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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 08, 2015 FBO #4883
SOLICITATION NOTICE

66 -- NMR Instrument System - Package #1

Notice Date

4/6/2015
 

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

FDA-SOL-1145507
 

Archive Date

5/2/2015
 

Point of Contact

Corina L Couch, Phone: 2404025352
 

E-Mail Address

corina.couch@fda.hhs.gov
(corina.couch@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

NMR Instrument System for FDA 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-1145507. 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. Please make all quotes valid until September 30, 2015. No funds are currently available at the point of solicitation but the Government does anticipate funds prior to award. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 High Performance Digital Nuclear Magnetic Resonance (NMR) Spectrometer System 1 EA $ Total Amount $ I. Background/Intro The FDA Pacific Regional Laboratory Southwest (PRL-SW) located in Irvine, CA, is an ISO 17025 accredited multi-purpose laboratory involved in the analysis of FDA regulated products and other scientific activities in support of the agency's public health mission. This work requires use of state-of-the-art scientific tools and modern analytical techniques whenever possible. In an effort to increase analytical capability, PRL-SW intends to purchase a new NMR instrument system to analyze a variety of chemical compounds such as controlled substances, organic chemicals, toxins, petroleum products, pharmaceuticals and food products to characterize and elucidate molecular and chemical structures. II. Objective The FDA PRL-SW has a requirement for the supply and installation of one (1) complete NMR system meeting requirements and salient characteristics at the place of performance within 180 days of contract award. III. Minimum Salient Characteristics The instrument and all parts and accessories must be new, not used, refurbished or previously used for demonstration. Onsite training covering the operation and routine maintenance of the system components, including operating software, will be provided at the time of installation. A separate training course will be provided for two (2) operators at the manufacturer's location after installation and familiarization with the instrument. This course will provide detailed, hands on coverage of operation, troubleshooting and maintenance. A. General Characteristics: The instrument will have the capability to perform the common 1H (hydrogen) and 13C (carbon) nuclei experiments in 1-D and 2-D with selectable decoupling, as well as 15N (nitrogen), 17O (oxygen), 19F (fluoride), 23Na (sodium), 31P (phosphorous), and 35Cl (chloride) in at least 1-D spectral data analysis and integration methods. 1. Nuclear Magnetic Resonance Spectrometer: a. Magnet/Shim/Lock System i. Superconducting magnet system with 5.4 cm bore (operation field ≥9.397 Tesla) ii. NMR-frequency (1H): 400 MHz iii. Drift rate (field stability) ≤ 4.0Hz/hr. iv. Digital frequency generation, computer-controlled lock regulation v. Liquid cryogenic level sensors for helium and nitrogen 1. Helium transfer line to be included 2. Helium and Nitrogen level sensor to be included vi. Frequency damped >3.8 Hz / resonance frequency = 2.6 Hz vii. Deuterium gradient shimming including Deuterium amplifier viii. Cryo shims: X, Y, Z, Z2, Z3, XZ, YZ, X-Y, X2-Y2 ix. Deuterium internal digital lock system with computer controlled auto-lock functions b. Stainless Steel RF Cabinet i. Cabinet with RF shielding and full front success to all sub-assemblies and cabling c. Amplifiers and Receiver i. Enhanced 2G Digital Quadrature Detection Receiver ii. Dual broadband amplifier, providing up to 150 Watts X-frequency and 50 Watts 19F or 1H frequency for both observe and homo/heteronuclear decoupling in both CW and high power pulse operations d. Frequency Generation, Digital Control & Acquisition i. Dual channel digital frequency synthesizer ii. Timing controller with 12.5 nsec timing resolution iii. Direct digital synthesis with ≤0.005Hz frequency resolution and ≤0.01º phase settability iv. High performance wave form memory for programming of experiment sequences v. Gradient Controller for simultaneous control of up to three magnetic field gradients e. Pre-Amplifiers: i. 1H preamplifier with 2D capability for lock and observe ii. Broad Band (BB) preamplifier f. NMR Probe and Gradient Supply: i. Broadband high resolution probe with 5 mm sample diameter ii. Probe facilitates observation/irradiation of all NMR nuclei in the range 31P to 15N in addition to 1H, 13C and 19F, including 29Si, 17O, 11B, 23Na, 35Cl, 39K, 41Ca, 75As and 33S. iii. Probe has ability to observe 1H and 19F decoupling and to perform two-dimensional 1H / 19Fspectroscopy iv. Probe can be fully automatically selected and optimally tuned and matched to selected nuclei v. Variable temperature capable of -150ºC to +150ºC g. Data System or Host Workstation: i. Window-based workstation ii. ≥2.5 GHz dual core processor iii. ≥4 GB RAM (Random Access Memory) iv. ≥500GB HDD (Hard Disk Drive) v. ≥2 x LAN 10/100/1000 ethernet adapter vi. 24" flat panel monitor vii. DVD+/-RW drive viii. Software 1. Capable of 1, 2, 3, and 4-D data acquisition and processing 2. Structure elucidation software for small molecule characterization and quantitation h. Variable Temperature i. Digital control module under full computer control with temperature accuracy±0.2°C (±0.1°C within the temperature range of +15 to +35°C) ii. Variable temperature control unit with a 26 liter N2 dewar, heat exchanger and insulated PUR transfer line 2. Vibration Dampers The NMR instrument will be on the second floor of a multi-floor lab building, so it is necessary to have the vibration dampers for reduction of the effects of strong floor vibrations in both the vertical and horizontal directions. 3. Operator Training Operator training will be provided in two stages a. The first stage will be on-site familiarization, with the routine operation and maintenance of the system including operating software, to be conducted at the time of installation. This On-Site Training will cover methods set-up and fine-tuning, structure elucidation, and report generation. An integral part of this training will be the analysis of actual sample materials from the FDA PRL-SW. These materials may include, for example, drug and dietary supplement samples. b. The second stage will be detailed training course covering operation, troubleshooting, and maintenance of the major sub-systems at the location of the manufacturer. B. 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: U.S. FDA/PRL-SW 19701 Fairchild Irvine, CA 92612 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 FDA-SOL-1145507. 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 Corina Couch at 240-402-5352 or email at Corina.Couch@fda.hhs.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1145507/listing.html)
 

Place of Performance

Address: U.S. FDA/PRL-SW, 19701 Fairchild, Irvine, California, 92612, United States

Zip Code: 92612
 

Record

SN03690565-W 20150408/150406235003-ca40010844c33e78c9deb7c3152bdd40 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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