{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"E11A Pediatric Extrapolation.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance provides a comprehensive and systematic approach to the use of pediatric extrapolation during drug development. The draft guidance also discusses study designs and statistical methodologies, including modeling and simulation, that can be utilized to develop and implement a pediatric extrapolation approach. The draft guidance is intended to provide recommendations for the use of pediatric extrapolation during drug development, which, when used appropriately, can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children.","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/2022/08/29/2022-18517.html","cfr_references":[],"citation":"87 FR 52788","comment_url":null,"comments_close_on":"2022-10-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by October 28, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2022-D-1562"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2022-08-29","updated_at":"2023-02-27T21:22:30.749-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-1562-0002","allow_late_comments":null,"id":"FDA-2022-D-1562-0002","comment_end_date":"2022-10-29","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":"2022-18517","effective_on":null,"end_page":52790,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/08/29/2022-18517.xml","html_url":"https://www.federalregister.gov/documents/2022/08/29/2022-18517/e11a-pediatric-extrapolation-international-council-for-harmonisation-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-18517?publication_date=2022-08-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-08-29/2022-18517/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":725,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-08-29/pdf/2022-18517.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-18517.pdf?1661517921","publication_date":"2022-08-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/08/29/2022-18517.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"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-1562-0002","regulation_id_number":null,"title":"“E11A Pediatric Extrapolation; International Council for Harmonisation; Draft Guidance for Industry; Availability”","checked_regulationsdotgov_at":"2023-02-28T02:22:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52788,"subtype":null,"title":"E11A Pediatric Extrapolation; International Council for Harmonisation; Draft Guidance for Industry; Availability","toc_doc":"E11A Pediatric Extrapolation; International Council for Harmonisation","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}