SOLICITATION NOTICE
66 -- Brand Name or Equal to a Picarro Combustion Module – Cavity Ring-Down Spectroscopy System for 13c/12c Analysis for FDA - Package #1
- Notice Date
- 8/19/2015
- 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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1152625
- Archive Date
- 9/12/2015
- Point of Contact
- Eric Rabinovich, Phone: 2404027631
- E-Mail Address
-
eric.rabinovich@fda.hhs.gov
(eric.rabinovich@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Combined Synopsis/Solicitation PART 1 - 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; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1152625. This solicitation is issued as a Total Small Business Set-Aside, Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13. This solicitation documents and incorporates provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2005-83-2-2-08032015, dated August 5, 2015. The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. The US Food and Drug Administration (FDA) intends to issue a Commercial Item Firm-Fixed-Price purchase order that meets the following specifications below. 1.1 Background The FDA's Office of Regulatory Affairs (ORA), Forensic Chemistry Center (FCC), has a requirement to purchase One (1) Picarro Combustion Module-Cavity Ring-Down Spectroscopy (CM-CRDS) system for the 13C/12C ratios of solid/semisolid samples, or Equivalent. 1.2 Objectives Stable carbon isotope ratio analysis (SCIRA) is becoming a more important analysis technique for the FDA as it has been demonstrated as a powerful tool to detect economic adulteration. The FCC has seen an increase in the number of samples needing SCIRA over the last 5 years. Current instrumentation (Isotope ratio mass spectrometer) was expensive, difficult to repair and has a high learning curve. Therefore, a more robust form of analysis would be beneficial to accommodate higher sample numbers. PART 2 - SUPPLIES OR SERVICES AND PRICES/COSTS These instruments must include a one (1)-year manufactured warranty for parts and labor, shipping and on-site training and installation, and two (2) option year periods for an extended warranty/maintenance agreement. The option year warranties shall begin after the one (1)-year manufacturer warranty has expired. The Quoter shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Picarro Combustion Module-Cavity Ring-Down Spectroscopy (CM-CRDS) System, or Equal 1 EA $ 0003 Shipping 1 EA $ 0004 Onsite Training and Installation 1 EA $ 0005 Option Year 1 - Extended Warranty Coverage 1 EA $ 0006 Option Year 2 - Extended Warranty Coverage 1 EA $ Total Amount $ PART 3 - TECHNICAL REQUIREMENTS All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and will be evaluated by the Government. A. General specifications: 1) The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. 2) Software must be multi-users capable from set up through results, automated sequence table, and data analysis. 3) The system must include a computer that meets the recommended requirements needed to fully operate the instrument control software. The monitor must be able to be connected to the computer and have a screen size of at least 15" (diagonal). Also, a keyboard and mouse are required. 4) The instrument must have reliable operation and durability with minimum maintenance; fully automated methods and extended sample-handling capability for walk-away operations. 5) On-site familiarization / training for up to two (2) operators covering operation of the instrument, software use, and general maintenance must be supplied during initial installation and should last less than one (1) week. 6) A one (1) year warranty is required with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied, including base instrument, computer, and monitor, unlimited on-site service visits for warranty repairs, factory-certified replacement parts, engineer labor and travel costs, and software updates and notifications. 7) The option to purchase two (2) one-year service contracts shall also be included, covering the same items as the base warranty The Contractor shall demonstrate and document upon installation that the item meets all stated performance specifications. The instrument will not be accepted by the Government until those performance specifications have been met. B. Salient Characteristics **Quoters shall address each of the salient characteristics in order to be considered for award.** Combustion Module-Cavity Ring-Down Spectroscopy System The ionization source must be capable of supporting electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI). A heated ESI probe capable of liquid flow rates of 5 μL/min to 3 mL/min and an APCI probe capable of liquid flow rates of 50 μL/min to 3 mL/min must be provided. 1) Must utilize Cavity Ring-Down Spectroscopy (CRDS) technology 2) Time-based laser measurement for quantifying spectral features in an optical cavity 3) Small cavity (< 35 mL) for fast sample turnover rate 4) Unit must have a Wavelength monitor (WLM) controls laser wavelength to within 2 MHz for precise quantification of spectral features 5) Unit should be tested for, and must pass: mil-spec drop test; vibration test on both axes; and environmental chamber test 6) All analyzer data files must be in universal data format, compatible for easy export and analysis 7) The unit must come with a combustion module with a furnace, a 50 position carousel autosampler, and have user replaceable inserts for removal of ash without the need for a service call 8) The unit must come with the proper hardware and software to interface the combustion module with the isotopic analyzer. 9) Unit must be able to achieve a guaranteed δ13C sample-to-sample precision of <0.4‰ for a carbon content in a sample of at least 250 μg and achieve a typical δ13C sample-to-sample precision of 0.2-0.3‰ for a carbon content in a sample of at least 400 μg. 10) The instrument must ensure precision by pulsing CO2 reference gas during the analysis. 11) Sample-to-sample analysis time must be less than 15 minutes. PART 4 - PACKING, MARKING AND SHIPPING All deliverables required under this purchase order shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the purchase order number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All equipment must be new, not used, refurbished or previously used for demonstration. Part 5 - INSPECTION AND ACCEPTANCE The Contracting Officer's Representative (COR) will perform inspection and acceptance of the equipment, installation and services to be provided. For the purposes of this PART (COR - to be determined upon purchase order award) is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the locations identified in Part 6. Acceptance will be communicated in writing, unless otherwise indicated in writing by the Contracting Officer or COR, within 30 days of receipt. This purchase order incorporates the following clause, FAR 52.246-2, Inspection of Supplies-Fixed Price (Aug 1996), by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available. PART 6 - DELIVERIES OR PERFORMANCE Satisfactory performance of this purchase order shall be deemed to occur upon completed delivery, installation, training, and performance of the services described in PART 3 and upon acceptance by the Contracting Officer, or the COR, of these products/services. Deliveries required by the Contractor shall be made F.O.B. destination within 90 days of purchase order award, to the addresses/addressees listed below: 6.1 Deliveries: To be completed at time of award. Supplies and Equipment shall be delivered Monday thru Friday, between 9:00am - 3:00pm Eastern Time. 6.2 Period of Performance: The equipment shall be delivered 90 days from purchase order award, unless the Government approves a different delivery schedule. The manufacturer warranty shall not begin until the equipment is delivered to the Government's location and successfully installed. Option Year 1: 09/16/2016 - 09/15/2017 (if exercised) Option Year 2: 09/16/2017 - 09/15/2018 (if exercised) PART 7 - CONTRACT ADMINISTRATION DATA Contracting Officer Representative (COR) The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award) 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. Contracting Officer (CO) 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 RFQ; (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 contact information for the Contracting Officer: James G. Whitt 5630 Fishers Lane Rockville, MD 20853 James.Whitt@fda.hhs.gov 240.402.7627 The contact information for the Contract Specialist: Eric Rabinovich 5630 Fishers Lane Rockville, MD 20853 Eric.Rabinovich@fda.hhs.gov 240.402.7631 PART 8 - FAR AND HHSAR CLAUSES The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition, with the following addenda to the provision: Period for Acceptance of Offers: The quoter agrees to hold the prices firm through September 30, 2015. FAR 52.204-16 Commercial and Government Entity Code Reporting (Nov 2014) FAR 52.225-18 Place of Manufacture (Mar 2015) FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certification (Dec 2012) The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. 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 clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. The Contractor shall submit one (1) original copy of each invoice to the address specified below: ATTN: FDA Vender Payments Team Office of Financial Services Food and Drug Administration Building 32, Room 2162, Mail Hub 2145 8th Floor, Room 8035A Silver Spring MD 20993-0002 (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this purchase order must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. Questions regarding invoices shall be directed to the FDA at the telephone number provided above. FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights (Apr 2014) FAR 52.204-18 Commercial and Government Entity Code Maintenance (Nov 2014) FAR 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (May 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: • 52.203-6 Restrictions on Subcontractor Sales to the Government (Sep 2006), with Alternate I (Oct 1995)(41 U.S.C. 4704 and 10 U.S.C. 2402). • 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). • 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). • 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note). • 52.219-6 Notice of Total Small Business Set-Aside (Nov 2011)(15 U.S.C. 644). • 52.219-8 Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)) • 52.219.14 Limitations on Subcontracting (Nov 2011)(15 U.S.C. 637(a)(14)) • 52.219-28 Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). • 52.22219 Child Labor-Cooperation with Authorities and Remedies (Jan 2014)(E.O. 13126). • 52.222-21 Prohibition of Segregated Facilities (Feb 1999) • 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) • 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) • 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) • 52.222-37 Employment Reports on Veterans (Jul 2014)(38 U.S.C. 4212) • 52.222-40 Notification of Employee Rights Under the National Labor relations Act (Dec 2010) E.O. 13496) • 52.222-50 Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627) • 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) • 52.225-13 Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury) • 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The provision at FAR 52.211-6 Brand Name or Equal (Aug 1999) is applicable to this requirement. The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html • 352.202-1 Definitions (Jan 2006) • 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010) • 352.227-70 Publications and Publicity (Jan 2006) PART 9 - INSTRUCTIONS TO QUOTERS It is the quoter's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Quoters that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from award consideration. All questions must be submitted via email to the point of contact listed below on or before August 24, 2015 by 1:00pm Eastern Time. All responsible sources may submit a quote, which if timely received, will be considered. The quote shall reference solicitation number FDA-SOL-1152625. The quotes are due by email to the point of contact listed below on or before August 28, 2015 by 1:00pm Eastern Time. Please contact Eric Rabinovich at (240) 402-7631 or email at Eric.Rabinovich@fda.hhs.gov. Evaluation The provision at FAR 52.212-2, Evaluation-Commercial Items (Oct 2014), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a purchase order resulting from this solicitation to the responsible quoter whose offer meets the specifications listed under Part 3 of this solicitation and is the lowest priced quote received in response to this solicitation. Therefore, award will be made to the quoter whose offer is determined to be the Lowest Priced-Technically Acceptable quote. The clause at FAR 52.217-5 Evaluation of Options (Jul 1990), is applicable to this requirement. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the offer shall result in a binding award 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.
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