SAM #75F40126Q135135

FDA Solicitation for Insect Rearing Chamber and Related Services

The FDA's Center for Biologics Evaluation and Research (CBER), Laboratory of Vector-Borne Viral Diseases (LVVD) is soliciting quotations for an insect rearing chamber and related services. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Biologics Evaluation and Research (CBER) - Laboratory of Vector-Borne Viral Diseases (LVVD) - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Products/Services Requested: - One insect rearing chamber - Must maintain 27°C ±0.2°C - Active humidification: 75–80% RH ±0.3% RH, up to at least 90% RH - Interior LED lighting with programmable 24-hour timer for diurnal cycles - Minimum interior capacity: 20 cubic feet - Cooling system for temperature stability - Newly manufactured, delivered as a turn-key solution with all hardware, software, supplies, and accessories - NIST-traceable calibration documentation - Operations and maintenance manuals - Minimum one-year warranty with technical support - Services: - Installation, calibration, and on-site operator training at the FDA facility in Silver Spring, MD - Shipping, handling, installation, and inside delivery included - Unique/Notable Requirements: - Strict temperature and humidity control specifications - Programmable lighting for diurnal cycles - Turn-key delivery with all necessary documentation and supplies - On-site training and calibration with NIST-traceable documentation - Minimum one-year warranty and technical support

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 specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The Contractor shall provide NIST-traceable calibration documentation for the chamber's temperature and humidity sensors. Documentation shall include a minimum three-point calibration certificate and be provided with the equipment upon delivery. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software.  All manuals and documentation shall be provided in hard copy and/or electronic format. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.     Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts. Phone and email technical support shall be included for a minimum of one (1) year. 

Place of Delivery:

FOB Point Destination. All items shall include shipping, handling, installation, and inside delivery to the destination identified herein.

FDA/CBER/OVRR

Building 52-72 room 5353

10903 New Hampshire Avenue

Silver Spring, MD 20993

Period of Performance:

Delivery, installation, calibration and training shall occur within 45 calendar days from date of award.

All responsible sources may submit a quotation, bid, or proposal, as appropriate, which will be considered by the agency For information regarding this notice, please contact Warren Dutter at 301-796-2486 or email warren.dutter@fda.hhs.gov.

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