SOLICITATION NOTICE
66 -- Specra Analysis DiscovIR for FDA - Package #1
- Notice Date
- 4/2/2015
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 15-223-SOL-00053
- Archive Date
- 5/2/2015
- Point of Contact
- Phillip K. Frame, Phone: 3018277169, Corina L Couch, Phone: 2404025352
- E-Mail Address
-
Phillip.Frame@fda.hhs.gov, corina.couch@fda.hhs.gov
(Phillip.Frame@fda.hhs.gov, corina.couch@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Brand Name or Equal to a Spectra Analysis DiscovIR 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 15-223-SOL-00053. This solicitation is issued as a, Total Small Business Set Aside in accordance with the SBA Non-Manufacture Rule waiver dated January 1, 2015, Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-80, Effective 02 Mar 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 & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 DiscovIR-GC System or Equal 1 EA $ 0002 Freight 1 EA $ Total Amount $ I. Background/Intro The Forensic Chemistry Center (ORA/CER/FCC) requires a Spectra Analysis DiscovIR gas chromatograph outfitted with a Fourier transform infrared spectroscopic and mass spectrometric detectors (GC-IR-MS), or equal. The Spectra Analysis DiscovIR GC-IR-MS consists of a "direct deposition" interface. The instrument will be used to help elucidate the structures of closely related compounds such as designer steroids, cathinones and synthetic cannabinoids and in the analysis of adulterated dietary supplements, illegal medicines and counterfeit pharmaceutical's. The instrument will be employed to identify analytes in complex matrices based on retention times, infrared and mass spectral characteristics of the compound. Unlike existing technology at the FCC, the Spectra Analysis DiscovIR GC-IR-MS instrument will allow for upfront sample separation (GC) and simultaneous MS and IR detection on a single sample, which will improve accuracy of analyte identification. By improving the accuracy of analyte identification using the Spectra Analysis DiscovIR (GC-IR-MS), the toxicity of these compounds can better be determined and thus enhancing the FDA's ability to protect the public health. II. Objective FCC utilizes both gas chromatography with mass spectral detection (GC-MS) and/or infrared (IR) spectroscopy on a routine basis to identify a variety of commonly encountered analytes. Although many analytes can be identified using one or the other technique, some compounds such as designer steroids, synthetic cannabinoids and cathinones often require both mass spectroscopy (MS) and infrared (IR) spectroscopic data for a positive identification. In many instances compounds may have similar mass spectra but can easily be differentiated by their IR spectra, or vice versa. As a result, a comprehensive analysis of a given sample is often needed for these analytes using both IR and MS to help determine the structure and orientation of the molecule. Since products containing designer drugs, synthetic cannabinoids and cathinones are often multi-component mixtures (analyte + excipients), front end separation is often required to isolate the analyte of interest prior to detection using MS and IR. At the FCC, this front end separation is achieved using either liquid chromatography (LC) or GC prior to MS detection. Current IR approaches for these samples require manual extractions or particle isolations followed by microspectroscopy or microspectroscopic imaging, which are not typically effective for the separation and identification of compounds with similar structures. While IR analysis can be conducted on fractions isolated from LC this approach is often prohibitively time-consuming and the mobile phase used can interfere with the IR spectra of the analyte. It is near impossible to obtain both MS and IR data on the same sample using existing instrumentation. There are currently two common types of GC-IR instruments, one type consists of a direct deposition interface; and the other type consists of a flow cell interface (MS can be attached to either). The direct deposition approach is superior regarding all pertinent analytical figures of merit (e.g., sensitivity, selectivity, etc.). First, the direct deposition instrument allows for unlimited co-additions, and thus provides a better signal-to-noise ratio (SNR) since the sample is condensed and retained. The higher SNR of the direct deposition instruments gives better detection limits for low concentration analytes. The number of co-additions for the flow cell approach is limited by the length of time the analyte is exposed to the IR radiation as it passes through the flow cell (typically seconds), the SNR of the flow cell instrument is often insufficient for differentiating molecules with similar structures. Second, the direct deposition instrument allows for superior spectral resolution, again because the sample is condensed and retained. Since the analyte is only exposed to the IR radiation for a limited amount of time using the flow cell approach, a reduced spectral resolution is often employed, which is typically insufficient for differentiating molecules with similar structures. Finally spectra collected using the direct deposition approach are high-quality, photometrically accurate and consistent with library spectra that were collected using other infrared techniques. The gas phase spectra collected using the flow cell approach often yield non-photometrically accurate spectra that exhibit significant band broadening as a result of the high temperatures, which cannot be compared to library spectra that were collected using other techniques. The preferred instrument is a direct deposition instrument and not a "flow cell" or "light pipe" instrument. The direct deposition approach is the only GC-IR technique that generates high SNR, high resolution infrared data sufficient for differentiating molecules with similar structures, which is the primary purpose for requesting this instrument. The Spectra Analysis DiscovIR is the only known direct deposition GC-IR instrument vendor. The Spectra Analysis DiscovIR (GC-IR-MS) instrument will provide the ability to separate and acquire both MS and IR data on a single sample, thereby improving the accuracy of analyte identification, including compounds with similar structures, for a wide variety of analytes, including designer drugs. By improving the accuracy of analyte identification using the Spectra Analysis DiscovIR (GC-IR-MS), the toxicity of these compounds can better be determined and thus enhancing the FDA's ability to protect the public health. III. Minimum Salient Characteristics All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the FCC prior to purchase. A. General Characteristics: • The system must consist of a gas chromatograph, mass spectrometric detector and a Fourier transform infrared (FT-IR) spectrometer with GC-IR interface. • The system must be able to split eluents post column so that one portion of each eluent is examined by infrared detection and the other portion is examined by mass spectrometric detection. • The system must include a "direct deposition" GC-IR interface and not a "flow cell" or "light pipe" GC-IR interface. • The system must include all software to operate the system, computer and monitor. • The system must be delivered with all necessary supplies and accessories required for installation and start-up. • The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. • The system must be warranted for parts and labor for a minimum of 12 months from the date of installation and shall include at a minimum: coverage on all non-consumable items and parts supplied. • The system must include two optional years for extending the warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied. B. FTIR Detector and Interface: • The system must be capable of collecting transmission spectra on solid phase (not gas phase) analytes with a spectral resolution of at least 4 cm-1 and an unlimited number of scans. • The IR detector must be a MCT detector with a spectral range from 4000 - 700 cm-1 • The system must include a gas chromatography column that directly deposits eluents on a cryogenically cooled infrared-transparent (e.g. ZnSe) sample disk. • The system must include electronic pneumatic control C. Gas Chromatographs (GC): • The GC shall be equipped with a capillary split/splitless inlet. • The system must include electronic pneumatic control. • The GC oven shall be able to operate at a temperature range of 4C above ambient to 450C. • System must allow constant pressure and flow modes with pressure and flow being programmable. • GC oven shall be able to compensate for barometric pressure and ambient temperature changes. This reduces the influence of environmental factors retention time repeatability. Methods remain stable when atmospheric pressure changes. • The system must include an autosampler able to accommodate at least 50 vials. D. Mass Spectrometer Detector (MSD): • System must be able to perform synchronous SIM / full scan operation. • System must have the capability of automatically converting a full scan method to a SIM or SIM/Scan method with auto-configuration. • System must be able to analyze up to maximum mass of 1050 Daltons. • System must have an electronic scan rate of up to 20,000 Daltons / second. • System must exhibit an EI SIM instrument detection limit (IDL) of 10 fg OFN using a 1 µL injection. • EI sensitivity in scan mode: signal-to-noise specification is 1500:1 for 1 pg OFN and minimum scan range of 50-300 Daltons • System must use an ion source constructed of inert material (not-coated or stainless steel construction) with turbo-molecular pump capable of handling flows up to 4 mL/min. • System must include an independently heated quadrupole mass filter with user-selected temperature from 100-200C. • Ion source temperature must be controllable up to 350C. E. Service Maintenance Agreement: The system shall include a one (1) year full manufacturer's warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum 72-hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications. F. Special instructions The offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place(s) of Delivery: One complete GC-IR-MS instrument to be shipped to and located at the following laboratory: 1) Forensic Chemistry Center U.S. Food and Drug Administration 6751 Steger Dr. Cincinnati, OH 45237 The system must be delivered during normal business hours (M-F, 8:00AM - 4:30 PM EST). 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 offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), 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 contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. 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 Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2014), 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 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2014), applies to this acquisition with the following addenda: Invoice Submission: A. The contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this contract 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. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Mar 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 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)). 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644 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) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.211-6 -- Brand Name or Equal (Aug 1999) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 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) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies 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. The COR name will be provided at time of 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. 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 contract; (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. 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. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number 15-223-SOL-00053. The quotes are due by email to the point of contact listed below on or before April 17, 2015 by 1:00pm ET. Please contact Phillip Frame at 240-402-7578 or email at Phillip.Frame@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/15-223-SOL-00053/listing.html)
- Place of Performance
- Address: Forensic Chemistry Center, U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, Ohio, 45237, United States
- Zip Code: 45237
- Zip Code: 45237
- Record
- SN03687003-W 20150404/150402235711-b58d455fad6d5c3fcda23f0d88295baa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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