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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Justifaction of other than full and open competition

I. Background The Laboratory of Malaria Immunology and Vaccinology (LMIV) conducts basic research on malaria pathogenesis and immunology, with an emphasis on studies in humans who are naturally or experimentally infected with malaria parasites. In parallel, the Vaccine Development Unit—which was launched in 2001 as the Malaria Vaccine Development Unit and then became the Malaria Vaccine Development Branch before taking its current shape—operates more like a small biotech firm than a typical research laboratory. Specialists in each step of the development process, from antigen selection to clinical trials, contribute their expertise as the candidate moves along the development pathway. This allows multiple vaccine candidates to move from concept to clinical trials efficiently and rapidly. Together, the discovery sections and Production Unit form a research and testing enterprise that can rapidly translate ideas into proof of concept trials and then capture basic information about human immunity and responses to infection during human clinical trials. This equipment is required for the Federal Food and Drug Administration’s (FDA) quarterly testing requirements for human vaccine approval.

II. Justification for Other than Full and Open Competition ☒ 41 USC 1901(e)(2) and FAR Part 13.106-1: Brand name

· The requirement has been determined, by market research, as being a Brand name requirement:

The requirement has been determined, by market research, as being a Brand name requirement: No other microplate models offered monochromator based multimode, with a dual monochromator optics and the filter optics and independent light source. BioTek Synergy H1 Hybrid Multi mode Microplate reader is the only one on the market that offer these characteristics and shows that this is a brand name request.

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