Federal Register #FDA2026D2839

HRSA Cooperative Agreement for Black Lung Data and Resource Center Support

This opportunity involves a cooperative agreement award from the Health Resources and Services Administration (HRSA) to support the Black Lung Data and Resource Center (BLDRC): - Government Buyer: - Health Resources and Services Administration (HRSA), Federal Office of Rural Health Policy - Award Recipient: - University of Illinois, Chicago - Services Requested: - Technical assistance for clinics funded through the Black Lung Clinics Program - Support and improvements for patient-level data collection and analysis - Enhancements to clinic operations and service quality - Products/Part Numbers: - No specific products or part numbers are requested - Unique Requirements: - Focus on improving data quality and clinic service breadth for black lung clinics - Emphasis on technical assistance and operational support rather than procurement of goods - OEMs and Vendors: - No OEMs or commercial vendors are mentioned; the University of Illinois, Chicago is the award recipient - Estimated Value: - $50,000 for the project period - Place of Performance: - University of Illinois, Chicago

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products." This guidance aims to assist sponsors in implementing streamlined approaches for general toxicology and nonclinical safety assessments of certain oncology pharmaceuticals. It is intended to facilitate drug development for biological and conjugated products for cancer treatment while reducing unnecessary animal use. The recommendations are based on data analysis of toxicology studies and practices developed during the COVID-19 pandemic to reduce the use of non-human primates.

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