SOURCES SOUGHT
66 -- Positron Emission Tomography (PET) and Computed Tomography (CT) System
- Notice Date
- 7/23/2013
- 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
- FDA-1122355
- Archive Date
- 8/21/2013
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@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 The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for a Positron Emission Tomography (PET) and Computed Tomography (CT) System, hereinafter referred to as PET-CT System. The FDA is seeking small businesses sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the PET-CT System described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The FDA/NCTR requires one high sensitivity and high resolution PET-CT modular system for the purpose of evaluating the general anesthetics-induced developmental neurotoxicity in small animals (mice, rats, and neonate non-human primates). This PET-CT System will be utilized to accomplish in vivo, non-invasive scanning to characterize transient and/or permanent neural responses via different types of intervention including chemical and biological compounds in small animals including non-human primates. Experiments will be directed at neuro-imaging of live subjects and as ongoing studies to characterize immediate neural expression and compound effects within the brain structures of small animals. The PET-CT System shall be a multimodality platform to provide molecular imaging to specific research applications with peripherals that will enable researchers within the bio-imaging lab at the NCTR to image small animals more efficiently and provide a refinement to data collected for neurological studies. The instrument will assist the research aimed to search for more efficient biomarkers of anesthetic-induced neurotoxicity (e.g., cellular apoptosis, disturbed neural regeneration). Currently, [18F]FEPPA is the only radiolabeled ligand applied in the baby non-human primates. F-18 is the radionuclide synthesized to the following: [18F] -N-2-((2-fluoroethoxy) benzyl)-N-(4-phenoxypyridin-3-yl) acetamide. This is a radioactive tracer used in the current PET system as a potential biomarker of Pathogenic Process in the brains of animals. The instrument will be used to carry out the research work to investigate on a range of candidates for radiolabeled ligands for anesthetic-induced neurotoxicity. Performance requirements • The PET-CT system shall be integrated/dockable - that is the data collected from multiple modalities (i.e. PET and CT) are unified and analyzed quantitatively. • The PET-CT system shall contain an advanced PET detector technology (LOS - Lutetium Oxyorthosilicate). The performance of a PET scanner depends greatly upon the physical and scintillation properties of the crystal detector material; which LSO offers the best combination of properties of any PET scintillator utilized. • The PET-CT system shall afford a fine 1.4 mm resolution at the center of view (FOV) with 1.6 mm x 1.6 mm detector pixel spacing. • The PET-CT system shall provide increased axial Field of View (FOV) (10 cm or above) and transaxial FOV (12.7 cm or above) materialized by 20 x 20 or larger array detection area. • The PET-CT system shall contain a 165 mm detector with variable-focus source in the CT platform (with high resolution of 20 microns or above.) • The PET-CT system shall provide a standard x-ray source of 80 W, tungsten anode, 35-80 kVp source with less than a 50 micron focal spot. This source provides a high x-ray flux for high speed scanning and large cone angle for high magnification studies. The achievable resolution with this x-ray source and the standard detector is around 40 microns. Typical scan times can be less than 5 minutes. • The PET-CT system training. Shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need. Instrument shall be warranted for not less than one (1) year to commence upon formal acceptance of the system by the FDA. Post-Warranty Service Agreement (preventive and corrective maintenance) for up to three (3) 1-year option period. FOB Point Destination. All items shall include delivery to the destination identified below. Desired delivery/installation date is within 120 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079. 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. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a 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 can meet the above requirements. 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. • Information on available service/maintenance plans. • Three (3) years of past performance information for the manufacture and/or sale and maintenance support 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. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. 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. 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 August 6, 2013 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1122355. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source 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 pre-solicitation synopsis and solicitation may be published in 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/NCTR/FDA-1122355/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03124467-W 20130725/130723235326-b5141f69995d0932ae2076019956d11d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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