SOURCES SOUGHT
66 -- Automated RNA Extraction Instrument
- Notice Date
- 5/6/2016
- 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
- FDA1166816
- Archive Date
- 5/31/2016
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@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 National Center for Toxicological Research (NCTR) requirement for an automated RNA extraction instrument. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. The instrument will be used in several NCTR protocols, including protocols funded under an Interagency Agreement between NCTR and National Institute of Environmental Health Sciences / National Toxicology Program (NIEHS/NTP). The instrument will be used to accurately identify and quantity biomarkers, including serum microRNAs, in biological samples and understand the mechanism of toxicity of products of interest to the FDA. The NCTR requires an automated instrument that will extract nucleic acids in a 96 well format, using superparamagnetic particle (magnetic beads) technology. This type of instrumentation will optimize NCTR’s ability to uniformly extract nucleic acids from small volumes of body fluids, while enabling the processing of a large number of samples. The minimum performance specifications are: 1. Shall be able to extract RNA, DNA, and protein from low volume body fluid samples (maximum 25 ul of serum) from 8 to 96 samples at one time, in an automated system. 2. Uses superparamagnetic particle (magnetic beads) technology, in which the beads are moved instead of transferring liquids. 3. The system shall be optimized to process serum samples using an appropriate total RNA isolation kit. The MagMax mirVana Total RNA Isolation kit has been optimized and is currently used in the laboratory for the manual isolation of serum microRNAs. 4. Uses reagent consumables which are matched specifically to the instrument to ensure uniformity and pure nucleic acids for downstream applications. 5. An automated system which can eliminate hands-on processes such as ethanol precipitation, phenol/chloroform extraction, and centrifugation. 6. Automation system is enclosed to prevent outside contamination of samples 7. Automation system can be used with multiple magnetic particle bead kits for the purification of genomic DNA, plasmid DNA, total RNA, mRNA, PCR products, whole cells and proteins from a variety of starting matrices (including serum, frozen and paraffin embedded tissues, cells, bone, feces, bacteria, swabs, etc.). 8. Can work with any magnetic bead system 9. Has a software that allows users (and kit manufacturers) to write and modify protocols and then upload them to the instrument 10. Utilizes a low elution volume to maximize nucleic acid concentration 11. Includes a snap-on heat block for applications requiring temperature control 12. Include a one-day training session Installation, Training and Additional System Requirements. The contractor shall provide inside delivery, installation and operator familiarization training for each system. The contractor shall provide one (1) day of on-site training (in addition to installation of the system) for up to six personnel to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. The contractor shall provide all installation materials. The US Government is responsible for room preparations for the installation of the equipment. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and components/materials otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year. The contractor shall provide warranty and maintenance service response time during warranty period. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery date is within 60 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a 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 can meet the above requirements. 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 in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the 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. · Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. · If a large business, identify the subcontracting opportunities that would exist for small business concerns; · Standard commercial warranty and payment terms; and · Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. 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 May 16, 2016 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1166816. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 FedBizOpps. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1166816/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Record
- SN04109007-W 20160508/160506234607-1b3f5140b33f92bc36269ea85fc528de (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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