Definitive Contract 75F40120C00198

The Food and Drug Administration (FDA) awarded a definitive cost-no-fee contract valued at $1.09 million to the University of Texas at Austin on September 29, 2020, to investigate the effect of repeat unit ordering on the properties of melt-extruded poly(lactide-coglycolide)-based long-acting implants. The research, to be conducted at UT Austin's Austin, Texas facility, focuses on understanding how the molecular structure and sequencing of polymer repeat units influences the performance characteristics of biodegradable implant systems, which are critical for sustained-release pharmaceutical delivery applications. This research supports the FDA's regulatory science mission by generating foundational data needed to establish standards and guidelines for long-acting implant formulations. The contract carries no set-aside designation and was awarded to UT Austin, a child entity of the University of Texas System, demonstrating competitive selection of the university's advanced materials science and pharmaceutical research capabilities.

The cost-no-fee contract structure indicates this engagement functions as a research partnership with the FDA's regulatory objectives taking precedence, with completion targeted for September 30, 2024. As a major research institution with extensive federal contract experience across scientific and technological domains, UT Austin brings substantial expertise in materials characterization and polymer science to support the FDA's mission of advancing drug delivery technologies and ensuring the safety and efficacy of implantable medical devices.