Attachment 1 36C24E24Q0086.docx

36C24E24Q0086 This document contains detailed information regarding quote submission requirements. Vendors are advised that their quotes may be determined non-responsive if they do not submit their quote as directed. See page 23 for more information.

Table of Contents

A.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C24E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

A.2 PRICE/COST SCHEDULE

ITEM INFORMATION

THA & Prep Contract Period: Base POP Begin: 07-26-2024 POP End: 12-31-2024 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) PRODUCT/SERVICE CODE: AN12 - Health R&D Services; Health care services; Applied Research

Test

POP Begin: 07-26-2024 POP End: 12-31-2024 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

CT Scan

POP Begin: 07-26-2024 POP End: 12-31-2024 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Reporting

POP Begin: 07-26-2024 POP End: 12-31-2024 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

A.3 DELIVERY SCHEDULE

4150 Clement St.

San Francisco, CA 94121

4150 Clement St.

San Francisco, CA 94121

4150 Clement St.

San Francisco, CA 94121

4150 Clement St.

San Francisco, CA 94121

San Francisco VA Medical Center 4150 Clement St.

San Francisco, CA 94121

GENERAL Specifications FOR Comparison mechanicaL testing of a VA-Developed femoral component for Total hip arthroplasty and a Predicate femoral component in a human cadaveric model

1.0 Background

The San Francisco VA Medical Center has developed a femoral component for total hip arthroplasty. Prior to evaluation in patients, the FDA requires that the VA implant is compared to a predicate femoral component in a human cadaveric model. The comparison will include evaluation of implant micromotion and migration in human femurs during and after mechanical loading in a laboratory system.

2.0 Project Scope

The San Francisco VA Medical Center is looking to compare the VA femoral component and the predicate femoral component during and after mechanical loading using mechanical testing machines. Implant micromotion and migration within human cadaveric bone will be measured and compared. A total of 4 to 8 samples for each implant will be required. No sensitive information involved with this purchase.

3.0 Specifications

3.1 The SF VAMC hip implant testing specifications are designed to comply with FDA requirements for the comparison of the VA femoral component and a predicate femoral component.

3.2 These requirements will be provided to the Government Point of Contact (POC) before final approval.

3.3 The testing must include the following:

3.3.1 Implants must be implanted in human femurs.

3.3.1.1 SFVA will provide the femurs, the subject implants, and the predicate implants.

3.3.1.2 The testing services will be performed at the contractor’s facilities.

The contractors must arrange delivery of the cadaveric femurs to their testing facility. Contractors must dispose of cadaveric samples after all testing, radiographic measurements, and evaluation has occurred.

3.3.2 Testing must comply with all FDA requirements for laboratory testing; FDA guidance will be included as a reference.

3.3.3 Micromotion must be evaluated

3.3.4 Migration must be evaluated

3.3.5 Particulate generation must be evaluated

3.3.6 Specific Tasks:

3.3.6.1 Dynamic loading is conducted in accordance with Race 2005 and Bergmann 2016

3.3.6.2 Destructive dynamic mechanical tests are conducted in compression/bending.

3.3.6.3The fixture applies cyclic loads to the stem/femur construct via the prosthetic femoral head.

3.3.6.4 Peak loads for each sample are normalized such that initial crosshead displacements are the same (+/-10%) for all donors. With this approach, stiffer (stronger) constructs are subjected to larger loads.The baseline normal displacement is defined by a synthetic composite femur and body weight of 75kg.

3.3.6.5 A head-load of 238% body-weights or 1,785 N is used and Sawbones Initial Displacement is measured for 100 cycles.

3.3.6.6 An initial conservative estimate of required head-load is made using endosteal and periosteal diameters.

3.3.6.7 The sample is loaded for 100 cycles and the Initial Displacement is noted.

3.3.6.8 The applied load is then increased in the proportion required to reach the Sawbones Initial Displacement.

3.3.6.9 Loading is applied at 3 Hz and R=0.2. Confirm frequency & record maximum compression and minimum compression in the program.

3.3.6.10 The load is applied to the femoral head through a flat plate mounted on the actuator.

3.3.6.11 Max/min compressive loads are measured by the test frame actuator for each cycle.

3.3.6.12 1,000 load cycles of pre-conditioning followed by a total of 300,000 cycles per femur shall be tested and confirm cycle counts in the program.

3.3.6.13 Motion of the femur and motion of the stem are measured synchronously with the fatigue loading.

3.3.6.14 Motion measurements are recorded at cycles 1, 100, 1k, 10k and then every 10k until run out or failure.

3.3.6.15 Motion measurements are taken for 20 cycles at each time point and averaged for subsidence and migration. Example: Cycles 1-20 are measured and averaged for the first time point. Cycles 90-110 are averaged for the second time point.

3.3.6.16 The Fatigue Loading stops when one of the following occurs:

3.3.6.16.1 300,000 fatigue loading cycles are completed.

3.3.1.16.2 Migration motion is equivalent or less than the predicate migration motion.

3.3.1.17 Particle collection will be performed according to the guidelines of ASTM F1877-16.

3.3.1.18 Apply 0-15 N compression. Check the position of the actuator to ensure the upper limit +50 mm is not crossed.

3.3.1.19 Begin the Femur Stem Fatigue Loading method on the load frame computer. Monitor actuator position and stress relaxation rate.

3.3.1.20 The actuator under displacement control at 25 mm/minute, is raised to minimum compression.

3.3.1.21 The actuator is cycled at 3 Hz for 10,000 cycles.

3.3.1.22 The actuator is raised at 25 mm/minute under displacement control until 0 N of compression.

3.3.1.23 Switch to low power in displacement Control.

3.3.1.24 Collect the deionized water from the Particle Collection Tank into Liquid Containers.

3.3.1.25 Label the containers according to Sample Test ID and Container Number.

3.3.1.26 Data files are exported from First principles in ASCII (degrees), n3d, c3d. in comma delimited format, CSV.

3.3.1.27 Each file will be numbered in the order of data collected.

3.3.1.28 Fill in Matlab I.D(s).

3.3.1.29 In the Experiment folder, copy “_cal” data files into a new folder titled “*session i.d* CAL files for Matlab”.

3.3.1.30 Convert files to .XLSX format using Excel and rename if necessary to correlate to respective matlab I.D(s).

3.3.7 The deliverable product will be a testing report that includes methods, results, statistical analysis, and conclusions.

3.3.8 Written responses to FDA about the testing report will be required, until FDA is satisfied with the responses. This may include multiple revisions that may be significant.

3.4 Contractor qualifications/experience

3.4.1 Contractor must have one year experience storing, testing, and disposing of human cadaveric specimens, as well as local, state, and/or federal regulatory approval as applicable to perform these actions.

3.4.2 Contractor must be able to arrange shipment of human cadaveric specimens to their test facility and dispose of these specimens

3.4.3 Contractor must have testing facilities that are capable of performing the indicated tests

3.4.4 Contractor must have at least one staff member working on this contract with at least a master’s degree in mechanical engineering, biomechanical engineering, or a related field

3.4.5 Contractor must have at least one staff member working on this contract with at least 10 peer reviewed publications in orthopaedic surgery or spinal surgery

4.0 Other Requirements

4.1 Delivery Location:

San Francisco VAMC 4150 Clement Street San Francisco, CA 94121

4.2 Delivery Requirements:

The Vendor shall notify the Government POC to plan the delivery date. This notification shall be provided at least one month prior to the vendor-anticipated delivery date. The Government’s required delivery date is 12/31/2024.

4.3 The C&A requirements do not apply, and a Security Accreditation Package is not required.

4.4 Records Management Language

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e- mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.222-49 SERVICE CONTRACT LABOR STANDARDS—PLACE OF PERFORMANCE UNKNOWN (MAY 2014)

(a) This contract is subject to the Service Contract Labor Standards statute, and the place of performance was unknown when the solicitation was issued. In addition to places or areas identified in wage determinations, if any, attached to the solicitation, wage determinations have also been requested for the following: N/A N/A. The Contracting Officer will request wage determinations for additional places or areas of performance if asked to do so in writing by due date for questions.

(b) Offerors who intend to perform in a place or area of performance for which a wage determination has not been attached or requested may nevertheless submit bids or proposals. However, a wage determination shall be requested and incorporated in the resultant contract retroactive to the date of contract award, and there shall be no adjustment in the contract price.

(End of Clause)

C.3 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.4 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause) (End of Addendum to 52.212-4)

C.5 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

(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.)

[X] (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).

[X] (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).

[X] (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.

[X] (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 (OCT 2022) (15 U.S.C. 657a).

[X] (16) 52.219–4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

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

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

[] (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 (FEB 2024) (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.

[X] (23) 52.219–14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 657s).

[] (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 Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (FEB 2024) (15 U.S.C. 657f).

[X] (26) (i) 52.219–28, Post-Award Small Business Program Representation (FEB 2024) (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 (OCT 2022) (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 (OCT 2022) (15 U.S.C. 637(m)).

[] (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) (15 U.S.C. 657s).

[X] (31) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[] (32) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (FEB 2024) (E.O. 13126).

[X] (33) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (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.

[X] (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).

[X] (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). (E. O. 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.)

[] (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 (MAY 2024) (42 U.S.C. 7671, et seq.).

[] (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (MAY 2024) (42 U.S.C. 7671, et seq.).

[] (44) 52.223-20, Aerosols. (MAY 2024) (42 U.S.C. 7671, et seq.).

[] (45) 52.223-21, Foams (MAY 2024). (42 U.S.C. 7671, et seq.).

[] (46) 52.223-23, Sustainable Products and Services (MAY 2024) (E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671I).

[] (47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

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

[] (48)(i) 52.225-1, Buy American—Supplies (OCT 2022) (41 U.S.C. chapter 83).

[] (ii) Alternate I (OCT 2022) of 52.225-1.

[] (49)(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].

[X] (iii) Alternate II (DEC 2022) of 52.225-3.

[] (iv) Alternate III (FEB 2024) of 52.225-3.

[] (v) Alternate IV (OCT 2022) of 52.225-3.

[] (50) 52.225–5, Trade Agreements (NOV 2023) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note [X] (51) 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).

[] (52) 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).

[] (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150).

[] (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C. 5150).

[X] (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) (E.O. 13513) [X] (56) 52.229–12, Tax on Certain Foreign Procurements (FEB 2021).

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

[] (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

[X] (59) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31 U.S.C. 3332).

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

[] (61) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (62) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

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

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

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

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

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

[X] (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[X] (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) (29 U.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).

[X] (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

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

[] (9) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).

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

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

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

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

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

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

(ii) 52.203–17, 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 Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iv) 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).

(v) 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).

(vi) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

(vii) (A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders— Prohibition. (DEC 2023) (Pub. L. 115–390, title II).

(B) Alternate I (DEC 2023) of 52.204–30.

(viii) 52.219–8, Utilization of Small Business Concerns (FEB 2024) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219–8 in lower tier subcontracts that offer subcontracting opportunities.

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

(x) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

(xi) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(xii) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

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

(xiv) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

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

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

(B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xvii) 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).

(xviii) 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).

(xix) 52.222-54, Employment Eligibility Verification (MAY 2022) (E. O. 12989).

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

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

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

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

(xxiii) 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).

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

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

(xxvi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

36C24E24Q0086 (End of Clause)

Page 1 of

Page 1 of

SECTION E - SOLICITATION PROVISIONS

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Provisions that are incorporated by reference (by Citation Number, Title, and Date), have 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 following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

Addenda to 52.212-1:

Reference word “offer”: delete “offer” and insert “quote” in its place.

Reference word “offeror”: delete “offeror” and insert “vendor” in its place.

Reference paragraph (c) period for acceptance of quotes: delete “30 calendar days” and insert “60 calendar days” in its place.

The following paragraphs are hereby deleted from this provision: (d) product samples, (e) multiple offers, and (h) multiple awards.

I. Quote Submission Instructions:

A. Failure to follow the instructions below may result in elimination from award consideration or a non-responsive determination.

1) Quotes shall be submitted through email only. Multiple emails are acceptable and may be required due to file sizes.

2) All quotes shall include one (1) separate electronic copy of each of the Section listed below. The Sections must be clearly identified as described below (either as the title of the document or on the actual document). The following should be a list of your attachments and represent your separate documents:

Section 1 Administrative Section 2 Technical (should include information included in the page count as addressed in C, 1, a) and b) Section 2 Qualification Support Docs(documents excluded from page count only) Section 2 Certifying Statement (not included in page count) Section 2 QA Plan Section 3 Redacted Technical (should include information included in the page count as addressed in C, 1, a) and b) Section 3 Redacted Qualification Support Docs (documents excluded from page count only) Section 3 Redacted Certifying Statement (not included in page count) Section 3 Redacted QA Plan Section 4 Price

3) No price information shall be included in the technical section (Section II and III). If pricing information is found in the technical section, the quote may automatically be considered non-responsive and not evaluated.

B. Section I Administrative/Regulatory Page limit: None. Please be advised that this Section is not sent for technical evaluation.

1) Completed certifications and representations located at FAR 52.212-3, or an indication that said certifications and representations are current and located in the SAM database. Signed acknowledgements of amendments (SF30). Applicable only if any amendments are issued against this solicitation.

2) In accordance with FAR 4.1102 and FAR 52.204-7 (b)(1) offerors must be registered in the System for Award Management (SAM) database at time of quote submission and at time of award. Registration may be done online at: www.acquisition.gov or www.sam.gov.

C. Section II Technical Please Note this section is not sent for Technical Evaluation. Page limit: 10 pages including any coversheets and table of contents. Exclusions to the page count are noted below.

1) Vendors shall provide a narrative which fully demonstrates how the offeror intends to meet the requirements of the Performance Work Statement (PWS). The following should also be submitted:

a) Narrative that describes how the vendor will complete the technical requirements outlined in 3.0 of the PWS.

b) Narrative that addresses the qualifications and experience outlined in PWS 3.4. (Certifications, resumes/CV and other documentation supporting this narrative are not included in the page count and labeled IAW A, 2 above).

c) A statement certifying that all employees will, for the life of the resultant contract, hold the same or better qualifications and certifications than those proposed in their technical quote. (Not included in page count. Please include as separate document IAW A, 2 above).

d) Quality Assurance (QA) Plan (Not included in page count and labeled IAW A, 2 above).

D. Section III Redacted Technical Redacted copy of Section II. Page limit: 10 pages including any coversheets and table of contents. Exclusions to the page count are noted in C above.

The redacted copy is the document that will be sent to the technical evaluators for the technical evaluation. The redaction should mirror Section II but it will eliminate any identifying data. Any items not included in the page count and as separate documents should be labeled as identified in C but will be labeled as Section III instead of Section II and redacted. The purpose of the redaction is an attempt to hold an unbiased evaluation.

E. Section IV Price No page limit. Please note, this section is not sent to the technical evaluators. Failure to follow these instructors may result in a non-responsive determination. Vendors shall include:

1) Completed Schedule.

II. 52.212-2 - Evaluation of Quotations Offers IAW FAR 13.106-2.

The Government intends to issue a single purchase order in response to this solicitation.

All quotes will be reviewed for responsiveness first. Any quotes deemed non-responsive (examples include but are not limited to: missing information, SAM not active, no redacted copy provided) may be excluded from further award consideration.

Go-No go technical evaluation will occur as the first evaluation step. This evaluation will be based only on the offeror’s certification statement listed in Section 1. C. 1) c). (and redacted statement as required by Section 1. D.) Failure to provide the certification and redacted copy will result in a “no-go” evaluation and no further award consideration will be provided to the vendor.

After the Go-no go technical evaluation a Comparative Evaluation of quotes will be performed in accordance with FAR 13.106-2(b)(3) based on the following (order does not indicate importance or significance):

Price— Government reserves the right to award to an offeror with other than the lowest price. Award will be made to the offeror whose quote represents the best overall value to the government.

Technical—Offeror clearly demonstrates in its response a clear understanding of all the Government’s requirements and effective approach for the completion of service in accordance with the SOW to include the following:

a) Narrative demonstrates a clear understanding of the proposed scope of work and fully describes how the vendor will complete the technical requirements outlined in 3.0 of the PWS.

b) Employee and company experience qualifications and experience outlined in PWS 3.4 were addressed, to include certifications represent an understanding of the required tasks, meet the requirements of the SOW and are appropriate for the requirement.

c) Quality Assurance Plan was provided and is logical and appropriate for the requirement.

Past Performance—Offerors must have a record of satisfactory or neutral past performance. If no record of past performance is found, the Offeror will receive a rating of neutral. The Government will utilize but is not limited to internal documentation including Federal Awardee Performance and Information System (FAPIIS) for determining the past performance of offerors.

Socioeconomic Considerations - In an effort to achieve socioeconomic small business goals, the Government may evaluate proposed participation in performance of the contract by Service-Disabled Veteran-Owned Small Businesses (“SDVOSB”) and Veteran-Owned Small Businesses (“VOSB”). The following clauses, which are included in the Addendum to FAR 52.212-4 and 52.212-5 in Section C in of this Solicitation, set forth what will be considered under this evaluation factor.

VAAR 852.215-70, SDVOSB and VOSB Evaluation Factors (DEC 2009) VAAR 852.215-71, Evaluation Factor Commitments (DEC 2009)

E.1 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 with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Provision)

E.2 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…