{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance consists of questions and answers that were developed to provide additional clarity about anticancer pharmaceutical development described in the ICH guidance \"S9 Nonclinical Evaluation for Anticancer Pharmaceuticals\" that was published in 2010 (ICH S9 (2010)), as well as to continue progress in the 3Rs of Reduction, Refinement, and Replacement in the use of animals.","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/2018/06/18/2018-12975.html","cfr_references":[],"citation":"83 FR 28241","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 18, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-2569"],"dockets":[],"document_number":"2018-12975","effective_on":null,"end_page":28243,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/18/2018-12975.xml","html_url":"https://www.federalregister.gov/documents/2018/06/18/2018-12975/s9-nonclinical-evaluation-for-anticancer-pharmaceuticals-questions-and-answers-international-council","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-12975?publication_date=2018-06-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-18/2018-12975/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":735,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-18/pdf/2018-12975.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-12975.pdf?1529066726","publication_date":"2018-06-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/18/2018-12975.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2018-07-08T10:01:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28241,"subtype":null,"title":"S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and Answers; International Council for Harmonisation","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}