SOURCES SOUGHT
66 -- Fluorescene Spectrophotometer
- Notice Date
- 4/13/2012
- 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
- 1101854
- Archive Date
- 5/5/2012
- Point of Contact
- Sondea Blair, Phone: 8705437469
- E-Mail Address
-
sondea.blair@fda.hhs.gov
(sondea.blair@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS FOR MARKET RESEARCH PURPOSES ONLY, NOT A REQUEST FOR PROPOSAL OR SOLICITATION. The U.S. Food and Drug Administration (FDA) is seeking small business concerns, including veteran-owned small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women owned small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential small business concerns for this effort: The government is seeking small business concerns capable of meeting the FDA's Center for Biologics Evaluation and Research (CBER) requirement for a fluorescene spectrophotometer. CBER's Tumor Vaccines and Biotechnology Branch at the Division of Cellular and Gene Therapy, Office of Cellular, Tissue and Gene Therapy, requires the fluorescene spectrophotometer to measure fluorescence from different sources such as bilogocals either alone or conjugated with specific fluorescence tags to evaluate identity, characteristics and biological activity of cellular and gene therapy based cancer vaccines. The instrument will support the mission-critical research for fluorescence and colorimetric tags coupled with antibodies specific for specified cancer antigens for in vitro and in vivo experiments in animal models of human cancers. This study is valuable and helpful in understanding the role of different biomarkers, which may serve as specifications for lot release tests and potency and efficacy of cancer vaccines. The analysis of study samples with this instrument will assist CBER reviewers to develop review strategies for regulation of cancer vaccines. Specifications -Capability for scan speeds of at least 15-60000 nm/min. with a slew speed of at least 60,000 nm/min. -Beam to be horizontal using less than 0.6 ml in standard quartz cuvette using a Grating-Grating monochromator with reference beam PMT. -Resolution for each monochromator at least 1.0 to 20 nm in minimum of 5 steps. -System must operate by PC using Microsoft® Windows XP platform. -Wavelength Range of at least 200 to 900 nm. -Signal to Noise of at least 800:1 or better using the Raman spectrum of water using Ex350, Em 397, bandwidth of 5/5nm and a 2 second response. Software to include scanning, time, and photometry as well as provide cut and paste to Microsoft® Excel and/or Word. -Automatic Peak Pick of sample peaks with algorithm to eliminate scatter and Raman band interferences. -Instrument source to use continuous 150 Watts Xenon Lamp. -Software should include packages for 3-D plots and Corrected Spectra capability. -Calcium Software to measure two probes during the same run. -The stirring of standard cells as well as micro cells controllable by accessory and not software. -The fluorescene spectrophotometer should have capabilities to measure fluorescence from a 96 well plate, regular cuvette of 3ml and microcuvette of 200 microliter with appropriate cuvette holders. Installation and Familiarization of the system: -Hardware Familiarization (power up/down sequence, flow path, pump purge/manual operation, detector lamp energy/wavelength checks and auto zero, autosampler syringe degassing and injection, leak sensors, consumables and spare parts, maintenance software and connectivity) -Software Familiarization ( user setup, project setup, instrument/method setup, single injection, create a sequence/sample set, basic integration/data/sequence processing via width/threshold/min area, review report templates/methods, and system suitability if applicable) The supplier must possess trouble-shooting capabilities based on demonstrable, complete knowledge of the entire instrument, immediate access to certified replacement parts. Service Technologists who are trained and certified by the manufacturer must provide Service and technologists should have access to the manufacturer's latest technical developments, repair procedures, application updates, and planned maintenance procedures. The contract must enable the Project Officer to have access 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. The supplier must be able to guarantee that a service representative will be able to schedule the on-site visit within two business days of the call and must begin work on-site within one week of scheduling the service. The supplier must provide all travel, labor and parts at no additional charge. The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Interested small business concerns must respond with capability statements which are due in person, by postal mail, fax or email to the point of contact listed below on or before April 20, 2012 by 09:00 AM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference FDA1101854. Respondents should supply: -Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB), point of contact name, mailing address (if different from business address), phone number and email address. -Indicate whether you are the manufacturer of the product put forth for consideration and if not the manufacturer, identify your position in the supply chain and identity the actual manufacturer. -Capability statement with sufficient descriptive literature that unequivocally demonstrates the technically capability of the product. -Description list of computer software, components, and accessories required to operate or otherwise support the instrument. -Capability statements must provide enough information to determine if the company can meet the requirement and be not longer than 5 pages excluding set-aside certifications. -Availability of requested equipment via U.S. General Services Administration (GSA) Schedule to include Schedule Number, Special Item Number (SIN), and Contract Number. -Informational pricing. -Prior experience over the last five (3) years in furnishing the requested service to include institution and point of contact name, phone number and email address for each institution identified. For information regarding this market survey, please contact Sondea Blair sondea.blair@fda.hhs.gov. The government is not responsible for locating or securing any information, which is not identified in the response. 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/DCASC/1101854/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02721888-W 20120415/120413235109-8bb1268acf7482469e71f51f3996d0c6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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