SOW_RFQ_75N91024Q00081.pdf

STATEMENT OF WORK

RFQ 75N91024Q00081 Page 1 of 27

1.0 TITLE

ANCHOR biorepository, sample shipping and handling, and datafile generation

2.0 BACKGROUND

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Infections and lmmunoepidemiology Branch (IIB) requires pulling, selecting, aliquoting and shipping of no more than 13,000 samples collected from participants in the NCI’s ANCHOR (ANal Cancer/HSIL Outcomes Research, ClinicalTrials.gov NCT02135419) and the generation of a datafile.

3.0 SCOPE

The Contractor shall provide all personnel, labor, facilities, materials and equipment necessary to perform the required tasks described in section 4 below. This purchase order includes services for two Tasks:

Task 1: The Contractor shall work with the ANCHOR Biorepository located in Tucson AZ to select, pull, aliquot, organize, and ship no more than 13,000 serum samples to the German Cancer Research Center (DKFZ), Germany, for HPV testing. The Contractor shall be responsible for the safety and security of the samples until successful delivery to DFKZ.

Task 2: The Contractor shall generate a datafile merging de-identifiable participant data with the HPV results generated by DFKZ.

Onsite services are not included in this order. Travel expenses are not authorized under this order. The Contractor shall not be reimbursed for any travel expenses or incidental expenses related to travel (e.g., parking fees).

The Contractor shall communicate with the study NCI scientific contact regarding any problems or difficulties arising with this work. Any deviation from the inputs determined by the Contractor and the Government as part of this task shall be discussed and agreed upon by NCI before the changes to the pipelines are applied. The Contractor shall confer as needed, by phone or email, with the study NCI scientific contact to discuss any technical issues with study tasks and any unexpected or urgent changes in study activities.

4.0 PURCHASE ORDER REQUIREMENTS

4.1 TASKS

An express condition precedent to the execution of this purchase order is certain HPV serology results must first be obtained in the ongoing “run-in study” as follows: pre-specified minimum observed sensitivity must be above the lower bound of the 95% Confidence Interval (CI) based on exact binomial computations of 4% and the pre-defined specificity must be above the lower bound of the 95%CI of 80%, as reasonably

RFQ 75N91024Q00081 Page 2 of 27 determined by NCI.

The Contractor shall perform the following tasks.

4.1.1 Task 1: Biorepository, sample shipping and handling

a. The Contractor shall identify and pull selected stored serum samples from the Biorepository located in Tucson AZ.

b. The Contractor shall generate aliquots of approximately 50 uL and temporarily store them at the proper temperature.

c. The contractor shall order the aliquots according to a predetermined order established by the NCI Technical point of contact, (TBD at award) or designee.

d. The Contractor shall prepare the shipment according to the International

Air Transport Association (IATA) regulations surrounding the shipment of biological material and shipment of materials on dry ice.

e. The Contractor is responsible for obtaining the necessary permits to export biological materials and for preparing all shipment documentation.

f. The Contractor is responsible for performing the shipping duties to track the packages and ensure the packages reach the final destination.

4.1.2 Task 2: Generation of a datafile

a. NCI Technical point of contact, (TBD at award) or designee, will share the HPV results with the ANCHOR Principal Investigator, (TBD at award) or designee.

b. The Contractor shall work with the ANCHOR Principal Investigator, (TBD at award) or designee, to generate a datafile with de-identifiable information using participant data including, but not limited to, age, race/ethnicity, HIV viral load, CD4 counts, with the HPV results.

c. The datafile shall not include any personally identifiable information.

d. The datafile shall be submitted to the NCI Technical point of contact, (TBD at award) or designee.

4.2 SPECIAL ORDER REQUIREMENTS

The Contractor must have access to the ANCHOR Biorepository. Confirmation of access to the facility must be provided during solicitation. The ANCHOR Biorepository is managed by the University of Arizona (UA), Tucson AZ.

As applicable, the Contractor should encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., RFQ 75N91024Q00081 Page 3 of 27 email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

4.3 PROHIBITION AGAINST PERSONAL SERVICES

The Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction.

The Government shall not supervise or direct Contractor employees in the performance of their assignments.

If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

The Contractor shall not perform any inherently governmental functions under this contract. No Contractor employee shall represent or give the appearance that he or she is a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government.

The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following the requirements of the Contract.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be 12 months from the award date.

7.0 PLACE OF PERFORMANCE

Services shall be performed at the Contractor's facility.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall submit the tracking number and provide updates on package while in transit and upon delivery to DFKZ to the NCI Technical Point of Contact, (TBD at award).

The TPOC for this order is: (TBD at award)

All written deliverables shall be sent electronically to the NCI Technical Point of Contact, (TBD at award), at award, in a Microsoft-compatible format, such as

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Microsoft Excel or text file unless approved by the TPOC in accordance with the following deliverable schedule:

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS DUE DATE

Task 1

Selection, pulling, aliquoting, ordering, and shipment to Germany of no more than 13,000 samples collected from participants in the ANCHOR trial.

Sample manifest shall be delivered to the NCI Technical point of contact via email and included in the shipment. The sample manifest(s) shall be provided as Excel files.

60 calendar days after receipt of the order.

Task 2

Generation of a datafile with de-identifiable information using participant data including, but not limited to age, race/ethnicity, HIV viral load, CD4 counts, with the HPV results.

The datafile shall be delivered to the NCI Technical point of contact via encrypted email.

The datafile shall be provided as Excel files.

30 calendar days after receipt of the HPV results.

9.0 INSPECTION AND ACCEPTANCE CRITERIA

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, (TBD at award), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and- standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards- and-guidelines

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Per Section 508 and as mandated under HHS Policy for Section 508 Compliance and Accessibility of Information and Communications Technology (ICT) (07/2020) all documents or electronic files provided to the NIH NCI under contract must be conformant with Section 508 standards and accessible to persons with disabilities. Conformance shall be confirmed by use of material provided at HHS OS Factsheets & Reference Guides and verified through the use of the HHS Checklist Documents (WCAG 2.0 Refresh); in addition, contractors and vendors are encouraged to make use of the instructional materials and checklists at GSA Section 508.gov’s Create Accessible Digital Products

10.0 PAYMENT

Payment shall be made in full upon the delivery, inspection and acceptance of the required deliverables. Payment authorization requires submission and approval of invoices to the NCI TPOC and NIH OFM, in accordance with the attached payment provisions listed below. The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number;

Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent

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Award Number.

7. Unique Entity Identifier (UEI) which is in the System for

Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.

11. Freight or delivery charge must be billed as shown on the award.

If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. It is the Contractor/Vendor’s responsibility to periodically check the OALM IPP website and be prepared to transition to IPP on the designated transition date.

Until the Contractor/Vendor has transitioned to IPP as specified on the OALM IPP website, the Contractor/Vendor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment and is on the website at https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files Questions concerning the transition to IPP should be directed to NIH-IPPinvoicing@mail.nih.gov. Questions concerning this award should be directed to the NIH Contracting Officer.

If this award is a parent indefinite delivery award or a Blanket Purchase Agreement Set-Up, then HHSAR 352.232-71 applies to all task/delivery orders or Blanket Purchase Agreement calls issued under this award.

https://oalm.od.nih.gov/IPP https://oalm.od.nih.gov/IPP https://oalm.od.nih.gov/IPP https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files mailto:NIH-IPPinvoicing@mail.nih.gov

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The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Purchasing Agent) and TPOC:

Approving Official: Purchasing Agent

Name – (TBD at award) Email Address-

TPOC

Name – (TBD at award) Email Address-

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301- 496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday – Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

II. Invoice Payment

A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

RFQ 75N91024Q00081 Page 8 of 27 amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, andregulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Mar 2023)

(a)

(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February

2, 2022)

(a) Definitions. As used in this clause-

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

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

https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 http://www.ipp.gov/

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

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

(End of Clause)

11.0 ACQUISITIONS UNDER NON-RESEARCH AND DEVELOPMENT

PROCEDURES

Both the Government and the Contractor agree this acquisition is being conducted under non-Research and Development (R&D) procedures; therefore, the following non- R&D terms and conditions apply:

a. Human Subjects

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans. Reference https://www.hhs.gov/ohrp/index.html for more information.

b. Confidentiality

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act. No research involving the collection or use of identifiable, sensitive information shall occur under this contract including:

• Human subjects research as defined in the Federal Policy for the Protection of

Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

https://www.hhs.gov/ohrp/index.html

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• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

• Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

c. Human Materials

The acquisition and supply of human specimen material (including fetal material) shall not be conducted under this contract.

d. Animal Welfare

It is hereby understood and agreed that the Contractor shall not use live, vertebrate animals for any work conducted under this contract. Reference the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: https://olaw.nih.gov/policies-laws/phs-policy.htm .

e. Institutional Review Board (Irb)

The Government has determined this to be a non-R&D requirement. Should the Contractor require Institutional Review Board (IRB) approval for any work conducted under this agreement, the Contractor shall promptly notify the Contracting Officer and Contracting Officer’s Representative in writing and immediately stop work until written Contracting Officer Authorization to continue performance is provided.

If at any time during the performance of this contract, the Contractor is not in compliance with paragraphs a. through e. above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with the Office for Human Research Protections (OHRP), Department of Health and Human Services or Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), terminate this contract in whole or in part.

12.0 SOLICITATION PROVISIONS

FAR 52.204-24 Representations Regarding Certain Telecommunications and https://olaw.nih.gov/policies-laws/phs-policy.htm https://olaw.nih.gov/policies-laws/phs-policy.htm

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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 https://www.acquisition.gov/far/part-52#FAR_52_204_26 https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-52#FAR_52_204_26 https://www.acquisition.gov/far/part-52#FAR_52_204_26 https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-52#FAR_52_204_25

RFQ 75N91024Q00081 Page 12 of 27 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— https://www.sam.gov/

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(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.

(End of provision)

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

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

RFQ 75N91024Q00081 Page 14 of 27 with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

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

(End of provision)

FEDERAL ACQUISITION REGULATION (FAR) – PROVISIONS INCORPORATED BY

REFERENCE:

PROVISION

REFERENCE

TITLE DATE

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation.

January 2017

FAR 52.204-7 System for Award Management October 2018

FAR 52.204-16 Commercial and Government Entity Code Reporting

August 2020

FAR 52.204-17 Ownership or Control of Offeror August 2020

FAR 52.204-20 Predecessor of Offeror August 2020

FAR 52.204-22 Alternative Line Item Proposal January 2017

FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services

November

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

October 2022

FAR 52.222-56 Certification Regarding Trafficking in Persons Compliance Plan

October 2020

FAR 52.223-22 Public Disclosure of Greenhouse Gas Emissions and Reduction Goals- Representation

December

FAR 52.229-11 Tax on Certain Foreign Procurements— Notice and Representation

June 2020

13.0 SOLICITATION CLAUSES

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

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FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services (DEC 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91).

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

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

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

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

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

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

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

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

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☐ (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

☒ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

☐ (6) [Reserved].

☐ (7) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L.

111-117, section 743 of Div. C).

☐ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

☒(9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

☐(10) 52.204–28, Federal Acquisition Supply Chain Security Act Orders— Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi- Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

☐ (11)(i) 52.204–30, Federal Acquisition Supply Chain Security Act Orders— Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

☐(ii) Alternate I (Dec 2023) of 52.204–30.

☒ (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

☐ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41 U.S.C. 2313).

☐ (14) [Reserved].

☐ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (SEP 2021) (15 U.S.C. 657a).

☐ (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (SEP 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

☐ (17) [Reserved]

☐ (18) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

https://www.govinfo.gov/link/plaw/115/public/390

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☐(ii) Alternate I (MAR 2020) of 52.219-6.

☐ (19) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

☐ (ii) Alternate I (MAR 2020) of 52.219-7.

☐ (20) 52.219-8, Utilization of Small Business Concerns (SEP 2023) (15 U.S.C. 637(d)(2) and (3)).

☐ (21) (i) 52.219-9, Small Business Subcontracting Plan (SEP 2023) (15 U.S.C. 637(d)(4)).

☐ (ii) Alternate I (NOV 2016) of 52.219-9.

☐ (iii) Alternate II (NOV 2016) of 52.219-9.

☐ (iv) Alternate III (JUN 2020) of 52.219-9.

☐ (v) Alternate IV (SEP 2023) of 52.219-9.

☐ (22) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

☐ (ii) Alternate I (MAR 2020) of 52.219-13.

☐ (23) 52.219-14, Limitations on Subcontracting (SEP 2021) (15 U.S.C. 637s).

☐ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C. 637(d)(4)(F)(i)).

☐ (25) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (SEP 2021) (15 U.S.C. 657f).

☐ (26) (i) 52.219-28, Post Award Small Business Program Representation (SEP 2023) (15 U.S.C. 632(a)(2)).

☐ (ii) Alternate I (MAR 2020) of 52.219-28.

☐ (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (SEP 2021) (15 U.S.C. 637(m)).

☐ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women- Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (SEP 2021) (15 U.S.C. 637(m)).

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☐ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

☐ (30) 52.219-33, Nonmanufacturer Rule (SEP 2021) (15U.S.C. 637(a)(17)).

☐ (31) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

☐ (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (NOV 2023).

☐ (33) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

☐ (34) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

☐(ii) Alternate I (FEB 1999) of 52.222-26.

☐ (35) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

☐ (ii) Alternate I (JUL 2014) of 52.222-35.

☐ (36) (i) 52.222-36, Equal Opportunity for Workers with Disabilities

(JUN 2020) (29 U.S.C. 793).

☐ (ii) Alternate I (JUL 2014) of 52.222-36.

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

☐ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

☒ (39) (i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

☐ (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O.

13627).

☐ (40) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

☐ (41) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (MAY 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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__ (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

☐ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

☐ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

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

☐(ii) Alternate I (OCT 2015) of 52.223-13.

☐ (45) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

☐ (ii) Alternate I (JUN 2014) of 52.223-14.

☐ (46) 52.223-15, Energy Efficiency in Energy Consuming Products (MAY 2020) (42 U.S.C. 8259b).

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

☐ (ii) Alternate I (JUN 2014) of 52.223-16.

☒ (48) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

☐ (49) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

☐ (50) 52.223-21, Foams (JUN 2016) (E.O. 13693).

☐ (51) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

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

☐ (52) 52.225-1, Buy American-Supplies (NOV 2021) (41 U.S.C. chapter 83).

☐ (53) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

☐ (ii) Alternate I [RESERVED] https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/2112 https://www.govinfo.gov/link/uscode/19/3805 https://www.govinfo.gov/link/uscode/19/3805 https://www.govinfo.gov/link/uscode/19/4001

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☐ (iii) Alternate II (DEC 2023) of 52.225-3.

☐ (iv) Alternate III (NOV 2023) of 52.225-3.

☐ (iv) Alternate IV (OCT 2022) of 52.225-3.

☐ (54) 52.225-5, Trade Agreements (NOV 2023) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

☒ (55) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

☐ (56) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

☐ (57) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150).

☐ (58) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C. 5150).

☐ (59) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

☐ (60) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

☐ (61) 52.232-30, Installment Payments for Commercial Products and Commercial Services (NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

☒ (62) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT 2018) (31 U.S.C. 3332).

☐ (63) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (JUL 2013) (31 U.S.C. 3332).

☐ (64) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

☐ (65) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

☐ (66) 52.242-5, Payments to Small Business Subcontractors (JAN 2017) (15 U.S.C. 637(d)(13)).

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

☒ (ii) Alternate I (APR 2003) of 52.247-64.

☒ (iii) Alternate II (NOV 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

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

☐ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

☐ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

☐ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (MAY 2014) (29U.S.C.206 and 41 U.S.C. chapter 67).

☐ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (MAY 2014) (41 U.S.C. chapter 67).

☒ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services- Requirements (MAY 2014) (41 U.S.C. chapter 67).

☐ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order

14026 (JAN 2022).

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

☐ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations

(JUN 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

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(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and

(d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct

(NOV 2021) (41 U.S.C. 3509).

(ii) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712).

(iii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing…