FDA-SOL-1146743_-_Combined_Synopsis_Solicitation_Final.doc

COMBINED SYNOPSIS/SOLICITATION FOR brand name or equal to aN AB Sciex QTRAP 6500 Triple Quadrupole/Linear Ion Trap Mass Spectrometer FOR FDA Solicitation Number: FDA-SOL-1146743

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-1146743. 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.

This solicitation documents and incorporates provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2005-82, dated June 08, 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 United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Northeast Regional Laboratory (NRL) has a requirement to purchase One (1) Q-TRAP 6500 System, AB Sciex QTRAP 6500 Triple Quadrupole/Linear Ion Trap LC/MS/MS Mass Spectrometer with One (1) Ultra High Performance Liquid Chromatograph, Shimadzu Nexera X2 UHPLC or Equivalent.

1.2 Objectives

The FDA’s Northeast Regional Laboratory requires one (1) triple quadrupole/linear ion trap mass spectrometer system to be used in conjunction with one (1) ultra-high performance liquid chromatograph. The addition of a QTRAP 6500 LC/MS/MS or Equal would enhance the analytical capabilities of the Northeast Regional Laboratory. The QTRAP 6500 or Equal would offer both full scan capabilities for qualitative purposes and MRM scanning capabilities for quantitative purposes.

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 traning and installation, and four (4) option 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:

of Issue Price

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 evaluated by the Government.

A. General specifications:

1) The system must include a benchtop, enhanced high performance triple quadrupole/linear ion trap LC/MS/MS mass spectrometer interfaced with an ultra-high pressure liquid chromatograph to form a complete LC/MS/MS system. The system must include a PC-based data system/instrument controller, including operating system, instrument control/data acquisition/data analysis software, and monitor. The system must include an ionization source with both heated electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) probes.

2) The system shall be delivered with all necessary supplies and accessories required for installation and start-up. Installation and operational training shall be included.

3) The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

4) The instrument software must be capable of controlling the UHPLC as well as the mass spectrometer.

5) Installation of the instrument shall include the interfacing of the supplied UHPLC system and include all necessary peripherals.

6) An applications training course for up to three (3) operators covering operation of the instrument, software use, and general maintenance shall be supplied for the complete LC/MS/MS instrument. This course may take place on-site.

7) 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 instruments, computer, monitor, printer, and power conditioning equipment; unlimited on-site service visits, with a maximum 72-hour on-site response time; factory-certified replacement parts; engineer labor and travel costs; software updates and notifications; and one (1) scheduled preventative maintenance visit.

8) Options for purchasing an instrument warranty on the instruments in Year 2, Year 3, and Year 4 (Option Years 1-3) of performance shall be provided and must include, at a minimum: coverage on all non-consumable items and parts supplied, including base instruments, computer, monitor, printer, and power conditioning equipment; unlimited on-site service visits, with a maximum 72-hour on-site response time; factory-certified replacement parts; engineer labor and travel costs; software updates and notifications; and one (1) scheduled preventative maintenance visit per year.

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.

A. Salient Characteristics **Quoters shall address each of the salient characteristics in order to be considered for award.** Triple Quadrupole/Linear Ion Trap Mass Spectrometer

1) 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.

2) The instrument must be capable of conducting: product ion scans, precursor ion scans, neutral loss or gain scans, scheduled multiple reaction monitoring (MRM) scans, and MS3 scans.

3) The mass spectrometer must have a scanning mass range of 5 m/z to 2000 m/z.

4) The mass spectrometer must have scan speeds up to 20,000 Da/sec.

5) The mass spectrometer must be capable of dwell times of at least 1 ms.

6) The mass spectrometer must have positive and negative polarity switching speeds of 20 msec or less.

7) While being analyte dependent, the linear dynamic range of the mass spectrometer must be capable of achieving at least four (4) orders of magnitude.

UHPLC System

1) The system must include two (2) LC pumps, a solvent degasser with reservoir tray, a thermostated autosampler and trays, a thermostated column compartment, central communication and control module, 10/100 ethernet network switch, high efficiency micro mixer, solvent bottles, and appropriate cables and event boards for operation.

2) The LC pump must have low volume plungers (10 µL or less) for pulse free solvent delivery, and be compatible with aqueous eluents from pH 0-14, and reversed-phase solvents.

3) The LC pump must be capable of forming quaternary low pressure gradients.

4) The maximum pressure requirement for the LC pump must be at least 15,000 psi.

5) The LC pump must have a flow rate range of at least 0.01 to 5 mL/min.

6) The system must be capable of handling columns with particle sizes of 3 µm or less.

7) The autosampler must be capable of injection volumes from 0.1 to 50 µL in 0.1 µL increments, without changing the injection loop.

8) The autosampler must be thermostated with a temperature range of at least 4 ºC to 40 ºC.

9) The autosampler must have a sample capacity for 1.5-mL sample vials of at least 100 vials.

10) The thermostated column compartment must have a temperature stability of at least ± 1 ºC.

11) The thermostated column compartment must have a temperature range of at least ambient to 100 ºC.

12) The degasser must include 4-channels for degassing 4 separate solvents and a 5th channel for degassing autosampler rinse solvent.

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:

Fred Gretch

FDA/Northeast Regional Laboratory

158-15 Liberty Avenue

Jamaica, NY 11433

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: 08/01/2016 – 07/31/2017 (if exercised)

Option Year 2: 08/01/2017 – 07/31/2018 (if exercised)

Option Year 3: 08/01/2018 – 07/31/2019 (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

· 352.201-70 Paperwork Reduction Act (Jan 2006)

· 352.202-1 Definitions (Jan 2006)

· 352.203-70 Anti-lobbying (Jan 2006)

· 352.215-70 Late proposals and revisions (Jan 2006)

· 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010)

· 352.223-70 Safety and health (Jan 2006)

· 352.224-70 Privacy Act (Jan 2006)

· 352.227-70 Publications and Publicity (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)

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 July 1, 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-1146743. The quotes are due by email to the point of contact listed below on or before July 8, 2015 by 1:00pm Eastern Time.

Please contact Eric Rabinovich at (240) 402-7631 or email at Eric.Rabinovich@fda.hhs.gov.

Evaluation Section 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.