United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2026_register executive 2026-05-13 article Notices D09002ee1e1a5e995 D09002ee1e1a5ea15 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 91 FR 27056 https://www.govinfo.gov/app/details/FR-2026-05-13/2026-09533 2026-09533 fr13my26-74 4164-01-P Docket No. FDA-2026-N-0005 https://www.govinfo.gov/app/details/FR-2026-05-13/2026-09533 https://www.govinfo.gov/content/pkg/FR-2026-05-13/html/2026-09533.htm https://www.govinfo.gov/content/pkg/FR-2026-05-13/pdf/2026-09533.pdf 5 p. 27056 27060 91 FR 27056 Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information; Federal Register Vol. 91, Issue NOTICE 2026-09533 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2026-07-13 Docket No. FDA-2026-N-0005 4164-01-P 2026-09533 Notice; request for information.

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.

Either electronic or written comments on the notice must be submitted by July 13, 2026. Yvonne Knight, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2142, Silver Spring, MD 20993, 301-796- 2133, Yvonne.Knight@fda.hhs.gov, with the subject line "Kidney Biomarker for CDER." Request for Information Biomarker Incubator: Urinary Kidney Safety Biomarkers, Yvonne.Knight@fda.hhs.gov https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 91, no. 92 Office of the Federal Register, National Archives and Records Administration 2026-05-13 continuing daily deposited born digital 297 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-05-13 P0b002ee1e1a52703 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13my26 https://www.govinfo.gov/app/details/FR-2026-05-13 https://www.govinfo.gov/content/pkg/FR-2026-05-13/pdf/FR-2026-05-13.pdf https://www.govinfo.gov/content/pkg/FR-2026-05-13/xml/FR-2026-05-13.xml fdlp 26893 27181 DGPO 2026-05-13 2026-05-13 FR-2026-05-13 machine generated eng FR FR-2026-05-13 91 92