Milliflex Rapid 2. 0

The Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services is seeking market research for the procurement of a Milliflex Rapid 2.0 Detection System for its Office of Pharmaceutical Quality Research (OPQR). The system is required for microbial quality control testing of purified bulk drug substances and final formulated drug products, and must be compatible with the agency's existing 2nd generation Milliflex Oasis filtration pump. Vendors must provide a comprehensive package including the detection system kit, power supplies, filtration pumps, cleaning kits, reagents, and associated accessories. Responses to the Sources Sought Notice are due by January 30, 2024, at 12:00 PM ET, and must include company details, NAICS codes, socioeconomic status, GSA schedule information, and domestic manufacturing status. The FDA will evaluate potential vendors based on their technical capabilities, equipment specifications, and ability to meet the detailed requirements outlined in the draft Statement of Work.

The pre-solicitation notice does not indicate a specific set-aside for small businesses, welcoming responses from both small and large businesses in the Analytical Laboratory Instrument Manufacturing sector (NAICS 334516). The contract requires delivery, installation, and training within 45 days of award, with an on-site installation qualification (IQ)/operational qualification (OQ) validation and three days of training for 3-5 personnel. The period of performance will be one year from the date of installation, with delivery and installation scheduled at the FDA facility in Silver Spring, Maryland. While no specific award value is mentioned, the comprehensive nature of the procurement suggests a significant investment in specialized laboratory equipment. The draft Statement of Work specifies precise requirements for the Milliflex Rapid System 2.0, indicating a targeted procurement with specific technical specifications that potential vendors must carefully review and address in their responses.