RFQ_for_posting_1144260.doc

RFQ – FDA-1144260

Solicitation Number: RFQ-FDA-1144260 Subject: Ion Chromatography System Part 1 – Description

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5.

This solicitation is being issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-80.

This will be set aside for Small Businesses. The equipment shall be brand name or equal and shall include the terms and conditions that are set in PART 3.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516.

The Government intends to award a firm fixed price order.

Part 2 – Supplies or services and Prices/Costs

2. Description of Supplies & Services

2.1 Contract Type: Firm-Fixed Price

The Food and Drug Administration’s (FDA) requires a Ion Chromatography System.

2.2 Pricing Table

Option Year 1

Option Year 2

Total:

Part 3 – Description/Specifications

3.0 Statement of Work:

The Food and Drug Administration’s (FDA) requires an Ion Chromatography System.

3.1 Silent Characteristics:

Scope of Work

STATEMENT OF WORK (SOW)

The ion chromatograph system shall have or meet the following requirements:

a. Ion Chromatograph System: System shall be modular in design consisting of pumps, conductivity detector, conductivity cell, degas assembly, column compartment, column heater, suppressor, injector, and columns. Other modular detectors shall be available to increase the flexibility of the system such as absorbance detectors, electrochemical detectors, and mass spectrometric detectors as a minimum.

b. Inert Design: Ion chromatograph system shall be of an inert design. Fluidic components throughout the system must be non-metallic. PEEK (polyether ether ketone) is preferred to ensure solvent compatibility, corrosion resistance, and metal contamination-free chromatography. Other non-PEEK polymers will be considered. Stainless steel is not acceptable for wetted components.

c. Eluent Generator: An Eluent Generator shall be available as an option and shall be available in either a single channel or dual channel configuration. The single channel must be field upgradeable to a dual channel and both channels shall be contained in the same enclosure.

1) Electrolytic Eluent Generation is preferred over dilution type types for simplicity, consistency and pump maintenance. Eluent concentration is varied by changing the applied current which allows gradients formations without the use of extra pumps, fittings, or valves. Electrolytic Eluent Generation reduces the overall maintenance of the pumping system by exposing the pump and its wetted components to just deionized water. No salts or corrosive acids or bases are present to reduce the longevity of pump seals.

2) The electrolytically generated gradient shall be infinitely variable throughout a single run. Eluent types generated shall include: KOH, NaOH, LiOH, Bicarbonate/Carbonate, and MSA.

3) The Eluent Generator shall be able to produce an unlimited number of linear, convex, concave, or inverse gradient profiles. System shall be able to perform gradients with either a quaternary mixing pump or electrolytically with the Eluent Generator.

d. Suppressor: A Suppressor is necessary in ion chromatography. System shall have 2 supressors to work with the 2 conductivity conductors.

1. Both electrolytic and chemical suppression of eluent for analyses shall be available.

2. Suppressor shall be operated continuously for greater accuracy and reproducibility without the need of switching motors and based on a single membrane based ion exchanger.

3. Suppressor device shall be able to suppress carbonate, hydroxide, or methanesulfonic acid eluents.

e. Sample Preparation Automation: Instrument shall permit field installation of an optional automation manager consisting of up to two 6-port or 10-port high pressure and/or two low pressure solenoid valves for post-column derivatizations or automated sample preparation operations such as online matrix elimination, online filtration, preconcentration, as well as large loop/small loop injections controlled by the data system. System must have at least one 6-port valve for these sample preparation operations.

f. Conductivity Detector: System shall have 2 Conductivity Detectors with the following characteristics:

1. Single-range digital output with operating range to 15000 (S/cm full-scale, and single-range analog signal output to 15000 (S/cm.

2. Shall be microprocessor-controlled with digital signal processing and a 8 kHz square wave cell drive

3. Shall be compatible with MSA.

4. Linearity of 1%

5. Resolution of 0.003 nS/cm

6. Filter rise times from 0 to 10 s, programmable

7. Sample rate of 1-100 Hz user settable or automatic

8. Cell temperature stability of <0.01 (C

9. Maximum cell pressure of 10MPa (1500 psi).

g. Electrochemical Detector: System shall have a Electrochemical Detector and associated cell with the following characteristics:

1. The electrochemical detector shall be capable of operating in the following modes: Integrated Amperometry, Pulsed Amperometry, DC Amperometry mode, and Cyclovoltammetry. Multiple waveforms and multiple integrations times shall be supported to optimize detection conditions for individual analytes.

2. The detector shall be auto ranging; potential range of -2.0 to 2.0V in 0.001 V increments; filter rise time of 0-10 s; small cell volume.

3. The cell electrodes shall be available in the following options: gold, silver, platinum, and glassy carbon.

4. Disposable electrodes shall also be available made from the same material to provide ease of use

h. Electrodes: Reference and working electrodes necessary for detectors.

i. Leak Detection: System shall have leak detection for laboratory safety and management to allow fast response to system leaks.

j. Degas: System shall have a built in vacuum degas assembly which provides in-line degassing of eluents ensuring reproducibility and protection of eluents from contamination and decomposition. Control of the degas operation shall be able to be automated to sense when degassing is required.

k. Pumps: The pumps are a critical part of any chromatography system. The following pump characteristics are required:

1. The pumps shall be of a dual piston serial design, microprocessor controlled, constant stroke, variable speed, and have isokinetic eluent pre-compression capabilities.

2. The pumping systems available shall be suitable for either quaternary low pressure mixing, isocratic analysis, or capillary flow rates.

3. The pump housing shall be able to incorporate up to two independent pumping systems which can be any combination of the available designs. Field upgradability to a second pump must be available.

4. The pump shall have a pressure range of be at least 0-5000 psi and must be able to withstand maximum pressures of 5,000 psi.

5. The flow rate range shall be 0.000-10.000 mL/min settable in 0.001ml/min increments in analytical without changing pump heads. This range will allow the system to accommodate a wide range of columns.

6. Flow rate precision shall be <0.1%, flow rate accuracy shall be <0.1%. Pressure ripple must be <1% at 1.0 mL/min, <0.2% at 10 (L/min. Gradient proportioning accuracy must be (0.5 at 2 mL/min.

7. The pumping system shall be suitable for either quaternary low pressure mixing, isocratic analysis, or capillary flow rates.

8. Pumps shall have an automated integrated piston seal wash which prolongs seal lifetime by preventing eluent crystallization on the seal surfaces. This will be useful when pumping harsh chemicals which might be required for certain analyses.

9. The pump shall have user-settable pressure limits to automatically stop pump flow in the event of leaks, flow restrictions, or depleted eluent reservoirs and an optical leak sensor in event of a leak.

10. The quaternary pump shall support an unlimited number of; linear, convex, concave, or inverse gradient profiles

11. Two dual pump modules are required.

1. Pump module one: one pump is quaternary gradient; the other is isocratic

2. Pump module two: two quaternary gradient pumps

l. Autosampler: System shall have a 2 integrated autosamplers with the following characteristics:

1. Autosampler shall be capable of performing full-loop and partial-loop injections.

2. Instrument must have optional software and hardware capability to analyze and automatically re-inject samples which exceed specified, user-selectable parameters such as peak area, peak height and amount. Method may include data system selection of a smaller loop, reduced direct injection volume (“partial loop” injection) or true “vial to vial” sample dilution.

3. Shall have an all PEEK flow path to minimize trace element contamination and be compatible aqueous and reverse-phase solvents.

4. Shall be capable of simultaneous or sequential injection.

5. Shall be capable of performing dilutions without additional hardware.

6. Shall have a moving-needle design to guarantee reliable sampling from a variety of sample vials.

7. Shall be capable of handling vials sizes of 10 mL, 1.5mL, or well plates.

8. Capable of modifying a run sequence anywhere within the sampler during the run without interrupting analysis.

9. Shall be capable of sampling a minimum volume of 10 (L from a 300 (L microvial or 20 (L from a 500 (L microvial.

10. Shall have a variable volume range of 1-100 (L in 0.1 (L increments or 100-7500 (L in 1 (L increments.

11. Shall have an injection precision of <0.3% RSD at 20 (L in full loop mode and <0.5% RSD at 20 (L in partial fill mode.

12. Shall have a dilution precision of <1% RSD for a 1:10 dilution, a dispensing precision of <0.2% RSD (by weighing), and a carryover of <0.01% with a 500 (L flush volume.

13. Shall have as an option the ability to measure conductivity and pH in-line prior to sample injection.

14. Shall have as an option the ability to house either one or two 6-port or 10-port vales for sequential injection, sample preparation, fraction collection, or sample injection.

15. Shall have as an option the ability to control sample temperature from 4-60 (C.

16. Shall be equipped with six vial racks to accommodate 40 1.5 mL vials in each rack.

17. Shall include 200 1.5 mL vials, caps and septas.

18. Shall include two 10-port high pressure switching valves

m. Chromatographic Column Set and Oven: System shall include a set of chromatographic columns and associated precolumns/guard columns with the following specifications:

1. The columns shall be comprised of a nonmetallic body and an inert packing material capable withstanding at least 4000 psi. The column set quoted shall be composed of a separator and precolumn packed with either the same column packing material or a packing material that is a complementary polymeric resin.

2. Columns shall be 2 mm internal diameter for capacity and sample concerns.

3. Columns supplied shall be able to separate and allow determination of the following: bromide, bromate, fluoride, iodide, iodate, chloride, perchlorate, sulfate, sulfite, nitrate, nitrite, cyanide, trivalent chromium, phosphate, hexavalent chromium, arsenite and arsenate.

4. Column oven shall be able to maintain column from 20 °C to 80 °C with a temperature stability of < 0.1 °C.

5. Shall include a column to remove trace quantities of transition elements from high pH eluents

n. Computer System and Software: System shall include a computer to control all aspects of the system, a monitor, a laser printer and software with the following specifications:

1. Color monitor at least 24 inches in size.

2. Laser printer capable of printing at least 300 dpi and at least 10 ppm.

3. The software shall be a 64 bit application for future upgradeability.

4. The software shall be able to provide full automatic control of the process of analyzing samples. This must include acquiring data, quantitation, producing a report, and the option to upgrade to an incorporated Excel like spreadsheet for report flexibility.

5. Standard curves shall be generated using a variety of curve fitting routines:

a) Shall be able to select curves with up to 5 point calibration curves

b) Shall be able to select linear, quadratic, or cubic fit curves

c) Shall be able to use weighing options for the calibration calculations.

d) Shall be able to calculate the confidence intervals at different confidence levels.

6. The software shall be able to automate integration updates without time consuming batch reprocessing of changes to an integration in a data set.

7. The Software shall allow real time integration monitoring in order for an instrument operator to monitor real time progress.

8. The software shall have the ability to customize the report format and content

9. The instrument software shall include self-diagnostic functions.

10. The software shall be able to control and acquire data from third party instrumentation including but not limited to chromatography pumps, autosamplers and detectors including AB Sciex mass spectrometers..

11. Software must include the ability to perform virtual analytical runs. The chromatographic simulation software must allow the analyst to predict the analytical performance of various columns, flow rates, gradients and eluents.

o. Warranty: Warranty shall meet the following specifications:

1. At least one year complete coverage which includes on-site repairs, parts, labor and technician travel.

2. All non-consumable parts shall be covered under warranty for an additional 2 years for the cost of the part and for the cost of shipping the parts to the Food and Drug Administration.

3. Installation and user familiarization by qualified technician.

3.2 Reporting Requirements and Deliverables:

Delivery

FDA

10903 New Hampshire Ave Building 64 Silver Spring, Maryland 20993

3.4 Period of Performance

The period of performance is 90 Days after Award.

Part 4– Contract Administration Data 4.Contracting Officers Representative (COR)

4.1 The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award)

4.1.1 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.

4.1.2 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.

4.1.3 The contact information for the Contracting Officer:

James Chestnut 5630 Fishers Lane

Rockville, MD 20857 James.Chestnut@fda.hhs.gov

Tel: (202) 402-7570

4.1.4 The contact information for the Contracting Specialist:

Lacetta T. Bowman

5630 Fishers Lane

Rockville, MD 20857

Lacetta.Bowman@fda.hhs.gov

Tel: (240) 402-7566

4.2. INVOICE SUBMISSION

A. The Contractor shall submit one original copy of each invoice to the Contract Specialist, COR (Contracting Officer Representative) and 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

OFS/PaymentServices@fda.hhs.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 – Central Contractor Registration) 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.

Part 5 – Special Contract Requirements 5 Government Holidays

5.1.4 Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January (New Year’s Day)

January (Martin Luther King Day)

February (President’s Day)

May

(Memorial Day)

July

(Independence Day)

September (Labor Day)

October (Columbus Day)

November (Veterans Day)

November (Thanksgiving)

December (Christmas Day)

Part 6 – Contract clauses

6. FAR Clauses Incorporated by Reference

6.1 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html 52.212-4 Contract Terms and Conditions-Commercial Items (DEC 2014)

52.216-24, Limitation of Government Liability (Apr 1984)

52.233-2, Service of Protest (Sep 2006)

6.2 FAR Clauses by Full Text

52.212-3 Offeror Representations and Certifications—Commercial Items.

Offeror Representations and Certifications—Commercial Items (March 2015)

An offeror shall only complete paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items.

Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (MARCH 2015)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)(Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 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).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved].

_ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

_X_ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Jan 2011) of 52.219-4.

__ (13) [Reserved]

X__ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (iv) Alternate III (Oct 2014) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (28) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X_ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014)(38 U.S.C. 4212).

__ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_X_ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

_X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (36)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-13.

__ (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

_X_ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

__ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (41) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (42)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

__ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (44) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (50) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (51) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (54)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.13495).

__ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

__ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

__ (10) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive Order 13658).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

(vi) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(vii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212)

(viii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(ix) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(x)

__(A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627).

__(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).

(xi) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xiii) 52.222-54, Employment Eligibility Verification (Aug 2013).

(xiv) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xvi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive Order 13658).

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

6.3 HHSAR Clauses Incorporated by Reference

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: http://www.gpoaccess.gov/cfr/index.html.

352.202-1, Definitions (Jan 2006)

352.203-70, Anti-Lobbying (January 2006) 352.215-70, Late proposals and revisions (Jan 2006)

352.223-70, Safety and health (Jan 2006)

352.224-70, Privacy Act (January 2006) 352.228-7, Insurance--Liability to third persons (Dec 1991)

352.242-71, Tobacco-free Facilities (January 2006)

352.242-73, Withholding of Contract Payments (January 2006)

352.270-10 Anti-lobbying (Jan 2006)

PART 7 – INSTRUCTIONS TO THE OFFERORS

7.1 Coverpage

The cover letter shall include price (s); FOB point; a poc (name and telephone number); delivery date (delivery date is of the utmost importance); business size; and payment terms. Offerors shall ensure the RFQ number is visible in the header of the email. Fax quotes shall not be accepted.

7.2 Offeror Response Dates and Time

Questions: All questions shall be submitted via email Lacetta.Bowman@fda.hhs.gov before Thursday, March 26, 2015.

RFQ Due Date: All quotes and revisions shall be submitted via email Lacetta.Bowman@fda.hhs.gov before 2:00 p.m. Eastern Time on Thursday, April 2, 2015.

Note: Late quotes will not be evaluated.

52.212-1, Instructions to Offerors - Commercial Items (APRIL 2014)

7.3 Price

6.3.1 The Offeror shall submit a complete pricing matrix for a firm fixed price as indicated in PART 2.2.2.

PART 8 – Evaluation Factors for Award

8.1 Evaluation Factors

The Government will evaluate the quote to ensure that it is lowest price technically acceptable in accordance with the requirements in Part 3.

8.2 Price

8.2.1 The price shall represent the Offeror’s response to the requirements of the RFQ. The Government will evaluate the total price of all base year and option year contract line items, if applicable.

8.3 SYSTEM FOR AWARD MANAGEMENT REGISTRATION

In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the -

Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance.

If a new Contractor, you will need only your personal information to create an account in SAM. If a Contractor with an active record in CCR, you will not need to establish a SAM account. The CCR record transfers to become the active SAM account.

(1) Definitions.

"Registered in the SAM database" means that-

(i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database;

(ii) The Contractor's CAGE code is in the SAM database; and

(iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record "Active". The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process.

"System for Award Management (SAM)" means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes-

(i) Data collected from prospective federal awardees required for the conduct of business with the Government;

(ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their Representations and Certifications and submit it with their proposal]; and

(iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the nonprocurement common rule by agencies, Government corporations , or by the Government Accountability Office.

(2) The Contractor shall be registered in the SAM database prior to submitting an invoice and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The SAM registration shall be for the same name and address identified on the contract, with its associated CAGE code and DUNS or DUNS+4. If indicated by the Government during performance, registration in an alternate system may be required in lieu of SAM.

If the Contractor does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A contractor may obtain a DUNS number-

(i) Via the internet at http://fedgov.dnb.com/webform or if the contractor does not have internet access, it may call Dun and Bradstreet at 1-866-705-5711 if located within the United States; or

(ii) If located outside the United States, by contacting the local Dun and Bradstreet office. The contractor should indicate that it is a contractor for a U.S. Government contract when contacting the local Dun and Bradstreet office.

(3) The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(4) Contractors may obtain information on registration and annual confirmation requirements via the SAM accessed through https://www.acquisition.gov or by calling 866-606-8220, or 334-206-

7828 for international calls. If there is any difficulty in updating this record, contact the Federal Service Help Desk at www.fsd.gov or 866-606-8220 for SAM assistance. https://www.sam.gov/portal/public/SAM/ Award Criteria:

Award will be made to the party whose quote offers the Lowest Priced Technically Acceptable overall.

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