Questions_and_Responses_FDA_RFQ11176399.docx

RESPONSE TO QUESTIONS FOR FDARFQ1176399

QUESTION:

Is access and usage of a BSL-3 facility a "Go/No-Go" requirement for consideration of a contract award? Would FDA consider a quote proposing use of a BSL-2 facility with a strongly supported technical approach/solution, facilities and past experience for a contract award?

RESPONSE:

The use of the BSL-3 greenhouse facility is a go/no go requirement. We are anticipating proposals enlisting the use of virulent strains of Salmonella at very high concentrations (106 or above) in protocols that will generate large aerosols. Our concerns with the use of these particular strains of Salmonella are environmental release of an organism that can contaminate fresh produce and survive for months in the environment outside of an animal host and longer if it happens to find an animal host. To mitigate these concerns FDA will not fund a proposal that does not employ the use of a BSL3 facility that is fully contained with HEPA filtration for all exhausted air flow and had drain traps to capture any waste water for full decontamination before release.