SOLICITATION NOTICE
66 -- Differential Scanning Calorimeter System - FDA-09-1056514 - DSC System Specifications
- Notice Date
- 6/22/2009
- Notice Type
- Combined Synopsis/Solicitation
- 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
- 09-222-SOL-00074
- 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
- N/A
- Description
- DSC System Specifications The Food and Drug Administration intends to award a Purchase Order for the supplies listed below. The requirement will be awarded using Simplified Acquisition Procedures in accordance with FAR Part 13. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 09-222-SOL-00074. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-32, May 14, 2009. The associated North American Industry Classification System (NAICS) Code is 334516– Analytical Laboratory Instrument Manufacturing, Size Standard 500 Employees. The Food and Drug Administration is soliciting for the following: Purchase of a new Differential Scanning Calorimeter System with pressure perturbation calorimeter accessory including desktop computer with monitor and keyboard with factory installed control data analysis software 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 using very small sample sizes, typically 0.01 - 0.05 mg. For overwhelming safety and cost reasons, a DSC system capable of analyzing small amounts of very toxic proteins is required. 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. FOB Point Destination An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Contract type: Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. FOB Point Destination. The Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079-9502. The provision at FAR 52.212-1 Instructions to Offerors – Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: Any firm that believes it is capable of providing the required services as stated herein may submit a capability statement to document its ability to provide the required services. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. Award will be made to the party whose quote offers the Best Value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to “Meet or Exceed the Requirement”, 2) Past Performance and 3) Price. Technical Capability and Past Performance is significantly more important than price. Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the service offered meets the Government's requirement. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Offerors shall include descriptive material, literature, brochures and other information, which demonstrates the capabilities of the offeror. Past Performance information to include recent and relevant contracts for the same or similar items (including contract numbers, points of contact with telephone numbers and other relevant information). Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications – Commercial Items with its offer. The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.219-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.223-15, 52.225-3, 52.225-13, and 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov. CCR Requirement – Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov It is the offeror’s responsibility to monitor the FedBizOpps website for any released amendments to the solicitation A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. Offers are due in person, by mail or fax on or before July 1, 2009 by 3:00 pm (Central Standard Time – Local Prevailing Time in Jefferson, Arkansas), at Food and Drug Administration OC/OSS/OAGS 3900 NCTR Road, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Barbara Arnold @ (870) 543-7483, FAX (870) 543-7990, email Barbara.arnold@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/09-222-SOL-00074/listing.html)
- Place of Performance
- Address: Jefferson Laboratories, National Ceter for Toxicological Research, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502, United States
- Zip Code: 72079-9502
- Zip Code: 72079-9502
- Record
- SN01852441-W 20090624/090622235919-8003f13b574b64e7d72a7a0231714f25 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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