SOURCES SOUGHT
66 -- Electrochemical Luminescence (ECL) System
- Notice Date
- 6/8/2015
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1151443
- Archive Date
- 7/1/2015
- 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 Electrochemical Luminescence (ECL) System, Supporting Accessories, and Post Warranty Maintenance Option Periods. 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 500 employees. Statement of Work (SOW) The Division of Viral Products (DVP) within CBER laboratory has been using a Meso Scale Diagnostics LLC Sector Imager 2400, Model 1250, Serial Number 1250070709271,, to quantify cytokines in various samples. Unfortunately, the instrument is no longer operable. The instrument will be obsolete in a few months and therefore parts and service on it will no longer be available. DVP requires a multiplex ECL instrument that will allow DVP to continue to measure cytokine concentrations in samples and be able to utilize plates (e.g., Human TH1/TH2 10-Plex Tissue Culture Kit cat # K15010B-2; Mouse TH1/TH2 9-Plex Tissue Culture Kit cat #K15013B-2) currently owned by DVP with the instrument. General Requirement 1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. 2. The entire system shall be warranted for parts and labor for a minimum of 12 months 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 necessary supplies and accessories 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, data analysis, 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 am to 4:30 pm, Eastern Time). Technical Requirement At a minimum, the Contractor shall provide an ECL and Supporting Accessories that shall meet the following: ●The plate reader shall be an electrochemiluminescence detection instrument ●Shall use multi-array and multi-spot microplates, coated with up to 10 cytokine/chemokine antibodies available for binding with corresponding cytokine/chemokine ●Shall use stable labels, non-radioactive, and conveniently conjugated to cytokines/chemokines; ●Shall read plates fast i.e., 3 minutes per plate ●Shall be equipped with an ultra-sensitive photodetector ●Shall have sensitivity of sub-pg/mL detection limits and more than 4 logs of concentration dynamic range ●Shall include data analysis package and a computer with the instrument ●Shall use simple and quick protocols; assays shall be completed in 4 hours ●Shall not require daily or monthly calibration ●Shall not include fluidics in the instrument Four (4) 1-Year Post-Warranty Option Periods for a Service Agreement shall include, at a minimum, the following: ●Shall include not less than one (1) planned preventative maintenance visit per contract year. ●Shall include unlimited corrective/remedial maintenance visits within 3 business days of initial call for service if problem(s) can't be resolved remotely. ●Shall include unlimited technical support, Monday - Friday (excluding Federal Holidays) between the hours of 8:30 AM - 5:00 PM (Eastern Time) within 24 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.). ●Shall include unlimited software and firmware updates. ●All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. ●Service coverage shall include trouble-shooting capabilities based on a high level of expertise and complete knowledge of the instrument. ●All maintenance pricing shall be inclusive of labor, travel, replacement parts, lasers, components, subassemblies, etc. Deliverables: Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. Place of Performance White Oak Campus Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Building 52/72 room 1351 Silver Spring, MD 20993 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. 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 16, 2015 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 FDA1151443. 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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