Profiling of MicroRNA transcripts in human and mouse plasma samples

Document Type: Combined Synopsis/Solicitation Solicitation Number: Amendment: 0001 FDA_19-223-SOL-1211894 Posted Date: June 19, 2019 Response Date: June 26, 2019 NAICS Code: 541380 - Testing Laboratories; with a Small Business Size Standard of $15 Million Contracting Office Address FDA/OO/OFBA/OAGS/DAP 4040 North Central Expressway Dallas, TX 75204 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items", as supplemented with additional information included on this notice and in conjunction with FAR Part 13.106, utilizing Simplified Acquisition Procedures. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued. The solicitation number is FDA_19-223-SOL-1211894. This solicitation is issued as a Request for Quote (RFQ). This solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-02 dated June 5, 2019. The associated North American Industry Classification System (NAICS) Code for this procurement is 541380 - Testing Laboratories; with a Small Business Size Standard of $15 Million. This combined/synopsis solicitation is Full and Open competition. STATEMENT OF WORK Profiling MicroRNA Transcripts in Plasma Samples Background: The Food and Drug Administration/National Center for Toxicological Research (FDA/NCTR) is in need of identification of early predictive biomarkers of doxorubicin-induced cardiac damage. Anthracyclines, such as doxorubicin are the potent anti-cancer drugs used in the treatment of different types of cancer in children and adults. However, a long-term clinical use of these drugs is limited by the serious adverse effect of cardiotoxicity which can occur during therapy or many years after cessation of treatment. Currently, there is a lack of biomarkers or technologies that can predict future heart damage in cancer patients or survivors. Thus, there is a need for identification of novel biomarkers of early cardiotoxicity induced by anthracyclines. Measurement of large number (~2000) of microRNAs (miRNAs; these molecules regulate expression of thousands of genes) using highly sensitive high throughput genomics technology in plasma samples collected from cancer patients treated with anthracyclines will aid in discovery of novel miRNAs released in plasma prior to the onset of cardiac dysfunction measured by echocardiography. These miRNAs can be used as early predictive biomarkers of cardiotoxicity and may prove valuable in identifying cancer patients or survivors at risk of heart damage, optimizing treatment regimen and/or designing new interventions to minimize cardiotoxicity tailored to susceptible sub-population. Additionally, profiling of microRNAs using highly sensitive high throughput genomics technology in plasma samples from mice treated with doxorubicin will aid in discovery of novel circulating miRNAs released in plasma prior to the onset of myocardial injury or pathology. These miRNAs can serve as early predictive biomarkers of cardiotoxicity and may have potential in identifying cancer patients or survivors at risk of future heart damage in clinics. Furthermore, profiling of miRNAs in hearts from these mice will provide important insights into the likely association between differential expression of miRNAs in heart and plasma following doxorubicin treatment. Therefore, a highly specific and sensitive miRNA Whole Transcriptome Assay (WTA) is required to accomplish this goal. Minimum Requirements: - Shall perform miRNA WTA using a robust, automated "Brand Name or Equal" HTG EdgeSeq technology coupled with the sensitivity and dynamic range of NGS-based detection. - Shall simultaneously quantitate >1500 miRNA transcripts in 15 - l human and mouse plasma samples using technology that does not require RNA extraction from the plasma. - Shall simultaneously quantitate >1500 miRNA transcripts using a small quantity of total RNA (10 ng) extracted from mouse heart tissue. - When sequencing the samples, the read length shall be a minimum of 75 bp with at least 1 million of reads per sample. - All samples shall be profiled under the same conditions at the same time to obtain reliable results. - Analysis from the miRNA WTA shall use "Brand Name or Equal" HTG EdgeSeq informatics package to significantly simplify data analysis and data output. - All data (raw and normalized) shall be provided to NCTR in a Microsoft Excel format within one month after receiving the samples for each study. - The remainder of the plasma samples shall be shipped back to NCTR. Contract Type: Firm Fixed Price Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Contract Line Item (CLIN) Description Quantity Unit Unit Price Extended Price 1 Profiling of microRNA transcripts in 104 samples (52 plasma and 52 heart RNA) from mice at 24 weeks after treatment with an anti-cancer drug, doxorubicin 104 EA 2 Optional Item 1 (FAR 52.217-7) - Profiling of 2,083 human microRNA transcripts in 100 plasma samples from pediatric cancer patients treated with anthracyclines 100 EA 3 Optional Item 2 (FAR 52.217-7) - Profiling of microRNA transcripts in 159 plasma samples from mice at 1-week after treatment with an anti-cancer drug, doxorubicin 159 EA Grand Total Items 1 thru 3 $___________________ Total Price, Base Year and Options: $_______________________ GSA Contract Number (If applicable): _______________________ *Significant price increases beyond those of expected inflation for Option Year services shall be explained and supported in the offer. Period of Performance: CLIN 1: samples will be sent within 15 calendar days after award. The contractor shall complete the work and provide all deliverables within 15 calendar days of receiving samples. CLINs 2 and 3 (Optional Items, see FAR Clause 52.217-7) If this "Option" is awarded, samples will be ready for shipment within calendar 30 days of award of the Option. Contractor shall complete the work and provide all deliverables within 30 days of the option exercise date. The selected vendor will not own the data (i.e., intellectual property). NCTR/FDA is the owner of the data. *This is a request of service for profiling of >1500 microRNA transcripts in human and mouse plasma samples as well as mouse heart RNA following treatment with anthracyclines (e.g. doxorubicin). The samples included are ready for shipment after award. FOB Destination: Deliverables shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows: New Year's Day Martin Luther King, Jr. Washington's Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran's Day Thanksgiving Day Christmas Day Place of Performance: Division of Systems Biology, Personalized Medicine Branch will ship samples from 3900 NCTR Road, Jefferson, Arkansas 72079, to the awarded vendor and upon completion the vendor will ship the remainder of plasma samples back to NCTR. Clauses and Provisions: The full text of FAR and HHSAR provisions and clauses may be accessed electronically at http://acquisition.gov/far/index.html or https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html. CLAUSES FAR 52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018) The following FAR 52.212-4 addenda apply: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the Contracting Officer. The TPOC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The following Technical Point of Contact (TPOC) will represent the Government for the purpose of this contract (To be provided upon contract award): Name: Email address: Phone: The contact information for the Contract Specialist: Name: Yolanda Rankin Email Address: contact@example.gov Phone: +1 (555) 000-0000 The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ The following FAR and HHSAR clauses, incorporated by reference, apply to this acquisition. FAR 52.204-13 System For Award Management Maintenance (Oct 2018) FAR 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option for one or more of the optional items identified in the schedule, at less than or more than the estimated quantities set forth in each optional line item by written notice to the Contractor within two years of the date of the award. This option may be exercised more than once. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) HHSAR 352.203-70 Anti-Lobbying (December 18, 2015) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.239-74 Electronic and Information Technology Accessibility DEC 2015 Paragraph (c). The Section 508 standards applicable to this contract are: - Must meet WCAG 2.0 A and AA - E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) - E203 Access to Functionality (Appendix A, Application and Scoping Requirements) - E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) - E205 Electronic Content (Appendix A, Application and Scoping Requirements) - 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) - Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. - E207 Software (Appendix A, Application and Scoping Requirements) - E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) - Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements) - Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) Payments FDA THREE-WAY-MATCH INVOICE SUBMISSION A. The contractor shall submit all invoices to: U.S. FOOD AND DRUG ADMINISTRATION Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 +1 (555) 000-0000 contact@example.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the Technical Point of Contact (TPOC). The TPOC will be determined at the time of award. B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements); (iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; (c) any other supporting information necessary to clarify questionable expenditures; (d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30); (vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment); (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer Identification Number (TIN); (x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT); (xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award; (xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) list of all invoices submitted to date under the subject award, including the following: (1) invoice number, amount, & date submitted (2) corresponding payment amount & date received (b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance; (xiii) Any other information or documentation required by the award. C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at contact@example.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue. Payments Payments will not be made more frequently than monthly in arrears. Advance payments will not be made. Be advised that FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date. QUESTIONS CONCERNING TERMS OF THIS ORDER (Other than invoice-related) SHOULD BE DIRECTED TO: Yolanda Rankin +1 (555) 000-0000 or contact@example.gov The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) Change the delivery schedule (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contract Officer for this order is: XXXXX, Contracting Officer 4040 North Central Expressway Room 917 Dallas, TX 75204 Phone: (214) 253-XXXX Email: contact@example.gov The TPOC is responsible for: Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract and; (5) Assisting in the resolution of technical problems encountered during performance. The TPOC for this order is: To be identified at time of award. (52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (May 2019) (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) 52.209-10, 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) (15 U.S.C.657a). __ (ii) Alternate I (Nov 2011) of 52.219-3. X (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). __ (ii) Alternate I (Jan 2011) of 52.219-4. __ (13) [Reserved] __ (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 (Aug 2018) (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. X (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. X (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. X (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). X (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 (Jun 2014) 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). __ (44) 52.223-21, Foams (Jun 2016) (E.O. 13693). __ (45) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a). __ (ii) Alternate I (Jan 2017) of 52.224-3. __ (46) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83). - X (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. X (48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C.2501, et seq., 19 U.S.C. 3301 note). __ (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 (Nov 2007) (42 U.S.C. 5150). __ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (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 (Jan 2017) (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 (Oct 2018) (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)(13)). __ (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. (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 2018) (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. (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 (Oct 2015) (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 Servi...