FDA-23-SOW-1266015.pdf

FDA-23-SOW-1266015

CENTER FOR DEVICES AND RADIOLEGICAL HEALTH (CDRH)

Office of Product Evaluation and Quality (OPEQ) Contractor (TBD)

Assessing Biological Variability in Minimum Inhibitory Concentrations Measured by the Broth Microdilution Method

BACKGROUND

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

The CDRH Office of Product Evaluation and Quality (OPEQ) implements the program areas through which medical devices are evaluated or cleared for clinical investigations and marketing. OPEQ protects and promotes the public health by evaluating, enhancing, and ensuring compliance with medical device laws. Also, it fosters the development of methodology, analysis, and clinical trial infrastructure to facilitate the assessment of medical device safety and effectiveness. OPEQ oversees device-specific clinical evidence and analysis.

The Division of Microbiology Devices (DMD) reviews premarket submissions (510(k)), for commercial antimicrobial susceptibility test (AST) devices, to ensure accurate and reproducible performance of these devices and determines substantial equivalence to a legally marketed predicate device. AST devices are a critical component in the appropriate management of microbial infectious diseases as the results from these devices directly impact therapeutic guidance and facilitate monitoring of new or emerging resistance to antimicrobial agents.

AST device performance for each antimicrobial agent is established by comparing the Minimum Inhibitory Concentration (MIC) results obtained with the AST device to the Clinical and Laboratory Standard Institute (CLSI) standard reference broth microdilution (BMD) method MIC results. Accurate and reproducible results of the BMD reference method are essential to establishing device performance and ultimately ensuring patient safety.

To receive premarket clearance for marketing, the FDA requires AST device manufacturers to demonstrate “acceptable” performance when comparing the MIC results of the AST device to the BMD method. Thus, the ability of the manufacturer’s AST device to generate an accurate result depends on the reproducibility of results generated by the BMD method.

The reproducibility of BMD method results may be limited by numerous biological factors (i.e., inherent strain properties, isolates with multiple resistance mechanisms,) for specific organism/antimicrobial combinations that may generate variable results. As such, variability in establishing the BMD method results for comparison with the AST device result can make establishing true performance a challenge.

Clinically, MIC values are performed once and reported as a single value; however, FDA recommends that manufacturers perform testing of the BMD reference method in triplicates, due to concerns about variability (REF: Class II AST Special Controls Guidance document).

Through this contract, in consultation with the FDA, the contractor will perform an interlaboratory susceptibility testing and investigate the reproducibility of the BMD method MIC results for specific organism/antimicrobial agents’ combinations which may exhibit variability. Based on findings from this study, the FDA may be able to make recommendations to device manufacturers regarding testing the BMD reference method and support regulatory decision making.

This information will advance CDRH’s priority to address the threat of antimicrobial resistance, as outlined in the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) initiative.

Through this contract, the contractor in collaboration with the FDA will support to advance the regulatory review of AST devices and the CARB initiative.

OBJECTIVE

The objective of this acquisition is to support the Center for Devices and Radiological Health (CDRH) in advancing the review of AST devices by identifying specific organism/drug combinations with inherent biological variable susceptibility results, when using the CLSI reference broth microdilution method as described in the CLSI M07 standard document.

SCOPE

The purpose of this procurement is to perform an interlaboratory reproducibility study and obtain experimental data to identify specific organism/drug combinations that may exhibit biological variability when testing is performed using the CLSI BMD method.

The study will require susceptibility testing of a minimum of 90 bacterial isolates in triplicate at three different sites (three measurement per site) against a broad range of antimicrobial agents (refer to Table 1 in Appendix I) using the CLSI BMD method as described in the M07 standard document.

Specifically, the study will identify specific organism/drug combinations that may generate variable results in the absence of confounding variables (i.e., operators, media lots). The contractor will record all testing and material conditions (i.e., temperature, inoculum, media, inoculator) and ensure all devices are calibrated.

The studies required by this SOW will use well characterized challenge bacterial isolates with known susceptibility patterns from the CDC & FDA Antibiotic Resistance and/or from other biorepository collected from various locations. Testing will include a minimum of 10 isolates per species (minimum of 90 isolates total) that produce on-scale results based on the concentration ranges chosen for the panel and surround the FDA-recognized breakpoints. The study will also include CLSI-recommended QC strains that produce on-scale results for routine QC testing.

Results of this study will enhance our understanding of the variability of BMD method and support FDA regulatory decision making. Summary results will be tracked in an internal database and may help re-shape FDA’s current thinking about the reference method when assessing AST device performance in premarket submissions.

TASKS

4.1 TASK ONE: PROJECT MANAGEMENT

Throughout this Contract, the Contractor shall work with the FDA’s Contracting Officer Representative (COR), Technical Point of Contact (POC) and the Contracting Officer (CO), to provide contacted deliverables for review and approval to CDRH to ensure that the tasks are performed efficiently, accurately, on time, and in compliance with the requirements of this SOW.

The Contractor shall coordinate, as necessary, with the COR and Technical POC to ensure that the tasks are managed consistently in accordance with overall Contract requirements.

The Contractor shall ensure timely and accurate submission of invoices.

1.1.1 Kick-Off Meeting

Within ten (10) business days after the effective date of the contract, the Contractor shall participate in a Kick-Off Meeting with the Technical POC, the COR and other involved FDA staff. The Contractor shall provide meeting materials and agenda two (2) days prior to the Kick-off meeting.

The Contractor shall prepare summary meeting minutes, detailing the discussion held, and provide a copy of the minutes to the COR and the Technical POC within five (5) business days after the meeting.

1.1.2 Monthly Status Report

The Contractor shall provide a brief monthly status report, as agreed upon with the COR and Technical POC, to track the status of the assigned tasks.

1.1.3 Project Work Plan

The contractor shall develop a proposed schedule and high-level Project Work Plan (PWP). The contractor shall identify in the PWP the resources that the CDRH needs to provide for this effort. The Contractor shall ensure the PWP aligns with the contract tasks and outline the supporting subtasks and projected timeline in enough detail to convey the associated activities, objective of the subtask, and alignment with the contract task or associated goal so that the

CDRH can provide relevant feedback. The Contractor shall ensure the PWP defines and details timelines and deliverables as well as any dependencies or associated constraints.

The Contractor shall provide the PWP to the COR in electronic format using one of the Microsoft Office products viewable and editable by FDA, such as MS Word, MS Excel, or MS PowerPoint.

The contractor shall present the draft PWP at the Kick-Off Meeting. The CDRH will have five (5) business days to review the draft PWP and provide feedback; the contractor shall have five (5) days to revise the proposed approach and workplan based on feedback from FDA before submitting a final PWP within two weeks after the Kick-off meeting.

The Contractor shall ensure the final PWP includes the timeline for all tasks and subtasks alongside detailed descriptions of deliverables and their respective due dates.

The PWP must be updated quarterly, with submission and government review periods defined in the initial approved PWP.

4.2 TASK TWO: CONDUCT THE STUDY

Through this contract, in consultation with the FDA, the contractor will perform an interlaboratory reproducibility study to investigate whether the MIC values differ for specific organism/drug combination in order to determine the extent of variability. Testing will be conducted at three different sites. Each isolate will be tested in triplicate at each site. MIC data will consist of nine replicates per isolate to investigate within-site and between-site variabilities (three replicates per site for a total of 9 MIC values).

The BMD method will be performed as described in the M07 CLSI standard document. The contractor will record all testing and material conditions (i.e., temperature, inoculum, media lots, inoculator, broth lot numbers) and ensure consistency of the procedure within and between sites.

In this contract, the contractor, in consultation with the FDA, will choose appropriate isolates to include in the study based on FDA’s proposed list of organism/drug combinations (refer to Appendix I) and perform reference BMD susceptibility testing for the chosen isolates. Since the MIC variability will likely have an impact on categorical agreement when the MIC value is around those categorical interpretive criteria for each drug/organism combination, the contractor shall consult the FDA’s Antibacterial Susceptibility Test Interpretive Criteria website for FDA-recognized breakpoints when selecting isolates to include isolates with MIC values around the breakpoints for the drug/organism combinations.

Multidrug resistant, well characterized challenge isolates can be selected from the FDA and CDC Isolate AR Bank or other biorepositories for this evaluation with final agreement from FDA on the selected isolates. The study will also include testing of appropriate QC strains that produce on-scale results recommended in the CLSI M100 standard document.

Antimicrobial agents shall be tested using a frozen panel prepared by the contractor according to CLSI method described in M07 standard document. The panel shall contain two-fold dilutions of each antimicrobial agent. Dilutions shall include the FDA recognized interpretive criteria with a minimum of https://www.fda.gov/drugs/development-resources/antibacterial-susceptibility-test-interpretive-criteria https://www.fda.gov/drugs/development-resources/antibacterial-susceptibility-test-interpretive-criteria one two-fold dilution above the resistant threshold and several below the susceptible threshold to provide a range for evaluating the results. Antimicrobial concentrations more than two doubling dilutions above and below the susceptible category shall provide more results that are on-scale, but this depends on the drug/organism MIC distribution.

A minimum of ten isolates per species shall be tested at each site in triplicate with the same inoculum prepared for each test. At least 10 isolates that produce on-scale results within the range of concentrations on the BMD panel shall be included in this analysis for each species. Testing and reading of the MIC results for each isolate will be performed by the same operator to eliminate inter-operator variability. Purity check plates shall be performed on all isolates tested during the study. If a purity plate indicates mixed culture, the isolate shall be rested to include three data points in the analysis. The CLSI-recommended QC strains shall be tested using each antimicrobial agent dilution range.

The contractor will calculate the reproducibility for within site (intra-site), for each site, and between sites (inter-site).

Results of this investigation will include reproducibility and quality control performance summary data.

The report which includes these findings will be tracked in FDA database for regulatory decision making.

Recommendations may be provided to CLSI to update the M07 CLSI standard document to include additional details in the procedures to minimize variability.

4.3 TASK THREE: DATA ANALYSIS

In collaboration with the FDA, the contractor will assess the reproducibility of each organism/drug combination by comparing the MIC data to identify which combination exhibit the lowest or highest percent variability. The mode of each isolate with 3 replicates per site will be calculated for each site separately and then three modes will be compared among each other.

The contractor shall provide a detailed data analysis report, that includes results of findings, to the FDA, not later than 30 calendar days prior to the contract end date.

5. DELIVERABLES

5.1 FORMAT OF DELIVERABLES

Deliverables (both in draft and final versions) shall be provided in hard and soft copy using MS Office products. Interim, informal, and working-copy products may be provided by e-mail on as need basis and.

Final soft copies of deliverables shall be developed using the current FDA version of Microsoft Office products and/or other standard application software Final hard copies of deliverables shall be typewritten on 8-1/2"x11" white paper.

5.2 DELIVERABLES SUBMISSION PROCEDURE

Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, and "padding,” or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction.

Upon discussion and agreement between FDA and contractor results maybe compiled into a peer-reviewed publication at an appropriate time in the future. The FDA representatives will be invited to review the processes and procedures and provided quarterly updates on the project.

5.3 SUMMARY OF DELIVERABLES

Task SOW Reference Deliverables Quantity/Frequency Due Date

1 4.1.1 Kick-off Meeting Minutes 1 Within 5 business days after the kick-off meeting date

1 4.1.2 Monthly Status Report 12 Monthly (date to be determined during the kick-off meeting)

1 4.1.3 Draft Project Work Plan 1 Within 5 business days after the kick-off meeting date.

1 4.1.3 Final Project Work Plan 1 Within 30 calendar days after the kick-off meeting date.

3 4.3 Draft Data Analysis Report 1 45 calendar days prior to the contract end date

4 4.3 Final Data Analysis Report 1 30 calendar days prior to the contract end date

6 CONTRACT TYPE

Firm Fixed Price

7 PLACE OF PERFORMANCE

Work Shall be performed at the Contractor’s site.

8 PERIOD OF PERFORMANCE

The period of performance shall consist of a base period for 12 months with 3, 12 month option periods using no more than 49 new drug organism combinations as mutually determined prior to exercising each option period.

9 GOVERNMENT CONTACTS

9.1 CONTRACTING OFFICER

Kyle Smith – kyle.smith@fda.hhs.gov

9.2 CONTRACTOR OFFICER REPRESENTATIVE

TBD

10 HOLIDAYS AND GOVERNMENT CLOSURES

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday, Government closure, or shut down for the Washington, D.C. area:

New Year's Day Martin Luther King Day President 's Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veteran 's Day Thanksgiving Day Christmas Day

The Contractor shall not schedule training during federal holidays or Government closure. As necessary, training scheduled during unexpected Government closures may be rescheduled following coordination with the COR. The Contractor shall not bill the Government for any training that the Contractor did not perform due to any Government closures.

11 CLAUSES

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 this/these address(es): www.acquisition.gov/far http://www.acquisition.gov/far

The following HHSAR and FAR clauses are incorporated by reference:

52.212-1 - Instructions to Offerors – Commercial Items (Oct 2018)

52.212-2 - Evaluation – Commercial Items (Oct 2014)

52.212-3 - Offeror Representations and Certifications-Commercial Items

(OCT 2018)

52.204-7 - System for Award Management (Oct 2018)

52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016)

52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016)

52.212-3 - Offeror Representations and Certifications -- Commercial Items (Oct 2018)

• If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.212-3 with this offer

52.219-1 - Small Business Program Representations (Oct 2014)

• If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.219-1 with this offer

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements- Representation. (Jan 2017)

52.219-8 Utilization of Small Business Concerns (Oct 2018) 52.219-14 Limitations on Subcontracting (Jan 2017)

52.222-26 Equal Opportunity (Sept 2016)

52.222-41 Service Contract Labor Standards (Aug 2018)

52.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

52.227-14 Rights in Data-General (May 2014) 52.227-17 Rights in Data-Special Works (Dec 2007)

52.232-40 Providing Accelerated Payments to Small Business (Dec

2013)

Provisions:

52.217-5 Evaluation of Options (Jul 1990)

52.219-6 Notice of Total Small Business Set-Aside (Nov 2011)

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

352.239-73 Electronic Information and Technology Accessibility Notice (Dec

2015)

FAR Clauses relevant to this requirement:

52.217-8 Option to Extend Services (Nov 1999)

52.217-9 Option to Extend the Term of the Contract (MAR 2000)

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 this/these address(es): https://acquisition.gov/far/

52.204-13 – System for Award Management Maintenance (Oct 2018) 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016)

52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018)

52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) (End of clause)

FAR 52.212.4 Contract Terms and Conditions – Commercial Products and Commercial Services (Dec 2022)

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (Mar 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 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 https://acquisition.gov/far/ https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_203-19

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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015). (4) 52.233-3, Protest After Award (Aug 1996) (31U.S.C.3553).

(5) 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:

[Contracting Officer check as appropriate.]

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C.4704 and 10 U.S.C.2402).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

(3) 52.203-15, 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.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) [Reserved].

(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L.

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

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite- Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

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

(10) [Reserved].

(11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15U.S.C.657a).

(ii) Alternate I (Nov 2011) of 52.219-3.

(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id189A70O0P1N https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062680 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048661 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048698 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063319 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063504 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063607 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064087 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section6101&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064214 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064243 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062590 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section6101&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062651 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-section2313&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637a&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3

(ii) Alternate I (Jan 2011) of 52.219-4.

(13) [Reserved]

_X_ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.644).

(ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

(ii) Alternate I (Oct 1995) of 52.219-7.

(iii) Alternate II (Mar 2004) of 52.219-7.

(16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and(3)).

(17) (i) 52.219-9, Small Business Subcontracting Plan (Aug2018) (15 U.S.C. 637(d)(4))

(ii) Alternate I (Jan 2017) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Nov 2016) of 52.219-9.

(v) Alternate IV (Aug 2018) of 52.219-9

(18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

(19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C.637(a)(14)).

(20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C.

632(a)(2)).

(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to,Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

(24) 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 (Dec2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O.11755).

_X_ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) (E.O.13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) (i) 52.222-26, Equal Opportunity (Sept 2016)(E.O.11246).

(ii) Alternate I (Feb 1999) of 52.222-26.

(29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35.

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-8 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057715 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057730 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057758 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057823 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057902 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057947 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055332 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055664 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055713 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title38-section4212&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230

(30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

(ii) Alternate I (July 2014) of 52.222-36.

(31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (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).

(34) 52.222-54, 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.)

(35) (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.)

(36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.

13693).

(37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun2016) (E.O. 13693).

(38) (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.

(39) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and

13514).

(ii) Alternate I (Jun2014) of 52.223-14.

(40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C.8259b).

(41) (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.

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

(43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

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(44) 52.223-21, Foams (Jun2016) (E.O. 13693).

(45) (i) 52.224-3 Privacy Training (Jan2017) (5 U.S.C. 552 a).

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

_X_ (46) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C.chapter 83).

(47) (i) 52.225-3, 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.

(48) 52.225-5, Trade Agreements (Aug 2016) (19 U.S.C.2501, et seq., 19 U.S.C. 3301 note).

_X_ (49) 52.225-13, 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).

(50) 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).

(51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).

(52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

(53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

(54) 52.232-30, Installment Payments for Commercial Items (Jan2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

(56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

(57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).

(58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

(60) (i) 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).

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

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

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id1668D08086F https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_224_3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_224_3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053372 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053446 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053446 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053446 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053446 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053648 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-section2501&amp%3Bnum=0&amp%3Bedition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-section3301&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1054249 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1054921 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055038 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055048 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050508 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050540 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050674 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section3332&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050705 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050789 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title5-section552a&amp%3Bnum=0&amp%3Bedition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_242-5 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560

(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.]

(1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

(2) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2014) (29 U.S.C.

206 and 41 U.S.C. chapter 67).

(5) 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).

(6) 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).

(7) 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).

(8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (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, 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.

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(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form.