Study titled, "bridging the GAP between urinary tract infection pharmacokinetic/pharmacodynamic in vitro models and the optimization of antibiotic selection, dosing strategies, clinical breakpoints,…
Active Definitive Contract Awarded Last action
- Contract number
- 75F40123C00185
- Awardee
-
Monash University UEI W2VLWNVNL728
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $399,988
Award facts
- Opportunity
-
- FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Solicitation · FDABAA2300123 · Posted Nov 14, 2022
- Contract value 100% obligated
- $399,988.00 Current and potential, with all options
- Completion date 84% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Negotiated Proposal / Quote
- Pricing
- Cost No Fee
- Place of performance
- Australia
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Supplemental Agreement for work within scope | $0 | |
| Other Administrative Action | $0 | |
| Change Order | $0 | |
| Original award | $399,988 |
About this award
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.
Description
Study 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." FY23C3BWP10.
Quick answers
Who was awarded contract 75F40123C00185?
75F40123C00185 was awarded to Monash University by Food and Drug Administration (Department of Health and Human Services) on September 25, 2023.
How much is contract 75F40123C00185 worth?
The government has obligated $399,988 on 75F40123C00185.
Was contract 75F40123C00185 competed?
The extent of competition for 75F40123C00185 was full and open competition. The government received 1 offer.
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