FDA_15-233-1150578.pdf

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. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement herein using Simplified Acquisition Procedures in accordance FAR 13.5 - Test Program for

Certain Commercial Items. The solicitation number is FDA_15-233-1150578. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2005-82, June 8, 2015.

The associated North American Industry Classification System (NAICS) Code is- 541711

Research and Development in Biotechnology SB Size status: 500 employees. This requirement is set aside for small business.

Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method of their complete proposal and any additional documents before 1:00 pm (Central Standard Time

- Local Prevailing Time in Jefferson, Arkansas) on June 24, 2015 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug

Administration, OO/OFBA/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Building

50, Room 424, Jefferson, AR 72079-9502.

PLEASE NOTE - The above contact information is for the Contracting Office and not the delivery address. The delivery address is indicated in the FOB Destination section below.

For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov.

Requirement:

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research

(CBER), Office of Biostatistics and Epidemiology (OBE) has a requirement for Validation and

Qualification of the Modular Immune In vitro Construct (MIMIC), specifically focusing on statistical data analysis and reporting portion of the project in close collaboration with the project officer in the OBE.

Background:

Preclinical evaluation of immunogenicity of live and inactivated vaccines is conducted in a variety of animal models. They have an obvious limitation determined by species-specific differences in immune response to different antigens. Therefore the ultimate assessment of immunogenicity is possible only in human systems. There are a number of in vitro models that study antigenic structure of vaccines rather than its ability to induce specific protective antibodies. The FDA intends to assess and qualify an in vitro biomimetic system that would mimic immune responses that occur in humans after administration of protective antigens.

VaxDesign developed a system called MIMIC, comprised of isolated primary human immune cells integrated into engineered tissue constructs that are functionally equivalent to the physiological environment of the human immune system. By accurately representing the cellular synergy and communication kinetics that are critical for the induction of adaptive immunity in vivo, VaxDesign has shown the potential of the MIMIC model to support the sensitization of primary human B and T cell responses in an in vitro setting.

The utility of the MIMIC system and associated functional immunoassays for evaluation of immunogenicity and efficacy of vaccines will be critically assessed and qualified. The MIMIC system, if validated, would be useful for initial screening of vaccine candidates prior to clinical trials and could bring significant savings in time and cost in delivering vaccines to protect public health.

Project Objective:

The goal of this Research Project is to develop a statistical approaches and application in analyses to evaluate and qualify the MIMIC System and functional immunoassays for

Determining the Immunogenicity of Vaccines. This goal is consistent with FDA’s Critical Path goals of bringing new technologies to the development, characterization and validation of the next generation of biological products.

The MIMIC system provides a step-wise immunological progression of a vaccine in the biomimetic of the human immune system. Broadly, this encompasses sera evaluations by novel functional assays, vaccine dosing/toxicity in immune cells, and examinations of vaccine inflammatory/reactogenicity potential in the PTE module and capacity to elicit cellular and humoral responses in the LTE module of the MIMIC system. The overarching objective is to demonstrate the results generated in vitro in the MIMIC platform correlate with in vivo responses generated in the same donors immunized with the vaccines. The inherent advantage to this approach is that each donor ‘subject’ serves as their own baseline control allowing a pair approach to analysis. However, such an objective might be difficult to evaluate and reach due to the availability of the current data where the MIMIC generated data do not have comparable clinical data with the same donors and due to unpredictability of a biological response to a certain extent.

The goal of the project is to further evaluatthe data generated by the MIMIC system and explore parameters that can optimize the performance of the system. The data include, but are not limited to, those related to Polio vaccine, Dengue vaccine, and influenza vaccine. In addition, evaluation of different statistical methods for comparing distribution curves is to be performed.

Such investigation will potentially allow for exploring the predictability of the data generated by the MIMIC system for immune responses in clinical trials.

Project Scope:

Key Contractor tasks shall include:

1. Further characterization of the parameters (such as within precision, limits of detection and quantitation, sensitivity, and specificity) the MIMIC system for various assays for various vaccines.

2. Explore the impact of the donor and procedural parameters on the performance of the system and develop algorithms that optimize the performance.

Development and Application of statistical methods (metrics) in comparing immune responses based on distribution curves such as the reverse cumulative distribution (RCD) curves. Statistical simulations are to be performed to compare between potential methods in various scenarios with different distribution curves in the existing MIMIC data.

DETAILED REQUIREMENTS

1. The contractor shall perform all analyses and assist in developing innovative statistical approaches.

2. The contractor shall maintain clear and timely communication with the project leader at

FDA/OBE at all times.

3. Bi-weekly telemeetings are required to update the progress and collaborate on project-related topics. Follow-up meetings as required for clarifications or updates. No more than two face-to-face meetings will be required during the contract period.

4. Monthly progress report to update the advancement of the project.

5. Detailed analytic plan and preliminary results which meet task description herein.

6. Develop statistical programs that are efficiently organized with modules that not only generate all results in the final report but also can be used for other vaccine data with similar format. Index sufficient to locate all programs. Sufficient documentations on all programs and macros.

7. Develop Final Report approved of by FDA/OBE staff consisting of description of statistical methods, presentation of analysis results presented in tables and figures, description of the results, conclusions and recommendations, and any information that may be needed for future reference.

8. Final deliverable including the final report, all programs with documentation, and references at the end of the project. The final deliverable should be submitted in a package which includes one hard copy of the final report, and a CD containing all files, programs, documentation, and reference materials used in this project.

9. The FDA will have unlimited rights to use any statistical tools developed and all data derived under this contract for use in further studies for future applicable studies.

DELIVERABLES

Deliverables Description Frequency Deliver To

Tele-meetings Update the progress on project-related topics

Bi-weekly COR

Written Progress

Reports

(submitted with invoice)

Update the progress of analysis results and collaborate on project-related topics

Monthly COR and

Contracting

Officer

Analytic Plan and

Preliminary

Results

Detailed analytic plan and preliminary results which meet the task descriptions in the Statement of Work

3 months from start of this contract

COR

Statistical analysis programs and documentations

Statistical programs that are efficiently organized with modules that not only generate all results in the final report but also can be used for other vaccine data with similar format. Index sufficient to locate all programs. Sufficient documentations on all programs and macros

6 months from start of this contract

COR

Final Analysis

Report

Final report approved of by FDA/OBE staff consisting of description of statistical methods, presentation of analysis results presented in tables and figures, description of the results, conclusions and recommendations, and any information that may be needed for future reference.

Draft will be due 5 months from the start of the contract and final approved report due 10 months from start of this contract.

COR

Final Deliverable Final deliverable including the final report, all programs with documentation, and references at the end of the project. The final deliverable should be submitted in a package which includes one hard copy of the final report, and a CD containing all files, programs, documentation, and reference materials used in this project.

11 months from start of this contract.

COR

Item #1

Validation and Qualification of the Modular Immune In vitro Construct (MIMIC) System

Proposed price shall include performance of all requirements as indicated above

Quantity: 1

Unit: Job

Unit Price: _____________________

Extended Price: __________________

GSA Contract Number (if applicable): ________________________

Period of Performance: September 1, 2015 - August 31, 2016

Location for Deliverables:

U.S. Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

10903 New Hampshire Ave.

Silver Spring, MD 20993

Contract Type - Commercial Item - Firm fixed Price.

Contract clauses-

The clause at FAR 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (May 2015)

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer / representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. No advance payment will be made under the resulting order/contract. Services shall be billed no more frequently than monthly in arrears.

The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov/far/

FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper. (May 2011)

FAR Clause 52.204-7 System for Award Management (Jul 2013)

FAR Clause 52.217-8 Option to Extend Services (Nov 1999)

"... within one (1) calendar day of contract expiration."

FAR Clause 52.227-17 Rights in Data Special Works (Dec 2007)

FAR Clause 52.232-32 - Performance-Based Payments (Apr 2012)

(c) Approval and payment of requests.

(1) …shall not be entitled to payment prior to successful accomplishment of the event as outlined…

Month Performance measure Percentage of

Contract Award

1 Discussion and ideas of analytic plan 5%

2 literature search and development of analytic plan 10%

3 Development of analytic plan 5%

4 Simulation set up and 10%

5 Simulation and preliminary results 5%

6 Application of methods in real world data 10%

7 Application of methods in real world data 5%

8 Application of methods in real world data 10%

9 Statistical programming and documentation of results 5%

10 Statistical programming and documentation of results 10%

11 Final Analysis Report development 5%

12 Final Analysis Report; complete wrap-up of the project 20%

Total 100%

(2) …payment office will pay approved requests on the 30th day after receipt of the request for performance-based payment…

FAR Clause 52.232-40, Providing Accelerated Payment to Small Business Subcontractors

(Deviation) (Dec 2013)

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 Contracting Officer for this order is: To be completed at time of award-

Name:

Phone:

Email:

The COR 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 COR for this order is: To be completed at time of award-

Name:

Phone:

Email:

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -

Commercial Items (May 2015)

(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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

(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 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:

___ (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 (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 (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) [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.

__ (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]

_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 2014) (15 U.S.C. 637(d)(2) and

(3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (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 (Oct 2014) 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—Subcon-tracting 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. 657 f).

_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 Economically Disadvantaged Women-Owned Small

Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

__ (24) 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_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O.

13126).

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

_X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

_X_ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014)(38 U.S.C. 4212).

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

793).

_X_ (31) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212).

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(Dec 2010) (E.O. 13496).

__ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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 (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.)

__ (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)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014)

(E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-13.

__ (37)(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.

__ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C.

8259b).

__ (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN

2014) (E.O.s 13423 and 13514).

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

_X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011) (E.O. 13513).

__ (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.

_X_ (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 (June 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. 2302 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:

[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 (May 2014) (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) (May 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 2014)(E.O. 13658).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42

U.S.C. 1792).

__ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 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 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 (Apr 2010) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 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 (l) of FAR clause 52.222-17.

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

(v) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

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

(viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212)

(ix) 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.

(x) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(xi)

__(A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O

13627).

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

(xii) 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).

(xiii) 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).

(xiv) 52.222-54, Employment Eligibility Verification (AUG 2013).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (Executive Order

13658).

(xvi) 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).

(xvii) 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.

(xviii) 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.

Solicitation provisions- The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The following FAR 52.212-1 addenda apply:

Paragraph (b). The government is not responsible for locating or securing any information, which is not identified in the proposal.

Paragraph (b)(4). Offerors shall describe their technical approach in sufficient detail such that the Government can conclusively determine that the proposed approach will meet or exceed the requirements herein.

Paragraph (b)(10). Recent is defined as within the last 3 years.

The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation.

The following subparagraph (a) factors apply:

(i) Technical Approach (See FAR Provision 52.212-1 (b) (4) and addenda thereto)

(ii) Past Performance (See FAR Provision 52.212-1 (b) (10) and addenda thereto)

(iii) Price

Technical Approach (i.e., how well the proposed approach will meets or exceed the

Government’s requirements) and Past Performance are more important than price in determining the best value to the government though price remains a significant consideration.

The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically via https://www.sam.gov/portal/public/SAM/#1. If an offeror has not completed the annual representations and certifications electronically at the website, the offeror shall complete only paragraphs (c) through (o) of this provision.

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

https://www.sam.gov/portal/public/SAM/#1