FBO_Combined_Synopsis_RFQ_for_1145526_final.pdf

PART 1 - Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and Solicitation for Commercial Items”, as supplemented with additional information included on this notice and in conjunction with FAR Part 13.106, utilizing Simplified Acquisition Procedures. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued.

The solicitation number is FDA-15-1145526. This solicitation is issued as a Request for Quote (RFQ).

This solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-82 dated June 8, 2015.

The associated North American Industry Classification System (NAICS) Code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing. This combined/synopsis solicitation is full and open competition.

PART 2 - BACKGROUND

The Food and Drug Administration’s Office of Regulatory Affairs (ORA) has a requirement for a Benchtop Single Reaction Chamber Digestion System.

The Southeastern Regional Laboratory and San Francisco Laboratory each require one Microwave / Benchtop Single Reaction Chamber Digestion System (two systems total) for sample analysis in the Elemental Analysis Program. The chemistry program optimization mandates utilizing simplified extraction techniques, such as microwave digestion. This technique is necessary for implementing more efficient analytical procedures utilizing multiple analyte methodologies by ICP, ICP-MS and speciation by LC-ICP-MS as part of routine elemental analysis. In order for the laboratories to continue to transition to such effective extractions, the equipment is needed to ensure the proper capacity for sample preparation and digestion.

Item Qty. List

Price DISCOUNT Price

High Throughput Microwave Digestion System 1 $ $ $

Option year One (1) Preventative Maintenance Agreement (if exercised)

1 $ $ $

Option year Two (2) Preventative Maintenance Agreement (if exercised)

1 $ $ $

Option year Three (3) Preventative Maintenance Agreement (if exercised)

1 $ $ $

Option year Four (4) Preventative Maintenance Agreement (if exercised)

1 $ $ $

TOTAL PRICE $ $ $

PART 3 – STATEMENT OF WORK/SPECIFICATIONS

The contractor shall provide:

A. Minimum Salient Characteristics for a High Throughput Microwave Digestion System

The system shall:

• Provide fully validated software to operate the microwave digestion system, a computer, monitor (minimum 24”), mouse, keyboard, and network compatible laser printer. The computer/controller shall be supplied with all the hardware necessary to communicate with the system. Computerized controlling software system is required.

o The software shall be available in the English language;

o Software system shall be compatible of communication with a Laboratory Information

Management System.

• Be a closed system to prevent cross-contamination and loss of volatile analytes

• Have a Maximum Temperature: 300C via direct temperature control

• Operate with 120V or 220V power connections. A 230V booster shall be included for each 220V requirement.

Maximum Wattage: 1500W

• Have the ability to digest up to 2.0 grams of organic material in a single run (e.g. near quantitative conversion of carbon to CO2 so as to minimize or eliminate TOC in solutions entirely).

• Digestion Acid Specification: Maximum of 5mL concentrated nitric acid for complete digestion

• Digestion Rack Specifications: Two Racks: 15 position rack which has a capacity of 15mL quartz vials; 22 position rack which has a capacity of 10mL quartz vials

• Be capable of running in racks of from 4 to 22 digestions during a single run in less than 40 minutes, including cooling. Sequential digestion systems are not accepted.

• Have a microwave digestion system that does not have a vessel assembly; a significant amount of time is lost due to vessel assembly and disassembly, which increases handling and the risk of contamination.

• Be capable of direct control over temperature and pressure as opposed to indirect control (e.g.

infrared sensors for indirect temperature control), with monitoring rates in the range of at least 20 measurements per second.

• Load: Sample vials sit in liquid that provides a consistent load for the delivered microwave energy, which ensures conductive heating and consistent conditions from run to run and eliminates the need for a rotating carousel

• Be able to withstand an over-pressurization of the reaction chamber without venting, and contain built-in sensors to directly monitor and maintain magnetron and microwave antenna temperatures during digestions (e.g. failsafe mechanisms in place in case of an over-pressurization in order to safely release the pressure inside the reaction chamber, as well as safety valves in the event of a power outage so that pressure may be released manually).

• Pre-pressurization to 40 bar with nitrogen or argon prevents boiling, bumping, spitting, and potential loss of volatiles or cross-contamination of the samples. System must operate with user choice of nitrogen and/or argon.

• Components, such as quartz vials and caps, are to be durable to endure hundreds of digestion cycles, not to be consumables which need to be replaced every year.

• Have one (1) digestion program for all food matrices, which eliminates the need to batch similar samples. Method development is largely eliminated since a single digestion program can be used for almost every sample type.

• Have a single reaction chamber lined with PTFE to prevent corrosion from acid vapors allowing any type of digestion acid or mixture to be used

• Rapid cool-down upon completion of digestion cycle through the use of a recirculating chiller--The digestion system should provide a fast temperature cool down time, at least from 240 degrees C to ambient temperature of approximately 22 degrees C in 15 minutes or less. Only liquid cooling is acceptable; no air cooling.

• Be a newly manufactured unit, not used and refurbished or previously used for demonstration.

• Installation qualification and operational qualification for microwave digestion system shall be performed by a vendor representative, not a third party contractor.

• A minimum of 5 instruments shall have already been sold and installed in laboratories other than the vendor’s laboratories as a demonstration of performance history.

• The system shall be a compact, bench-top design to fit the space constraints of the laboratory. An external recirculating chiller that fits under or behind the laboratory bench is acceptable.

D. Additional Requirements The system shall be delivered with all necessary supplies and accessories required for installation and start-

up. Installation and operational training shall be included.

A two (2) year warranty is required with the purchase and shall include at a minimum:.

-coverage of all non-consumable items, and parts supplied -unlimited on-site service visits -maximum of 48-hour onsite response time -factory-certified original replacement parts -engineer labor and travel costs -software updates and notifications.

All warranty work must be performed by the instrument vendor, not a third party contractor.

Training:

Installation and two days of on-site operational training must be included.

Part 4 – Packing, Marking and Shipping:

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. There will be one shipping location (identified under Part 8). Delivery and installation shall be inclusive of all labor, parts, and travel expenses. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All equipment shall be new and not used.

Part 5 – Inspection and Acceptance:

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment, installation and services to be provided. For the purpose of this PART, (COR – to be determined upon contract award) is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the locations identified in part 8. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt.

PART 6 – DELIVERIES OR PERFORMANCE:

DELIVERIES:

Satisfactory performance of this contract shall be deemed to occur upon delivery and installation of the systems described in PART 3 of this contract. The Contracting Officer Representative (COR) must accept the test in the qualification report before the installation starts. The instrument must pass all the tests required by the manufacturer and the test performance of the equipment must be accepted by the COR.

The complete process for installation and qualification shall occur within two (2) weeks after delivery. If this timeframe cannot be met, it is the responsibility of the Contractor to contact the COR to make other arrangements to complete the installation and qualification. The new equipment shall be installed and property validated within two (2) weeks from the date received in the FDA facilities.

Deliveries required by the contractor shall be made F.O.B. destination within 60 days from receipt of the award of contract to the addresses/addressees listed below:

DELIVERY LOCATION:

US FDA

Southeast Regional Laboratory 60 8th ST NE Atlanta, GA 30309

US Food & Drug Administration San Francisco Laboratory 1431 Harbor Bay Parkway Alameda, CA 94502

Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see PART 8) between the hours of 8:00 a.m. and 4:00 p.m. Eastern Time only. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

The Contractor shall provide the FDA with one (1) week’s scheduling notice prior to the setup of the laboratory instrument and component parts.

Part 7 – Contract Administration Data:

7.1 Contracting Officers 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.

7.2 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 Contract Specialist is:

Karen Petty 5630 Fishers Lane Room 2103 Rockville, MD 20857 karen.petty@fda.hhs.gov Tel: (240) 402-7681; Fax: (301) 827-7106

7.3 Invoice Submission

The Contractor shall submit an original invoice to the address specified below.

Office of Financial Services Food and Drug Administration Attn: Vendor Payments 10903 New Hampshire Avenue Bldg 32, Rm 2162, Mail Hub 2145 Silver Spring MD 20993-0002

(301) 827-3742 or (866) 807-3742 Email: fdavendorpaymentsteam@fda.gov mailto:karen.petty@fda.hhs.gov mailto:fdavendorpaymentsteam@fda.gov

Invoices submitted under this contract must comply with the requirement set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer System for Award Management (SAM)) and/or other applicable FAR Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(1). Name and address of the Contractor;

(2). Invoice date and number;

(3). Contract number, contract line item number and, if applicable, the order number;

(4). Description, quantity, unit of measure, unit price and extended price of the items delivered;

(5). Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(6). Terms of any discount for prompt payment offered;

(7). Name and address of official to whom payment is to be sent;

(8). Name, title, and phone number of person to notify in event of defective invoice; and Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(9). Electronic funds transfer (EFT) banking information. The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(10). If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer- System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

(11.) Name and Telephone Number of the FDA Contracting Officer Representative (COT) or Other Program Center/Office Point of Contact, as referenced on the purchase order; and (12.) Any other information or documentation required by the purchase by the purchase order/award. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF)

Payments

Payments will not be made more frequently than monthly in arrears. Advance payments will not be made.

QUESTIONS CONCERNING TERMS OF THIS ORDER (Other than invoice-related) SHOULD BE DIRECTED TO: Karen Petty (240) 402-7681 or karen.petty@fda.hhs.gov

The supplies and/or services 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.

Part 8 – Special Contract Requirements

8.1 Government Holidays

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 9 - FAR and HHSAR CLAUSES Incorporated by Reference:

Clauses and Provisions:

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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: https://www.acquisition.gov/far/

CLAUSES

CLAUSES

FAR 52.212-4 Contract Terms and Conditions-Commercial Items (Dec 2014)

FAR 52.204-7 System for Award Management (Jul 2013)

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

(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.)

https://www.acquisition.gov/far/ https://acquisition.gov/far/current/html/52_207_211.html#wp1146366 https://acquisition.gov/far/current/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_233_240.html#wp1113344 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1141983 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1144881

__ (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.

__ (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] __ (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).

_X_ (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).

https://acquisition.gov/far/current/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1151163 https://acquisition.gov/far/current/html/52_200_206.html#wp1151299 https://acquisition.gov/far/current/html/52_207_211.html#wp1140926 https://acquisition.gov/far/current/html/52_207_211.html#wp1145644 https://acquisition.gov/far/current/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1135955 https://acquisition.gov/far/current/html/52_217_221.html#wp1135970 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1135970 https://acquisition.gov/far/current/html/52_217_221.html#wp1136004 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 https://acquisition.gov/far/current/html/52_217_221.html#wp1136032 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 https://acquisition.gov/far/current/html/52_217_221.html#wp1136174 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_217_221.html#wp1136175 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136186 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136387 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1144950 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_217_221.html#wp1144420 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1147479 https://acquisition.gov/far/current/html/52_222.html#wp1147630 https://acquisition.gov/far/current/html/52_222.html#wp1147656 https://acquisition.gov/far/current/html/52_222.html#wp1147711 https://acquisition.gov/far/current/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

_X_ (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).

__ (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.

__ (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.

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

13513).

_X_ (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).

_X_ (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)).

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__ (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).

_X_ (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.

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(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.

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52.217-8 -- Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time prior to contract expiration.

52.217-9 -- Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within any time prior contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 2 years.

HHSAR Clause 352.202-1

Description Definitions

Date (Jan 2006)

352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (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)

Part 10– Instructions to the Offerors

The cover letter shall include FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are SAM Registered under NAICS code 334516; delivery date (delivery date is of the utmost importance); business size; and payment terms. Offerors shall ensure the RFP number is visible in the header of the email. Fax quotes shall not be accepted.

Price: The Offeror shall submit a complete pricing matrix for a firm fixed price as indicated in PART 2.

Contractors quote shall be good through September 30, 2015.

Technical: Offerors shall submit sufficient information for the Government to determine the technical acceptability of the proposed equipment and or services including brochures and detailed equipment or services speciation. In order for a product or service to be considered technically acceptable, it shall meet all the requirements listed under the SOW and listed under Part 4.

Evaluation Award Criteria: Award shall be made to the lowest price technically acceptable offeror, providing all Services, technicians; equipment meets requirements outlined under the SOW under Part 4.

SAM: Vendor must be registered in the System for Award Management (SAM) prior to the award of the contract. You may register by going to www.sam.gov. Your will need your Tax ID, DUNS Number and banking information.

Vendors who are not registered in SAM will not be eligible for award.

http://www.sam.gov/

QUESTIONS DEADLINE: All questions are to be submitted via email to Karen Petty at karen.petty@fda.hhs.gov no later than July 23, 2015 by 2:00 pm EST.

QUOTATIONS DUE: All quotations shall be submitted to Karen Petty at karen.petty@fda.hhs.gov before July 29, 2015 by 2:00 pm EST.