Screening of Non-Sterile OTC Monograph Drug Products for Microbial Contamination
Closed Solicitation Posted
- Solicitation number
- FDA-CDER-25-130338
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- PSC
- Q301 Reference Laboratory Testing
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration (FDA), through the Department of Health and Human Services Office of Acquisition and Grant Services, is seeking to procure laboratory testing services for screening non-sterile over-the-counter (OTC) monograph drug products for microbial contamination. The contract requires an accredited laboratory to purchase and test approximately 70 aqueous OTC drug product samples using compendial test methods, specifically from United States Pharmacopeia (USP) chapters. The testing focuses on OTC drug products that are not intended to be sterile, meaning they do not carry sterile labeling requirements. The solicitation is classified under NAICS code 541990 (All Other Professional, Scientific, and Technical Services) and PSC code Q301 (Reference Laboratory Testing). The deadline for submitting quotes is September 15, 2025, providing contractors with only six days from the posting date to prepare and submit their responses.
This procurement does not include any set-aside designations and is open to all qualified contractors. No incumbent contractors or current service providers are identified in the solicitation materials. While specific budget ranges or award values are not disclosed in the available documentation, the scope involves purchasing and testing approximately 70 OTC drug product samples throughout the contract performance period. The place of performance is designated as Silver Spring, Maryland 20993, which is the location of FDA headquarters and associated facilities. The solicitation includes standard federal acquisition regulation provisions and HHS-specific class deviations related to trade agreements and accelerated payments to small business subcontractors.
Notice text
The overall scope of the project is to have a contract laboratory purchase and test ~70 aqueous OTC monograph drug product samples for microbial contamination using compendial test methods during the period of performance. These OTC drug products are not intended to be sterile (e.g., they are not labeled as sterile).
Files
| File | Type | Posted |
|---|---|---|
| Attachment 1 FAR Class Deviation.pdf | ||
| Attachment 2 - HHS Class Deviation.pdf | ||
| RFQ FDA-CDER-25-130338.pdf |
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Sterile Compounding Services | Veterans Integrated Service Network 17 | Service-Disabled Veteran-Owned Small Business | |
| Microbiological media purchase order for Clinical Microbiology laboratory. | Veterans Integrated Service Network 20 | No set-aside | |
| FDA Scientific & Regulatory Support Services(SRS) | FDA Office of Acquisition and Grant Services | Total Small Business | |
| Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ | FDA Office of Acquisition and Grant Services | Service-Disabled Veteran-Owned Small Business | |
| FDA/CDRH Scientific Technical Capacity for Regulatory Review | FDA Office of Acquisition and Grant Services | No set-aside |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity