Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-0005] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information. SUMMARY: 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 ( printed page 27057) 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. DATES: Either electronic or written comments on the notice must be submitted by July 13, 2026. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 13, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered tim…
Citation: 91 FR 27056
