HT942523Q0004.pdf

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Attached to
Serum Biochemistry Laboratory Services Federal contract opportunity
Solicitation number
HT942523Q0004
Issued by
Department of the Army Medical Command

About this file

This request for proposal solicits laboratory services for serum biochemistry analysis. The contractor will be required to measure levels of leptin, luteinizing hormone, sex hormone binding globulin, estradiol, testosterone, and provide analysis reports using approximately 920 frozen serum samples per year from the US Army Research Institute of Environmental Medicine volunteers. Proposals must be submitted by December 2nd, 2022. The contract will have a period of performance through May 15th, 2023 for delivery of services at the customer's Natick, MA facility. The solicitation is designated for full and open competition under NAICS code 621511 with an estimated value over $750,000.

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This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Quotes are being requested and a written solicitation will not be issued. The solicitation number is HT942523Q0004. The solicitation is issued as a request for proposal (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2005-99 which are effective July 16, 2018. Unless otherwise specified, all Federal Acquisition Regulation (FAR) and other directive material contained in FAC 2005-100 is effective June 15, 2018, except Item I, which is effective July 16, 2018. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses https://acquisition.gov/far/index.html and http://www.acq.osd.mil/dpap/sitemap.html. The NAICS code is 621511, with a small business size of $36.5M. This is a Full and Open Competition requirement; all qualified vendors are encouraged to submit a quote.

Proposals are due 2 December 2022 by 12:00 PM ET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job Serum/Plasma analysis for Leptin (RIA)

FFP

Serum/Plasma analysis for Leptin (RIA). Ref PWS 3.1.1 FOB: Destination

PURCHASE REQUEST NUMBER: 0011833173

PSC CD: Q301

NET AMT

0002 1 Job Serum/Plasma analysis for Luteinizing

FFP

Serum/Plasma analysis for Luteinizing Hormone (CLIA) Ref PWS 3.1.2 FOB: Destination

0003 1 Job Serum/Plasma analysis for Sex hormone

FFP

Serum/Plasma analysis for Sex hormone binding globulin (CLIA) Ref PWS 3.1.3 FOB: Destination

0004 1 Job Serum/Plasma analysis for Testosterone

FFP

Serum/Plasma analysis for Testosterone (free and total) (LC/MS/MS) Ref PWS 3.1.4 FOB: Destination

0005 1 Job Serum/Plasma analysis for Estradiol

FFP

Serum/Plasma analysis for Estradiol (LC/MS/MS) Ref PWS 3.1.5 FOB: Destination

0006 1 Job Analysis Report

FFP

Analysis Report Ref PWS 3.1.6 FOB: Destination

0007 1 Job Interpretation and manuscript

FFP

Interpretation and manuscript Ref PWS 3.1.7 FOB: Destination

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government 0005 Destination Government Destination Government 0006 Destination Government Destination Government 0007 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 15-MAY-2023 1 US ARMY RESEARCH INSTITUTE OF

US ARMY RESEARCH INSTITUTE OF

10 GENERAL GREENE AVENUE BLDG 42

NATICK MA 01760

FOB: Destination

W561UG

0002 15-MAY-2023 1 (SAME AS PREVIOUS LOCATION)

0003 15-MAY-2023 1 (SAME AS PREVIOUS LOCATION)

0004 15-MAY-2023 1 (SAME AS PREVIOUS LOCATION)

0005 15-MAY-2023 1 (SAME AS PREVIOUS LOCATION)

0006 15-MAY-2023 1 (SAME AS PREVIOUS LOCATION)

0007 15-MAY-2023 1 (SAME AS PREVIOUS LOCATION)

PWS

SECTION 1 PURPOSE

1.1 Introduction

The US Army Research Institute of Environmental Medicine (USARIEM) is a research-based institute consisting of three divisions: Military Performance, Military Nutrition, and Thermal Mountain Medicine.

1.2 Mission

USARIEM provides solutions to enhance Warfighter health and performance through biomedical research.

1.3 Background

Stress fractures are a major cause of morbidity during Basic Combat Training (BCT) in both men and women.

Common stressors during BCT, including low energy availability, strenuous exercise, psychological stress, and sleep disturbances, disrupt the hypothalamic-pituitary adrenal (HPA) axis and the hypothalamic pituitary-gonadal (HPG) axis. This suppression alters the ability of the pituitary gland to secrete pulses of luteinizing hormone at an optimal frequency. Luteinizing hormone pulsatility reflects the pulsatile secretion of gonadotropin-releasing hormone from the hypothalamus, and abnormal GnRH secretion can lead to low serum estradiol and testosterone concentrations. Estrogen and testosterone are important mediator of bone health in men and women.

Traditional assays utilized to measure serum estradiol and testosterone concentrations are typically not sensitive enough to quantify estradiol in men or testosterone in women. Similarly, among those with suppressed HPG function, traditional assays are not sensitive enough to determine testosterone levels in men or estradiol levels in women. This research project aims to determine sex hormone levels using high sensitivity assays and their relationship with bone health and strength during 10 weeks of U.S. Army BCT. The intent of the project is to identify physiological mechanisms that may lead to stress fracture to inform future interventions that can reduce the burden of musculoskeletal injury on the Warfighter and the Department of Defense.

1.4 Scope

Frozen serum from approximately 200 volunteers over 5 timepoints will be packed appropriately and shipped on dry ice priority overnight from USARIEM to the contractor’s lab. Upon receipt, the samples should be stored at -80C until the samples are batched for analysis of luteinizing hormone (LH), leptin, sex hormone binding globulin (SHBG), estradiol, and testosterone.

SECTION 2 GENERAL REQUIREMENT

2.1 Performance

2.1.1. Place of Performance – TBD

2.2 Type of Services

2.2.1 Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

2.2.2 Severable / Non-Severable Services

This award identifies services that are non-severable in nature.

2.2.3 Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

2.3 Contract Management

2.3.1 Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

2.3.2 Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

2.3.2.1. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.4 Reports

2.4.1 Reports and documents. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-13, Patent Rights. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 The contractor shall provide all necessary personnel required to perform services for the USARIEM Military Performance Division. The contractor shall provide quarterly data reports for the measurement of required analytes in the provided serum/plasma samples. The following section specifies the Performance Objectives and Performance Elements for the contract:

3.1.1 Measurement of leptin in up to 920 samples per year by radioimmunoassay (RIA), capable of providing results with <1 mL of sample volume with lab- verified inter- and intra-assay coefficients under 9%

3.1.2 Measurement of luteinizing hormone in up to 920 samples per year using direct chemiluminescent immunoassay capable of providing results with .5 mL sample with lab-verified inter- and intra-assay coefficients of variation under 7%.

3.1.3 Measurement of urine sex hormone binding globulin (SHBG) in up to 920 samples per year using chemiluminescent immunoassay capable of providing results with .5 mL sample with lab-verified inter-and intra-assay coefficients of variation under 6%.

3.1.4 Measurement of free and total serum testosterone in up to 920 samples per year using liquid chromatography-tandem mass spectrometry (LC/MS/MS) capable of providing results with <.5mL sample with lab-verified inter- and intra-assay coefficients of variation under 7%.

3.1.5 Measurement of estradiol in up to 920 samples per year using liquid chromatography-tandem mass spectrometry (LC/MS/MS) capable of providing results with .5mL sample with lab-verified inter- and intra-assay coefficients of variation under 12%.

3.1.6 Provide analysis report in the form of an excel spreadsheets with analytical results at a minimum of each quarter and maintain original data in a secure database for a minimum of 1 year following the final batch of data analysis.

3.1.7 Provide assistance to the USARIEM investigator in interpretation of the data.

SECTION 4 DELIVERABLES

4.1 DELIVERABLES. The contractor shall provide the following deliverable as listed.

Item PWS Ref Title Distribution Initial Subsequent

Deliverable

3.1.1-3.1.5 Hormone assays KO, COR Start Period of Performance

No later than 15 May

Deliverable

3.1.6 Provide assay

results in report

KO, COR Start Period of Performance

No later than 15 May

Deliverable

3.1.7 Provide

interpretation assistance

KO, COR Start Period of Performance

No later than 15 May

SECTION 5 APPLICABLE DIRECTIVES, REGULATIONS AND POLICIES

5.1 Environmental Requirements

5.1.1 Mandatory Compliance. Occupational Safety and Health Act and AR 200-1 Environmental Protection and Enhancement.

5.1.2 Non-Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil.

5.2 Applicable Directives. N/A

5.3 Mandatory Compliance

5.3.1 Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer. Business Program Management Office (PMO) approval for publication will require provisions that protect the intellectual property and patent rights of both Business PMO and the Contractor.

5.3.2 Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

5.3.3 Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives in order to assist with interpretation of analysis results. Contractor personnel shall make their contractor status known during introductions.

5.3.4 Use of Military Rank by Contractor Personnel

Contractors may not use or allude to former or current military rank during the performance of this work.

5.3.5 Data Rights

The Government will retain rights to all data produced in the course of developing, deploying, training, using and supporting USARIEM or other federal agencies that utilize this order.

Data in Transit: The Parties are responsible for ensuring that any data shared is transmitted, protected, and stored in a secured information system network that is fully compliant with all applicable Federal legal authorities and DoD regulations. The data described above may be shared through electronic file transfer via a secure, mutually agreed upon method such as DOD SAFE (https://safe.apps.mil/). Hard copies of such files will be handled per applicable DoD or Service regulations and guidelines.

5.3.6 Section 508 Requirement

The Contractor shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Specifically, the procurement, development, maintenance, or integration of electronic and information technology (EIT) under this contract must comply with the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at CFR part 1194.

5.3.7 Protection of Human Subjects and Adherence to Ethical Standards in Department of Defense (DoD)-Supported Research The Contractor shall adhere to all applicable DoD regulations pertaining to Human Subjects Protection and Ethical Standards. Specifically, 32 Code of Federal Regulations (CFR) 219, National Defense, Protection of Human Subjects; Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011; Army Regulation (AR) 70-25 (under revision): Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990. Applicable US CFR regulations are: Title 21, CFR Part 50 Protection of Human Subjects, Title 21 CFR Part 56, Institutional Review Boards; Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014; Title 32 CFR Part 219, Protection of Human Subjects; Title 45 CFR 46, Protection of Human Subjects, April 1, 2014.

5.3.8 Public Key Infrastructure Authentication and Encryption Contractors shall follow the DoD standards, policies, and procedures related to the use of Public Key Infrastructure (PKI) certificates and biometrics for positive authentication including authentication to DoD private web servers or applications. Where interoperable PKI is required for the exchange of unclassified information, including the encryption of e-mail containing sensitive information, between DoD and its Contractors, industry partners shall obtain all necessary certificates if they are not eligible for a DoD Common Access Card. (refer to: http://iase.disa.mil/pki/eca/ and http://www.cac.mil/)

QASP

QASP

Performance Requirement

Performance Standard Acceptable Quality

Level Method of

Surveillance Frequency

PWS Ref 3.1.1 Measurement of leptin analyte in serum/plasma.

Measurement of Leptin analyte in serum/plasma utilizing radioimmunoassay methodology.

Measurement of leptin in all samples.

Surveillance by

COR.

Upon Completion of Analysis

PWS Ref 3.1.2 Measurement of luteinizing hormone analyte in serum/plasma.

Measurement of Luteinizing hormone analyte in serum/plasma utilizing CLIA methodology.

Measurement of luteinizing hormone in all samples.

Surveillance by

COR.

Upon Completion of Analysis

PWS Ref 3.1.3 Measurement of sex hormone binding globulin analyte in serum/plasma.

Measurement of sex hormone binding globulin analyte in serum/plasma utilizing CLIA methodology.

Measurement of sex hormone binding globulin in all samples.

Surveillance by COR.

Upon Completion of Analysis

PWS Ref 3.1.4 Measurement of testosterone (free and total) analyte in serum/plasma

Measurement of testosterone (free and total) analyte in serum/plasma utilizing liquid chromatography with tandem mass spectrometry methodology.

Measurement of testosterone (free and total) in all samples.

Surveillance by

COR.

Upon Completion of Analysis

PWS Ref 3.1.5 Measurement of estradiol analyte in serum/plasma.

Measurement of estradiol analyte in serum/plasma utilizing liquid chromatography with tandem mass spectrometry methodology.

Measurement of estradiol in all samples

Surveillance by

COR.

Upon Completion of Analysis

PWS Ref 3.1.6 Analysis report

Provide analysis report in the form of spreadsheets with all analytical results.

Government quality and on time spreadsheet documentation that is easily understandable to the end user.

Surveillance by

COR.

Upon Completion of Analysis

PWS Ref 3.1.7 Data interpretation and assistance

Assist USARIEM investigators with data interpretation and manuscripts.

Data interpretation that is easily understood by to the end user.

Adequate collaboration with

USARIEM.

Surveillance by COR. Upon

Completion of Analysis

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions JUN 2020 52.203-3 Gratuities APR 1984 52.203-5 Covenant Against Contingent Fees MAY 2014 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(JUN 2020) -- Alternate I

NOV 2021

52.203-7 Anti-Kickback Procedures JUN 2020 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014 52.203-11 Certification And Disclosure Regarding Payments To

Influence Certain Federal Transactions

SEP 2007

52.203-12 Limitation On Payments To Influence Certain Federal Transactions

JUN 2020

52.203-13 Contractor Code of Business Ethics and Conduct NOV 2021 52.203-15 Whistleblower Protections Under the American Recovery and

Reinvestment Act of 2009

JUN 2010

52.203-16 Preventing Personal Conflicts of Interest JUN 2020 52.203-17 Contractor Employee Whistleblower Rights and Requirement

To Inform Employees of Whistleblower Rights

JUN 2020

52.203-18 Prohibition on Contracting With Entities That Require Certain Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

52.204-2 Security Requirements MAR 2021 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

52.204-6 Unique Entity Identifier OCT 2016 52.204-7 System for Award Management OCT 2018 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

JUN 2020

52.204-12 Unique Entity Identifier Maintenance OCT 2016 52.204-13 System for Award Management Maintenance OCT 2018 52.204-14 Service Contract Reporting Requirements OCT 2016 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-21 Basic Safeguarding of Covered Contractor Information Systems

NOV 2021

52.204-22 Alternative Line Item Proposal JAN 2017 52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.212-4 Contract Terms and Conditions--Commercial Products and Commercial Services

NOV 2021

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.227-1 Authorization and Consent JUN 2020 52.232-1 Payments APR 1984 52.232-17 Interest MAY 2014 52.232-23 Assignment Of Claims MAY 2014 52.232-25 Prompt Payment JAN 2017 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

NOV 2021

52.233-1 Disputes MAY 2014 52.233-3 Protest After Award AUG 1996 52.242-1 Notice of Intent to Disallow Costs APR 1984 52.242-3 Penalties for Unallowable Costs SEP 2021 52.242-5 Payments to Small Business Subcontractors JAN 2017 52.242-13 Bankruptcy JUL 1995 52.244-6 Subcontracts for Commercial Products and Commercial

Services

OCT 2022

52.246-4 Inspection Of Services--Fixed Price AUG 1996 52.249-1 Termination For Convenience Of The Government (Fixed

Price) (Short Form)

APR 1984

52.253-1 Computer Generated Forms JAN 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

DEC 2019

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

252.209-7002 Disclosure Of Ownership Or Control By A Foreign Government

JUN 2010

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7048 Export-Controlled Items JUN 2013

252.225-7050 Disclosure of Ownership or Control by the Government of a Country that is a State Sponsor of Terrorism

SEP 2021

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.244-7000 Subcontracts for Commercial Items JAN 2021 252.247-7016 Contractor Liability for Loss or Damage DEC 1991

CLAUSES INCORPORATED BY FULL TEXT

52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (MAY 2022)

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is 621511.

(2) The small business size standard is $36,500,000.

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition--

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b)(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

( ) Paragraph (d) applies.

( ) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements--Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.204-26, Covered Telecommunications Equipment or Services--Representation. This provision applies to all solicitations.

(vii) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations--Representation.

(viii) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(ix) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(x) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(xi) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xii) 52.219-1, Small Business Program Representations (Basic, Alternates I, and II). This provision applies to solicitations when the contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii).

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(C) The provision with its Alternate II applies to solicitations that will result in a multiple-award contract with more than one NAICS code assigned.

(xiii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii).

(xiv) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xvi) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial products or commercial services.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA- designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals--Representation. This provision applies to solicitations that include the clause at 52.204-7.)

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $92,319, the provision with its Alternate II applies.

(D) If the acquisition value is $92,319 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan--Certification. This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certification. This provision applies to all solicitations.

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.]

(i) 52.204-17, Ownership or Control of Offeror.

(ii) 52.204-20, Predecessor of Offeror.

(iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

(iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Certification.

(v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

(vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA- Designated Products (Alternate I only).

(vii) 52.227-6, Royalty Information.

(A) Basic.

(B) Alternate I.

(viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The Offeror has completed the annual representations and certifications electronically in SAM accessed through https://www.sam.gov. After reviewing the SAM information, the Offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [ offeror to insert changes, identifying change by clause number, title, date]. 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.

FAR Clause Title Date Change

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 on SAM.

(End of provision)

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, 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

(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.

52.204-26 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) Representations.

(1) 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.

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS--

REPRESENTATION (NOV 2015)

(a) Definitions. Inverted domestic corporation and subsidiary have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10).

(b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.

(c) Representation. The Offeror represents that--

(1) It [ ___ ] is, [ ___ ] is not an inverted domestic corporation; and

(2) It [ ___ ] is, [ ___ ] is not a subsidiary of an inverted domestic corporation.

52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (AUG 2020)

(a)(1) The Offeror certifies, to the best of its knowledge and belief, that-

(i) The Offeror and/or any of its Principals-

(A) Are ( ) are not ( ) presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(B) Have ( ) have not ( ), within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract; violation of Federal or State antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property (if offeror checks “have”, the offeror shall also see 52.209-7, if included in this solicitation); and

(C) Are ( ) are not ( ) presently indicted for, or otherwise criminally or civilly charged by a governmental entity with, commission of any of the offenses enumerated in paragraph (a)(1)(i)(B) of this provision;

and

(D) Have , have not , within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds the threshold at 9.104-5(a)(2) for which the liability remains unsatisfied.

(1) Federal taxes are considered delinquent if both of the following criteria apply:

(i) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(ii) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

(2) Examples. (i) The taxpayer has received a statutory notice of deficiency, under I.R.C. Sec. 6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(ii) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. Sec. 6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(iii) The taxpayer has entered into an installment agreement pursuant to I.R.C. Sec. 6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.

(iv) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code).

(ii) The Offeror has ( ) has not ( ), within a three-year period preceding this offer, had one or more contracts terminated for default by any Federal agency.

(2) Principal, for the purposes of this certification, means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager;

head of a division or business segment; and similar positions).

(b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time prior to contract award, the Offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

(c) A certification that any of the items in paragraph (a) of this provision exists will not necessarily result in withholding of an award under this solicitation. However, the certification will be considered in connection with a determination of the Offeror's responsibility. Failure of the Offeror to furnish a certification or provide such additional information as requested by the Contracting Officer may render the Offeror nonresponsible.

(d) Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render, in good faith, the certification required by paragraph (a) of this provision. The knowledge and information of an Offeror is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.

(e) The certification in paragraph (a) of this provision is a material representation of fact upon which reliance was placed when making award. If it is later determined that the Offeror knowingly rendered an erroneous certification, in addition to other remedies available to the Government, the Contracting Officer may terminate the contract resulting from this solicitation for default.

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

(a) Definitions. As used in this provision--

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means--

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror ( ) has ( ) does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in--

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management,…

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