SOLICITATION NOTICE
66 -- Post Column Derivatization Unit with four (4) 1-year Post-Warranty Maintenance Option Periods - Package #1
- Notice Date
- 7/9/2013
- 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_13-223-SOL-112066
- Archive Date
- 8/3/2013
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479
- E-Mail Address
-
yolanda.peer@fda.hhs.gov
(yolanda.peer@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Combined Synopsis/Solicitation for a Post Derivatization Unit with four (4) 1-year Post-Warranty Maintenance Option Periods. Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA_13-223-SOL-112066 Posted Date: July 9, 2013 Response Date: July 19, 2013 NAICS Code: Small Business Size Standard: 334516 500 employees Contracting Office Address FDA/OO/OFBA/OAGS/DAP National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items", as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued. The Government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the attached requirement using Simplified Acquisition Procedures. This solicitation number is FDA_13-223-SOL-112066. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular FAC 05-68 dated June 26, 2013. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This combined synopsis/solicitation is a Total Small Business set aside. The U.S. Food and Drug Administration (FDA) is seeking quotes from vendors that can provide the Office of Regulatory Affairs (ORA) with a Post Column Derivatization Unit with four (4) 1-year Post-Warranty Maintenance Option Periods. Background The Denver laboratory that is part of the Office of Reglatory Affairs (ORA) currently performs animal feed samples for monensin. The laboratory frequently turns away garlic and cruciferous vegetable sulfite samples because they interfere with the official method. The laboratory needs a unit that can perform analysis for sulfites in garlic cruciferous vegetables that the laboratory is unable to perform via an old method. However, sulfite in these types of samples is easily determined using a post column derivatization unit. In addition, the unit will provide the flexibility to perform additional suites of analyses. Minimum Performance Specifications: The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The entire system shall be warranted for parts and labor for 12 months from date of installation acceptance. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Installation and operator familiarization should be included for all modules. The vendor shall demonstrate upon installation that the item meets all performance specifications. The instrument shall not be accepted until those performance specifications have been met. Functional specifications for post column derivatization system: The post column derivatization system to be quoted must meet the following specifications. In order to determine the true cost of ownership pricing for replacement consumables must also be provided along with a copy of the current published price list for those items. POST COLUMN DERIVATIZATION SYSTEM SPECIFICATIONS • Electrical: 100-120 V, 50/60 Hz, 1.7 A, 200 W or 200-240 V, 50/60 Hz, 0.8 A, 200 W • Mains voltage ± 10 % of nominal • Installation (over voltage) category II, pollution degree 2 • Indoor use only • Environmental: Altitude up to 6000 ft • Ambient Temperature 15 °- 25 °C • Relative humidity up to 80 % at 31 °C REAGENT PUMPS • True pulse-free syringe pump • Single piece ceramic barrel • Completely inert flow path • Maximum operating pressure 500 psi • Programmable flow rate • Flow range: 50 μL to 1500 μL/minute • Refill cycle of 60 seconds • Automatic piston wash • Automatic reagent flush cycle • No check valves CONTROL • Computer controlled • Windows PC with 2000, NT, XP • USB connection or network REACTOR • Heated reactor for temperature from 5 °C above ambient to 130 °C • Easy replacement reactor coil cartridges • Range of reactor dwell volumes; 0.1 mL to 3 mL • Reaction coil withstands up to 42 bar (600 psi) inlet pressure at 130 °C • Thermal safety switch limits temperature to 150 °C to prevent damage • Fast response SAFEGUARDS • In-line check valve: Prevents reagent back flow into the column when HPLC pressure drops • Post-column system over pressure: A pre-calibrated relief valve opens at 35 bar (500 psi) to prevent rupture of the post-column reactor tubing in the event of down-stream blockage • Back-pressure regulator: Applies 7 bar (100 psi) to the detector flow cell outlet (waste) to prevent detector noise and precipitation due to out-gassing or boiling COLUMN HEATER AND REACTOR CONTROLLER • Heater accepts up to 6 or 8 mm OD (0.25 or 0.31 inch) x 50-250 mm in length (column and guard) • Programmable temperature gradient • Power cooling capability • Temperature holds within ± 0.4 °C from the set point. Can be set with 1 °C resolution from 5 °C above ambient to 75 °C • Easy column access INSTRUMENT PACKAGE AND FLOW PATH • Advanced fluidics valve management system • Easy access to internal components • Standard fittings • Post-column pressure relief valve • Side panels easily removed for service access • Corrosion proof pan and panels GAS PRESSURE MANIFOLD AND REGULATOR • Panel mount manifold • Regulator maintains 0.3 bar (3-5 psi) on reagent reservoirs with 3-5 bar (45-75 psi) source pressure • Safety pressure relief valve opens at 1 bar (14 psi) • Manifold has two 1/4-28 tubing connections • Gas lines with anti-syphon valves PRESSURIZED REAGENT RESERVOIR • One liter capacity (2 and 5 L reservoirs available) • Maintained under inert gas pressure to inhibit oxidation of oxygen sensitive reagents • Valve built into reservoir cap permits sparging during reagent preparation • Reagent reservoirs fitted with 3.1 mm (1/8") OD, oxygen-impermeable SARAN tubing for oxygen-sensitive reagents WARRANTY: • All labor must be covered during warranty period. • All parts must be covered during warranty period. • The warranty must not have any situational limitations. • Travel charges must be included during warranty period. • Remote trouble shooting and support must be provided during warranty period. • An official company warranty statement must be included with the bid and must also be stated in the operator's manual. Initial Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) Services: The Vendor will provide initial qualification, operational qualification, and performance qualification for all provided components. 4 (1-year Post-Warranty Maintenance Option Periods): • On-Site Preventive Maintenance, inclusive of all labor, travel, and parts, components, subassemblies, etc. • Unlimited Technical Support and Trouble Shooting Assistance (generally accomplished by phone, email, live-chat Interface, etc. within 24-48 hours from initial contact) • Unlimited On-Site Corrective Maintenance/Repairs (On-Site repairs are only necessary in instances where problems cannot be resolved remotely after 2-3 days) • Unlimited Software Updates and Firmware Updates during coverage period • Preventive and Corrective Maintenance performed by technicians following OEM specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc. Schedule of Items FOB Destination: U.S. Food and Drug Administration, Denver Laboratory (DEN-LAB) Denver Federal Center, 6th and Kipling, Building 20, Denver CO 80225 Contract Type: Firm Fixed Price CLIN DESCRIPTION QUANTITY *UNIT PRICE TOTAL PRICE 0001 Post Column 1 tiny_mce_marker_________ tiny_mce_marker__________ Derivatization Unit Catalog/Item/Part Number: _____________ *Option Year 1: - Service Maintenance agreement for a Post Column Derivatization Unit For the services the Contractor shall provide in the option year 1, the Government will pay the contractor the fixed price of tiny_mce_marker________________ *Option Year 2: - Service Maintenance agreement for Post Column Derivatization Unit For the services the Contractor shall provide in the option year 2, the Government will pay the contractor the fixed price of tiny_mce_marker___________________ *Option Year 3: - Service Maintenance agreement for Post Column Derivatization Unit For the services the Contractor shall provide in the option year 3, the Government will pay the contractor the fixed price of tiny_mce_marker_______________________ *Option Year 4: - Service Maintenance agreement for Post Column Derivatization Unit For the services the Contractor shall provide in the option year 4, the Government will pay the contractor the fixed price of tiny_mce_marker_______________________ Total Price, Base Year and Options: tiny_mce_marker______________________ GSA Contract Number (If applicable): _______________________ *Significant price increases beyond those of expected inflation for Option Year services shall be explained and supported in the offer. Actual dates will be established once the system is formally accepted by the FDA. Delivery Address US Food and Drug Administration Denver Laboratory (DEN-LAB) Denver Federal Center 6th and Kipling Building 20 Denver CO 80225 Clauses and Provisions: The full text of FAR and HHSAR provisions and clauses may be accessed electronically at http://acquisition.gov/far/index.html or http://www.hhs.gov/policies/hhsar/. CLAUSES FAR 52.212-4 Contract Terms and Conditions-Commercial Items (JUN 2013) The following FAR 52.212-4 addenda apply: FAR 52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011) FAR 52.204-7 Central Contractor Registration (DEC 2012) FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a) "...one (1) calendar day of contract expiration;.....30 calendar..." (c) "...four (4) years, exclusive CLIN 0001 and its associated warranty period." HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-Lobbying (JAN 2006) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) HHSAR 352.223-70 Safety and Health (JAN 2006) HHSAR 352.231-71 Pricing of Adjustments (JAN 2001) HHSAR 352.242-71 Tobacco-Free Facilities (JAN 2006) Invoice Submission The Contractor shall submit one (1) original copy of each invoice 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, Fax 870-543-7224. Alternatively, an electronic invoice can be emailed to nctrinvoices@fda.hhs.gov. 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: XXXXX, Contracting Officer 3900 NCTR Road HFT-320 Jefferson, AR 72079 Phone: (870) 543-XXXX Email: xxxxxx@fda.gov 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. Other Terms and Conditions Maintenance and Repair All maintenance and repair activities (including warranty work) shall be accomplished in accordance with the Original Equipment Manufacturer (OEM) specifications. Service 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, not later than the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair activities for the previous month. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders (JAN 2013) The following FAR 52.212-5(b) clauses apply: 52.204-10, 52.209-6, 52.219-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 2.223-18, 52.225-1, 52.225-3 Alt I, 52.225-13, 52.232-33 (c) 52.222-51 Clauses and provisions incorporated by reference can be obtained at http://www.acquisition.gov/far/index.html. PROVISIONS The following solicitation provisions apply to this acquisition: FAR 52.212-1 Instruction to Offerors-Commercial Items (FEB 2012) The following FAR 52.212-1 addenda applies: The offeror agrees to hold the prices firm until September 30, 2013. 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). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. In accordance with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the - Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance. The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document. To access the SAM website go to: https://www.sam.gov/portal/public/SAM/ FAR 52.212-2 Evaluation-Commercial Items (JAN 1999) 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 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: (i) Technical capability of the items/services offered to best meet or exceed the Government's requirement (ii) Past Performance (iii) Price Technical and past Performance, when combined, are significantly more important when compared to price in determining the best value to the Government; however, price remains a significant factor. Technical capability will be determined and evaluated by review of information submitted by the offeror, which must provide sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Offerors shall specifically address the specifications stated above as well as technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. Past Performance will be determined and evaluated by the identification of federal, state, local Government, or private contracts for which the offeror has, in the past three (3) years, for which the offeror has sold the same system for use in same or similar applications. Provide name, telephone number, email address, contract number, past performance point of contact and dollar amount of sale. The Government is not responsible for locating or securing any information, which is not identified in the proposal, however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Offeror's shall include the firm's DUNS number with quote. Price proposed must be detailed and represent the offeror's response to the schedule of items above. FAR 52.212-3 Offerors Rerepresentations and Certifications-Commercial Items (DEC 2012). An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically via http://www.acquisition.gov/. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (o) of this provision. This solicitation is being issued under the premise that the offeror will certify that the combination of equipment/service it will propose to fulfill this requirement is 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 (provision is set forth below), 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 No. WD 05-2081 (Rev.-13) dated 06/25/2013 available at the following location: http://www.wdol.gov/wdol/scafiles/std/05-2081.txt?v=13 FAR 52.222-48, Exemption from Application of the Service Contract Act 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. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The offer must reference solicitation FDA_13-223-SOL-112066. Offers are due in person, by postal mail or email to the point of contact listed below on or before July 19, 2013 by 1:00 PM, (Local Time Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT-320, Building 50 - Room 420, Jefferson, AR 72079-9502 or yolanda.peer@fda.hhs.gov. For information regarding this solicitation, please contact Yolanda Peer at yolanda.peer@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_13-223-SOL-112066/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, Denver Laboratory (DEN-LAB), Denver Federal Center, 6th and Kipling, Building 20, Denver, Colorado, 80225, United States
- Zip Code: 80225
- Zip Code: 80225
- Record
- SN03110847-W 20130711/130709235001-12d0ac62dd29731fdc9f30e5c98bfa33 (fbodaily.com)
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