Surveillance of Non-Sterile OMUFA Products for Objectionable Microbial Contamination
Closed Solicitation Posted
- Solicitation number
- 75F40124Q00471
- 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 Food and Drug Administration (FDA) is seeking a qualified small business to provide surveillance testing of non-sterile over-the-counter (OTC) monograph drug products for microbial contamination. The selected contractor must be an FDA-registered, ISO-accredited laboratory with the capability to test approximately 100 aqueous OTC drug product samples (1,100 units total) within a 12-month period of performance. Key contract requirements include established processes for sample receipt, management, and traceability, as well as the use of verified compendial test methods. The evaluation criteria prioritize scientific merit, ability to complete the analyses, price, and timely completion.
This procurement is set aside for small businesses. The contract is a firm-fixed-price type, and the anticipated award date is September 30, 2024. The work will be performed in Silver Spring, Maryland, and the NAICS code is 541380 (Testing Laboratories and Services) with a PSC of Q301-P (Reference Laboratory Testing).
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_75F40124Q00471.pdf | ||
| RFQ_75F40124Q00471.pdf |
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