Federal Register #FDA-2026-N-1736

FDA regulatory review and information collection for IND applications, featuring BIZENGRI (zenocutuzumab-zbco)

This opportunity centers on the Food and Drug Administration's (FDA) regulatory review and information collection requirements for Investigational New Drug (IND) applications, with a specific focus on the biologic drug BIZENGRI (zenocutuzumab-zbco). - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Office of the Commissioner - OEMs and Vendors: - BIZENGRI (zenocutuzumab-zbco) is manufactured by the applicant referenced in the regulatory review (exact OEM not specified in the summary) - Products/Services Requested: - Regulatory review and information collection for IND applications - Reporting and recordkeeping for biologics and human drugs - Specific focus on BIZENGRI (zenocutuzumab-zbco), indicated for advanced unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma with NRG1 gene fusion - Unique/Notable Requirements: - Compliance with FDA IND application requirements - Use of FDA forms and adherence to reporting and recordkeeping burdens - Patent term extension requests for BIZENGRI - Annual reporting and recordkeeping burden estimates - Regulatory review period totals 2,909 days (testing and approval phases) - No physical products or procurement of goods/services; focus is on regulatory compliance and information collection

Description

The Food and Drug Administration (FDA) is announcing a proposed collection of information related to Investigational New Drug (IND) applications. This collection supports implementation of provisions governing investigational new drugs and applications, including submission requirements, reporting, and recordkeeping. The notice invites public comments on the information collection by September 16, 2026. The regulations cover various types of INDs, including Investigator INDs, Emergency Use INDs, and Treatment INDs, and include requirements for sponsors and investigators.

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