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

The contract involves a study to assess microbial contamination in non-sterile, aqueous-based over-the-counter (OTC) monograph drugs. This initiative aims to improve the FDA's monitoring and safety surveillance of OTC monograph products, potentially lowering the risk of adverse events caused by microbial contamination. The study will provide valuable data to enhance regulatory oversight and ensure consumer safety in the OTC drug market. The contract is forecasted by the Food and Drug Administration under the NAICS code 541714, which relates to research and development in the physical, engineering, and life sciences. While specific details such as the contracting officer and location of performance are yet to be determined, the FDA remains the responsible agency. Points of contact include the CDER Acquisition Liaison, and additional information can be accessed through the FDA's industry opportunity forecast platform.