Description
The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1000 employees. This requirement is a small business set aside. Background: The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Laboratory of Vector-Borne Viral Diseases (LVVD) requires the purchase of an Insect Rearing Chamber. The LVVD of Division of Viral Products conducts research on important vector-borne viral pathogens, including dengue, Zika, and chikungunya viruses. We frequently review product submissions that involve live-attenuated vector-borne viruses intended as vaccines. An important consideration with any such product is whether it is capable of being transmitted to insect vectors by the vaccinated patient. In the past, we have been relying on individual reviewer expertise in medical entomology garnered through past experience. With the need for more personnel trained in vector biology and primary research into vector-related products, we have concluded that solely relying on past experience can no longer keep up with the pace of regulatory review and the industry. In order to revitalize the FDA's expertise in vector-borne disease research, which is incomplete without studying insect vectors, we require a dedicated insect cell incubator for rearing mosquito colonies. Maintaining stable temperature, light cycles, and humidity is critical to the integrity of ongoing research involving insect colonies. To support this work, the laboratory requires the purchase of a dedicated insect rearing chamber capable of maintaining consistent temperature and relative humidity conditions suitable for insect rearing applications. The Contractor shall provide one (1) insect rearing chamber that meets the following minimum requirements: Temperature Control Capable of maintaining a temperature setpoint of 27°C. Temperature control accuracy of ±0.2°C or better. Humidity Control Active humidification capable of maintaining 75–80% relative humidity (RH). Humidity control accuracy of ±0.3% RH or better. Humidity range from ambient conditions to at least 90% RH. Lighting: Interior LED lighting with a programmable 24-hour timer capable of simulating day/night (diurnal) cycles appropriate for insect rearing. Capacity: Minimum interior capacity of 20 cubic feet. Cooling System: Equipped with a cooling system that ensures temperature stability during normal operation and in the event of a component failure. Installation, Training and Additional System Requirements : The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specificat…
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