SOLICITATION NOTICE
66 -- Automated Fluorogenic Thrombin Generation Test System
- Notice Date
- 5/30/2013
- Notice Type
- Combined Synopsis/Solicitation
- 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
- FDA_13-233-1119231
- Archive Date
- 6/20/2013
- Point of Contact
- Howard Nesmith, Phone: 870-543-7459
- E-Mail Address
-
howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the below requirement under Simplified Acquisition Procedures. The solicitation number is FDA_13-233-1119231. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66, April 1, 2013. The associated North American Industry Classification System (NAICS) Code is- 334516 - Analytical Laboratory Instrument Manufacturing; Size standard 500 in numbers of employees. This acquisition is a 100% Total Small Business set-aside requirement. For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov. 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 June 5, 2013 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration (FDA), OO/OFBA/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, 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. The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is in need of and soliciting for the purchase of Automated Fluorogenic Thrombin Generation Test System. Any award resulting from this solicitation is contingent on the availability of funds within the 2013 Fiscal Year. Quotes shall be valid thru September 30, 2013. Item 1 Automated Fluorogenic Thrombin Generation Test System Includes fluorescence recording instrument, calcium chloride injector, computer, analysis software capable of internal thrombin calibration Technical Requirements: • Automated Calcium Chloride Dispenser • 96-Well Microplate Format, up to 94 Sample Testing Simultaneously • Internal Thrombin Calibration • Automated Thrombin Generation Analysis • Ability to use internal thrombin calibration in plasma to correct for fluorescent artifacts: inner filter effect, plasma quenching of fluorescence, substrate consumption • Automated thrombin Generation Test analysis: internal calibration in units of thrombin and calculation of thrombin peak height, lag time, area under the curve and velocity • Associated Software • Accommodating Desktop Computer • Onsite Installation and Training Quantity: 1 Make: _________________________ Model: ________________________ Unit Price (Including Delivery and Installation): _____________________ GSA Contract Number (if applicable): ________________________ FOB Destination - U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), 29 Lincoln Drive, Bethesda, MD 20892 Contract Type - Commercial Item - Firm fixed price. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Solicitation Provisions: The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012. 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 the purchase order to the responsible offeror who offer conforming to the solicitation will be the most advantageous to the Government on price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the services offered to meet the Government's requirement. (ii) Price. The government will award the purchase order to the lowest price technically acceptable quote. Technical capability will be determined by review of information submitted by the respondent, which must provide a description in sufficient detail to show that the service quoted meets the Government's requirements. 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 offeror. 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 via https://www.acquisition.gov. (Nov 2012) An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Contract clauses- The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (Feb 2012) The following addenda have been attached to the clause: 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. Other Terms and Conditions Maintenance and Repair All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications. Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment 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. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper. (MAY 2011) FAR Clause 52.204-7 Central Contractor Registration. (DEC 2012) FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a)... within 1 day of contract expiration;.... at least 15 days before the contract expires... (c)...shall not exceed 5 years. The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.202-1 Definitions JAN 2006 352.203-70 Anti-Lobbying JAN 2006 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009 352.223-70 Safety and Health JAN 2006 352.231-71 Pricing of Adjustments JAN 2001 352.242-71 Tobacco-Free Facilities JAN 2006 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contracting Officer for this order is: To be completed at time of award: Phone: (xxx) xxx-xxxx Email: xxxx The COR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance. The COR for this order is: to be completed at time of award. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 2013), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-40, 52.223-18, 52.225-3 Alt (ii), 52.225-13, and 52.232-33. Clauses and provisions incorporated by reference can be obtained at https://www.acquisition.gov/far.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_13-233-1119231/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), 29 Lincoln Drive, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03075060-W 20130601/130530234708-3866887c1bdbfc4e32f4b757b8eed095 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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