Closed Solicitation · DEPARTMENT OF HEALTH AND HUMAN SERVICES

    SCREENING OF NON-STERILE OTC MONOGRAPH DRUG PRODUCTS FOR MICROBIAL CONTAMINATION

    Sol. FDA-CDER-25-130338Combined Synopsis/SolicitationROCKVILLE, MD
    Closed
    STATUS
    Closed
    closed Sep 15, 2025
    POSTED
    Sep 9, 2025
    Publication date
    NAICS CODE
    541990
    Primary industry classification
    PSC CODE
    Q301
    Product & service classification

    AI Summary

    The Department of Health and Human Services is seeking a contract laboratory to purchase and test approximately 70 aqueous OTC monograph drug product samples for microbial contamination. Testing will utilize compendial methods, and the products are not intended to be sterile. This opportunity is classified as a combined synopsis/solicitation.

    Contract details

    Solicitation No.
    FDA-CDER-25-130338
    Notice Type
    Combined Synopsis/Solicitation
    Posted Date
    September 9, 2025
    Response Deadline
    September 15, 2025
    NAICS Code
    541990AI guide
    PSC / Class Code
    Q301
    Primary Contact
    Rodney D. Aytch
    State
    MD
    ZIP Code
    20857
    AI Product/Service
    service

    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).

    Key dates

    1. September 9, 2025Posted Date
    2. September 15, 2025Proposals / Responses Due

    AI search tags

    Frequently asked questions

    SCREENING OF NON-STERILE OTC MONOGRAPH DRUG PRODUCTS FOR MICROBIAL CONTAMINATION is a federal acquisition solicitation issued by DEPARTMENT OF HEALTH AND HUMAN SERVICES. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.

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