D CSS-C RFQ 75N95022Q00214.pdf

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Waters ACQUITY UPLC I-Class PLUS Triple with QDa system or equal (COVID-19 action)

RFQ: 75N95022Q00214

SAM.gov: https://sam.gov/opp/7caa69a99f8d49eab542593c57a60fc1/view

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95022Q00214 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-06, with effective date

05/01/2022.

(iv) The associated NAICS code is 334516 - Analytical Laboratory Instrument Manufacturing and the small business size standard is 1000 employees. This requirement is full and open with no set-aside restrictions.

(v) The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS DPI plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum.

The NCATS DPI Analytical Chemistry Core (ACC) maintains a state-of-the-art laboratory whose mission is to support translational research throughout NCATS by providing analytical chemistry services involving the isolation, purification, identification and analysis of various therapeutic modalities for targeted disease states.

https://sam.gov/opp/7caa69a99f8d49eab542593c57a60fc1/view

NCATS has become a key partner in the Antiviral Program for Pandemics (APP), a multi-agency initiative that includes National Institute of Allergy and Infectious Diseases

(NIAID) and Biomedical Advanced Research and Development Authority (BARDA), to accelerate antiviral development through early discovery and preclinical development of safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as (i) target validation, (ii) high-throughput screening (HTS) for drug starting points, (iii) medicinal chemistry for lead optimization, and (iv) preclinical, investigational new drug

(IND)-enabling development.

APP chemists within DPI are tasked with the discovery and development potential small molecule antiviral treatments for a range of viruses that have pandemic potential. In order to meet the increased demand for sample purification and analysis, the ACC needs to improve throughput and expand capabilities through procurement of additional instrumentation and equipment, as well as the application of new technologies.

As part of this initiative, the ACC is working on the development of an automated purification platform that would operate as a stand-alone system or an integrated module within the automated synthetic laboratory. This automated purification system named

FluidCore is a dual arm fraction collection bed that incorporates analytical and purification liquid chromatography (LC) systems into a single automated platform. The custom system will be integrated into the SMART centralized sample purification and processing platform as an upgrade to the current workflow. The ACC is currently working on the design and development of this innovative and custom purification system by retrofitting NCATS current auto purification semi-preparative purification instrument.

Thus, ACC needs an Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector to be the analytical LC system for FluidCore, which is required to be readily integrated with the existing NCATS purification system.

Additionally, the Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector has to be compatible with Waters Automation Portal as a means of transferring analytical samples from the fraction collection bed to the analytical Ultra Performance Liquid Chromatography (UPLC) system for analysis.

Thus, without acquisition of an Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector, the ACC will be unable to advance NCATS purification capabilities aimed at meeting the support and resource needs of the APP and DPI Chemistry

(vi) The Analytical Chemistry Core (ACC), within the Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) seeks to purchase an Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass

Spectrometry (MS) detector in order to advance NCATS purification capabilities aimed at meeting the support and resource needs of the APP and DPI Chemistry.

For reference purposes, the Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector that meet the need of this requirement is the Waters ACQUITY UPLC I-Class PLUS Triple with QDa system or Equal, as per the specific requirement and salient characteristics provided in the attached PURCHASE

DESCRIPTION (PD).

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is required within thirty (30) days after receipt of order (ARO). Delivery will be f.o.b. destination. The place of delivery and acceptance will be National Center for Advancing Translational Sciences (NCATS) at 9800 Medical Center Drive, Rockville, MD 20850.

(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb

1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)

• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

• FAR 52.211-6, Brand Name or Equal (Aug 1999)

• FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021)

• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov

2021)

• FAR 52.225-6, Trade Agreements Certificate (Feb 2021)

• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice

(December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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:

https://www.acquisition.gov/browse/index/far

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug

2020)

• FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Nov 2021).

Addendum to this FAR clause applies to this acquisition and is attached.

• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015)

• HHSAR 352.239-74, Electronic and Information Technology Accessibility

(December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services- Representation (Oct 2020)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders--Commercial Items (May 2022)

• NIH Invoice Instructions with IPP (April 2022)

• NIH Invoice Instructions without IPP (April 2022)

(ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].

(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer.

If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov

2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

(xii) Additional contract requirement(s) or terms and conditions applicable to this acquisition:

This COVID-19 requirement will be funded with COVID-19 funds at time of award. The following language is applicable and shall be included in the resultant COVID-19 award.

“HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—

Health Resources Priorities and Allocations System.”

(xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point

(Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations.

Respondents proposing on an equal product of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

http://www.sam.gov/ http://www.sam.gov/

All questions must be received by 9:00 a.m., Eastern Daylight/Standard Time, on May 5, 2022, and reference Solicitation Number 75N95022Q00214. Questions may be submitted electronically to Renato Gomes, Contract Specialist, at renato.gomes@nih.gov.

All quotations must be received by 9:00 a.m., Eastern Daylight/Standard Time, on May

10, 2022, and reference Solicitation Number 75N95022Q00214. Responses must be submitted electronically to Renato Gomes, Contract Specialist, at renato.gomes@nih.gov.

Fax responses will not be accepted.

Attachments:

• Purchase Description

• FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26, Covered Telecommunications Equipment or Services- Representation(Oct 2020)

• Addendum to FAR 52.212-4 Terms and Conditions – Commercial Items

• FAR 52.212-5, Contract Terms and Conditions—Commercial Products and Commercial Services (May 2022)

• FAR 52.225-6, Trade Agreements Certificate (Feb 2021)

• NIH Invoice Instructions with IPP (April 2022)

• NIH Invoice Instructions without IPP (April 2022)

Purchase Description

Name of Item or Project Title:

Waters ACQUITY UPLC I-Class PLUS Triple with QDa system (Brand-name or equal).

Statement of Need and Purpose:

The Analytical Chemistry Core (ACC), within the Division of Preclinical Innovation (DPI) at the

National Center for Advancing Translational Sciences (NCATS) seeks to purchase an Ultra

Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector in order to advance NCATS purification capabilities aimed at meeting the support and resource needs of the APP and DPI Chemistry.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS DPI plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum.

The NCATS DPI Analytical Chemistry Core (ACC) maintains a state-of-the-art laboratory whose mission is to support translational research throughout NCATS by providing analytical chemistry services involving the isolation, purification, identification and analysis of various therapeutic modalities for targeted disease states.

NCATS has become a key partner in the Antiviral Program for Pandemics (APP), a multi-agency initiative that includes National Institute of Allergy and Infectious Diseases (NIAID) and

Biomedical Advanced Research and Development Authority (BARDA), to accelerate antiviral development through early discovery and preclinical development of safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as (i) target validation, (ii) high-throughput screening (HTS) for drug starting points, (iii) medicinal chemistry for lead optimization, and (iv) preclinical, investigational new drug (IND)-enabling development.

APP chemists within DPI are tasked with the discovery and development potential small molecule antiviral treatments for a range of viruses that have pandemic potential. In order to meet the increased demand for sample purification and analysis, the ACC needs to improve throughput and expand capabilities through procurement of additional instrumentation and equipment, as well as the application of new technologies.

As part of this initiative, the ACC is working on the development of an automated purification platform that would operate as a stand-alone system or an integrated module within the automated synthetic laboratory. This automated purification system named FluidCore is a dual arm fraction collection bed that incorporates analytical and purification liquid chromatography

(LC) systems into a single automated platform. The custom system will be integrated into the

SMART centralized sample purification and processing platform as an upgrade to the current workflow. The ACC is currently working on the design and development of this innovative and custom purification system by retrofitting NCATS current auto purification semi-preparative purification instrument. Thus, ACC needs an Ultra Performance Liquid Chromatography

(UPLC) system coupled with a Mass Spectrometry (MS) detector to be the analytical LC system for FluidCore, which is required to be readily integrated with the existing NCATS purification system. Additionally, the Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector has to be compatible with Waters Automation

Portal as a means of transferring analytical samples from the fraction collection bed to the analytical Ultra Performance Liquid Chromatography (UPLC) system for analysis.

Thus, without acquisition of an Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector, the ACC will be unable to advance NCATS purification capabilities aimed at meeting the support and resource needs of the APP and DPI

Chemistry.

Generic Name of Product:

Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry

(MS) detector.

Purchase Description:

For reference purposes, the Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector that meet the need of this requirement is the

Waters ACQUITY UPLC I-Class PLUS Triple with QDa system, as follows:

Line Item No.

Part No. Item Description Qty

1 176815023 ACQUITY UPLC I-Class PLUS Triple w/QDa System 1

1.a 176015111 ACQUITY I-Class PLUS Sys. (CM-A) w/SM-FTN-I 1

1.b 176015091 ACQUITY UPLC I-Class eK PDA Detector 1

1.c 700011803 ACQUITY I-Class PDA Tubing Single Detector 1

1.d 176003208 ACQUITY QDa Detector (Performance) 1

1.e 176004266 ACQUITY I-Class PLUS QDa Kit 1

1.f 205001275 Kit, Ethernet Switch Box w/ Bracket 1

1.g 186008515 Acquity QDa Fluidics Valve, Stainless Steel 1

1.h 700009641 ESI PROBE ASSEMBLY 250mm 1

1.i 176003244 ISM & ACQUITY Splitter Kit 1

1.j 176015027 ACQUITY UPLC ELSD w/Nebulizer 1

1.k 700002848 ACQUITY UPLC / UV and ELSD Qualification Standards Kit

1.l 700002669 ACQUITY UPLC / UV Start-up Standards Kit 1

1.m 700002741 ACQUITY / Quattro micro or Quattro Premier MS Start-up Solution Kit

1.n 176001060 ML 4.1 & Standard PC 1

1.o 668000273 MONITOR, 23" 1

1.p 741000472 QDa SYSTEM INSTALLATION CERT 1

1.q 176003950 Analytical LC-MS Solvent Install Kit 1

2 176015048 ACQUITY UPLC CM-Aux Add-on (3/4) 1

3 720002242EN Implementation Kit 1

The salient characteristics of the Ultra Performance Liquid Chromatography (UPLC) system coupled with a Mass Spectrometry (MS) detector include:

• Ultra-performance liquid chromatography (UPLC) analysis, which is required for increased sample throughput. Method run times of 1-2 min are capable decreasing the time in which chemists receive sample data.

• Binary solvent pumps with two integrated solvent select valves providing access to four solvents for high pressure mixing, binary gradient

• 11 gradient curves (linear, step (2), concave (4), and convex (4))

• A maximum operating pressure of 18,000 psi at up to 1 mL/min and 12,000 psi at up to 2 mL/min

• A solvent flow accuracy of ±1.0% of set flow rate at 0.500 ml/min, as per Empower SystemsQT

• A solvent flow precision of ≤0.075% RSD or 0.01 min SD, (0.2 to 2.0 ml/min), whichever is greater using premixed solvent

• A solvent composition ripple of ≤1.0 mAu

• A solvent composition precision of ≤0.15% RSD or ±0.01 min SD, whichever is greater

• A solvent composition accuracy of ±0.5% absolute from 5% to 95%, 0.2 to 2.0 ml/min

• A cycle time of ≤15 s inject to inject, with load ahead enabled

• A sample manager flow-through-needle (SM-FTN) setup for robust needle sealing at high pressures while minimizing extra-column band spread

• Integrated vacuum degassing, six lines with two allocated for the injector needlewash/purge solvents

• An integrated, active, and programmable injection needle wash

• Sample Manager must be configurable to accommodate any two combinations of the following sample formats: 96-well microtiter plate, 384-well microtiter plate, 2 mL vial plate (48 position), 0.65 mL micro-centrifuge tube plate (48 position), and 1.5 mL micro-centrifuge tube plate (24 position)

• Sample compartment temperature range of 4 to 40 °C that is settable in 0.1 °C increments; maintain 19 °C below ambient with a tolerance range between -2 and +4 °C

• An operational pH range of 1 to 12.5

• A column manager compartment for holding up to 4 columns with a temperature range of 4 to 90 °C that is settable in 0.1 °C increments

• Column tracking using the eCord Technology

• Capable of utilizing an integrated photodiode array (PDA) detector, an evaporative light scattering detector (ELSD), and a Quadrupole Dalton (QDa) detector

• System must be operable with MassLynx, Empower, and UNIFI software

• Electrical power requirements of 100 to 240 VAC with a line frequency of 50 to 60 Hz

• Readily integrated with NCATS existing Waters purification system

• Compatible with Waters Automation Portal

• Handling and Shipping to NCATS, FOB Destination.

• Installation and equipment familiarization on-site (NCATS)

• Twelve (12) month warranty on the instruments after installation

Quantity:

One (1) Waters ACQUITY UPLC I-Class PLUS Triple with QDa system (Brand-name or equal) as described in the Purchase Description.

Delivery:

Delivery is required within thirty (30) days after receipt of order (ARO). Delivery shall be made to the below address with FOB Destination.

National Center for Advancing Translational Sciences (NCATS)

9800 Medical Center Drive

Rockville, MD 20850

The installation and equipment familiarization shall be conducted on dates and times agreed upon by the vendor and the NCATS point of contact designated on the award.

52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

As prescribed in 4.2105(a), insert the following provision:

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 or 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 https://www.acquisition.gov/far/4.2105#FAR_4_2105 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 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) Representation. The Offeror represents that—

(1) It □ will, □ will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It □ does, □ does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable);

or https://www.sam.gov

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable);

or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

Parent topic: 52.204 [Reserved]

Name of Authorized Individual Signature of Authorized Individual Date

Title Name of Organization

CERTIFICATION:

https://www.acquisition.gov/far/52.204

52.204-26 Covered Telecommunications Equipment or Services-Representation.

As prescribed in 4.2105(c), insert the following provision:

Covered Telecommunications Equipment or Services-Representation (Oct 2020)

(a) Definitions. As used in this provision, "covered telecommunications equipment or services" and "reasonable inquiry" have the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) 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".

(c)

(1) Representation. The Offeror represents that it □ does, □ 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.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it □ does, □ does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

(End of provision)

Parent topic: 52.204 [Reserved]

Name of Authorized Individual Signature of Authorized Individual Date

Title Name of Organization

CERTIFICATION:

http://159.142.191.108/far/4.2105#FAR_4_2105 http://159.142.191.108/far/52.204-25#FAR_52_204_25 http://159.142.191.108/far/52.204

52.212-3 Offeror Representations and Certifications—Commercial Products and Commercial Services.

As prescribed in 12.301(b)(2), insert the following provision:

Offeror Representations and Certifications—Commercial Products and Commercial Services (Nov 2021)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v)) of this provision.

(a) Definitions. As used in this provision—

"Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

https://www.acquisition.gov/far/12.301#FAR_12_301 https://www.sam.gov/ https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174).

Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended."Sensitive technology"—

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3)of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veteransor, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C. 101(16).

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships.

SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned— http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C.

101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

(b)

(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.] http://www.sam.gov https://www.acquisition.gov/printpdf/11302#FAR_52_212_3 https://www.acquisition.gov/far/4.1201#FAR_4_1201

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it □ is, □ is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it □ is, □ is not a small disadvantaged business concern as defined in 13 CFR124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that-

(i) It □ is, □ is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: __________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that-

(i) It □ is, □ is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that–

(i) It □ is, □ is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in…