SOURCES SOUGHT
66 -- Magnetic Resonance Imaging System
- Notice Date
- 3/18/2015
- 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
- 1145769
- Archive Date
- 4/17/2015
- Point of Contact
- Sondea R Blair, Phone: 8705437469, Nick Sartain, Phone: 8705437370
- E-Mail Address
-
sondea.blair@fda.hhs.gov, nick.sartain@fda.hhs.gov
(sondea.blair@fda.hhs.gov, nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small and large businesses in providing a Magnetic Resonance Imaging System with installation, training, and up to four (4) 1-Year periods for post warranty Preventive and Corrective Maintenance. The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Neurotoxicology requires a wide bore, high-field Magnetic Resonance Imaging System to characterize MRI-measurable transient and permanent responses to different kinds of intervention including chemical, pharmacological, and biological compounds in larger animals (non-human primates). The system will be used for translational research in the areas of neurotoxicology and developmental toxicology, including pediatric anesthesia safety and translational imaging biomarkers of toxicity research; systems biology, including drug-induced liver disease. The results obtained using non-invasive imaging of monkeys will greatly improve the understanding of the mechanisms of drugs and chemicals toxicity in higher species comparing to small animals like mice and rats. The system will furthermore help to advance the research tools and biomarkers discovered using small animals to larger animals and eventually to clinical and research use in humans. Experiments will be directed as imaging of live subjects with the possibility of repeating such imaging over prolonged periods of time to follow the development of disease, treatment, or other morphological and/or functional changes of the subject. Part II: Work Requirements A. Magnetic Resonance Imaging System At a minimum the contractor will be required to provide: • Minimum 4.7 tesla magnetic field strength • At least 4-channel proton receive capability to accommodate phase array RF coils • Multi-nuclear capability including19F, 1H, 23Na, 13C, frequency tuning • At least 40 cm bore size with at least 22 cm bore available for subject placement • Wide array of available imaging and spectroscopy pulse sequences including multi-echo spin echo, gradient echo, echo planar, diffusion weighted, arterial spin labeling, PRESS, STEAM, zero echo time, susceptibility weighted, spectroscopic imaging, FASTMAP, gradient shimming, angiography, and others • External gating capability • Animal physiological monitoring and gating equipment including respiration, pulse oximetry, and temperature options • Zero boil-off cryogenic recirculation system • Active magnetic shielding B. Training At a minimum the contractor will be required to provide: • On-site training for system operators including but not limited to system operations (inclusive of hardware and software), quality control, instrument programming, diagnosing instrument problems, basic and routine preventative maintenance procedures, cleaning requirements, troubleshooting, and system maintenance. C. Minimum Service Requirements I. Warranty At a minimum the contractor will be required to provide: • Minimum 12-month warranty on the entire system, inclusive of hardware and software components. • Warranty shall be inclusive of parts, labor, and travel expense to commence upon completion and acceptance of system and training. II. Post-Warranty System Service Plan: Preventive Maintenance/Corrective Maintenance Service At a minimum, the Contractor will be required to provide: • One (1) scheduled preventive maintenance visit annually inclusive of parts, travel, and labor expense • Include unlimited corrective/remedial maintenance visits within 3 business days of call for service • Include unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) • Include unlimited software and firmware updates • All maintenance and repair activities shall be performed by trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. • Access for the FDA Contracting Officer's Representative (COR) and system operator personnel to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument • Services inclusive of labor, travel, replacement parts, components, subassemblies, etc. D. Turnkey System At a minimum, the Contractor will be required to provide: • Turn-key solution which shall include, but not be limited to: all hardware, software, components, connectors, interfaces, instruments, supplies, kits, on-site familiarization, installation and operational qualification (i.e., IQ and OQ), required to meet these specifications and the FDA's stated need and intended use for the system. • Site preparation will be accomplished by the Government. Part III: Supporting Information A. Place of Performance U.S. Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 B. Period of Performance System delivery, installation, and training shall occur within 360 calendar days (or less) from date of award. Part IV: Instructions to Prospective Respondents Respondents shall furnish sufficient information necessary for the Government to fully understand the capabilities of their MRI System(s) and associated services as it relates to the requirements and intended use set forth herein. 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; ~Descriptive literature, brochures, specifications, marketing material, etc. that clearly detail the dimensions, attributes, specifications, capabilities, and user maintenance requirements of/for the respondent's MRI System(s) and associated services as it relates to the requirements and intended use set forth herein AND site preparation requirements necessary for the installation and operation of the respondent's MRI System(s); ~Prior experience/usage information for same or near same use of the respondent's MRI System(s) and associated services to include the MRI System(s) configuration, description of application(s) for which the MRI System9s) was used, 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; ~Identify any issues or concerns with the requirements as currently stated to include any additional information that may be desired when the solicitation is ultimately released; ~If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; ~Although 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 the information required herein, which is due in person, by postal mail or email to the point of contact listed below on or before April 2, 2015 by 9:00 AM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, Bldg 50, Room 421, HFT‐320, Jefferson, AR 72079‐9502 or email sondea.blair@fda.hhs.gov. Reference Number 1145769 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in better understanding the capabilities of MRI Systems as it relates to the requirements and intended use set forth herein, assist in better defining the Government's requirements for a MRI System and associated services in terms that would promote competition without negatively impacting the intended use set forth herein, facilitate the preliminary planning and design for facility renovations necessary to house and operate the MRI System as it relates to those common/similar site preparation requirements across the marketplace, and determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open 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 solicitation (No. FDA-15-223-SOL-1145769) may be published via 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/1145769/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03671261-W 20150320/150318234632-963a9a40462e72b4225c4cc774f32f65 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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