SOURCES SOUGHT
66 -- Capillary Genetic Sequencing /Analyzer Systems Plus Service Maintenance Agreement
- Notice Date
- 2/24/2011
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFI-1081931
- Archive Date
- 3/7/2011
- Point of Contact
- Linda Troutman, Phone: 3018277168
- E-Mail Address
-
linda.troutman@fda.hhs.gov
(linda.troutman@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Document Type: Sources Sought Release Date: February 24, 2011 Response Date: March 01, 2011 at 4:30pm local time via email to Linda.Troutman@fda.hhs.gov Contracting Office Address: Food and Drug Administration, Linda Troutman, Contract Specialist Description of Services/Supplies: (3) Three Capillary Genetic Sequencing/Analyzer Systems and Service Maintenance Agreement for 4 Option Years This is a Request for Information (RFI) to identify the capabilities of the marketplace of all interested parties. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. According to FAR Part 10, Market Research, the results of the market research will be used to: i) Determine if sources capable of satisfying the agency's requirements exist; (ii) Determine if commercial items or, to the extent commercial items suitable to meet the agency's needs are not available, nondevelopmental items are available that- (A) Meet the agency's requirements; (B) Could be modified to meet the agency's requirements; or (C) Could meet the agency's requirements if those requirements were modified to a reasonable extent; (iii) Determine the extent to which commercial items or nondevelopmental items could be incorporated at the component level; (iv) Determine the practices of firms engaged in producing, distributing, and supporting commercial items, such as type of contract, terms for warranties, buyer financing, maintenance and packaging, and marking; (v) Ensure maximum practicable use of recovered materials and promote energy conservation and efficiency; and (vi) Determine whether bundling is necessary and justified. (vii) Assess the availability of electronic and information technology that meets all or part of the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at 36 CFR Part 1194. The extent of market research will vary, depending on such factors as urgency, estimated dollar value, complexity, and past experience. The contracting officer may use market research conducted within 18 months before the award of any task or delivery order if the information is still current, accurate, and relevant. Market research involves obtaining information specific to the item being acquired and should include- (i) Whether the Government's needs can be met by- (A) Items of a type customarily available in the commercial marketplace; (B) Items of a type customarily available in the commercial marketplace with modifications; or (C) Items used exclusively for governmental purposes; (ii) Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs; (iii) Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products or services are made; (iv) The requirements of any laws and regulations unique to the item being acquired; (v) The availability of items that contain recovered materials and items that are energy efficient; (vi) The distribution and support capabilities of potential suppliers, including alternative arrangements and cost estimates; and (vii) Size and status of potential sources. Mission and Objectives: FDA anticipates the need for (3) three Capillary Genetic Sequencing/Analyzer Systems and Maintenance Agreement for 4 Option Years to provide the agency with a more reliable method of providing for the rapid and precise identification of microbial contaminants. RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall be:  identified with the RFI number ;  no more than ten (10) pages in length;  not submit marketing materials;  submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability Functional Specification: Is your company capable of providing (3) Three Capillary Genetic Sequencing/Analyzer? Does this system have a fluorescence-based 24-capillary electrophoresis system used for genetic analysis? Does this system come with all power sources, light sources, cables, lamps, sensors, optics and tooling required to use the system with user supplied substrate and be compatible with a 96-well thermal cycler? Does the system include a computer workstation with software capable of identifying and classifying unidentified bacterial or fungal sequences? Does this system have the following components and meet the following technical specifications? 1. Size: No larger than width of 61cm (closed door) & 122cm (open door), depth (61cm), Height (72cm), i.e., benchtop. 2. Process multiple runs with up to 24 samples per run 3. Detect and analyze six fluorescent dyes simultaneously for DNA fragment analysis. 4. Run a variety of sequencing and fragment analysis applications to include micro-satellite analysis, AFPL, LOH, SNPlex TM validation, SNP screening, and de novo sequencing and re-sequencing (mutation profiling). Capable of running full range of applications on a single polymer and capillary array meaning user shall be able to run mixed applications on one plate. 5. Computer controlled for automated operation. The analyzer shall be programmable for continuous and unattended operation with auto-injection capability. 6. Include the ability to function in 96-well and 384-well formats that are compatible to 96-well and 384-well thermal cyclers, and be able to analyze multiple samples simultaneously. 7. Include an automated polymer delivery system that eliminates manual syringe washing and filling associated with instrument setup and maintenance is required. 8. Automatically inject samples into the twenty four capillary arrays. 9. Include the ability to seamlessly switch between sequencing and fragment analysis runs either between plates or within a single plate. 10. Include a 24 capillary pre-assembled array of variable lengths that are designed for use with industry standard 96- and 384-well microtiter plates 11. Achieving accurate read lengths at least 1,000 base pairs in a single sequencing reaction using an 80 cm capillary array. 12. Perform de novo DNA sequencing and generate an average of 700 bases and up to 1000 bases per sequencing reaction. 13. Perform DNA fragment analysis in size 50-600 base pairs, such as Amplified Fragment Length Polymorphism (AFLP), and perform comparison among multiple AFLP samples, and output the comparison result automatically. Does this system have 96-well Thermal Cycler that includes the following? 1. The Thermal Cycler able to perform thermal cycle sequencing and regular PCR reactions in 96-well, 0.2mL per well format. Does the Thermal Cycler have six temperature controlling zones for PCR optimization? 2. The Thermal Cycler contains multiple thermal blocks that can be programmed independently for maximal versatility and flexibility. 3. The Thermal Cycler provide user friendly interface for programming and can display real-time temperature profiles during the running of reactions. The Thermal Cycler has an option to save the programmed PCR methods to the instrument and to a portable USB memory device. 4. The Thermo Cycler compatible with the above provided DNA sequencer/genetic analyzer Does this system have Gene Sequence Reference/Identification Database with the following capabilities? 1. Includes a reference database for microbial 16s rRNA gene that can be used for microbial identification. 2. Expandable to add custom generated sequences. 3. Create a customized library of any given gene and able to perform in-house sequence comparisons. 4. Output the sequencing results in FASTA (FASTA-All) format. 5. Software and database installed and operated on a stand-along workstation or computer. Does this system have includes the following software and algorithms at a minimum? 1. Sequencing analysis software for base calling 2. Sequence scanner software that enables user to view, edit, print and export sequence data, and generate graphically expressive reports on results 3. Software to allow user to view, edit, analyze, print and export fragment analysis data 4. Software designed for reference based and non-reference based analysis in support of mutation detection and analysis, SNP discovery and validation, and sequence confirmation 5. Software tools to assist with regulatory and compliance requirements associated with FDA 21CFR Part 11 Does this system allow for an extended warranty for 4 years total? If not, what is your customary practice warranty for this type of instrument? Does this system include installation and training? Does this system include a sufficient number of test kits to perform a minimum of 500 PCR and sequencing applications? Part B. Size of Business State whether your company is a large business, small business (and also state socioeconomic status), College/University, or a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. Under $150,000.00 Over $150,000.00 and Under $500,000.00 Over $500,000.00 and Under $1,000,000.00
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-1081931/listing.html)
- Place of Performance
- Address: Multiple Location, United States
- Record
- SN02386704-W 20110226/110224234334-84dd5ea26804b6b21372036b509866b4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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