{"abstract":"The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or Agency) is announcing a request for information regarding a regulatory science initiative. The aims of the initiative are to advance biomarker validation through the compilation of data from multiple sources and through a specific pilot project focused on aggregating data for biomarkers of drug-induced kidney injury. The purpose of this notice is to inform the public of the aims of this initiative, to encourage human data submission and sharing, and to identify opportunities to enhance interactions between relevant stakeholders and FDA. The Agency intends to use the information submitted to inform future activities related to data sharing, biomarker development, and broader translation of biomarkers of drug-induced kidney injury.","action":"Notice; request for information.","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/2026/05/13/2026-09533.html","cfr_references":[],"citation":"91 FR 27056","comment_url":null,"comments_close_on":"2026-07-13","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the notice must be submitted by July 13, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-0005"],"dockets":[{"supporting_documents":[{"title":"Reference 3 - Kalaria SN, TR Farchione, MV Mathis, M Gopalakrishnan, I Younis, R Uppoor, M Mehta, Y Wang, and H Zhu, 2020, Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia, Journal of Clinical Pharmacology, 60(7): 848–859, doi: 10.1002/jcph.1580.","document_id":"FDA-2026-N-0005-0004"},{"title":"Reference 2 - Kalaria SN, TR Farchione, R Uppoor, M Mehta, Y Wang, and H Zhu, 2021, Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder, Journal of Clinical Pharmacology, 61: S117–S124, doi: 10.1002/jcph.1836.","document_id":"FDA-2026-N-0005-0003"},{"title":"Reference 1 - Chen J, J Florian, W Carter, RD Fleischer, TS Hammerstrom, PR Jadhav, W Zeng, J Murray, and D Birnkrant, 2013, Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies, Gastroenterology, 144(7):1450–1455.e2, epub ahead of print March 5, 2013, doi: 10.1053/j.gastro.2013.02.039.","document_id":"FDA-2026-N-0005-0002"}],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2026-05-13","updated_at":"2026-07-14T01:56:38.056-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-0005-0001","allow_late_comments":false,"id":"FDA-2026-N-0005-0001","comment_end_date":"2026-07-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":3,"id":"FDA-2026-N-0005","title":"Public Seminar"}],"document_number":"2026-09533","effective_on":null,"end_page":27060,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/13/2026-09533.xml","html_url":"https://www.federalregister.gov/documents/2026/05/13/2026-09533/biomarker-incubator-urinary-kidney-safety-biomarkers-request-for-information","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-09533?publication_date=2026-05-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-13/2026-09533/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":1378,"last_updated":"2026-07-28 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-13/pdf/2026-09533.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09533.pdf?1778589920","publication_date":"2026-05-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/13/2026-09533.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - Kalaria SN, TR Farchione, MV Mathis, M Gopalakrishnan, I Younis, R Uppoor, M Mehta, Y Wang, and H Zhu, 2020, Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia, Journal of Clinical Pharmacology, 60(7): 848–859, doi: 10.1002/jcph.1580.","document_id":"FDA-2026-N-0005-0004"},{"title":"Reference 2 - Kalaria SN, TR Farchione, R Uppoor, M Mehta, Y Wang, and H Zhu, 2021, Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder, Journal of Clinical Pharmacology, 61: S117–S124, doi: 10.1002/jcph.1836.","document_id":"FDA-2026-N-0005-0003"},{"title":"Reference 1 - Chen J, J Florian, W Carter, RD Fleischer, TS Hammerstrom, PR Jadhav, W Zeng, J Murray, and D Birnkrant, 2013, Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies, Gastroenterology, 144(7):1450–1455.e2, epub ahead of print March 5, 2013, doi: 10.1053/j.gastro.2013.02.039.","document_id":"FDA-2026-N-0005-0002"}],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-0005","supporting_documents_count":3,"docket_id":"FDA-2026-N-0005","document_id":"FDA-2026-N-0005-0001","regulation_id_number":null,"title":"Public Seminar","checked_regulationsdotgov_at":"2026-07-15T08:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27056,"subtype":null,"title":"Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information","toc_doc":"Biomarker Incubator: Urinary Kidney Safety Biomarkers","toc_subject":"Request for Information","topics":[],"type":"Notice","volume":91}