Drug Induced Liver Injury (DILI) Toxicity Services for Biomarker Development
Added: Aug 09, 2014 3:33 pm This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.5 Test Program for Certain Commercial Items. The solicitation number is FDA-14-223-SOL-1133650 and the solicitation is issued as a Request for Quote (RFQ).The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) 2005-76 effective July 25, 2014.The associated North American Industry Classification System (NAICS) Code is 541711- Research and Development in Biotechnology; Small Business Size Standard is 500 employees. This acquisition is issued as a small business set-aside.Contract Type: Commercial Item-Firm Fixed Price. Part I: General InformationIntroduction:The US Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR), Division of Bioinformatics & Biostatistics requires services to support the Government's requirement for Drug Induced Liver Injury (DILI) Toxicity Services for Biomarker Development with one Option Year.Background:The objective of LTKB analysis is to develop content-rich resources to improve the understanding of liver toxicity at the mechanistic level, thereby providing a valuable information for scientific researchers, the pharmaceutical industry, and regulatory bodies. This project involves the collection of diverse data (e.g., DILI mechanisms, drug metabolism, histopathology, therapeutic use, targets, side effects, etc.) associated with individual drugs, and the use of systems biology analysis to integrate the data for DILI assessment and prediction. Importantly, both conventional and high-toughput molecular biomarker assays will be conducted for selected drugs to develop novel biomarkers based on knowledge accumulated from this project.Scope and Objectives:The scope of the overall project consists of tee phases (1) collecting diverse data (e.g., DILI mechanisms, drug metabolism, histopathology, therapeutic use, targets, side effects, etc) associated with individual drugs; (2) applying systems biology and network pharmacology approaches to integrate these data for DILI assessment and prediction; and (3) verifying the results using conventional and high-toughput molecular biomarker assays for selected drugs to develop novel biomarkers.The scope of this specific requirement addresses phase tee of the above stated project, which consists of contractor verification of results using conventional and high-toughput molecular biomarker assays for selected drugs to develop novel biomarkers. The objective of this requirement is to 1) Evaluate the severe DILI prediction potential of in vitro human hepatocyte assayed with 4 end points and 2) Develop a dose-response relationship of tested drugs for a quantitative measure of drug toxicity and rank order the severe DILI drugs.Part II: RequirementsA. Overall Project Management The Contractor shall provide overall project management to insure that the scope, schedule, and cost of project are controlled and consistent with this contract.B. ResponsibilitiesWithin 30-days of contract award, the FDA will provide the stock solution of 200 drugs with identities blinded for the contractor for testing.The contractor shall produce validation reports inclusive of reference range (10 donors), intra- and inter- plate variability, assay robustness, reagent stability, and run-to-run reproducibility. The contractor shall provide Standard Operating Procedures (SOPs) describing the experiment procedure, including the standardized assay protocol, and reagent and sample storage conditions on the proposed assays, to maintain the raw data generated from the assays for auditing and to communicate any obstacles and problems for the completion of this contract. The reports shall be sent to the Government within 90-days of receipt of the stock solutions, and all reports shall be in Microsoft (MS) Word and Excel formats and emailed to a FDA point of contact (to be determined upon contract award). The contractor shall furthermore conduct teleconferences with the appointed FDA scientist(s) to discuss the research findings and related data as appropriate.Upon key break with data analysis complete, the FDA will share, via email and teleconference, the results with the contractor of the identities and annotated information of the tested drugs, within 45-days of receipt and analysis of the raw data.C. Deliverables• Cryopreserved human hepatocytes from 10 donors with 85% viability and 3D spheroid culture as well as hepatocyte co-cultures• Raw data generated from 4 assays performed on pooled hepatocytes with 7 concentrations, two time points and technical duplicates• Quality RNA samples (1ug of RNA per sample, and RIN (RNA Integrity Number) > 8 and the 28S/18S ratio > 0.9) produced from selected drugs enough for next-generation sequencing, with qrtPCR for the candidate genes on purified mRNAPart III. Schedule of Services(See attached PDF file identified as FDA-14-223-SOL-113650 with Sch of Items)Part IV: Supporting InformationA. Place of PerformanceWork shall be performed on-site at the contractor location with deliverables sent to the following Government location:US Food and Drug AdministrationNational Center for Toxicological ResearchJefferson Laboratory3900 NCTR RoadJefferson, AR 72079B. Period of PerformanceSeptember 30, 2014 to January 29, 2015Contractor payment will be made upon receipt and acceptance of final deliverable.Option Period One January 30, 2015 to January 29, 2016FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.htmlSolicitation ProvisionsThe provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (April 2014) applies to this solicitation. The following addenda apply:Prices shall be firm tough September 30, 2014 and are subject to the availability of funds.The provision at FAR 52.212-2 Evaluation-Commercial Items (Jan 1999) is applicable to this solicitation.The specific evaluation criteria to be included in paragraph (a) of that provision are asfollows:The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:(i) Technical Capability (ii) Past Performance(iii) Price (inclusive of options)When combined, technical capability, and past performance are more important than price in determining the best value to the Government. If the Government determines non-price factors to be essentially equal, price becomes more important as the discriminating factor.Technical CapabilityTechnical capability will be determined by review of information submitted by the offeror demonstrating corporate ability and experience in conducting research with Liver Toxicity Knowledge Base drug testing and biomarker development. Describe in detail the existing facility and equipment that will be dedicated to successful performance of the required services identified above. Address the professional qualifications and experience of key staff who may be assigned in the testing and analysis and subsequent production of reports related to this requirement. Discuss specific procedures and protocols that will be used in the testing of the drug stock solutions, and the software that will be used in the development of reports.Recent and Relevant Past PerformanceIdentify all ongoing and completed work (within the last 3 years from date of this solicitation) relevant to these requirements in terms of type, scope, complexity, and size. For each of these past performance references, provide a detailed description of the work, the period of performance, the dollar value of the work, your role and responsibilities as either a prime or subcontractor, the client name and address and client point of contact name, phone number, and email address. Any relevant past performance and/or collaborative research with major universities and/or federal agencies involved in publishing results in the assembly, testing, and a research with Liver Toxicity Knowledge Base drug testing, and biomarker development.Offerors shall provide detailed costs supporting their firm-fixed price, ensuring that the price proposal is consistent with the technical proposal in all respects since the price proposal may be used as an aid to further determine the Offeror's understanding of the technical requirements. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).The Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, offerors must furnish as part of their proposal all descriptive material necessary for the government to unequivocally determine whether the service meets the technical requirements.The Government reserves the right to make an award without discussions.The Provision at FAR 52.212-3, Offeror's Representations and Certifications - Commercial Items (May 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) tough (o) of this provision.The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (May 2014) applies to this acquisition. The following addenda have been added:Inspection and AcceptanceThe deliverables and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the deliverables or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the deliverables/ services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.Invoice SubmissionInvoices shall be submitted in arrears as described in Part III Deliverables, to the attention of the Office of Financial Services identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions.I. 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) Purchase order/award number; (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; and (c) any other supporting information necessary to clarify questionable expenditures;(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading, if applicable; (vi) Terms of any discount for prompt payment offered, if applicable; (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) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;(xi) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order;(xii) Company's DUNS number; and(xiii) Any other information or documentation required by the purchase order/award.II. An original and two (2) copies shall be submitted to:Sondea Blair HFT320 Bld 50, Rm 4213900 NCTR RoadJefferson, AR 72079An electronic invoice can be emailed to the following address:sondeablair@fda.hhs.govIV. Questions regarding invoice payments should be directed to the FDA payment office at (870) 543-7446 or (870) 543-7042 or electronically at nctrinvoices@fda.hhs.govThe following clauses are incorporated by reference:HHSAR Clause 352.202-1 Definitions (Jan 2006)HHSAR Clause 352.203-70 Anti-Lobbying (Jan 2006)HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010)HHSAR Clause 352.223-70 Safety and Health (Jan 2006)HHSAR Clause 352.231-71 Pricing of Adjustments (Jan 2001)FAR 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (April 2014) FAR 52.204-4, Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)FAR Clause 52.217-9 Option to Extend the Term of the Contract (March 2000)(a) ... within 1 day of contract expiration; .... at least 10 days before the contract expires...(c) ...shall not exceed 2 yearsFAR 52.223-6 Drug-Free Workplace (May 2001)FAR 52.225-8 Duty-Free Entry (Oct 2010) FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)FAR 52.242-13 Bankruptcy (July 1995)FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (July 2014)(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) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 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:_X__ (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 (Apr 2010) (41 U.S.C. 3509).___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).X_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).___ (5) [Reserved]___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (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 (Aug 2013) (31 U.S.C. 6101 note). ___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).___ (10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).___ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a)._ _ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).___ (13) [Reserved]_X__ (14) (i) 52.219-6, Notice of Total Small Business 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.__X_ (16) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)).___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)).___ (ii) Alternate I (Oct 2001) of 52.219-9.___ (iii) Alternate II (Oct 2001) of 52.219-9.___ (iv) Alternate III (July 2010) of 52.219-9.___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).X_ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (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) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).___ (ii) Alternate I (June 2003) of 52.219-23.___ (22) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).___ (23) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).___ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f)._X_ (25) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).___ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).___ (27) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m))._X_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755)._X__ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126)._X_ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999)._X_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246)._X__ (32) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212)._X_ (33) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793)._X_ (34) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212)._X_ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).___ (36) 52.222-54, Employment Eligibility Verification (Aug 2013). (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.)___ (37) (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.)___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).___ (39) (i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).___ (ii) Alternate I (Dec 2007) of 52.223-16._X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).___ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).___ (42) (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.___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note)._X_ (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2303 Note).___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f))._X_ (50) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332).___ (51) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).___ (54) (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.(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:__ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).Employee Class: Monetary Wage/ Fringe Benefits GS-2210/9-13 $24.74-$42.66/36.25%_ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).___ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).___ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495).___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).(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 teshold, 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 (Apr 2010) (41 U.S.C. 3509).(ii) 52.219-8, Utilization of Small Business Concerns (May 2014) (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 $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).(vii) 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.(viii) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).(x) 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.)(xi) 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)(xii) 52.222-54, Employment Eligibility Verification (Aug 2013).(xiii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).(xiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.(xv) 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)Additional InformationIt is the offeror's responsibility to monitor the internet site for the release of any information related to this combined synopsis/solicitation.Offerors are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 9:00 am (Central Time - Local Prevailing Time in Jefferson, Arkansas) on August 20, 2014 to sondea.blair@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Sondea Blair, 3900 NCTR Road, Building 50, Room 421 Jefferson, AR 72079-9502.For information regarding this solicitation, please contact Sondea Blair by e-mail at sondea.blair@fda.hhs.gov. Questions regarding this solicitation will be accepted only via email. Please reference solicitation number FDA-14-223-SOL-1133650 in subject line of all correspondence. FDA-14-223-SOL-1133650 Department of Health and Human Services Food and Drug Administration
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