Screening of Non-Sterile OTC Monograph Drug Products for Microbial Contamination

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Maryland
Type of Government: Federal
FSC Category:
  • Q - Medical Services
NAICS Category:
  • 541990 - All Other Professional, Scientific, and Technical Services
Set Aside: No Set aside used
Posted Date: Sep 9, 2025
Due Date: Sep 15, 2025
Solicitation No: FDA-CDER-25-130338
Original Source: Please Login to View Page
Contact information: Please Login to View Page
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Description

Follow
Screening of Non-Sterile OTC Monograph Drug Products for Microbial Contamination
Active
Contract Opportunity
Notice ID
FDA-CDER-25-130338
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
FOOD AND DRUG ADMINISTRATION
Office
FDA OFFICE OF ACQ GRANT SVCS
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General Information
  • Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
  • Original Published Date: Sep 09, 2025 09:13 am EDT
  • Original Date Offers Due: Sep 15, 2025 12:00 pm EDT
  • Inactive Policy: Manual
  • Original Inactive Date: Sep 16, 2025
  • Initiative:
    • None
Classification
  • Original Set Aside: No Set aside used
  • Product Service Code: Q301 - REFERENCE LABORATORY TESTING
  • NAICS Code:
    • 541990 - All Other Professional, Scientific, and Technical Services
  • Place of Performance:
    Silver Spring , MD 20993
    USA
Description

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).


Attachments/Links
Contact Information
Contracting Office Address
  • 4041 Powder Mill Road 4th Floor
  • Beltsville , MD 20705
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Sep 09, 2025 09:13 am EDTCombined Synopsis/Solicitation (Original)
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