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The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-58, 18 May 2012.
The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees and is not a small business set-aside.
The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) requires a fluorescence spectrophotometer to measure fluorescence from different sources such as biologicals either alone or conjugated with specific fluorescence tags to evaluate identity, characteristics and biological activity of cellular and gene therapy based cancer vaccines.
Fluorescence Spectrophotometer
Specifications
*Capability for scan speeds of at least 15-60000 nm/min. with a slew speed of at least 60,000 nm/min.
*Horizontal beam 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, which shall be included with the Fluorescence Spectrophotometer.
*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 shall 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 fluorescence spectrophotometer shall have capabilities to measure fluorescence from a 96 well plate, regular cuvette of 3ml and microcuvette of 200 micro-liter with appropriate cuvette holders.
Additional Required Items (included with Fluorescence Spectrophotometer):
*Photomultiplier Tube Detector
*Microcell quartz 10 mm square
*Quartz cell, ultra-high quality
*Intracellular cation measurement with thermostatted cell holder, microcell quartz, and intracellular calcium measurement program
*Microplate reader
* A standard commercial warranty on parts and workmanship of not less than
12-months from the date of government acceptance of the system:
-During the warranty period, the contractor 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.
Price__________________
2. Installation and Familiarization of the system:
*Inside delivery installation and familiarization training to be provided by certified manufacturer personnel
*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)
Price__________________
Contract Type: Commercial Item-Firm Fixed Price. Single award is anticipated.
Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.
FOB Destination - US Food and Drug Administration
Center for Biologics Evaluation and Research
8800 Rockville Pike
Rockville, MD 20892
The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation.
The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows:
The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:
1. Technical capability of the products offered to meet the Government's requirement.
2. Price.
Technical acceptability will be determined by review of information submitted by the quoter who must provide sufficient descriptive literature that unequivocally demonstrates that offered products meet the technical requirements as stated herein.
The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offered products.
The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically at http://orca.bpn.gov.
The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause:
Addenda to FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (Feb 2012).
HHSAR Clause 352.270-10 Anti-lobbying. (January 2006)
The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.
Service Records and Reports
The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-3, 52.225-13, and 52.232-33.
It is the offeror's responsibility to monitor the internet site for the release of any information related to this combined synopsis/solicitation.
Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.
Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far and http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html.
Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 9:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on May 25, 2012 to [email protected], Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Sondea Blair, 3900 NCTR Road, Building 50, Room 421 Jefferson, AR 72079-9502.
PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below.
When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time.
For information regarding this solicitation, please contact Sondea Blair by e-mail at [email protected]. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 11:00 AM CST on May 23, 2012.