FDA-SOL-1146050.doc

Solicitation Number: FDA-SOL-1146050

Part 1 – DESCRIPTION THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERICAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT I FART SUBPART 12.6 – STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERICAL ITEMS - AS SUPPLEMENTED WITH ADDITIONAL INFORMATON INCLUDED IN THIS NOTICE. THIS ANNOUNCMENT CONSTITUTES THE ONLY SOLICITATION: QUOTATION ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-82. This requirement is a 100% Total Small Business Set-Aside. The associated North American Industrial Classification System (NAICS) code for this procurement is 541690. Its associated Small Business size standard is $12 Million.

Part 2 – Supplies or services and Prices

2. Description of Supplies & Services

2.1. The FDA has a requirement for scientific and consulting services to extend the HL7 Structured Product Labeling (SPL) fir the FDA.

2.2. Contract Type

2.2.1. Firm-Fixed Price Purchase Order.

2.3 PRICING:

PRICE

TOTAL CONTRACT PRICE

Part 3 – Statement of work

Project Title: Structured Product Labeling Data Standard Enhancement and Maintenance – Scientific and Technical Consulting.

3.1. BACKGROUND

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging establishment and product information. Health Level Seven is an ANSI accredited international standards development organization that develops interoperable healthcare data exchange standards.

Essential to the success of the SPL standard, as it is utilized by FDA, is the need to maintain SPL within the US realm and establish an international scope for SPL by engaging in standards development processes. As SPL continues to emerge as an international standard it is critical that the SPL model and related models such as the HL7 Common Product Model (CPM) and HL7 Chemical Substances Model include the elements and attributes necessary to create health and regulatory documents prepared for submission to and exchange with the FDA.

Regulated product data such as the content of labeling, establishment registration, and product listing and reporting and identification information can be currently captured in SPL format. However, alterations in FDA regulatory requirements and business processes will continue to necessitate the implementation of new data elements to enhance the SPL standard to support FDA’s goals and mission to improve patient and consumer safety and health. The standardization of the format of regulatory data received by the agency will afford an opportunity for FDA to share data amongst its centers and other Federal agencies using one standard and store that data in a single authoritative database which is based on the Health Level Seven (HL7) Reference Information Model (RIM).

To ensure that FDA can continue to exchange SPL data with industry, other United States government agencies as well as international regulatory bodies and health care information suppliers, the SPL standard must remain in conformance with the HL7 RIM and with FDA regulatory requirements and business processes. The SPL standard utilizes the HL7 CPM’s (which improves the alignment between the different representations of products) common message element type and the HL7 Chemical Substances model. Therefore, alterations to the SPL model can result in the simultaneous update of the CPM and the Chemical Substances models. The SPL, CPM, and Chemical Substance models need to incorporate data requirements to permit the exchange of this standardized data.

3.2. OBJECTIVES

The HL7 Structured Product Labeling (SPL) standard is the data standard which permits the capture of content of labeling, establishment registration and reporting, and product reporting and listing data in a format that FDA can process, index, review, and archive. The centralized storage of this standardized data in the Agency’s HL7 RIM-based database permits the tracking of registered facilities which manufacture multiple types of regulated products and the product-component/ingredient data. Standardization of the data will also assist in the improvement of the accuracy, validation, capturing, indexing, and integration of regulatory data as well as the facilitation of design of reporting and analytical tools.

To ensure that the SPL, CPM, and Chemical Substance models continue to permit the exchange of current and additional data submitted to FDA in SPL format, the aforementioned models should be enhanced and maintained to remain in conformance with the HL7 RIM.

As regulatory requirements and business processes are updated, alterations to the SPL Schematron documents to incorporate the changes are required as the documents submitted to FDA need to undergo quality control to ensure that the data conform to updated SPL XML schema and FDA business rules. The Schematron documents will be utilized to validate the data provided in SPL format to ensure conformance with the SPL schema and FDA business validation procedures.

Additional data collected in SPL format will require the update of the SPL implementation guides needed by the FDA-regulated product industry to create SPL files for submission to FDA. The SPL implementation guides are FDA documents that are used by industry, FDA and SPL software developers who create HL7 SPL documents.

The FDA regulated industry, FDA employees, and other regulatory entities will need to view the data in SPL documents submitted to FDA. SPL documents, which are XML documents can be rendered and displayed in hypertext markup (HTML) or XHTML language using an Extensible Stylesheet Language Transformation (XSLT). XSLT is the language that can be utilized to transform XML document into HTML or XHTML documents. The SPL XSLT stylesheet specifies the default font, indentation, orientation, formatting, word wrapping, line spacing, and other properties that will be used for the display of product information submitted in SPL format. The SPL documents can also be converted into Word and PDF format. The current SPL stylesheets will need to be updated to render additional data collected in SPL format.

3.3. SCOPE OF WORK

FDA would like to contract with an organization which is capable of extending the HL7 SPL standard to include the additional data elements for FDA required and voluntary establishment registration and reporting, product listing and reporting, indexed, and identification data for processing, reviewing, and archiving by FDA. This contractor would also possess the capability of developing and maintaining an open source Schematron 1.5 document based on the business rules and data relationships for FDA regulated establishment registration and product data defined by FDA which, when processed through an Extensible Stylesheet Language Transform (XSLT), XForms and other software, can be used to assist in quality control by validating a SPL file and producing a report outlining the detected errors. The organization must also be able to generate a HL7 SPL implementation guide to be utilized by industry and SPL software developers to generate valid regulatory submissions for processing, reviewing, and archiving by FDA and software to create the aforementioned documents respectively. Outside the scope of this contract is to create an implementation guide for the creation of SPL for a specific product and instructions on the use of extensible mark up language (XML). The organization must also possess an extensive knowledge of Extensible Markup Language (XML), Extensible Stylesheet Language Transformation (XSLT).

During the enhancement of the SPL model, the contractor shall ensure that the standard is interoperable with other HL7 data standards and that it maps to the HL7 Reference Information Model.

3.3. WORK REQUIREMENTS

The contractor shall complete the following taskings:

SPL Data Standard Development & Maintenance

Task #

SPL Schematron Development & Maintenance

Update and maintain Schematron 1.5 framework design and tools which are capable of validating regulated establishments and product information included in SPL files based upon business rules and data relationships that are defined in the SPL implementation guide documents. Schematron document should be editable using Microsoft Word software.

Meet telephonically every two weeks with FDA and, if necessary, other subject matter experts to discuss business requirements

Task #

SPL Implementation Guides

Task #

Common Product Model & Substance Model Development & Maintenance

Task #

SPL Stylesheets Development & Maintenance

Task #

SPL Reports

3.4. DELIVERABLES

The contractor shall furnish the following deliverables:

3.4. GOVERNMENT MATERIAL

FDA subject matter experts will furnish contractor with proposed new elements and certain terminologies (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162061.htm) to be incorporated into the SPL message. Files containing aforementioned material will be sent electronically or via postal mail. FDA’s subject matter experts will be available to answer contractor’s questions in person or via teleconference.

3.5. PERIOD OF PERFORMANCE

The period of performance shall be a base year plus four additional option periods.

The FDA has a unilateral right to exercise the following four one year option periods under the same terms and conditions agreed to in the base period.

The optional periods of performance, if exercised, shall commence as follows:

3.6. PLACE OF PERFORMANCE

The place of performance shall be the contractor’s worksite.

PART 4 – INSPECTION AND ACCEPTANCE

4. The Contracting Officer’s Representative (COR) will, in accordance with FAR 52.212-4, perform inspection and acceptance of all services, reports and deliverables required.

4.1. For the purpose of this PART, (COR – To be determined after award) is the authorized representative of the Contracting Officer.

4.2. Inspection and acceptance will be performed at the delivery location identified in Part 5.3.

PART 5 – DELIVERY LOCATION

5. DELIVERIES

5.1. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in PART 3 of this solicitation and upon delivery and acceptance by the Contracting Officer, or the COR, of all deliverables required.

5.2. Deliveries required by the contractor shall be F.O.B. destination to the

Address/addresses listed below:

5.3. DELIVERY LOCATION:

The U.S. Food and Drug Administration

Attn: (To be determined after award)

5100 Paint Branch Parkway College Park, MD 20740

5.4. Unless otherwise specified, deliveries services shall be delivered to the Delivery Location specified above, Monday through Friday (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EASTERN TIME only.

PART 6: CONTRACT ADMINISTRATION

6.1. Contracting Officers Representative (COR)

6.1.1.

The COR is responsible for: (1) monitoring the Offeror'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.

6.1.2.

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 RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Offeror any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

6.1.3.

The contact information for the Contracting Officer:

TBD

@fda.hhs.gov

240-402-XXXX

6.1.4. The contact information for the Contract Specialist:

William Lee

William.Lee@fda.hhs.gov

240-402-7594

6.1.5.

The contact information for the Contractor Point-of-Contact:

Name:

Email:

Phone#

6.2. PAYMENT SCHEDULE

The contractor shall submit Invoice no more frequent than monthly to the FDA.

6.3. INVOICE SUBMISSION

2-Way Invoicing:

A. The Contractor shall submit all invoices to the addresses and in the manners specified below:

(I) One original to the Contract Specialist:

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

ATTN: Dan Feldman, Contract Specialist

5630 Fishers Lane

Room 2129, HFA-500

Rockville, MD 20857

Email: William.Lee@fda.hhs.gov

(II) One copy to the COR clearly marked as a “Courtesy Copy Only:”

U.S. Food and Drug Administration

ATTN: (To be determined upon contract award); COR

Address: TBD Email: XXXXX@fda.hhs.gov Acceptable methods of delivery include mail, hand delivery, and email. Please submit all invoices by email in adobe portable document format (pdf) whenever possible.

B. Invoices submitted under these contracts must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer— System for Award Management (SAM) (Jul 2013)) and the other applicable FAR clauses specified herein. The Contractor shall maintain current, accurate, and complete information in the SAM database, as displayed on the SAM website, until receipt of final payment under their contract.

To constitute a proper invoice, the invoice must be submitted on company letterhead and include the following:

(I) Name and address of the Contractor;

(II) Invoice date and number;

(III) Contract and task order numbers;

(IV) Description, quantity, unit of measure, unit price, and extended price for 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 shipping, 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;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the contract, task order, or in a proper notice of assignment)

(VIII) Name, title, and phone number of person to notify in event of a 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 COR; and (XII) Any other information or documentation required by the contract or task order.

The Contractor shall 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 order, including the following: (1) invoice number, amount, and date submitted to the Contract Specialist; and (2) corresponding payment amount and date received payment.

(b) Total estimated amounts yet to be invoiced under the task order.

D. Questions regarding invoice payments shall be directed to the FDA Payment Office at the following mail and email addresses and phone numbers:

Office of Financial Services U.S. Food and Drug Administration

10903 New Hampshire Avenue

W032, Second Floor

Mail Hub 2145

Building 32, Room 2162

Silver Spring MD 20993-0002

Attn: Vendor Payments

Phone Numbers: (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov Payment is only authorized upon successful completion of tasks and/or deliverables in accordance with the payment and pricing terms of each task order and upon receipt and acceptance of a proper invoice. Proper invoice submission includes following the invoice instructions herein and the terms of the task order. Payment will be made on a task order basis. Final payment of a task order will occur upon verification by the FDA COR there is successful completion of the task order.

PART 7 – SPECIAL CONTRACT REQUIREMENTS

7.1. Property Rights

All material deliverables will be sole property of the United States Food and Drug Administration. FDA reserves the right publish material deliverables for use by FDA regulated product industry, other US Federal Government agencies and Departments and interternation regulatory entities.

7.2. Contractor Conformance with Applicable Laws, Regulations, Policies and Standards The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. HHS documents are found at: http://www.cdc.gov/irmo.

7.3. Security and Privacy

It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contract personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the Project Officer.

7.4. Contractor Performance Evaluations

In accordance with FAR 42.15, FDA will complete annual and final Contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at the FDA’s Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon expiration of the contract.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) to execute annual and final Contractor performance evaluations. CPARS is a secure Internet website located at the following address: https://cpars.cpars.gov/. FDA will register the Contractor in CPARS upon receipt of the names and email addresses of two individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the Contractor in CPARS, the Contractor will receive an automated CPARS email message which contains user identification information and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contacts will receive an email instructing them to access CPARS to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, the Contractor shall submit rebuttal comments via CPARS within 14 days from the date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and Contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a three year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

The Contractor may obtain CPARS training material and register for on-line training at the following website: https://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of CPARS.

7.5. System for Award Management Registration

In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the -Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance. If a new Contractor, you will need only your personal information to create an account in SAM. If a Contractor with an active record in CCR, you will not need to establish a SAM account. The CCR record transfers to become the active SAM account.

(1) Definitions.

"Registered in the SAM database" means that-

(i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database;

(ii) The Contractor's CAGE code is in the SAM database; and

(iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record "Active". The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process.

"System for Award Management (SAM)" means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes-

(i) Data collected from prospective federal awardees required for the conduct of business with the Government;

(ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their

Representations and Certifications and submit it with their proposal]; and

(iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the nonprocurement common rule by agencies, Government corporations , or by the Government Accountability Office.

The Contractor shall be registered in the SAM database prior to submitting an invoice and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The SAM registration shall be for the same name and address identified on the contract, with its associated CAGE code and DUNS or DUNS+4. If indicated by the Government during performance, registration in an alternate system may be required in lieu of SAM.

If the Contractor does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A contractor may obtain a DUNS number-

(i) Via the internet at http://fedgov.dnb.com/webform or if the contractor does not have internet access, it may call Dun and Bradstreet at 1-866-705-5711 if located within the United States; or

(ii) If located outside the United States, by contacting the local Dun and Bradstreet office. The contractor should indicate that it is a contractor for a U.S. Government contract when contacting the local Dun and Bradstreet office.

(3) The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(4) Contractors may obtain information on registration and annual confirmation requirements via the SAM accessed through https://www.acquisition.gov or by calling 866-606-8220, or 334-206- 7828 for international calls. If there is any difficulty in updating this record, contact the Federal Service Help Desk at www.fsd.gov or 866-606-8220 for SAM assistance. https://www.sam.gov/portal/public/SAM/

7.6. Post Award Evaluation of Contractor Performance

Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluations will be prepared annually to coincide with the anniversary date of the contract. Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

PART 8 - CONTRACT CLAUSES

FAR CLAUSES INCORPORATED BY REFERENCE

52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one of more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquistion.gov/far/index.html

FAR CLAUSES IN FULL TEXT

Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2015)

1. (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)).

2. (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.]

_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 (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).

_X_ (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.

_X_ (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)).

__ (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).

_X_ (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).

_X_ (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 (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.

3. (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:

4. [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)).

5. (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.

6. (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 (Apr 2015) (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.

(End of clause)…