SOURCES SOUGHT
66 -- Fast Protein Liquid Chromatography System
- Notice Date
- 6/12/2013
- 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
- FDA1119535
- Archive Date
- 7/4/2013
- 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 a Fast Protein Liquid Chromatography (FPLC) 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 associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Introduction Congress mandated the FDA to develop a counter terrorism program to address licensing of products to counter the threat of biological release of bioterrorism agents. The FPLC system is crucial to study pathogenesis and test therapeutics, diagnostics, and vaccines. The FPLC system will be used to perform FDA mission-oriented research that has been classified as high-priority and has been funded by the Medical Countermeasures Initiative at the FDA. Statement of Work (SOW) The Laboratory of Emerging Agents performs FDA mission-oriented research in hepatitis viruses and bioterrorism agents. A Fast Protein Liquid Chromatography (FPLC) system is required to perform experiments under Biosafety Level 2 (BSL) containment conditions. The FPLC system is required to purify recombinant proteins to conduct experimentation in molecular biology, immunology, vaccine development, and diagnostics of bioterrorism agents. Due to work with viruses and bacteria, FDA requires a versatile FPLC system with two UV detectors and high maximum flow of 50 ml/min. FDA also require great flexibility to accommodate different preloaded columns and pre-programmed features to automate and simplify the research performed at the Laboratory. Technical Requirements • Multipurpose Fast Protein Liquid Chromatography (FPLC) System • Flow rate range 0.001 - 25 ml/min • Flow rate range, gradients 0.1 - 25 ml/min • Maximum flow rate, of at least, isocratic 50 ml/min • Maximum pressure 20 MPa • Optional Sample Pump • Maximum flow rate, sample pump 50 ml/min • Maximum pressure, sample pump 10 MPa • Automatic pressure flow control • Injection valve with pump and loop positions • Extra inlet positions (any type) • Optional Integrated column by-pass and reverse flow • Optional Loop valve (enables multi-step purification) • Optional Mixer valve (enables by-pass of mixer/in-line filter) • Conductivity monitor • pH valve with on-line calibration and storage • Integrated air sensors in inlet valves • Extra air sensors • Pre- column pressure monitor • Optional Delta column pressure • Maximum of 2 fraction collectors • Maximum of 6 deep-well plates • Drag-and-drop method definition Software • Interactive process picture • Pre-defined methods for GE columns • Optional Software Design of Experiments • Data base storage • Power-save Instrument shall include delivery, installation, training and a minimum 12 month warranty. New instrument: The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. 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. 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 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 June 19, 2013 by 12:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, Office of Acquisition & Grants Services, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1119535. 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/NCTR/FDA1119535/listing.html)
- Place of Performance
- Address: FDA/CBER, 8800 Rockville Pike, Rockville, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03087139-W 20130614/130612235146-e77bd87df8aed2c72dc984a00a79cde5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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