SOURCES SOUGHT
66 -- Differential Scanning Calorimeter System - Sources Sought Text document
- Notice Date
- 5/29/2009
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- FDA-09-1056514
- Point of Contact
- Barbara J Arnold, Phone: (870) 543-7483
- E-Mail Address
-
barbara.arnold@fda.hhs.gov
(barbara.arnold@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Sources Sought Text document 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. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. The applicable North American Industry Classification System (NAICS) code is 334516 and the size standard is 500 employees. The U.S. Food and Drug Administration (FDA) is seeking to identify sources with the capabilities of providing a Differential Scanning Calorimeter System in accordance with the following specifications: Description: In general, differential scanning calorimetry is a method used to determine the thermodynamic constants governing diverse types of physical and chemical processes. Conventional DSC instruments are used to characterize physical/chemical transformations occurring in medium-to-larger sample quantities (20 - 1,000 mg). A specialized type of DSC instrument is required for the analysis of very small quantities (≥0.02 mg) of potentially dangerous biomacromolecules. It is unreasonably dangerous, unwise, and cost prohibitive to produce, store, or utilize the large quantities of dangerous protein toxins required for analysis by conventional DSC. Bioterrorism and food safety studies on the stabilities of protein toxins (ricin, abrin, and shiga-like toxins) are performed by my laboratory using very small sample sizes, typically 0.01 - 0.05 mg. For overwhelming safety and cost reasons, we require a DSC system capable of analyzing small amounts of very toxic proteins. Performance Specifications: The complete DSC system must satisfy the following critical elements: A.Low short term Signal-to-Noise Ratio (SNR). 0.5 microcalorie/°C (RMS average) when scanning from 5°C - 110°C at 90°C/hr scan rate using a 30 second time filter. Low SNR is required for accurate integration of excess heat capacities to determine ΔHm or discern minor differences in ΔCp expected when using microgram quantities of protein samples. B.Appropriate scanning temperature range. -5°C to 130°C. Measurements made far above normal cooking temperatures (200°C, or 400°F) are less relevant for most protein chemistry experiments and extended temperature ranges typical for conventional DSC are inappropriate for our planned studies. Higher precision measurements of Tm should be expected with an instrument whose operating temperature range is focused in that expected for protein samples. C.Baseline reproducibility. Standard deviation for replicate scans should be 1.5 microcalorie/°C within the temperature range typical for protein denaturation (5°C - 95°C) at 90°C/hr scan rate using a 30 second filter. D.Internal Peltier device. External water baths cannot provide precise thermal control to the degree achieved by Peltier thermal control circuits. E.Maximum sensitivity. Thermodynamic measurements have been made using microcalorimetry DSC systems using as little as 0.0125 mg lysozyme. Conventional DSC systems typically require 20 mg protein per analysis, a potentially lethal quantity for some of the toxins studied by our laboratory. F.Automated sample degassing/thermostatting. The DSC system must be equipped to perform reliable degassing and thermal equilibration of sample and reference materials prior to analysis. G.Minimal sample and reference chamber volumes. The sample and reference chambers should contain ≤0.5 mL, minimizing the need for large sample volumes. H.Adjustable scan rates. 0°C/hr to 90°C/hr (heating mode); 0°C/hr to minus 60°C/hr (cooling mode). Variable scan rates are required to study the mechanisms of protein toxin denaturation and renaturation. I.Biochemically inert sample and reference chamber materials. The sample and reference chambers must be constructed from temperature-resistant, biochemically inert materials. J.Adiabatic sample and reference chambers. The sample and reference chambers must be thermally isolated from the environment completely to allow small differences in excess heat capacity between the chambers to be reproducible and significant. K.Pressure perturbation calorimetry (PPC). The sample and reference chambers must be equipped for reliable PPC experiments at ≥5 atm. L.Integrated software/computer control. A computer system (desktop or notebook computer with monitor, keyboard, mouse, no printer) is required for operation of the instrument and data analysis. The computer system must provide adequate performance (processor speed, internal memory, card slots, disk space, etc.) required to operate the instrument control software. The computer system must provide compatibility with the FDA/NCTR intranet. The software interface must be Section 508-compliant and satisfy DHHS/FDA/NCTR VPAT requirements. Software and computer system must be compatible with MS Windows XP OS. Data generated by the DSC software system must be compatible with or exportable to MS Excel 2003 and MS PowerPoint 2003. As appropriate experiments are performed related to the thermodynamic stability of protein samples, the software system must perform data analysis to measure heat capacity (Cp), change in heat capacity with temperature (ΔCp ), derive transition temperatures (Tm), van’t Hoff enthalpy (ΔHvH ), calorimeter enthalpy (ΔHcal ), entropy (ΔS), Gibbes free energy (ΔG ), and equilibrium constant (Keq). Software must also be capable of instrument control, data collection, and data analysis for PPC experiments to derive coefficients of thermal expansion (α) and volumetric changes in proteins associated with ligand binding. M.Documentation. Users manuals for the software system and all system components must be provided. Field service manuals must be provided for all components. N.Warranty. Supplier must provide a warranty period of 12 months from the date of installation. O.Field service and technical support. The supplier must offer field service for installation and instrument repair beyond the scope of the NCTR instrument repair contractor (Bionetics). The supplier must offer technical support for training and consultation. P.Delivery/installation date. All components will be delivered within 60 days of purchase. System installation will be completed within 30 days of delivery. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents capacity and capability to provide the required specified equipment. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. 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, and reference FDA-09-1056514. 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. Please provide the following information to determine if the company can meet the requirement: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information corresponding to each item, which demonstrates the capabilities of the contractor’s equipment. Interested Contractors must respond with capability statements which are due in person, by mail, fax or email to the point of contact listed below on or before June 8, 2009 by 1:00 pm (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, National Center for Toxicological Research, Attn: Barbara Arnold, 3900 NCTR Road, HFT-320, Jefferson AR 72079-9502.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-09-1056514/listing.html)
- Place of Performance
- Address: Jefferson, Arkansas, 72095, United States
- Zip Code: 72095
- Zip Code: 72095
- Record
- SN01830385-W 20090531/090529235430-1bb59823dba78b154d222e15d398e62f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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