MODIFICATION
66 -- One Automated Open Platform Microbial Molecular Detection System with 4 (1-year Maintenance Option Periods) - Amendment 1
- Notice Date
- 3/21/2013
- Notice Type
- Modification/Amendment
- 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-SOL-13-1116246
- Archive Date
- 4/16/2013
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479
- E-Mail Address
-
yolanda.peer@fda.hhs.gov
(yolanda.peer@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notification for One Automated Open Platform Microbial Molecular Detection System 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 Office of Regulatory Affairs (ORA) requirement for one Automated Open Platform Microbial Molecular Detection System with 4 (1-year Maintenance Option Periods) (capable of next day detection of Salmonella, Shigatoxigenic Group of Escherichia Coli (STEC's) and Listeria for Southeast Regional Laboratory (SRL). The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. In addition, the FDA is seeking business sources 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. The associated North American Industry Classification System (NAICS) Code is- 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard of 500 Employees. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: Background The SRL is in need of a faster more efficient way to screen samples for pathogenic organisms. An automated microbial molecular detection system that utilizes target capture, transcription mediated amplification, and a hybridization protection assay to detect individual pathogens could be a faster and moe efficient way of microbial detection. Intended Use of Product The instrument will be initially utilized in a single laboratory validation with a future intent of multi-lab validations for Salmonella and Listeria species. This instrument must be capable, as delivered, to create customized analysis not readily available in kit form. The Contractor shall meet the following Specifications: Detailed Instrument Characteristics Power requirements for this instrument is as follows: Voltage: between 100-240. This system must evaluate the analysis of samples for Listeria and Salmonella in multiple food and environmental matrices. This system, as delivered, also must be fully capable of screening for STEC's. This system must have an open platform allowing customer's development of new assays. System must minimize operator hands-on time. System must generate results for greater than 200 samples in an 8 hr period. Instrument must have automated liquid level sensing and verifcation for onboard reagents. System must provide automated tracking, barcoding, and storage of data for accountability and traceability. The instrument must be fully automated from sample purification through detection and results. General Duties / Description of Work The automated open platform microbial molecular detection System must be capable of next day detection of Salmonella, STEC's and Listeria for SRL. Trade and Service Specifications 1. The automated open platform microbial molecular detection system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance. 2. The entire system must be warranted for parts and labor for 12 months from the date of installation. 3. Vendor must install the instrument in a building whose access is as follows: Dimensions of doorways, hallway, and elevator inside of facility: Elevator - 48'WideX106 Deep' X82' high, doorway 82' height, hallway 60' wide, and lab doors-82'x48'. 4. Inside delivery and setup of the equipment and on-site operator familiarization training by the vendor is required. 4 (1-year Post Warranty Maintenance Option Periods): •Minimum of one planned preventive maintenance visit per year to include OEM-prescribed/recommended calibrations/recalibrations; •Unlimited corrective/remedial maintenance visits per year, to included OEM-prescribed/recommended calibrations/recalibrations, within 3 business days of service call; •All preventive and corrective/remedial maintenance shall be performed by OEM-certified technicians, following OEM specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc.; •Pricing for preventive and corrective/remedial maintenance shall be inclusive of all labor, travel, and parts, components, subassemblies, etc.; •Unlimited 24X7 Telephone Technical Support and Trouble Shooting Assistance; and •Unlimited Software and Firmware Updates. Place of Performance: FDA/SRL Atlanta, GA 30309 Responses to this sources sought shall unequivocally demonstrate that respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. 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 and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again if responding to provide a product manufactured by another firm.] •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 (should also include drawings and photos), 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; •Descriptive literature, brochures, marketing material, etc. detailing the nature of the items the responding firm is regularly engaged in manufacturing and/or selling; •If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; •If a large business, identify the subcontracting opportunities that would exist for small business concerns; and •Though this is not a request for quote, informational pricing is encouraged. 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. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before April 1, 2013 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Yolanda Peer, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email yolanda.peer@fda.hhs.gov. Reference FDA-SOL-13-1116246. 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/DCASC/FDA-SOL-13-1116246/listing.html)
- Place of Performance
- Address: FDA/SRL, 60 8th Street NE, Atlanta, Georgia, 30309, United States
- Zip Code: 30309
- Zip Code: 30309
- Record
- SN03017999-W 20130323/130321234915-4a8fca32861264540c6f7c4c5757cc09 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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