S2 High Performance Sample Preparation Instrument

The Food and Drug Administration intends to award a Contract for the services and 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. This is a 100% Small Business Set Aside. The solicitation number is 09-222-SOL-00153. 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) 2005-36, August 11, 2009. The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The Food and Drug Administration is soliciting for the following items: 1. Covaris Item Number 500003 S2 High Performance Sample Preparation Instrument Single Sample Processing - Includes Laptop Computer 2. Covaris Item Number 500117 S2 - DNA Kit: (1) Each of 500114 Holder, 500142 Prep Station and (4) Bags of 520045 6x16mm 100ul Tube, AFA Fiber and Cap System (100 Tubes Total) 3. Covaris Item Number 520045 Microtube with AFA Fiber, 25 Tubes and Caps 4. Covaris Item Number 500163 Water Conditioning System 5. Covaris Item Number 510001 CH01 Recirculating Chiller for use with Covaris Instruments 6. Covaris Item Number 530013 Installation and On-Site Training - Half Day 7. Covaris Item Number 530006 Full Service Plan for the S-series Second Year Service Contract 8. Service Contract Discount at Time of Instrument Purchase Statement of Need: Due to recent and foreseen increases in the demand for second-generation pyrosequencing of human pathogens and/or the host, the Genomic Core facility requires an apparatus for DNA template shearing and disruption of bead emulsions, for second-generation DNA sequencing, template library preparation involves production of random collection of adapter-modified DNA fragments. In some applications, such as variant detection resequencing of amplicons, a very tight fragment size distribution is required. Sequence-independent fragmentation processes include: hydrodynamic processes (i.e., nebulization and hydroshearing), and acoustic high-energy processes (i.e., ultra sound disruption). DNA fragmentation by nebulization is rapid and can generate fragments of 200-1500 base pairs (bp), however, shearing is not effective for DNA fragments <1000 pb or for chromatin and the generated fragment size distribution (~100-bp) are too wide, meaning that large portions of generated fragment are of incorrect size, for our requirements, moreover, approximately half of the DNA vaporizes during nebulization leading to substantial sample losses and a minimum input requirement, and the nebuilization process is sensitive to contamination. In contrast, ultrasonic digestion with focused acoustic shock waves is effective for shearing DNA fragments >300pb and intense mixing or disruption of tissues. Process time must be balanced with temperature control to prevent loss of sample integrity. Performance Features: Uses Covaris AFA (Adaptive Focused Acoustic) process for producing a controlled acoustic field inside a closed vessel. Uses dish shaped transducer to converge energy to a small localized area. Isothermal process 500 MHz transducer enabling high frequency focused ultrasonic energy. System can be easily configured for various tubes and vials for single sample processing. Can be integrated into larger automatic systems for high throughput applications. System includes laptop computer operating Covaris proprietary SonoLab software. Process times for shearing to 100 base pairs - 8 min. 200 base pairs = 90 sec, 500 base pairs = 90 sec. Covaris DNA shearing protocols require Covaris microTubes. Tissue samples typically are lysed in 1 - 2 minutes. System size is 21 cm wide, 31 cm high, and 52 cm deep. Minimum Requirements: 1. Computer controllable time and acoustic energy transfer, and real-time monitored temperature, to ensure sample-to-sample sample reproducibility. 2. User-tunable, generated fragment size distribution (range: 150-bp to 6-kbp) for a variable sample volumes (50-500 uL). 3. Closed tube, non contact process producing a controlled focused acoustic field inside a closed vessel. This is essential to limit sample cross-contamination and attendant contamination by human pathogens. The focused field allows for faster, continuous sample treatment, whereas with unfocused devices, longer treatment times result in introduction of significant heat into the system and are unable to be operated isothermally. 4. System frequency must be within the ultrasonic range (wavelengths on average less than 1mm in length), and thus outside the human audible range. This is essential so that the instrument can be operated in a general laboratory bench setting without extra expense for system enclosures to ensure proper ear protection. 5. Sample input flexibility: tubes, vials, for single sample processing; and sample shearing, solubilization/disruption or extraction applications. 6. Maintain sample integrity during processing, isothermal apparatus. 7. Maximum system size cannot exceed 21 cm wide by 52 cm deep owing to space limitations. 8. System which does not require hearing protection or segregation from the common laboratory environment. 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. FDA, Center for Food Safety & Applied Nutrition, 5100 Paint Branch PKWY, College Park, MD 20740. 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: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the items/services offered to meet the Government's requirement (ii) Past Performance (ii) Price. Technical and past performances, when combined, are equal when compared to price. The technical evaluation will be determination as whether the proposed contractor is capable of providing the services or supplies. 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 products/services offered meets the Government's requirement. Past performance will be evaluated based on information provided by the offeror as to actual sales of the proposed product and/or services to industry or government agencies. Past performance will consider the ability of the items to meet technical specifications as advertised by the offeror, past record or meeting delivery schedules and service/maintenance reputation. The government reserves the right to make an award without discussions. 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. The offer shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Government reserves the right to obtain information for use in the valuation from any and all sources including sources outside of the Government. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer or indicate certifications in ORCA at http://orca@bpn.gov. 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: 52.219-4, 52.219-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-1, 52.225-3 ALT II, 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, e-mail or fax on or before September 12, 2009 by 1:00 p.m. (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas), at Food and Drug Administration OC/OSS/OAGS, Attn: Barbara Arnold, 3900 NCTR Road, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Barbara Arnold @ (870) 543-7483, FA