SOLICITATION NOTICE
66 -- Floor Model Centrifuge
- Notice Date
- 6/28/2013
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1119664
- Archive Date
- 7/20/2013
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- 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 requirement under Simplified Acquisition Procedures. The solicitation number is 1119664 and this solicitation is issued as a Request for Quote (RFQ). RESPONSE DATE: 07/18/2013 The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-68 effective June 26, 2013. The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; FSC Code is 6640. Small Business Size Standard is 500 employees. Acquisition is unrestricted. Contract Type: Commercial Item-Firm Fixed Price. REQUIREMENTS: Background: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Laboratory of DNA Viruses requires one (1) high performance, high capacity refrigerated floor model centrifuge to include inside delivery, installation, set-up, and post-warranty maintenance for up to 4 option years. This instrument is necessary for studying the oncogenicity of DNA and the tumorigenicity of cell substrates used for vaccines. As part of the studies on vaccine safety, the FDA is developing in vivo assays to detect oncogenic activity of DNA. The centrifuge will be used at several stages of these experiments. In the case of mammalian cell cultures, protein and DNA are prepared from cell lines established from tumors. To prepare plasmid DNA, bacterial cells are harvested by centrifugation, and DNA plasmids are prepared and purified for inoculation into animals. Scope: In the research, rodents are used to study the possible induction of tumors that result from their subcutaneous exposure to various cell substrates and oncogenic DNA. Tumor formation can take up to six months, and in some cases, no tumors are observed. When preparing the DNA for inoculation, the DNA goes through an extensive purification process. First, large scale bacterial cultures are spun down in 500 mL bottles to isolate the bacterial cells carrying the desired DNA plasmid. Next, the cells are transferred to 40 mL round bottom tubes and are lysed to allow for separation of the plasmid. During this step, the tubes are spun at 18,000 rpm. From this stage, the plasmids are transferred to 50 mL conical tubes and are then spun at lower speeds. Once the DNA is purified it is used, as mentioned above, in rodent models to study tumor formation. When a tumor is induced, it is excised from the animal and a cell line is created. The cell lines are then carried in cell culture. This centrifuge will be used to spin down uninfected cells and viral-infected cells from these cultures. It will also be used for the clarification of virus supernatants to prepare viral stocks for frozen storage. These cells must be spun down at low speed in a refrigerated centrifuge to maintain viability. Technical Requirements: The system: - Shall be a refrigerated floor model centrifuge with temperature ranging from -10 to +40 degrees C - Shall have a speed range of 500 rpm to 24,000 rpm - Shall not be required to be bolted to the floor - Shall have an automatic rotor locking system securing rotor to spindle and push button release of rotor after run - Shall have rotors made of carbon fiber that are lighter, have a handle to lift and carry, do not derate, and are repairable - Shall include the following 3 carbon fiber rotors: one 6x500 ml bottle fixed angle carbon fiber rotor, one 14x50 ml conical tube fixed angle carbon fiber rotor, and one 12x50 ml round bottom tube fixed angle carbon fiber rotor - Shall also include one 4x400 ml bottle stainless steel swinging bucket rotor with aluminum buckets and conical adapters - Shall have an automatic rotor recognition system and automatic data entry - Shall have a touchscreen with library of setup programs to select from, integrated calculator for protocol modifications and operator run logging with password - Shall provide all labor, travel, and tools for inside delivery, installation and set-up of centrifuge to address provided below. Once installed, equipment must be tested to verify that all aspects are operating within parameters of required specifications - Shall be covered by a two year warranty on centrifuge and rotors Post-Warranty Maintenance Agreement: The vendor shall provide post-warranty maintenance/service for up to 4 option years, each year consisting of one (1) preventive maintenance visit and unlimited on-site, unscheduled repair visits/year with all costs covered for travel, labor and non-consumable parts. Vendor shall perform all maintenance and repair activities with formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified new replacement parts, components, subassemblies, etc. Records and Reports of Service 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. Security: Contractor shall pass through NIH Main Campus (Bethesda) security for access to NIH Campus and deliver to 29 Lincoln Drive, Building 29A loading dock, Bethesda, MD 20892 Place of Performance/Deliver to: U.S. Food and Drug Administration Attn: Marilyn Lundquist (301-827-0393) 29 Lincoln Drive Building 29A, Room 3D08 (via loading dock) Bethesda, MD 20892 Delivery and installation shall be closely coordinated with the COR, Marilyn Lundquist. Period of Performance: Delivery, to include inside delivery, installation, set-up, and training, shall occur within 60 days of award with up to 4 post-warranty annual maintenance option periods. Schedule of Items: High Performance, High Capacity Refrigerated Floor Model Centrifuge - 1 each, in accordance with specifications above (Provide price breakout with offer to include all components, in-side delivery, installation, and set-up etc) tiny_mce_marker____________ Option Year 1, Post-Warranty Maintenance tiny_mce_marker____________ Option Year 2, Post-Warranty Maintenance tiny_mce_marker____________ Option Year 3, Post-Warranty Maintenance tiny_mce_marker____________ Option Year 4, Post-Warranty Maintenance tiny_mce_marker____________ Total tiny_mce_marker____________ GSA Contract No.(if applicable) ____________________ FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items (FEB 2012) applies to this solicitation. Addenda to this provision are as follows: Offerors are afforded the opportunity to inspect the site for installation of the equipment prior to solicitation response date by contacting the Contract Specialist, Crystal G. McCoskey, crystal.mccoskey@fda.hhs.gov, phone: 870-543-7267, to schedule an appointment. Failure to inspect the system will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered. This solicitation is being issued under the premise that the Contractor will certify that the post-warranty maintenance services are exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 2005-2103 (Rev.13): http://www.wdol.gov/wdol/scafiles/std/05-2103.txt?v=12 FAR 52.222-48 - Exemption From Application Of The Service Contract to Contracts For Maintenance, Calibration, Or Repair Of Certain Equipment Certification (Feb 2009) (a) The offeror shall check the following certification: CERTIFICATION The offeror [ ] does [ ] does not certify that- (1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations; (2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment. (i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. (ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and (3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements, will not be included in any resultant contract awarded to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. (End of provision) The following provision is incorporated by reference: • FAR 52.233-2, Service of Protest (Sep 2006) The provision at FAR 52.212-2 Evaluation-Commercial Items (JAN 1999) is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: (i) Technical capability of the offered system to meet the Government's requirements. (ii) Price (inclusive of post-warranty maintenance options) Technical capability is more important when compared to price. Technical capability will be determined by review of information submitted by the Offeror which must provide a description in sufficient detail to show that the items/service quoted meets the Government's requirement and demonstrate successful performance of the items/service requested with any specific equipment (if stated) herein. The government is not responsible for locating or securing any information, which is not identified in the quote. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the item/service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required service, which demonstrates the capabilities of the Offeror. Proprietary information shall be clearly marked. The provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items (DEC 2012), applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (JUN 2013), applies to this acquisition. Addenda to this clause are as follows: Other Terms and Conditions Inspection and Acceptance 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. Records and Reports The Contractor shall, commensurate with the completion of each service call, 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 each time service and/or repair is performed. Invoice Submission Payment terms net 15 days after government acceptance of the supplies/services. Invoices shall be submitted to the attention of the Office of Financial Services identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. An original and two (2) copies shall be submitted to: FDA/OC/OA/OFO/OFS Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor, suite 616 Jefferson, AR 72079 Phone: (870) 543-7446 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy each to the Contracting Officer and Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov. The following clauses are incorporated by reference: • FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000) (a) "...by written notice to the Contractor within one (1) day of contract expiration;...preliminary written notice of its intent to extend at least 30 days before the contract expires." (b) "...shall not exceed 4 years beyond the warranty expiration." • HHSAR Clauses: 352.222-70, 352.231-71 and 352.242-71 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: (b) 52.204-10, 52.209-6, 52.219-4, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3 with Alt I, 52.225-13 and 52.232-33 (c) 52.222-51 Additional Information It is the offeror's responsibility to monitor the internet site for the release of any information related to this combined synopsis/solicitation. Offerors are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 2:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 18, 2013 to crystal.mccoskey@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Crystal G. McCoskey, 3900 NCTR Road, Building 50, Room 426 Jefferson, AR 72079-9502. When appropriate, offerors 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 Crystal G. McCoskey by e-mail at crystal.mccoskey@fda.hhs.gov. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 09:00 AM CST on July 16, 2013. Please reference solicitation number 1119664 in subject line of all correspondence. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the Place of Performance section above.
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