Definitive Contract 75F40123C00185
- Not listed
- This is a firm-fixed-price definitive contract awarded by the Food and Drug Administration (FDA), a civilian federal agency, to the Institute for Clinical Pharmacodynamics, Inc., a minority-owned for-profit organization based in Schenectady, New York. The $248,553.46 contract is for the development of modernized susceptibility guidance for the antibiotic nitrofurantoin using a dynamic urinary tract in vitro infection model and pharmacometric approaches. This award is part of the FDA's Broad...
- The Food and Drug Administration awarded a $554.8K definitive contract on September 16, 2021, to The University of Auckland Research Office to develop in-vitro tools designed to simulate the chewing of pharmaceutical opioid drug products. This firm fixed-price contract, which carries an ultimate completion date of March 31, 2025, supports FDA's regulatory science mission by advancing methodologies that evaluate how opioid medications behave under physiological conditions relevant to human...
- The Food and Drug Administration (FDA) awarded a $4,935,108 definitive contract to the Commonwealth Scientific and Industrial Research Organisation (CSIRO), a non-profit research organization based in Australia. The contract is for a scientific research study entitled "Strengthening COVID-19 Animal Models and Regulatory Science Using a Systems Biology Approach." This contract was awarded under the FDA's Broad Agency Announcement for Advanced Regulatory Science, which aims to...
- The Food and Drug Administration awarded a $400,000 firm fixed-price contract to the Regents of the University of Michigan on September 26, 2022, to advance regulatory science methodologies in drug development. Specifically, the contract supports the FDA's Broad Agency Announcement seeking research and development proposals across multiple areas of interest, with this award focused on advancing the science of in vitro studies, animal models, pharmacokinetic studies, and real-world evidence...
- The U.S. Food and Drug Administration (FDA) awarded a $687,062 firm-fixed-price contract to the University of Sydney, doing business as the International Clinical Trials Symposium, for the development of a laser-based testing platform for generic dry powders. This definitive contract has a completion date of September 20, 2025. The University of Sydney is a leading Australian educational institution that frequently receives federal contracts and grants from various U.S. government agencies,...
- This $399,991 federal contract was awarded by the U.S. Food and Drug Administration (FDA) to Midwestern University, a private, non-profit educational institution, to develop and validate population pharmacokinetic models for beta-lactam antibiotics used in critical care settings, specifically to guide treatment for patients with hospital-acquired pneumonia. The contract is a definitive, cost-no-fee contract with a completion date of September 29, 2025. This contract was issued under a Broad...
- The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $1.89 million delivery order to Pharmacology Discovery Services Taiwan, LTD. on July 15, 2024, for the development of murine models of urinary tract infections caused by antibiotic-resistant bacteria. This delivery order falls under the Pre-Clinical Models of Infectious Diseases indefinite-delivery/indefinite-quantity (IDIQ) contract vehicle, which carries a ceiling value of $146.3 million and extends through July...
- The Food and Drug Administration awarded a $307,205 cost-no-fee contract to The Johns Hopkins University under Broad Agency Announcement PMWP#173 to evaluate the impact of extended-infusion beta-lactam administration strategies on improving clinical outcomes and reducing the subsequent emergence of antimicrobial resistance. The contract was awarded through the Department of Health and Human Services' Fiscal Year 2021 FDA Broad Agency Announcement for Advanced Research and Development of...
- 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...
- The Department of Health and Human Services Food and Drug Administration awarded a definitive contract to Purdue University, an institution of higher education and research, to characterize the structure and interactions of carboxymaltose with an iron core. The $667,142.00 cost-no-fee contract, awarded on September 22, 2021, has a completion date of September 29, 2023. This contract is associated with the FDA's Broad Agency Announcement for Advanced Regulatory Science, which solicits research...
The Food and Drug Administration awarded a $399,988 cost-plus-no-fee definitive contract to Monash University on September 25, 2023, to conduct advanced research titled "Bridging the Gap Between Urinary Tract Infection Pharmacokinetic/Pharmacodynamic In Vitro Models and the Optimization of Antibiotic Selection, Dosing Strategies, Clinical Breakpoints, and Novel Drug Development." The contract will be performed in Australia and is scheduled for completion by June 28, 2027. This award emerged from the FDA's Broad Agency Announcement solicitation posted in November 2022, which sought proposals addressing regulatory science and innovation in product development, post-market surveillance, and public health preparedness. The contract does not carry a set-aside designation and was awarded on the basis of technical merit and research capabilities. Monash University, an international non-profit research institution based in Victoria, Australia, is well-positioned to execute this work given its extensive track record performing sophisticated scientific research for multiple U.S. federal agencies. The university's prior federal contract portfolio includes substantial biomedical and advanced technology projects for the Department of Defense, National Institutes of Health, and the Defense Advanced Research Projects Agency, demonstrating established expertise in complex research execution. This FDA contract focuses on developing improved in vitro pharmacokinetic and pharmacodynamic models to optimize antibiotic selection and dosing strategies for urinary tract infections, which directly supports the agency's regulatory science mission to enhance drug development and clinical decision-making.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FDABAA-23-00123_Award | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Award Notice 2/2 | 10/18/23, 1:51 PM | |
FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FDABAA-23-00123 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Solicitation 1/2 | 11/14/22, 12:20 PM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00004 | Other Administrative Action | $0 | 10/16/25 | |
| P00003 | Supplemental Agreement for work within scope | $0 | 8/22/25 | |
| P00002 | Other Administrative Action | $0 | 6/27/25 | |
| P00001 | Change Order | $0 | 11/14/23 | |
| Not listed | Not listed | $400.0k | 9/25/23 |