SB-Solicitation.pdf

SOLICITATION SB FDA-125631

Title: Structured Product Labeling Data Standard Enhancement and Maintenance, Schematron, and Stylesheets

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation shall not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-07. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541690, Other Scientific and Technical Consulting Services. Business size standard of $15.0 million in dollars. This solicitation in set aside for small business.

SUPPLIES OR SERVICES AND PRICES/COSTS

PRICE SCHEDULE: See Attachment 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 is an international standard it is critical that the SPL model and related models such as the HL7 Common Product Model (CPM) 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 for products and facilities such as those regulated by CBER, CDER, CVM, Office of Color Additives and Colors 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 FDA-regulated industry, other United States 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. Therefore, alterations to the SPL model can result in the simultaneous update of the CPM. The SPL and CPM models need to incorporate data requirements to permit the exchange of this standardized data.

CONTRACT TYPE

This contract will be a Firm Fixed Price type contract.

OBJECTIVE

The HL7 Structured Product Labeling (SPL) standard is the data exchange 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 to directly support FDA’s obligations identified in several statutes and regulations such as the Drug Supply Chain Security Act, Section 503B of the FD&C Act, Section 745A(a) of the FD&C Act, FDA Amendments Act, Modernization of Cosmetics Regulation Act, Medicare Prescription Drug, Improvement, and Modernization Act, Generic Drug User Fee Amendment, etc…

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, and CPM models continue to permit the exchange of current and additional data submitted to FDA in SPL format, the aforementioned models should be enhanced and/or 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.

SCOPE

FDA would like to contract with an organization which can extend FDA’s utilization of the Health Level Seven (HL7) SPL data exchange standard to include the additional data elements required for FDA required and voluntary establishment registration and reporting, product listing and reporting, indexed, and identification data for processing, reviewing, and archiving by FDA to directly support FDA’s obligations identified in several statutes and regulations such as the Drug Supply Chain Security Act, Section 503B of the FD&C Act, Section 745A(a) of the FD&C Act, FDA Amendments Act, Modernization of Cosmetics Regulation Act, Medicare Prescription Drug, Improvement, and Modernization Act, Generic Drug User Fee Amendment, etc…

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 statutes and, when applicable, FDA regulations or guidance which, when processed through an Extensible Stylesheet Language Transform (XSLT) and FDA’s 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, FDA and SPL software developers, including health information system providers 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 markup 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.

REQUIREMENTS/TASKS

The contractor shall complete the following tasks:

Task # 1 Task Title Description SPL Data Standard Development & Maintenance

1.1 Identify HL7 SPL data

elements Utilize data element requirements provided by FDA subject matter experts for the capture of additional structured information for regulated products and establishments to utilize in the exchange with FDA-regulated industry, health information system providers other Federal Government organizations and international regulatory bodies.

1.2 Model data elements Model SPL data element requirements against the HL7 v3 Reference Information Model (RIM), if necessary

1.3 Update schema and

model interchange format files (MIF)

Update the HL7 SPL schema (.xsd) and HL7 MIF files for FDA regulated establishments and product listing and reporting, indexing and identification documents to incorporate additional data required as a result of alterations in regulatory requirements and business processes.

1.4 Harmonize SPL model

with releases of HL7

RIM

Harmonize SPL model, and schema against existing and future HL7 models, including the HL7 RIM.

1.5 Create and submit

HL7 ballot material for standard

Create and submit HL7 ballot material for SPL standard, if necessary.

1.6 Ballot standard Manage standard through the HL7 ballot process.

Participate in ballot reconciliation activities and, if necessary, reconcile ballot comments.

Task #

Task Title Description

SPL Schematron Development & Maintenance

2.1 Requirements

gathering Use provided and, if necessary, gather business requirements for FDA regulated establishment and product SPL submissions

2.2 Update and maintain

SPL schematron

Update and maintain Schematron 1.5 framework design and tools which are capable of validating documents regulated establishments and many types of different 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.

2.3 Update and Maintain

XSLT files for schematron

Update and maintain the Extensible Stylesheet Language Transformation (XSLT) file to incorporate new legal and regulatory requirements and business process using the SPL Schematron document to produce a human readable report outlining the detected validation errors.

2.6 Attend

teleconferences

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

Task Title Description

SPL Implementation Guides

3.1 Write and/or update

implementation guides for FDA regulated establishments registration and product listing, reporting, indexing and identification data SPL documents.

Create and/or update clear and well written documents which provide technical conformance criteria for SPL files based on the FDA regulated establishment registration and reporting and product, information listing, indexing and reporting processes as well as the indexing of SPL files with product data. Incorporate CPM and Chemical Substance data elements and attributes into the SPL implementation guide when appropriate for utilization in SPL.

3.2 Discuss

implementation guides with FDA and industry members of

HL7

Meet with FDA subject matter experts, Health Level Seven members, and members of the FDA-regulated product industry as necessary to discuss SPL implementation guides and new HL7 data elements and attributes

Task Title Description

Common Product Model Development & Maintenance

4.1 Identify additional

data elements for Common Product Model and Chemical Substance Model

Meet with FDA and external subject matter experts to discuss the implementation of additional data elements to be utilized in the Common Product Model

Model Common Product Model and Chemical Substance data elements

Model Common Product Model data element requirements against the HL7 v3 Reference Information Model (RIM), if necessary.

Update Common Product Model and Chemical Substance schema and model interchange format files (MIF)

Update the HL7 Common Product Model and schemas (.xsd) to incorporate changes based on capture of additional data in FDA submissions, if necessary.

Harmonize Common Product Model and Chemical Substances Model with releases of

HL7 RIM

Harmonize Common Product Model schema against existing and future HL7 models, including the HL7

RIM.

4.3 Create HL7 ballot

material for Common Product Model and Chemical Substance Model

Create HL7 ballot material for Common Product Model standard, if necessary.

4.4 Ballot Common

Product Model and Chemical Substance standards

Manage Common Product Model through the HL7 ballot process. Participate in ballot reconciliation activities and, if necessary, reconcile ballot comments.

Task Title Description

SPL Stylesheets Development & Maintenance

5.1 Use provided or, if

necessary, gather requirements for views

Meet with FDA subject matter experts to discuss the rendering of the FDA regulated establishment registration and product listing data in SPL documents

5.2 Update SPL

stylesheets

Update or create non-proprietary Use stylesheets with XSLT, concomitant cascading stylesheet files, Javascript files, and XML files designed against the XHTML transform of SPL to yield a FDA-specified standard rendering of the transformed SPL documents with FDA regulated establishment and product data in Microsoft Edge Chrome, Microsoft Internet Explorer Mode, Chrome, Safari and Firefox browsers

5.3 Maintenance of SPL-

to-Word Stylesheets

Update the existing SPL-to-Word stylesheets to include alterations.

5.4 Provide release notes Provide complete release notes which describe the stylesheet rules and updates

5.5 Support and

maintenance of stylesheet files

Perform maintenance on XSLT stylesheets for SPL based on functional requirements for the stylesheet viewing via internet browsers Microsoft Edge Chrome, Microsoft Internet Explorer Mode, Chrome, Safari, and Firefox.

DELIVERABLES

The contractor shall furnish the following deliverables:

# SPL Data Standard Deliverable Due Date 1 Extend SPL model including additional data elements required by alterations to regulatory requirements and business processes If necessary, six months after award and when needed thereafter for duration of the period of performance

2 Model Interchange Format (MIF) file for extended standard If necessary, six months after award, and when needed thereafter for duration of the period of performance

3 SPL schema files in .xsd format and references Six months after award, and when needed thereafter for duration of the period of performance

4 Develop a work plan indicating the planning, design, test, implementation, and support phases for all tasks described.

Six months after award and when needed thereafter for duration of the period of performance

5 Provide SPL ballot material (schema (.xsd) and HL7 MIF files) Six months after award 6 Meetings with FDA subject matter exports and HL7 members to discuss development of standard and schematron.

As needed

# SPL Schematron Deliverables 1 Updated SPL Schematron document As needed 2 Updated XLST files SPL Schematron document As needed 3 Graphical user interface utilized for updated SPL Schematron document As needed

4 Perform maintenance updates to the Schematron document, XSLT files and user interface for a one and one-half year period after delivery.

5 Provide validation procedures document in Word format and a user manual for schematron document.

One week after completion of updates to the schematron

# SPL Implementation Guide Deliverables Due Date 1 HL7 SPL implementation guides As needed 2 HL7 ballot material for implementation guide As needed

Common Product Model Due Date Extended CPM model including additional data elements required by alterations to regulatory requirements and business processes

If necessary, six months after award and when needed thereafter for duration of the period of performance

Model Interchange Format (MIF) file for extended CPM If necessary, six months after award and when needed thereafter for duration of the period of performance

CPM schema files in .xsd format and references Six months after award and when needed thereafter for duration of the period of performance

Develop a work plan indicating the planning, design, test, implementation, and support phases for all tasks described.

Six months after award and when needed thereafter for duration of the period of performance

Provide CPM ballot material (schema (.xsd) and HL7 MIF files) If necessary, six months after award and when needed thereafter for duration of the period of performance

Meetings (teleconferences) with FDA subject matter exports and HL7 members to discuss development of standard and schematron.

# SPL Stylesheet Deliverables Due Date 1 Maintenance of SPL stylesheets (XHTML, SPL-to-PDF, SPL-to-

Word As needed for duration of contract

2 Provide release notes for stylesheets and updates As needed for duration of contract

VI. Period of Performance.

The period of performance is one base year with four one-year options

VII. Government Provided 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.

VIII. Criteria for Acceptance

Criterion # SPL Data Standard, CPM, Chemical Substance Development &

Maintenance Criterion Description 1 Expertise in HL7 Reference Information Model 2 Expertise with the HL7 standards 3 Very high level of experience with implementation of HL7 SPL and CPM standard for a specific use.

4 Experience with management of a standard through HL7 ballot process 6 Must possess a mastery of Extensible Markup Language (XML)

Criterion # SPL Schematron Criterion Description 1 Expert in Schematron standard as used by FDA 2 Experience in creating very complex Schematron documents 3 Knowledge of FDA regulated product and establishment data to be utilized in SPL standard 4 Knowledge of subject matter and uses

Criterion # SPL Implementation Guide Criterion Description 1 Technical writing skills 2 Expertise in HL7 Reference Information Model 3 Knowledge of HL7 data standards and HL7 implementation guides 4 Knowledge of the HL7 ballot process

Criterion # SPL Stylesheet Criterion Description 1 Proficient in development of XSLT, Javascript, and Cascading Stylesheets 2 Possess expert knowledge of Extensible Markup Language (XML) 3 Knowledge of FDA regulated establishment and product data to be utilized in SPL standard

RELEVANT EXPERIENCE

Due to the multiple incoming electronic submissions sent to FDA in SPL format, the contractor must be able to demonstrate relevant experience directly relevant to the types of work needed. Such experience includes projects performed in the past two years similar in scope to the requirements of this Statement of Work.

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 international regulatory entities.

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.

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.

WEEKLY STATUS REPORTS

The Contractor shall submit weekly status reports in the Enterprise Status Tracking and Reporting System (eSTARS). The project names used for the project intake process shall be used as project names in eSTARS. The COR will provide the project intake details, such as project names and project intake numbers, if applicable. eSTARS is a web application that makes it easier for Contractors to submit their weekly status reports and for supervisors, leads, PMs, and CORs to review the report submissions in a centralized system. Each Contractor staff member must first be granted access before they can use eSTARS. eSTARS is only accessible from within the FDA internal network. The eSTARS URL will be provided by the COR upon contract award.

Weekly Status Reports are due each Tuesday by the close of business (COB) for the work performed the previous week. If Tuesday is a non-working day the report shall be due by COB, the following business day. The Contractor shall provide the information for each task that was performed during the weekly reporting period.

This information includes the following, but not limited to:

Project Area/Name Planned Start and End Date Accomplishments Description/Comments Issues/Risks/Mitigation Plans Deliverables Role Action Items

PLACE OF PERFORMANCE

The place of performance is the contractor’s site.

CONTRACT ADMINISTRATION

The contact information for the FDA Contracting Officer’s Representative (COR) is the following: TBD

The contact information for the FDA Contracting Officer (CO)is the following: TBD

The contact information for the FDA Contract Specialist (CS)is the following: TBD

The contact information for the Contractor (KTR)is the following: TBD

CONTRACT CLAUSES

FAR Clauses Incorporated by Reference:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

52.202-1 Definitions (June 2020) 52.203-5 Covenant Against Contingent Fees (May 2014) http://www.acquisition.gov/far/index.html

52.203-7 Anti-Kickback Procedures (June 2020) 52.212-4 Contract Terms and Conditions-Commercial Items (Nov 2023) 52.217-8 Option to Extend Services (NOV 1999) 52.217-9 Option to Extend the Term of the Contract (MAR 2000) 52.227-14 Rights in Data (MAY 2014) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

FAR Clauses in Full Text:

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2025)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L.

115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (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.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

https://www.acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1179194 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_203-19 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id189A70O0P1N https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#unique_1968408723 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062680 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048661 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048698 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063319 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063504 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063607 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064087 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim

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

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

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

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

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

__ (10) [Reserved].

__ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-3.

__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-4.

__ (13) [Reserved] __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-6 (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6 .

__ (15)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

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

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

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

__ (iv)Alternate III (Jun 2020) of 52.219-9.

__ (v)Alternate IV (Jun 2020) of 52.219-9 __ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

(ii) Alternate I (Mar 2020) of 52.219-13.

_X_ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657f).

__ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May 2020) (15 U.S.C. 632(a)(2)).

(ii) Alternate I (MAR 2020) of 52.219-28.

https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064214 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064243 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062590 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062651 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057715 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057715 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057730 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057758 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057823 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women- Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan2020) (E.O.13126).

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

_X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

__ (ii) Alternate I (Jul 2014) of 52.222-35.

X__ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

_X_ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

_X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X__ (35) (i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

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

13627).

_X_ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

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

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

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

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

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

_X_ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C.chapter83, 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_ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 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).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (Jun 2020).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

_X_ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

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__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

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

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

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

__ (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).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.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) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O.

13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement.

Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

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