BARDA CSS 75A5012Q00017.pdf

COMBINED SYNOPSIS / SOLICITATION

75A50121Q00017

TITLE: Plasma Collection for Vaccinated Subjects

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

(ii) The solicitation number is 75A50121Q00017 and the solicitation is issued as a request for quotes

(RFQ). This acquisition is for a commercial services and is conducted under the authority of the

Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, FAR Part 12—

Acquisition of Commercial Items, and FAR Subpart 18.202(b), and is expected to exceed the simplified acquisition threshold.

(iii) This is a competitive combined synopsis/solicitation. Award(s) will be made to the offerors whose proposal(s) successfully address each of the identified requirements, and for which the proposed price is determined to be fair, reasonable and realistic.

(iv) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03, dated February 16, 2021.

(v) The associated NAICS code is 621991 and the Small Business size standard is $32.5M. This requirement is competitive and is not set aside exclusively for small businesses.

DESCRIPTION

(vi) The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to plasma collected from vaccinated subjects.

As part of the Federal COVID-19 Response, the U.S. Government is establishing a new interagency COVID-19 serum biorepository that will allow for in vitro assessments of vaccine efficacy against newly emerging variants of SARS-CoV-2. In order to provide serum for the biorepository, there is an urgent need to source plasma from COVID-19-naïve subjects to have received a COVID-19 vaccine authorized for use under an Emergency Use Authorization (EUA) by the FDA.

This acquisition seeks to identify qualified vendors who are capable of identifying, testing, and drawing plasma via plasmapheresis from patients who have been vaccinated. The work must be conducted under an IRB-approved protocol. The plasma collected must meet the U.S.

government’s specifications as set forth in the requirements. The plasma will then be packaged, temporarily stored, and shipped to a vendor of the U.S. Government’s choice for processing into serum. Additional retain samples must also be collected, stored, and shipped to support additional testing. A quality audit of the facility may be warranted pre-award to ensure vendor capabilities and quality controls.

See attached Purchase Description for complete requirement details.

EVALUATION AND AWARD

(vii) The Government anticipates including a two-month delivery lead time for the panels related to the Moderna and Pfizer vaccines and an eight-month delivery lead time for the remaining TBD, three additional vaccines.

(viii) The Government plans to award a purchase order resulting from this solicitation. The resulting award will be made to the responsible Offeror whose offer is the lowest priced, technically acceptable quote. Technically acceptable is defined as capability of the item offered to meet the agency need.

SUBMISSION INSTRUCTIONS

(ix) All responses to this RFP must be received by 3:00pm Eastern Time on Wednesday, April 28, 2021 and must reference the solicitation number cited above. Responses must be submitted via email to

Jeffrey Schmidt at Jeffrey.Schmid2@hhs.gov

(x) This is an RFQ. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by Offeror. Any representations and/or certifications attached to this RFQ must be completed by the Offeror.

(xi) Responses to this RFQ must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses must also include the Dun

& Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size.

(xii) The Government reserves the right to request clarifying information after receipt and evaluation of your quote.

(xiii) The Government reserves the right to enter into discussions.

(xiv) For information about this RFP, contact Jeffrey Schmidt, Contracting Officer, at 202- 205-0260 or Jeffrey.Schmidt2@hhs.gov.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xv) The provision at 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 with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at www.acquisition.gov.

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

(a) The provision at FAR 52.204-7, System for Award Management (Oct 2018).

(b) The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul

2016).

(c) The provision at 52.204-26, Covered Telecommunications Equipment or Services-

Representation (Oct 2020).

(d) The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Oct 2018).

(e) The provision at FAR 52.212-2 Evaluation—Commercial Items (Oct 2014).

(f) The provision at 52.212-3, Offeror Representations and Certifications—Commercial Items

(Dec 2019).

(xvi) The clause at FAR 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 www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:

(a) The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018).

(b) The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul

2016).

(c) The clause at FAR 52.204-23, Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018).

(d) The clause at FAR 52.204-24, Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment (Oct 2020).

(e) The clause at FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and

Video Surveillance Services or Equipment (Aug 2020).

http://www.acquisition.gov/ http://www.acquisition.gov/

(f) The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Oct 2018).

(g) The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015).

(xvii) The following documents are attached:

(a) Purchase Description.

(b) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Nov 2020).

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

Priorities and Allocations System.”

Attachment 1 RFQ: 75A50121Q00017

PURCHASE DESCRIPTION

Plasma Sourcing Requirements for EUA Serum Repository (via Purchase Order)

Specifications:

1. 6 vaccine panels:

a. Pfizer, Moderna, Janssen, plus up to three additional vaccines (TBD)

2. Vendor/Sponsor/Collection site

a. EUSLA between Contractor and BARDA-selected destination for defibrination (TBD)

[Note: the EUSLA is a simplified material transfer agreement governing the use of the clinical samples for the COVID-19 response]

3. Sample criteria for each vaccine panel:

a. Inclusion:

i. 35 adults (Risk mitigation to offset non-responders or low titers to Spike)

1. Balanced distribution of donor ages and gender across the 35 samples

a. 18–35, 36–50, and 51/+ years old (or similar grouping)

b. ~50/50 female/male

ii. Peak immunogenicity (see “6. Collection timeframe”)

b. Exclusion:

i. Subjects on antiretroviral therapy or immunomodulators (e.g., for transplants, rheumatoid arthritis) 1-week exclusion window

ii. Sample positive for anti-N protein antibodies via 1 of the following 3 tests in a CLIA lab (Certificate of Analysis required)

1. Elecsys anti-SARS-CoV-2 Assay (Roche)

a. Ag/Ab principle: electrochemiluminescence immunoassay;

nucleocapsid antigen

b. Specimen: human serum and plasma

2. SARS-CoV-2 IgG assay (Abbott)

a. Ag/Ab principle: automated, 2-step immunoassay using chemiluminescent microparticle immunoassay tech;

nucleocapsid

b. Specimen: human serum, serum separator tube and plasma

3. Platelia SARS-CoV-2 total Ab assay (BioRad)

a. Ag/Ab principle: ELISA; SARS-CoV-2 full-length nucleocapsid

b. Specimen: human serum and plasma EDTA

c. Additional screening for recipients of the Janssen vaccine:

i. Pre-screened for titer level using Monogram’s PhenoSense SARS-CoV-2

Neutralizing Antibody assay (third-party lab is acceptable)

1. Ideal: even distribution of low/med/high-titer subjects

2. Alternate:

a. At least 17 of the 35 Janssen vaccine recipients must have a high titer (threshold for high-titer to be discussed) https://www.monogrambio.com/phenosense-sars-cov-2-neutralizing-antibody https://www.monogrambio.com/phenosense-sars-cov-2-neutralizing-antibody

b. Remaining 18 subjects can be either low- or high-titer (there is no minimum requirement for the quantity of low-titer subjects)

4. Restrictions:

a. None beyond IRB

5. Collection specifications:

a. Target plasma volume/subject (primary): 600–800 mL

i. Additional samples (secondary): 2 x 1 mL samples for testing

1. Pulled at same time as primary plasma volume

ii. Collected into bags (primary) and tubes (secondary) with sodium citrate as an anticoagulant

b. Contingencies:

i. Samples that fail to meet the lower bound of volume (600 mL) are ineligible for delivery for our use

ii. However, if a patient cannot donate at least 600 mL in a single sitting, they are eligible to donate additional plasma IF the two donations are separated by a 48-hour interim period (per FDA guidelines) AND are within the requested post-vaccination collection timeframe (see “6. Collection timeframe”)

c. Primary sample packaging (post-collection): bags or bottles of ~100–250 mL each

i. Labeled appropriately and according to quality standards

ii. In either case, those with compromised integrity will be replaced by the Vendor

d. Sterile collection process and handling

6. Collection timeframe:

a. One-dose vaccines (e.g., Janssen)

i. Collected 8–10 weeks post-single dose

b. Two-dose vaccines (e.g., Pfizer, Moderna)

i. Collected 4–6 weeks post-second dose

7. Documentation (must be auditable):

a. IRB approval of the collections

b. Proof of subject vaccination, including manufacturer, via copy of COVID-19 Vaccination

Record Card

c. Date of vaccination via copy of COVID-19 Vaccination Record Card

d. Subject demographics (age, gender) and exclusionary window for

ART/immunomodulators of 1 week, if applicable

e. Quality Assurance audit prior to issuance of purchase order, including:

i. Pre-assessment of capabilities and compliance of SOPs

f. BARDA may also follow up after initial samples are collected to verify whether collections adhere to requirements and to assure a complete set of subject forms for BARDA’s files

8. Cold chain:

a. Frozen and stored within 12 hours of collection: -40°C

b. Transport: -40°C with data logger for monitoring temperature

i. Please confirm whether you or the recipient will be responsible for downloading the data logger and your process for data logger return

9. Chain of custody:

a. Overview:

i. (Provider and collection site)BARDA-selected destination for defibrination/aliquot/label (TBD)BEI (storage/distribution)

b. Company-specific chain of custody for where primary (600–800 mL) and secondary (2 x 1 mL) samples are all going after Provder confirms seronegativity

i. Two-dose vaccines (e.g., Moderna, Pfizer)

1. Primary: collected, frozen*, and batch-shipped* to Defibrination facility

2. Secondary: collected simultaneously with primary, frozen*, and batch-shipped* to BEI for storage until future titer testing

ii. One-dose vaccines (e.g., Janssen)

1. Primary: collected, frozen*, and temporarily stored* at Provider until titer testing of 1 mL is confirmed; then batch-shipped* to Defibrination facility

2. Secondary: collected simultaneously with primary, frozen, and:

a. 1 mL vial batch-shipped to Monogram for titer testing

b. 1 mL vial batch-shipped to BEI for storage

iii. *See “8. Cold chain” for freezing, temporary storage, and transport temperatures

10. Timeline for delivery to BARDA-selected destination:

a. As soon as possible: First three panels (Pfizer, Moderna, Janssen)

[Note: targeting collection initiation in early May, depending on award date]

b. Subsequent panels within 4 months of EUA of the vaccine in question

11. Packaging/Shipping requirements (BEI; storage/distribution facility):

a. All shipments need to be coordinated with BEI at least 48 hours in advance

b. Shipment manifest is required

Will follow up with contact information

12. Packaging/Shipping requirements (Defibrination facility):

Will follow up once a Defibrination facility has been awarded

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

ITEMS ( )

(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 items:

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

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 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 items:

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(2)

(3)

(4)

(5)

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(10)

(11)

52.203-6

52.203-13

52.203-15

52.204-10

52.204-14

52.204-15

52.209-6

52.209-9

52.219-3

Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509)).

Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L.

109-282) (31 U.S.C. 6101 note).

[Reserved].

Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L.

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

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

[Reserved].

Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C.657a).

(ii) Alternate I (Mar 2020) of 52.219-3.

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52.219-4

52.219-6

52.219-7

52.219-8

52.219-9

52.219-13

52.219-14

52.219-16

52.219-27

52.219-28

52.219-29

52.219-30

52.219-32

52.219-33

(i), Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(ii) Alternate I (Mar 2020) of 52.219-4.

[Reserved].

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

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

(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.

Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

(i), Small Business Subcontracting Plan (Jun 2020) (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 (Jun 2018) of 52.219-9.

(i) Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).

Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657 f).

Post Award Small Business Program Rerepresentation (Nov 2020) (15 U.S.C. 632(a)(2)). May require contractor completion.

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

Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar 2020) (15 U.S.C. 637(m)).

Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

Nonmanufacturer Rule (Mar 2020)(15 U.S.C. 637(a)(17)).

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

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52.222-3

52.222-19

52.222-21

52.222-26

52.222-35

52.222-36

52.222-37

52.222-40

52.222-50

52.222-54

52.223-9

52.223-11

52.223-12

52.223-13

52.223-14

52.223-15

52.223-16

52.223-18

52.223-20

Convict Labor (June 2003) (E.O. 11755).

Child Labor—Cooperation with Authorities and Remedies (Jan 2020) (E.O. 13126).

Prohibition of Segregated Facilities (Apr 2015).

(i) Equal Opportunity (Sept 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26. If this is checked, some terms have been waived.

(i) Equal Opportunity for Veterans (Jun 2020)(38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35. If this box is checked, some terms have been waived.

(i) Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(ii) Alternate I (July 2014) of 52.222-36. If this box is checked, some terms have been waived.

Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(i) Combating Trafficking in Persons (Oct 2020) (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). Alt I requires CO completion.

Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(i) 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.) Requires CO completion.

(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.) Alt I requires contractor certification.

Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). Requires contractor completion.

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

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

(ii) Alternate I (Oct 2015) of 52.223-13.

(i) Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

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

(ii) Alternate I (Jun 2014) of 52.223-16.

Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

Aerosols (JUN 2016) (E.O. 13693).

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52.223-21

52.224-3

52.225-1

52.225-3

52.225-5

52.225-13

52.225-26

52.226-4

52.226-5

52.232-29

52.232-30

52.232-33

52.232-34

52.232-36

52.239-1

52.242-5

52.247-64

Foams (JUN 2016) (E.O. 13693).

(i), Privacy Training (JAN 2017) (5 U.S.C. 552a).

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

Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

(i), Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

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 (May 2014) of 52.225-3.

(iii) Alternate II (May 2014) of 52.225-3.

(iv) Alternate III (May 2014) of 52.225-3.

Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

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. 2302 Note).

Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). Requires CO completion.

Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C.

3332).

Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). Requires CO completition.

Payment by Third Party (May 2014) (31 U.S.C. 3332).

Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

(i), Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.

1241(b) and 10 U.S.C. 2631).

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

(iii) Alternate II (FEB 2006) of 52.247-64.

Tax on Certain Foreign Procurements—Notice and Representation (Jun 2020)(55) 52.229-12

(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 items:

[Contracting Officer check as appropriate.]

52.222-41 Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67). (1)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). Requires CO completion.

(2)

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).

(3)

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).

(4)

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).

(5)

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).

(6)

52.222-55 Minimum Wages Under Executive Order 13658 (Nov 2020). (7)

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). (8)

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

(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 items. 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 (Jun 2020) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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.

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

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

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

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

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

(xi) 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.

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

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Oct 2020) (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).

(xiv) 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).

(xv) 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).

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

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

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

(xx) 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. 2302 Note).

(xxi) 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.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.1241

(b) 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 items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)