SOURCES SOUGHT
66 -- Immuno Assay System
- Notice Date
- 7/1/2014
- 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-1135331
- Archive Date
- 7/25/2014
- 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 Center for Biological Evaluation and Research (CBER) requirement for an immuno assay system. The FDA is seeking small business 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 a stainless steel exposure module 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 Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) requires an electrochemiluniescence immunoassay multiplexing system. The system will be used on the project titled: Functional Analysis of CD8+ T lymphocyte Activities Responding to Vaccine Dendritic Cells loaded with Different Tumor peptides, and other immunoassay required projects run in the Division of Cellular and Gene Therapies. The system will be used on projects to measure the amount of cytokine/chemokine, or other proinflammatory agents secreted by CD8+ T lymphocytes, the cytotoxic immune cells in fighting with tumor cells. Detection of certain cytokines/chemokines, such as interferon gamma in lymphocytes, is the indexes of tumor specific CD8+ T lymphocyte are activated. The process is called function analysis. The function analysis is required for research projects related to develop tumor vaccines and immune-therapies against cancers, the mission of the Branch of Tumor Vaccine and Biotechnologies of Division of Cellular and Gene Therapies with CBER. Performance requirements to best accomplish the projects, the immunoassay system shall: - Use multi-array and multi-spot microplates that coated up to 10 cytokine/Chemokine antibodies available for binding with corresponding cytokine/chemokine secreted by lymphocytes in biological samples; - Use stable labels, non-radioactive, and conveniently conjugated to cytokines/Chemokines; - Use multiplexing instrument to read above immunoassay plates with fast speed, 3 minutes per plate, ; - An electrochemiluniescence detection instrument that equipped with ultra-sensitive photodetector offering superior sensitivity of sub-pg/mL detection limits and more than 4 logs of concentration dynamic range to collect and quantitatively measure light emitted from the microplates; - Include data analysis package and a computer with the instrument; - Complete assays in 4 hours; - Provide full and qualified scientific support covering training, assay development, and data analysis; - Capability to provide customer designed immunoassay plates. The system shall be also suitable for using in other research projects, such as in detection of biomarkers for Alzheimer's Disease, Oncology, Toxicology, Metabolic Disease, Vascular and Growth factors, Cell Signaling Pathways, Immunogenicity, Cell-Based Assays, Vaccine/Bioproduction. Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation and operator familiarization training for each system. The contractor shall provide one (1) day of on-site training. Offered systems 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. The systems shall be delivered (in-side delivery) with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Post-Warranty Service Agreement (preventive and corrective maintenance) shall, at a minimum, include the following - Minimum of one (1) planned preventative maintenance visit per contract period per instrument; - Unlimited phone and email support for technical troubleshooting, assay development during the contractor's normal operating hours; - Preventative maintenance shall include all labor, travel, and parts (except consumables); - Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.; - Access by 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; - System software and firmware updates required for reliability improvements and correction of any defects; - 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. 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 29 Lincoln Dr, Bethesda, MD 20814. 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 in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the 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 July 10, 2014 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1135331. 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-1135331/listing.html)
- Place of Performance
- Address: 29 Lincoln Drive, Bethesda, Maryland, 20814, United States
- Zip Code: 20814
- Zip Code: 20814
- Record
- SN03412015-W 20140703/140702002832-821c42ad90d305ed3365860f902019fc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |