SOURCES SOUGHT
66 -- Immunoassay System
- Notice Date
- 2/3/2016
- 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
- FDA1161996
- Archive Date
- 2/26/2016
- 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 National Center for Toxicological Research (NCTR) requirement for an Immunoassay 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 500 employees. Statement of Work (SOW) Background/Objective Drug-induced cardiac toxicity is one of the common adverse effects which cause concern by FDA and physicians. This kind of cardiotoxicity often leads to cardiac injury over time. Troponin I has been used in clinic for detecting the cardiac injury after it occurs. The NCTR, Division of Systems Biology (DSB) conducts several ongoing studies at NCTR that are focused on early biomarkers for drug-related cardiotoxicity. Plasma samples are used to assess cardiac injury in these studies since this non-invasive approach can be easily applied to clinic studies in the future. The level of cardiac troponin I, one of the most commonly used cardiac injury biomarkers, needs to be measured to help access the severity of drug-induced cardiac injury. One of the challenges DSB are facing is the low level of troponin I in mouse plasma compared to human plasma. DSB requires an Immunoassay System that can quantify the cardiac troponin I efficiently with high sensitivity in mouse plasma since the level of cardiac troponin I in mouse plasma is relative low compared to human plasma sample. The data gained from this instrument will directly help to interpret the drug treatment effect. 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 NCTR, 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, Central Time). Technical Requirement At a minimum, the Immunoassay System shall meet the following requirement: •Beaded-based, fluorescence-coupled, single-molecule counting for ultra-sensitivity and low background. •Low limit of detection at 0.1 picogram/milliliter for Troponin I assay. •Linear dynamic range of up to 4 orders of magnitude for detection. •High precision counting with low end average cardiovascular (CV) less than 12 percent for Troponin I assay. •Small volume (down to 50 microliters) needed for each assay. Three One (1) Year Post Warranty Option Periods Minimum Service Agreement Requirements: •Shall include 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 7:00 AM - 4:00 PM (Central 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. •All maintenance pricing shall be inclusive of labor, travel, replacement parts, 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. FOB Point Destination: Delivery/Installation is within one-hundred twenty (120) calendar days after receipt of contract award. Delivery Address: National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 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 February 11, 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 FDA1161996. 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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