Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 16, 2015 FBO #4891
MODIFICATION

66 -- UHPLC-UV Mass Spec

Notice Date

4/14/2015
 

Notice Type

Modification/Amendment
 

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-1146767
 

Archive Date

5/13/2015
 

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

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-1146767. This solicitation is issued as a 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, dated March 02, 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 Ultra-High Performance Liquid Chromatography (UHPLC) with single quadrupole mass detector (MS) and UV/Vis Spectrophotometer (PDA) detector 1 EA $ 0002 IQ/OQ/PQ 1 EA $ 0003 Shipping 1 EA $ 0004 Onsite Training and Installation 1 EA $ 0004 Option Year 1 - Post Warranty Preventative Maintenance 1 EA $ 0005 Option Year 2 - Post Warranty Preventative Maintenance 1 EA $ 0006 Option Year 3 - Post Warranty Preventative Maintenance 1 EA $ 0007 Option Year 4 - Post Warranty Preventative Maintenance 1 EA $ Total Amount $ I. Intro/Background The United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) has a requirement to purchase a Ultra-High Performance Liquid Chromatography (UHPLC) with single quadrupole mass detector (MS) and UV/Vis Spectrophotometer (PDA) detector. II. Objectives The FDA needs to purchase Ultra-High Performance Liquid Chromatography (UHPLC) with single quadrupole mass detector (MS) and UV/Vis Spectrophotometer (PDA) detector. It is needed to transfer and develop methods using UV detector and confirm the analyte of interest by a single quadrupole detector simultaneously. Additionally, the MS detector can be used for quantification purposes. III. Requirements All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. A. General 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 both UHPLC and mass spectrometer modules. The vendor shall also provide pricing for an optional extended warranty/maintenance agreement for four additional years.,However, this information shall not obligate FDA to purchase the extended warranty/maintenance agreement. The specific requirements for this optional service contract are: 1) Service contract coverage shall include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer. 2) Service shall be provided by service engineers who are trained and certified by the original manufacturer. Engineers shall have access to the manufacturer's latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. 3) The contract shall enable the Project Officer to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. 4) The offeror shall be able to guarantee that a service engineer will be scheduled to work with priority over non service contracted work. 5) The vendor shall provide all travel, labor and parts at no additional charge. There shall be at least one (1) scheduled maintenance visit per year of the contract. The vendor shall also include coverage for software and firmware updates. The vendor shall demonstrate and document upon installation that the item meets all performance specifications, including the mass spectrometer sensitivity specification (IQ/OQ/PQ). The instrument shall not be accepted until those performance specifications have been met. B. Salient Characteristics **Offerors shall address each of the salient characteristics in order to be considered.** 1. The system modules, including the mass detector, must be stackable due to space restriction in the laboratory. UHPLC cannot take more than 15 inch space width x 29 inches depth. 2. The system must come with all necessary modules to operate automatically: Auto-sampler with cooling capabilities, Column heating compartment, Detectors as mentioned below, assembly parts and Pumps. 3. Must work with a power connection of 120VAC. 4. Operating in a flow rate range between 0.01 to 2.000 mL/min. 5. The pump must handle at least four solvents (quaternary pump) 6. The software must include the System Suitability package. 7. System software must be capable of tracking column usage and condition automatically. 8. Maximum operating pressure of at least 15,000 psi. 9. Operational between the pH range of 2 to 12. 10. Integrated leak detection sensors. 11. Heating HPLC column compartment from 4C to 90C and include a solvent pre-heater. 12. One (1) Diode Array Detector (PDA) compatible with UHPLC. a. Must perform automated diagnostics at start-up. b. Collect UV spectra from 190nm to 500nm. c. Software must allow the handling of 3D data. Change chromatogram by manipulating the absorbance wavelength. d. Sampling rate up to 80 points/s. e. Optical resolution of at least 1.2nm f. Wavelength accuracy of at least +1nm. 13. One (1) Single Quadrupole Mass Spectrometer Detector. a. Must have atmospheric pressure ionization electrospray source. b. Mass calibration and resolution verification must be performed automatically. c. Must perform automated diagnostics at start-up. d. Must perform full scan and Select ion analysis. e. Mass Range: 30 to at least 1250 m/z f. Must have a fast Acquisition rate to obtain enough data points in the analyte peak for quantitation purposes. g. Mass accuracy of at least 0.2 Da h. Must switch polarity within 25 ms. i. Must have a resolution of at least 0.7Da j. Must come with all parts and software needed to operate. 14. One (1) monitor (minimum specification of at least 21 inch), computer, software and printer necessary to operate the UHPLC and mass spectrometer detector. 15. The instrument must be capable of quantitating the analyte of interest simultaneously in both detectors at PDA concentration level. Must be capable of producing a linear calibration curve in both detectors with one injection. 16. The instrument must have the capability of using each detector individually. 17. Must come with at least two columns. 18. The system must come with one year warranty that includes parts, labor, travel, support, etc. 19. Must include installation service, IQ/OQ and documentation. C. Delivery Addresses: Southeast Regional Laboratory (ORA) US Food & Drug Administration 60 8th Street, NE Atlanta, GA 30309 Supplies and Equipment shall be delivered Monday thru Friday 9:00am - 3:00pm. D. 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 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: • 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)). • 52.222-21 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 52.217-5 Evaluation of Options (July 1990) 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 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-1146767. The quotes are due by email to the point of contact listed below on or before April 28, 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-1146767/listing.html)
 

Place of Performance

Address: Southeat Regional Laboratory (ORA), US Food & Drug Administration, 60 8th Street, NE, Atlanta, Georgia, 30309, United States

Zip Code: 30309
 

Record

SN03698996-W 20150416/150414235317-5647f4fab9dda38cb511b733b50eab2f (fbodaily.com)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |