FDA-20-SOL-1228152.pdf

FDA-20-SOL-1228152

STATEMENT OF WORK

Automated Rail System

Background

The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. On May 10, 2016, FDA published its final rule, “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act;

Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” (Deeming rule) extending FDA's tobacco product authority to ENDS, among other products. This law commonly called the Tobacco Control Act gives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products including electronic nicotine delivery systems (ENDS).

On July 12, 2019, the court issued a further order directing FDA to require that premarket authorization applications for all new deemed tobacco products be submitted to the Agency by May 12, 2020 and providing for a one-year period during which products with timely filed applications might remain on the market pending FDA review.

Purpose

The Southeast Tobacco Laboratory (STL) would like to purchase an automated CTC analytical rail to be able to handle the expected high sample volume of premarketing tobacco product applications (PMTA). STL needs this system to increase the sample analysis throughput. STL is not going to be able to handle this high sample volume assignment, expected in May 2020, without this instrument. In addition, this system can be used to automate other sample preparation of any product for performing nicotine, flavor, and volatile organic compound (VOC) analysis, as well as other methods involving liquid-liquid extraction and GC/MS that may arise in the future.

Scope

The Contractor shall be capable of providing an instrument that can perform as specified in the Statement of Work and provide Preventative Maintenance in accordance with the manufacturer’s specification during the contract periods of performance.

Salient Characteristics and General System Requirements

The automated rail system must contain the following modules / functions to be considered a complete system for the purposes of this acquisition. All modules mentioned below must connect to the 200-centimeter CTC rail and be electronically compatible / controlled using the Robotic Heads described in (2) and computer software, described in (12) below. All modules mentioned in these general requirements function together on the automated rail system.

https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm246129.htm https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm246129.htm

Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government.

1. The instrument must consist of a standard CTC Analytics rail system 200 centimeters in length.

2. The instrument must have two (2) Robotic heads on the CTC rail consisting of 1 Robotic head and 1 Robotic exchangeable head, with the Robotic exchangeable head capable of automatically changing liquid syringe head tools during an automated sequence or process to any liquid syringe size head (see ahead), a headspace syringe head, or a SPME (solid phase micro-extraction) head. (See item# 13 in these general requirements for a definition of “tools”). There must be one (1) liquid syringe holder for the following liquid syringe volumes: 5uL, 10uL, 25uL, 50uL, 100uL, 250uL, and 500uL. Furthermore, there must be one (1) liquid syringe holder for the following syringe volumes: 1000uL (or 1.00 mL), and 2500uL (or 2.50 mL). In addition, there must be a minimum of five (5) liquid syringe tools, one for each Robotic head (2) and three (3) additional liquid syringe tools, one (1) for each position of the tool station, to be described next in item #13 of these general requirements.

3. The rail must include three (3) tray holders with attachments for ALL of the following vial options: 10/20mL vials (1 tray of 60 slots, and 3 trays for a total of 135 vials), 2 mL vials (3 trays for a total of 162 vials), 40mL vials (3 trays for a total of 36 vials), 1 mL vials (3 trays for a total of 210 vials), 2 mL autosampler vials (3 trays of 96 or 384 vials), and microtiter plates (3 trays of 96 or 384 microtiter positions).

4. The instrument must have a standard wash station module for rinsing of syringes with solvent washes during sequence operations. It must contain two (2) times 10mL solvent wash bottles and two (2) times 10mL waste bottles, and a fifth (free) position (e.g. for holding an adsorption tube).

5. The instrument must have a module for automatically opening and closing initially closed vials (2mL, 10mL and 20 mLvials). Caps for each vial are made of magnetic metal and the septa are made of a combination of silicone/PTFE material. The module is capable of opening any of the vial types indicated and closing them, making a seal. (This module is also referred to as a “capper/decapper”).

6. The module must consist of four (4) 1-liter bottles (total) capable of dispensing volumes of any of the four (4) solvents to any size vials during a sequence or automated operation. (This module may be described as a solvent filling / delivery station for brevity).

7. The module must be capable of mixing / shaking vials for any length of time.

Adapters are available for any vial size indicated in section (3) of the general system requirements. This module may be described as a mixer or shaker for brevity.

8. A module capable of centrifugation of standard 10mL headspace vials, containing a rotor with a minimum of six (6) positions. This module may be described as a centrifuge capable of at least 2000 rpm.

9. A module (thermal desorber) for thermally desorbing adsorption tubes into a programmable temperature vaporizer inlet of a gas chromatograph /mass spectrometer instrument. The module must connect to an electronic pressure control interface that controls the flow of carrier gas through the thermal desorber unit and an Agilent GC system at large and must be compatible/controllable in part using Masshunter software. This unit can be referred to as a Thermal Desorption module for brevity. This module must operate at any temperature between 10o and 250o centigrade and be programmable from 1oC to 400oC/minute. This module must be capable of operating using split, splitless and solvent vent modes during desorption processes.

10. A module (programmable temperature vaporizer) capable of linear heating (0.5o to 12oC/sec) that can interface (connect) to the thermal desorber unit. The module must connect to the pneumatics of the Agilent 7890 GC and be controllable in part using Masshunter software. It must also be controllable from the electronic pressure control module of the thermal desorption unit. It must physically fit into the space reserved for a GC split/splitless or multimode inlet of the Agilent gas chromatograph. A septumless sampling head must be available to attach to this module whenever the thermal desorption module is disconnected from this module. The programmable temperature vaporizer must be able to be cooled accurately (within 1oC) to liquid nitrogen temperature (77 K) and heated up to at least 300oC at a maximum rate of 12oC/second.

11. A module for performing dynamic headspace analysis must be available. It must contain a unit for holding an adsorption tube (thermostat controllable from 10oC to 150oC) and a unit for holding either a 10mL or 20mL headspace bottle. As with all modules described thus far, this module must be controllable using software to program the rate and duration of purging and heating of the sample vial during extraction of the sample.

12. Control Software must be available to control all modules listed in these general requirements. It must be capable of being integrated into Agilent Masshunter software, and operate as a stand-alone software system if necessary (both options must be available). The software provides the ability to automate the operations of each of the modules listed in these general requirements to perform any sequence of operations.

13. A module for holding tools on the rail. Tools are defined as the go-between devices that marry the sampling implement (e.g. liquid syringe and holder, SPME or solid phase microextraction syringe and holder, gas syringe sampling syringe and holder) to the Robotic head. The robotic exchangeable head (one of the robotic heads) can exchange automatically (without user intervention) one head tool for another during any sequence operation or automated process involving the rail.

Trade and Service Specifications

• The instrument must be a newly manufactured unit and, not used and refurbished or previously used for demonstration.

• Equipment shall have at least a minimum one (1) year OEM-warranty for parts and labor.

• Equipment shall be delivered with all necessary supplies and accessories required for installation and start-up.

• Contractor shall install and perform installation and operation qualification (IQ/OQ) and include all supplies needed to perform the IQ/OQ.

• Contractor shall provide at least 1 full day of onsite training for up to 4 analysts.

• FOB Point destination to include inside delivery and clean-up of area after installation.

The shipping and handling price must include the removal of the crates from the delivery truck, including any needed fork lifts, to a location in storage at the installation site and removal of any wooden pallets and or crates once installation is completed.

Service Calls

• The Contractor shall respond within 2 business days after receipt of a service call.

• The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9-5 p.m. EST.

• All repairs must result in the instrument(s) serviced meeting the manufacturer specifications and must use factory new replacement parts.

• Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information that the FDA may return the parts to the Contractor at the Contractor’s cost within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

• The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications

Service Conditions

• To the maximum extent practicable, service must be rendered on-site at the

FDA.

• In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the FDA, 60 8th ST.NE, Atlanta, GA. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The Contractor shall also provide a shipping account number to pay for the shipment.

• The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by the manufacturer.

Deliverables

Deliverable Quantity Delivery Date automated rail system and all required accessories to install the system

1 June 2020

Installation and Operational Qualification Automated Rail System

1 June 2020

Familiarization Training for 4 Analysts

1 June 2020

Service Reports Varies NLT 5th work day following the end of each month during any months which work is performed on the instrument.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

Packing, Marking and Shipping

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

All packing material shall be removed from the FDA premise by the contractor.

Shipping Destination/Place of Performance

Satisfactory performance of this contract shall be deemed to occur upon delivery, installation, training, and performance of services described above or 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 45 days from receipt of the award of order to the address listed below:

Food and Drug Administration (FDA) Southeast Tobacco Lab (STL) 60 8th St., NE Atlanta, GA 30309

POC: TBD

Period of Performance

The period of performance shall be for a base period of one year.

BASE YEAR June 2020 – June 2021

Unless otherwise specified, services shall be performed Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Government Holidays

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

January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) July (Independence Day) December (Christmas Day)

FAR / HHSAR Clauses

52.212-4 Contract Terms and Conditions Commercial Items (JAN 2017)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items. (OCT 2019)

(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

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

(4) 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 (Oct 2015) (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 (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_x_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (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 (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1158787 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/sites/default/files/current/far/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://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1144881 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151163 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151299 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1140926 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1145644 https://www.acquisition.gov/sites/default/files/current/far/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 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://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955 https://www.acquisition.gov/sites/default/files/current/far/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://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135970 https://www.acquisition.gov/sites/default/files/current/far/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://www.acquisition.gov/sites/default/files/current/far/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://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/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

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

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

_x_ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (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, or Sole Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (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 2018)

(E.O. 13126).

_x_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_x_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

_x_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

_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 (FEB 2016) (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 (OCT 2015). (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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (39)(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.

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__ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C.

8259b).

__ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

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

_x_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011) (E.O. 13513).

__ (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

_x_ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (47)(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.

__ (48) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_x_ (49) 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).

__ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

__ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_x_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

_x_ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C.

637(d)(12)).

__ (60)(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:

__ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

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__ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C.

206 and 41 U.S.C. chapter 67).

__ (4) 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).

__ (5) 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).

__ (6) 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).

__ (7) 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).

__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

__ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014)

(42 U.S.C. 1792).

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

(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 (Oct 2015) (41 U.S.C.

3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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 $700,000 ($1.5 million for https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160021 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1153423 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148260 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148274 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1155380 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162590 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1163027 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1170084 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1120023 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://www.acquisition.gov/sites/default/files/current/far/html/52_215.html#wp1144470 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%204_7.html#wp1082800 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1158787 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/ construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 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.

(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

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

793).

(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(x) 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.

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

(xii)

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

(xiii) 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).

(xiv) 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).

(xv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xviii)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xix) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xx) 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.

(xxi) 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.

(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) Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause.”

Alternate II (Nov 2017). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

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(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(A) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010)…