Screening of sterile OTC monograph drug products for microbial contamination
Closed Solicitation Posted
- Solicitation number
- 75F40124Q00375
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541380 Testing Laboratories and Services
- PSC
- Q301 Reference Laboratory Testing
- Place of performance
- Silver Spring, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Food and Drug Administration (FDA) is seeking a contract laboratory to test approximately 100 aqueous over-the-counter (OTC) monograph drug product samples, including eye drops, oral solutions, nasal washes, and mouthwashes, for microbial contamination. The contract laboratory must be accredited and registered with the FDA, use compendial test methods described in USP chapters, and have an established process for sample receipt, management, and traceability. The evaluation criteria include scientific merit, ability to complete analyses, price, and turnaround time. Proposals are due by August 22, 2024, and the contract will be a firm fixed-price with a 12-month period of performance.
This solicitation is set aside for small businesses. The contract has no identified incumbent or current contractor. The estimated value is not provided, but the scope involves testing approximately 100 OTC drug product samples. The place of performance is Silver Spring, MD.
Notice text
2 versions
Update #2 · Latest ·
See attached solicitation.
Solicitation revised with the following change: The start date of Test Results/Analytical Worksheets submitted to FDA as part of monthly progress reports in the Deliverables table changed from June 2024 to October 2024.
Update #1 ·
See attached solicitation
Files
| File | Type | Posted |
|---|---|---|
| Rev_RFQ_75F40124Q00375.pdf | ||
| RFQ_75F40124Q00375.pdf |
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