SOURCES SOUGHT
66 -- Automatic DNA/RNA Extraction System
- Notice Date
- 6/6/2016
- 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 - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1168964
- Archive Date
- 6/29/2016
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for an Automatic DNA/RNA Extraction System. This is a Sources Sought Notice to determine the availability and capability of Small Business Manufacturers or Small Businesses capable of supplying a U.S. made product of a small business manufacturer or producer. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, 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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The appropriate NAICS code for this acquisition is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. Statement of Work (SOW) Background/Objective The Facility for Biotechnology Resources (FBR) at the Center for Biologics Evaluation and Research (CBER) provides next generation DNA sequencing (NGS) services to CBER scientists using two sequencers, Illumina HiSeq 2500, Serial Number 7001029 and MiSeq DNA sequencer, Serial Number M10542. These sequencers support scientists' in-depth genetic, genomic, pathogenic, and viral studies through massive parallel DNA sequencing. Several critical steps in next generation sequencing include; 1) the preparation of high quality, size-selected DNA/RNA fragments suitable for library construction; 2) amplification of cluster formation on Illumina flow cells; and 3) sequencing reactions, based on "sequencing by synthesis (SBS)" in a sequencer. Step 1 is most critical and labor intensive, involving multiple steps sample handling and laborious bench work to produce high quality DNA or RNA for the subsequent experiments. An Automatic DNA/RNA Extraction System will help ease intensive labor required for handling multiple samples for yielding high quality DNA and RNA form cells, tissues, feces, etc. General Requirement 1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. 2. The instrument shall be warranted for parts and labor from date of installation acceptance. All warranty work shall be performed on-site at CBER, i.e., returning the equipment to the manufacturer is unacceptable. 3. The system shall be delivered with all components, accessories, start-up supplies required for installation and start-up., i.e., a turn-key solution. 4. The Contractor shall provide on-site (Government-site) operator familiarization training of the system upon completion of installation. Such familiarization shall include system operations, optimization, and basic preventive maintenance procedures. 5. The Contractor shall include all parts, travel, and labor to complete installation. Installation shall be performed and completed during normal duty hours (Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time). Technical Requirement At a minimum, the instrument shall meet the following requirement: a. The instrument shall be capable of carrying out automatic DNA and RNA extraction from cells, tissue, saliva, blood, and fecal samples. b. The instrument shall be a table-top with dimension not to exceed 13"x14"12" (W × D × H) due to space limitation, and is powered by regular 110-120V power supply. c. The purification method uses sample lysis and binding to paramagnetic particles as the primary separation principle. d. The instrument shall be able to use pre-filled reagent cartridges for easy reaction set-up. e. The instrument shall be able to purify; 1) DNA from a wide range of sample types including blood, buffy coat, buccal swab, cells, tissue, FFPE (formalin-fixed paraffin-embedded), fecal samples, saliva, ccf (circulating, cell-free) DNA from plasma, plant, and soil; 2) RNA from blood, cells, tissue, FFPE, and plant; 3) microRNA from tissues; and 4) total nucleic acid from serum and plasma. f. Shall include an instrument control computer integrated, comes pre-loaded with protocols, and is ready-to-use through an intuitive touch screen interface. g. The contractor shall provide firmware upgrades, updated protocols, and new applications for future use. h. The instrument shall be fully automated, capable of processing of 1 to 16 samples per instrument purification run in less than 70 minutes. i. The instrument shall use UV radiation for sanitization and hated elution to improve the yield. FOB Point Destination: Delivery/Installation is within one-hundred twenty (120) calendar days after receipt of contract award. Delivery Address: Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Building 52, Room 1152 Silver Spring, MD 20993 POC (will be provided at time of award) The respondent to this source sough shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide products/services and components meeting the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying U.S. made system of another small business manufacturer or producer, all interested parties may respond. At a minimum, responses shall include the following: Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered products and services meet or exceed above specifications. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. The government is not responsible for locating or securing any information, not identified in the response. Interested parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before June 14, 2016 by 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1168964. 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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