Sol_RFQ Attachment_75F40123Q00375.pdf

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Ion Chromatography Systems Federal contract opportunity
Solicitation number
75F40123Q00375
Issued by
Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services

About this file

This document is a Request for Quotation (RFQ) for two new ion chromatography systems and accessories to replace aging equipment for the U.S. Food and Drug Administration (FDA). The FDA seeks to procure two ion chromatography systems equipped with two autosamplers each to perform routine analysis of inorganic ions, sulfate and chloride in color additives. Quotations are due by August 24, 2023. Award will be made to the responsible offeror providing the lowest priced technically acceptable quote. The contract will have a one-year base period for the systems, installation, and training, with four optional one-year periods for extended warranty and preventative maintenance. Required equipment includes the ion chromatography systems, autosamplers, software, installation, training, and a one-year warranty. Optional extended warranty and preventative maintenance periods are also requested.

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This is a combined synopsis/solicitation for commercial products and services prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6 as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00375 and is being issued as a Request for Quotation (RFQ). The NAICS Code for this solicitation is 334516 and the Small Business Size Standard is 1,000 employees. This requirement is being solicited as a total small business set-aside; only quotations submitted from small businesses will be considered for award. Prospective quoters are responsible for downloading the solicitation and any amendments from SAM.gov. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial quote is providing the Best Value and discussions are not necessary.

The U.S. Food and Drug Administration (FDA) is requesting quotations for two each (2) new ion chromatography (IC) systems equipped with two autosamplers as outlined in the Statement of Work (SOW) below.

Interested quoters shall submit any questions concerning the solicitation at the earliest time possible to enable the Government to respond. Questions shall be submitted directly by email to the quotation submission point of contact as indicated below. No phone calls. Questions not received by the question submission deadline of: Tuesday, August 22, 2023 at Noon ET may not be considered.

The deadline for receipt of quotations for this requirement is: Thursday, August 24, 2023 at 5:00 PM ET. Quotation submissions must be submitted by email only to Contract Specialist Benjamin Dorgan at:

benjamin.dorgan@fda.hhs.gov. Subject line of the email should be titled: “Quotation Submission: 75F40123Q00375_ Ion Chromatography Systems”.

1. QUOTATION SUBMISSION INSTRUCTIONS

1.1 The Contractor shall submit a firm-fixed-price quote, including details of all costs supporting the price for the required deliverables.

1.2 The Contractor shall complete the pricing chart below. Pricing shall include all applicable fees including FOB Destination shipping and handling. Any charges presented after contract award shall not be considered/acceptable.

1.3 Quotes shall be in two volumes: Volume I shall be Technical and Volume II shall be Price. The volumes shall be

Line Item Description Quantity Unit Price per Unit Extended Price

1 Ion Chromatography System with Accessories 2 EA $ $

2 Autosampler 2 EA $ $ 3 Instrument Controller/PC System 2 EA $ $ 4 Installation and On-site Training Dollars $ 5 Initial One-Year Factory Service Warranty Dollars $

Base Period (Lines 1 through 5) Total: $

6 Option Period 1 (Ext. Warranty for Year 2) Dollars $ 7 Option Period 2 (Ext. Warranty for Year 3) Dollars $ 8 Option Period 3 (Ext. Warranty for Year 4) Dollars $ 9 Option Period 4 (Ext. Warranty for Year 5) Dollars $

Base Plus Options (All Lines) Total: $ mailto:benjamin.dorgan@fda.hhs.gov separate and complete, so the evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in Volume I. This volume shall provide the equipment description including specs, warranty, delivery, etc. and not exceed 10 pages in length.

1.4 Quotes shall clearly reference the solicitation, date of quotation, company quoting and point of contact.

1.5 The Contractor’s current address and Unique Entity ID (UEI) shall be included in the quote.

1.6 Quotes shall be for all of the deliverables required within the SOW.

1.7 Quotes shall be valid for at least 60 days after close of solicitation.

1.8 The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

2. AWARD CRITERIA:

Quotations that do not respond to all requirements in the solicitation may be considered non-responsive without further evaluation, deliberation, or discussion. The Government reserves the right to award without discussions.

The Government contemplates award of a Firm-Fixed-Price Purchase Order resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government and whose quote is the Lowest Priced Technically Acceptable (LPTA).

****************************************************STATEMENT OF WORK********************************************************

1. PURPOSE

The purpose of this requirement is to acquire two each (2) new ion chromatography (IC) systems equipped with two autosamplers which will replace two Thermo Fisher Scientific Dionex Ion Chromatography Systems (ICS-2100) and two AS-AP autosamplers.

2. BACKGROUND

The instruments have been selected to be used to perform routine laboratory of inorganic ions, sulfate and chloride in color additives submitted to the U.S. Food and Drug Administration (FDA) for batch certification as specified in the Code of Federal Regulations (CFR). The replacement of the IC systems is critical to the mission of Office of Cosmetics and Colors (OCAC) in supporting the Agency Color Certification Program.

3. SCOPE OF WORK AND SALIENT CHARACTERISTICS

a. IC Systems (Quantity: 2) (Brand- Name or Equal when a brand name is indicated)

i. Shall be able to function with current methods anion guard column used for trapping the dye; Dionex IonPac AG22 Fast RFIC Guard Column (4 x 30 mm)

ii. Shall be able to function with current methods anion separator column; Dionex IonPac AS22 Fast Analytical Column (4 x150 mm)

iii. Shall include an anion self-regenerating suppressor equivalent to current suppressor being used; Dionex AERS 500 4mm RFIC Electrolytically regenerated suppressor for anions

1. Self-regenerating suppressor is needed to enhance detection of sample ions and increase sensitivity

iv. Shall include a conductivity detector to help characterize ions in the samples

v. Shall include a degassing unit

vi. Shall include an automatic eluent generator

1. Uses Deionized or UltraPure water to prevent contamination

vii. If needed for mixing, the system shall include Mixers

viii. The column compartment shall be able to hold a temperature of 1.7 °C and accommodate a guard and separator column

ix. Shall provide two-liter eluent containers or bottles for each IC system if needed

x. Shall be able to store/fit IC systems (and autosamplers) on a benchtop

b. Sensitivity

i. The limit of detection for current method is 0.1875% Na2SO4 and 0.375% NaCl.

ii. System and columns Shall be compatible with and able to detect azo dyes.

c. Autosamplers

i. Shall include two Autosamplers with temperature control, one for each IC system

ii. Shall include an option capable of washing with solvents to minimize carryover

iii. The autosamplers should allow an injection of at least 25 uL

iv. Autosampler tray shall be able to hold 1.5 mL vials and at least 75 samples.

d. Computers

i. Shall include and install appropriate Ion Chromatography automation software that is compatible with Windows 10

ii. All software and hardware shall be pre-approved and comply with FDA Office of Information Management and Technology (OIMT) requirements (See paragraph f below for further details)

iii. The software shall control the IC systems and auto-samplers using a single software program

iv. Software shall be able to archive/backup data

e. Training

i. Shall include on-site training on new IC systems, autosamplers and chromatography software. Training shall be provided by Contractor within 7 business days after installation has been completed.

ii. The complete system including instrumentation, associated software, and all hardware shall include full training for a minimum of two employees that is conducted on-site for at a minimum of two (2) days.

f. Information Technology (IT) Purchasing Requirements NOTE to Contractor: Before a purchase order is awarded under this SOW, the FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information Officer (CIO).

All software required must be approved on FDA’s Master Approved Technology (MAT) list and comply with Office of Information Management and Technology (OIMT) requirements. Software not already on the FDA MAT list may be considered but must be approved on MAT list prior to award. For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware (rack, network cables, power supplies/cords, etc.). This will require the applicable vendor to provide a complete list of hardware and/or software-firmware-freeware that the Vendor will use in fulfilling this order.

This list must include the following:

IT hardware: manufacturer, nomenclature and model number Software (all types): manufacturer, nomenclature and version number

g. IT Accessibility and Section 508 Compliance

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

Item that contains ICT: Ion Chromatography Automation Software

E201.1 Scope ICT that is procured, developed, maintained, or used by agencies shall conform to the Revised 508 Standards.

E206.1 General. Where components of ICT are hardware and transmit information or have a user interface, such components shall conform to the requirements in Chapter 4.

E208.1 General Where an agency provides support documentation or services for ICT, such documentation and services shall conform to the requirements in Chapter 6.

4. SPECIFIC TASKS FOR MAINTENANCE AGREEMENT

The Contractor shall include at a minimum a one-year original factory warranty valid for 12 months from the date of installation.

a. The Contractor shall provide for four (4) additional optional periods of service, including at a minimum one preventative maintenance (PM) visit per option period.

b. The PM (annual) visit shall include software updates.

c. The Contractor shall authorize service technicians only to provide maintenance parts and labor.

d. All service conducted on the complete systems, including maintenance and repairs, shall be performed by qualified engineers/authorized service technicians that are trained and certified following manufacturer specifications to service the specific models offered and using original manufacturer parts.

e. Only Contractor certified replacement parts shall be used in the systems.

f. The one- year original factory warranty and optional years of service shall include full coverage on repair parts, labor, and travel.

g. 48-hour on-site response time.

h. Phone and email access to Technical Support (18 hours per day, Monday through Friday)

i. The requirements shall cover the cost of parts and labor for all service calls which shall be completed in a timely manner.

j. After servicing, the instrument shall perform better or equal than when it was installed.

5. DELIVERABLES

Table 1. Deliverables / Schedule

Item Number Description Quantity Delivery Requirement/Period of

Performance

(Brand- Name or Equal) Full Integrion System

The (Brand-Name or Equal) Full Integrion system includes the following essential parts: HPIC Pump, 6-port injection valve, 25µL injection loop, 2 L eluent bottle, one electrolytic power outlet ( for suppressor), high pressure RFIC-EG degasser, and an additional two electrolytic power outlets, a column oven, thermostated detector compartment (TDC), consumables tracking, and eluent generation.

2 Within 180 days after award

2 (Brand-name or equal) Dionex UCI-50 and UCI-100 Universal Chromatograph Interface, USB hub, and requisite cables. 2 Within 180 days after award

3 Service, Installation, and Familiarization of Systems including travel and labor. 2 Within 180 days after award

4 Standard US Power Cord with 125 Volt and 10 AMP 2 Within 180 days after award

Autosampler Rack/Trays for AS-AP autosampler, which accommodates up to 40 vials with a size capacity of 1.5mL or 0.3mL glass or plastic vials.

2 Within 180 days after award

6 Rhenodyne Switching Valve assembly with one 2 way 6-port valve and Mounting Hardware. 2 Within 180 days after award

Vial kit with a minimum of 100 vials with the dimensions of 1.5mL polypropylene with screw caps and PTFE pre-slit septa.

Critical feature: sample vials and septa shall fit into the autosampler racks (Refer to Line 6 in the Deliverables Table)

2 Within 180 days after award

(Brand-name or equal) Dionex Integrion CD Conductivity Detector and Integrated Cell contains

(1) Data collection rate 1 to 100 Hz,

(2) Electronic Noise <50 PC,

(3) Flow Cell Max Pressure 1500 psi,

(4) Flow Cell Volume 0.7µL.

2 Within 180 days after award

License Code for (Brand-name or equal) Chromeleon 7.3 (or later). Chromatography Data Software includes:

New License Code, Installation Media, and comes with Chromeleon CDS Software

(Brand-name or equal) Chromeleon CDS Software version 7.3 “Work Group” Edition. This software includes Instrument Controller, Four class 1( Thermo Scientific) Instrument Licenses, Data Client, Instrument Operation, Report Designer Pro, Fraction Collection, and Workstation License only

2 Within 180 days after award

(Brand-name or equal) Dell Optiplex XE3 Desktop Computer includes Core i7, 32 GB Ram, 500 HDD, 512 SSD, and Windows 10 Operating System

2 Within 180 days after award

(Brand-name or equal) Dell 24” Flat Screen Monitor includes LED Backlit LCD Monitor,

92.53 pixel per inch, and contrast ratio 1000:1.

2 Within 180 days after award

(Brand-name or equal) Thermo/Dionex ASA22 Ion Pac AG22 Fast Guard columns contains:

4 mm ID and 30 mm length, analytical bore, and guard/trap column.

These columns are high-capacity carbonate-selective anion exchange columns

2 Within 180 days after award

(Brand-name or equal) Thermo/Dionex ASA22 Fast columns contains 4 mm ID and 150 mm length.

These columns are designed for compliance monitoring of inorganic anions in accordance with U. EPD Methods 300

2 Within 180 days after award

15 Carbonate mixer bracket for (Brand-name or equal) Integrion 2 Within 180 days after award

(Brand-name or equal) Thermo/Dionex Carbonate Eluent Generate Cartridge. Specifications for the Thermo/Dionex Carbonate Eluent Generate Cartridge:

Use with ICS-5000+, ICS-6000 and Integrion HPIC (High Pressure Ion Chromatography) systems, Generates “Carbonate-Only” eluent as potassium carbonate using water only, Cartridge flow rate 0.1 to 3.00 mL/min, Pressure limits 34.5 MPA (3000 psi), and concentrations 0.1 to 100mM.

17 (Brand-name or equal) Dionex EGC 500 Carbonate Mixer Kit contains Specifications- standard bore 4mm ID 2 Within 180 days after award

As-AP Autosampler, Base configuration contains:

Volume 1 to 100 µL ; 100 to 7500 mL Injection cycle time: <30 sec Injection Cycle Precision: Fixed Loop < 0.3% RSD at 20µL;

Partial Loop <0.5% RSD at 20 µL, Injection Volume Range: 1 to 100 µL in 0.1 µL increments; 100 to 7500 µL in 1 µL increments.

Injection Type: Simultaneous or Sequential Sample Capacity: 81 x 10 mL vials, 120 x 1.5 mL vials, 3 x 96 well plates, 3 x 384 well plates Thermostatting: None

2 Within 180 days after award

(Brand-name or equal) Dionex Anionic Electrolytic Ally Regenerator Suppressor for Carbonate Eluents contains:

4mm IS standard bore Concentration Range: Up to 15 mM Maximum Eluent Flow: Up to 3mL/min Void Volume : Less than 50 µL

2 Within 180 days after award

20 Three day on-site training for the Brand-Name or Equal Full Integrion System 2 Within 180 days after award

21 (Brand-name or equal) Dionex EPM 500 Electrolytic pH Modifier 2 Within 180 days after award

22 (Brand-name or equal) Dionex CR-ATC 600 (Anion) Trap column 2 Within 180 days after award

23 One-Year Factory Service Warranty for both complete IC systems 1 12 months from the date of installation of systems

24 Installation of the Brand-Name or Equal Full Integrion System Within 7 business days after installation of systems

25 Extended Warranty for both complete IC systems: Option Period 1 12-months from the end of base-year warranty

26 Extended Warranty for both complete IC systems: Option Period 2 12-months from the end of option-year

1 warranty

27 Extended Warranty for both complete IC systems: Option Period 3 12-months from the end of option-year

2 warranty

28 Extended Warranty for both complete IC systems: Option Period 4 12-months from the end of option-year

3 warranty

6. SHIPPING DESTINATION/INSTALLATION/MAINTENANCE ADDRESS

All deliverables shall be shipped FOB Destination to the address listed below. Installation, training and ongoing warranty/maintenance service shall be completed at the same location as listed. Contact name to be provided at award.

Location:

U.S Food and Drug Administration Office of Cosmetics and Colors University Station (CPK2) Lab 1071 4300 River Road College Park MD 20740

The delivery or services shall be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM Eastern Time, excluding holidays.

7. PERIOD OF PERFORMANCE

a. Delivery of all equipment outlined above in section 5 shall be made within one hundred and eighty (180) days after award.

b. The complete systems shall include no less than a one-year warranty (beginning from the date of installation) including parts, labor, and travel.

c. Four (4) separate 12-month option periods of service maintenance as outlined above in section 4 shall be provided.

Exercising of option periods is based solely at the discretion of the Government.

8. POINTS OF CONTACT (POCS)

a. Technical Point of Contact (TPOC)

To Be Provided at Award

b. Contract Specialist (CS)

Benjamin Dorgan U.S. Food Drug Administration Office of Acquisitions and Grants Services Tel: (301) 796-6542 Benjamin.Dorgan@fda.hhs.gov

c. Contracting Officer (CO)

Monifa Coleman U.S. Food Drug Administration Office of Acquisitions and Grants Services Tel: (240) 402-7601 Monifa.Coleman@fda.hhs.gov

************************************************END STATEMENT OF WORK****************************************************** mailto:Benjamin.Dorgan@fda.hhs.gov mailto:Monifa.Coleman@fda.hhs.gov

CONTRACT CLAUSES

I. FEDERAL ACQUISITION REGULATION (48 CHAPTER 1) CLAUSES

I.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 these addresses: www.acquisition.gov AND www.acquisition.gov/hhsar

I.2 52.212-4 CONTRACT TERMS AND CONDITIONS -- COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (DEC 2022)

I.3 52.247-34 F.O.B. DESTINATION (NOV 1991)

I.4 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 2023)

(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 products and commercial services:

(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) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 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 products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C. 3509)).

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

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (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) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L.

117-328).

_X_ (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) ( 31 U.S.C. 6101 note).

http://www.acquisition.gov/ http://www.acquisition.gov/hhsar https://www.acquisition.gov/far/part-52#FAR_52_204_27

__ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C.

2313).

__ (11) [Reserved].

__ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) ( 15 U.S.C. 657a).

__ (13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (14) [Reserved] _X_ (15) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (16) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

__ (17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) ( 15 U.S.C. 637(d)(2) and (3)).

__ (18) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) ( 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 (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2021) of 52.219-9.

__ (19) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (20) 52.219-14, Limitations on Subcontracting (Oct 2022) ( 15 U.S.C. 637s).

__ (21) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) ( 15 U.S.C. 657f).

_X_ (23) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Mat 2023)( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) ( 15 U.S.C. 637(m)).

__ (25) 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 (Oct 2022) ( 15 U.S.C. 637(m)).

__ (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (27) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C. 637(a)(17)).

_X_ (28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Dec 2022) (E.O.13126).

_X_ (30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (31) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

_X_ (32) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (ii) Alternate I (Jul 2014) of 52.222-35.

_X_ (33) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

_X_ (34) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (36) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

__ (37) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (38) (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.)

__ (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (41) (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.

__ (42) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

__ (43) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) ( 42 U.S.C. 8259b).

__ (44) (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_ (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (46) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (47) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (48) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

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

_X_ (49) (i) 52.225-1, Buy American-Supplies (Oct 2022) ( 41 U.S.C. chapter 83).

__ (ii) Alternate I (Oct 2022) of 52.225-1.

__ (50) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) (19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 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 [Reserved].

__ (iii) Alternate II (Dec 2022) of 52.225-3.

__ (iv) Alternate III (Jan 2021) of 52.225-3.

__ (v) Alternate IV (Oct 2022) of 52.225-3.

__ (51) 52.225-5, Trade Agreements (Dec 2022) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (52) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (53) 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. Subtitle A, Part V, Subpart G Note).

__ (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C. 5150).

__ (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ( 42 U.S.C. 5150).

__ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C.

4505, 10 U.S.C. 3805).

_X_ (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C.

3332).

__ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

__ (61) 52.232-36, Payment by Third Party (May 2014) ( 31 U.S.C. 3332).

__ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C. 637(d)(13)).

__ (64) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

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

__ (iii) Alternate II (Nov 2021) 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 products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter67).

__ (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) (Aug 2018) ( 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) ( 29U.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) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 42 U.S.C. 1792).

(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, as defined in FAR 2.101, on the date of award of this contract, 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 products or commercial services. 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 (Nov 2021) (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) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117- 328).

(vi) 52.219-8, Utilization of Small Business Concerns (Oct 2022) ( 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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(viii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(ix) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

(x) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

(xi) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

(xii) 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.

(xiii) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xiv) (A) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

(xv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, https://www.acquisition.gov/far/part-52#FAR_52_204_27

Calibration, or Repair of Certain Equipment-Requirements (May 2014) ( 41 U.S.C. chapter 67).

(xvi) 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).

(xvii) 52.222-54, Employment Eligibility Verification (May 2022) (E.O. 12989).

(xviii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

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

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

(xxi) 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. Subtitle A, Part V, Subpart G Note).

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxiii) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) (46 U.S.C. 55305 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

I.13 FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

1. The Government may extend the term of this contract by written notice to the Contractor before contract/award expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 0 days before the contract expires. The preliminary notice does not commit the Government to an extension.

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

3. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months.

HHSAR and FDA Clauses:

I.14 HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS

I.15 HHSAR 352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(a) Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(c) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(d) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(e) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

I.16 FDA ELECTRONIC INVOICING AND PAYMENT REQUIREMENTS - INVOICE PROCESSING PLATFORM (IPP)

(JAN 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

5. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742);

or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

SOLICITATION PROVISIONS

II. FEDERAL ACQUISITION REGULATION (48 CHAPTER 1) PROVISIONS:

II.1 52.212-1 INSTRUCTIONS TO OFFERORS- COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(MAR 2023)

II.2 52.225-25 PROHIBITION ON CONTRACTING WITH ENTITIES ENGAGING IN CERTAIN ACTIVITIES

OR TRANSACTIONS RELATING TO IRAN--REPRESENTATION AND CERTIFICATIONS (JUN 2020)

II.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services -- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it ‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019

(Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115- 232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM)

(https://www.sam.gov) for entities excluded from receiving federal awards for ``covered telecommunications equipment or services.''

(d) Representations. The Offeror represents that--

(1) It [_] will, [_] will not provide covered telecommunications equipment or services to the Government in the performance of any contract,…

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