SOURCES SOUGHT
66 -- Real-Time Label-Free Cell Analysis System
- Notice Date
- 1/7/2015
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-15-223-1144137
- Archive Date
- 2/7/2015
- Point of Contact
- James Scott Rawls, Phone: 8705437540
- E-Mail Address
-
james.rawls@fda.hhs.gov
(james.rawls@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- 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) Division of Biochemical Toxicology (DBT) requirement for a Real-Time Label Free Cell Analysis System to monitor the effects of various drugs on cardiomyocytes. 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 associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Statement of Need Numerous drugs have the potential for adverse effects on prolonging the QT interval, a marker for torsade de pointes (TdP), which can cause the heart to stop beating. The current FDA guidelines are very useful for identifying QT prolonging drugs, but some QT "positive" drugs have no demonstrable clinical risks of TdP. Researchers are aiming to establish an appropriate, strong pre-clinical proarrhythmia screening model that can directly measure and rank TdP risk and the influence of sex hormones. DBT requires a system that can monitor cells in real-time without the potential artifacts generated through the use of labels. DBT researchers require a non-invasive measurement method that allows detection of changes in adherence, morphology and viability without the need for over-expression of reporter and target proteins. Statement of Work (SOW) General: New instrument: The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The Contractor shall warranty all systems for parts and labor for a minimum of 12 months from date of Government's formal acceptance. The Contractor shall provide in-side delivery, installation, and shall provide on-site training on the installed system. Installation: The vendor shall demonstrate upon installation that the item meets all performance specifications. The instrument shall not be accepted until those performance specifications have been met. The system shall be delivered with all necessary supplies and accessories required for installation and start-up. Technical Specifications: The system shall include the following: •The system shall offer impedance-based, real time dynamic monitoring of beating cardiomyocytes on a millisecond timescale. •The system shall have the capacity to be placed in a standard tissue culture incubator and be able to withstand the high temperature and humidity typical of that environment. •Software provided with the system shall have the capacity to be programmed to acquire beating data on a millisecond timescale, at intervals ranging from minute to weeks for assessment of both acute and long-term cardiotoxic effects. •The system shall be able to produce highly sensitive and reproducible results even when dealing with low cell numbers. •The system shall be capable of measuring essentially the entire bottom surface of the well, such that, the dynamic range of the system approaches 2 logs of cell growth - from 100 cells per well to confluence (depending on cell type). Also, well-to-well precision and accuracy are extremely important. The typical well-to-well CVs shall be less than 10%. •The software package shall be fully integrated into the control software and offer specialized algorithms such as - slope, cell index doubling time, EC50 (Half Maximal Effective Concentration), IC50 (Half Maximal Inhibitory Concentration), maximum cell index, minimum cell index, area under the curve, time dependent EC50 determination, beating rate, beat amplitude, normalized beating rate/amplitude, beating period/duration, beating rhythm irregularity. •The system shall be able to perform a number of applications such as cell proliferation, cell quality, compound mediated cytotoxicity, cell-mediated cytotoxicity, cell adhesion and spreading, functional monitoring and receptor tyrosine kinase and GPCR (G Protein-Coupled Receptor) signaling, cell-mediated cytolysis, and viral quantification. •The system shall be a low-maintenance system that does not require any calibration. Place of Performance FDA/NCTR Jefferson Laboratories Complex 3900 NCTR Road Jefferson, AR 72079 The respondent to this source sought notice 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 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 for use on same or similar applications--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 January 23, 2014 by 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: James "Scott" Rawls, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email james.rawls@fda.hhs.gov. Reference FDA-15-223-1144137. 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)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-15-223-1144137/listing.html)
- Place of Performance
- Address: HHS/FDA/NCTR, 3900 NCTR Rd., Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03610259-W 20150109/150107234206-1d6c47bc515f9782481ffaeeabeaabee (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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