/2024-31026/e11a-pediatric-extrapolation-international-council-for-harmonisation-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31026?publication_date=2024-12-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-12-30/2024-31026/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":260,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-30/pdf/2024-31026.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31026.pdf?1735307138","publication_date":"2024-12-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/12/30/2024-31026.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-2022-D-1562","supporting_documents_count":0,"docket_id":"FDA-2022-D-1562","document_id":"FDA-2022-D-1562-0007","regulation_id_number":null,"title":"“E11A Pediatric Extrapolation; International Council for Harmonisation; Draft Guidance for Industry; Availability”","checked_regulationsdotgov_at":"2024-12-31T16:00:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":106515,"subtype":null,"title":"E11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"E11A Pediatric Extrapolation","toc_subject":"Guidance","topics":[],"type":"Notice","volume":89}