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OMUFA - Screening Non-Sterile OTC Monograph Products for Microbial Contamination

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The Food and Drug Administration is preparing to initiate a study focused on screening non-sterile, aqueous-based over-the-counter monograph drugs for microbial contamination. This initiative aims to strengthen the FDA’s ability to monitor the safety and quality of OTC monograph products by identifying potential microbial hazards that could lead to adverse health outcomes. The research will contribute to a more robust surveillance system, helping to reduce the occurrence of product-related illnesses and improve public health protections. The contract, titled “OMUFA - Screening Non-Sterile OTC Monograph Products for Microbial Contamination,” is listed under NAICS code 541714 and is currently in forecast status with a posted date of May 25, 2026. The effort will be led by the FDA’s Center for Drug Evaluation and Research, with the program point of contact available through cderacquisitions@fda.hhs.gov. The contracting officer role has not yet been assigned, and there is no specified place of performance or set-aside designation. This opportunity is intended to support regulatory oversight and may inform future guidelines or enforcement actions related to microbial safety in non-sterile OTC drugs.

General Info

Study assessing microbial contamination in OTC drugs to enhance FDA safety and regulatory oversight.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)View NAICS

Place of Performance

US

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedMay 25

forecast

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / Agency

Food and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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OMUFA - A study will be designed to evaluate non-sterile, aqueous based, OTC monographdrugs for microbial contamination. This will enhance FDA's surveillance of OTC monograph products andpotentially reduce the incidence of adverse events.

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