This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including HUBZone firms; certified 8(a), Small Disadvantaged, veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. The U.S. Food and Drug Administration (FDA) is seeking capability statements from companies that are capable of providing a Isothermal Titration Calorimeter.

A. Introduction
The Center for Biologics Evaluation & Research (CBER)/Structural Biology section of the Laboratory of Bacterial Polysaccharides requires the purchase of an Isothermal Titration Calorimeter (ITC) to measure the binding constants of oligosaccharides to their cognate antibodies. Subsequently, these will be used to better characterize their interactions with antibodies by Nuclear Magnetic Resonance (NMR) spectroscopy.

B. Background
The ITC will be used to characterize and measure the binding strength of oligomers of sialic acid and their cognate antibodies. This will allow the Structural Biology section of the Laboratory of Bacterial Polysaccharides to facilitate their study by NMR spectroscopy. The physical parameters that will be measured by NMR include coupling constants and relative orientations of molecules to yield the three-dimensional structures. These studies will improve CBER understanding of how polysaccharide vaccines function.

C. Statement of Work
Isothermal Titration Calorimeter - Qty 1 ea.
Salient Characteristics:
Ability to measure binding constants of carbohydrate-antibody complexes;
Ability to measure binding constants of carbohydrate-metal ion complexes;
Ability to measure binding constants of carbohydrate-protein complexes;
An online degasser to reduce bubble formation in the reaction cell;
Gold coated cell walls to eliminate unwanted chemical reactions and binding;
On-site installation and instruction;
Software to run the calorimeter and analyze the data;
Low-speed sample mixing (less than 400 rpm);
200 uL cell;
Cylindrical cell;
On-line degasser.

The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees.

Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures.
Capability statements should include sufficient descriptive literature that demonstrates the offered products and services meet or exceed the above technical requirement. At a minimum provide the following: Descriptive material necessary for the government to determine whether the product offered meets the technical requirements, to include: technical specifications, descriptive material, literature, brochures, accessory options, installation, training, service and maintenance, and other information which demonstrates the capabilities of the contractor to meet the requirement. Indicate whether the organization is the manufacturer of the items or authorized reseller. This is not a request for quote, provide informational pricing if available. Potential contractors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number, email address of point of contact. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested.

Interested Contractors must respond with capability statements which are due in person, by postal mail, fax or email to the point of contact listed below on or before August 26, 2011, 1:00 pm (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Office of Acquisitions and Grants Services, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference sources sought number FDA1089479.

Disclaimer and Important Notes.
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."

 

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