Talc_Scoping_RFQ_-_FINAL__8.28.19.pdf

Document Type: Request for Quote Solicitation Number: FDA RFQ 1214205 Subject: Scoping Review and Systematic Review of

Cosmetic Talc Use and Adverse Human Health Risks

Posted Date: 28 August 2019 Questions Date: 30 August 2019 Response Date: 04 Sept. 2019 NAICS Code: 541690 Other Scientific & Technical

Consulting Services

Contracting Activity

DHHS/FDA/OAGS/DAP

Attn: Howard S. Yablon 4041 Powder Mill Road Beltsville, MD 20705

Part 1. - Intro

The U.S. Food & Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), is requesting quotes for scoping review and systematic review of cosmetic talc use and adverse human health risks. This is a small business set aside.

Contract Type: Commercial Item: Firm Fixed Price

Part 2: Prices/Cost

Task Number

Task Deliverables: Estimated time period to delivery Price

BASE YEAR

1.1.1 TASK 1: Draft work

plan. Two (2) weeks after contract award $

1.1.2 TASK 1: Kickoff

meeting with COR and OCAC, either in-person or via telecom, to

Three (3) weeks after contract award $ discuss and revise work plan.

1.2 TASK 2: Revised and

final work plan.

Five (5) weeks after contract award $

1.3 TASK 3: Draft protocol

for conducting a scoping review.

Two (2) months after contract award $

1.4 TASK 4: Meeting with

COR and OCAC, either in-person or via telecom, to discuss and revise draft protocol for scoping review;

Revised and final protocol for scoping review.

Two (2) months and two (2) weeks after contract award

1.5 TASK 5: Scoping

review of scientific literatures on the toxicological endpoints, human health effects, and mechanisms of action of cosmetic talc;

All references reviewed, full text, in pdf, along with a reference list.

Seven (7) months after contract award $

1.9 TASK 9: Create and

present PowerPoint slides to OCAC. Slides shall be delivered by email and CD.

Twelve (12) months after contract award

1.10 TASK 10: Bi-weekly

meeting (via telecom) with COR and OCAC

Every two (2) weeks after kick-off meeting until acceptance of all to report the progress and clarify any questions.

deliverables or twelve (12) months after contract award.

TOTAL BASE YEAR $

OPTION YEAR 1

1.1.1 TASK 1: Draft work

plan.

Two (2) weeks after option year begins

1.1.2 TASK 1: Kickoff

meeting with COR and OCAC, either in-person or via telecom, to discuss and revise work plan.

Three (3) weeks after option year begins

1.2 TASK 2: Revised and

final work plan.

Five (5) weeks after option year begins

1.6 TASK 6: Draft protocol

for systematic review.

Seven (7) months and two (2) weeks after option year begins

1.7 TASK 7: Meeting with

COR and OCAC, either in-person or via telecom, to discuss and revise draft protocol for systematic review;

Revised and final protocol for systematic review.

Eight (8) months after option year begins

1.8 TASK 8: A systematic

review on the association between talc exposure and cancer-related endpoints;

Twelve (12) months after option year begins

All literatures evaluated, full text, in pdf, along with a reference list.

2.9 TASK 9: Create and

present PowerPoint slides to OCAC. Slides shall be delivered by email and CD.

Twelve (12) months after option year begins

2.10 TASK 10: Bi-weekly

meeting (via telecom) with COR and OCAC to report the progress and clarify any questions.

Every two (2) weeks after kick-off meeting until acceptance of all deliverables or twelve (12) months after option begins

TOTAL OPTION

YEAR 1

TOTAL CONTRACT

VALUE

Part 3. STATEMENT OF WORK Statement of Work

Scoping Review and Systematic Review of Cosmetic Talc Use and Adverse Human Health Risks

1. Purpose The purpose of this acquisition is to ask for a scoping review of the literature on identified toxicological endpoints or adverse health outcomes associated with use of talc as an ingredient in cosmetic products. The scoping review is to be followed by a systematic review on the possible association between talc use and cancer-related endpoints.

2. Background

The Food and Drug Administration (FDA), Office of Cosmetics and Colors (OCAC) is responsible for providing regulatory oversight of the safety and proper labeling of cosmetics.

FDA, OCAC is interested in evaluating the safety data of talc in cosmetic products, specifically from dermal, inhalation, oral, and perineal routes of exposure.

Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg3Si4O10(OH)2. Talc has many uses in cosmetics and other personal care products; in food, such as rice and chewing gum; and in drugs, for the manufacture of tablets. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product.

Other international regulatory bodies, such as the International Agency for Research on Cancer (IARC) and Environment and Climate Change Canada (ECCC)/Heath Canada (HC), have developed positions on talc and its health effects. For example, ECCC/HC recently in their “Draft screening assessment talc” reviewed both toxicological and epidemiological data from the literature focusing on non-cancer lung effects after talc inhalation and on ovarian cancer after perineal talc exposure and concluded that inhaling loose talc powders and using certain products containing talc in the female genital area may be harmful to human health. The FDA’s position was published in 2014, as a response to 2 citizen petitions, where the FDA concluded that available data did not present conclusive evidence of a causal association between talc use in the perineal area and ovarian cancer. In order for the FDA to continue its investigations into the safety of talc in cosmetics, we would like to commission a systematic literature survey of talc.

Specifically, the FDA is interested in conducting a scoping review as well as a systematic review of talc, summarizing the scientific data related to selected toxicological endpoints or adverse health outcomes related to the use of talc in cosmetics. The ultimate goal would be to assess whether there is any association between cosmetic talc use and cancer-related endpoints.

3. Objectives The objective of this requirement is for FDA to 1) obtain a scoping review that maps the available literature on selected toxicological endpoints in animal studies, potential adverse health outcomes in humans, and the relevant underlying mechanisms for the observed toxicities or adverse health outcomes; and 2) to conduct a systematic review on a potential association between exposure to talc-containing products and cancer-related endpoints, considering all available in vitro, animal, and epidemiological studies.

4. Scope Independently and not as an agent of the government, the Contractor shall furnish the necessary personnel and services required for, or incident to, the performance of the work as described in the projected task areas listed below in Sections 5 and 6 to overall include:

To assist FDA with gaining a better understanding of the potential hazards associated with cosmetic talc, the Contractor shall conduct a scoping review of literature (published from 1945 till 2019) on talc regarding its toxicity and health risk in humans, considering both noncancer and cancer endpoints, as well as possible mechanisms of action. The scope shall be limited to talc used in cosmetics (i.e., not from occupational exposure), summarizing any data relevant to the selected toxicological endpoints of concern, based on oral, dermal, and inhalation routes of exposure, obtained from animal, human, and in vitro studies. The Contractor shall also conduct, on the basis of the scoping review, a systematic review specifically on any possible association between talc use and cancer-related endpoints.

4.0 Specific Tasks

5.1 Task 1. Draft Work Plan and Kick Off Meeting

5.1.1 Contractor shall prepare a draft work plan that shall outline the activities and deliverables for each task along with a proposed delivery date for each task.

• The work plan should identify the names and expertise of personnel involved in each task.

5.1.2 Contractor shall meet with Contracting Officer’s Representative (COR) and staff of the

Division of Cosmetics at the Office of Cosmetics and Colors (OCAC) to clarify outstanding questions and confirm the scope. This task shall include, but not limited to:

• Discussion of the Contractor’s draft work plan and possible revision.

5.2 Task 2. Revised and Final Work Plan

5.2.1 Contractor shall revise work plan based on input from COR and OCAC.

5.2.2 After receipt of the COR’s acceptance of the revised work plan, the Contractor shall submit the final work plan.

5.3 Task 3. Development of the Scoping Review Protocol

5.3.1 Contractor shall develop a protocol for conducting a scoping review of published scientific literature on cancer and noncancer endpoints talc toxicity and health risk in humans, both noncancer and cancer endpoints, and studies examining talc mechanisms of action. The protocol shall include, but not limited to:

• Objectives, background, and methods.

• Details of the proposed plan including databases that will be searched, strategies for literature searching, justifications of inclusion, and exclusion criteria selected, data extraction and charting procedures, collating, summarizing and reporting the results, approach for discussion of the findings, approach for drawing conclusion, and making recommendations for the selection of the topic that will be the subject of the systematic review.

• A plan for presenting the results.

5.4 Task 4. Revised and Final Scoping Review Protocol

5.4.1 Contractor shall meet with the COR and OCAC, in person or via telecom, to discuss the protocol and possible revision.

5.4.2 Contractor shall revise protocol for the scoping review based on input from COR and

OCAC.

5.4.3 After receipt of the COR’s acceptance of the revised protocol for the scoping review, the

Contractor shall submit the final protocol for the scoping review.

5.5 Task 5. Conduct of the Scoping Review

5.5.1 Contractor shall conduct a scoping review according to the protocol developed under

Section 5.4 (Task 4). This scoping review shall include, but not limited to:

• All components outlined in the scoping review protocol (5.4) including objectives, background, searching strategies, databases searched, inclusion & exclusion criteria, data extraction, charting of the results, summarizing of the results, conclusions, and implications.

• A flowchart or diagram detailing the search decision process and narrative description of this process.

• An overall summary of the studies evaluated in terms of toxicological endpoints in vitro or in animals or human health effects following exposure to cosmetic talc via oral, dermal, and inhalation routes.

• Potential noncancer effects focusing on the respiratory system; cancer effects on respiratory system, pleura and peritoneum, gastrointestinal organs, and reproductive organs in particular ovaries.

• Results presented as a map or tabular form along with a narrative description and summary of the results.

• Detailed summary of results/individual studies classified into in vitro studies, animal studies, epidemiological studies, and others, and/or by exposure routes (when applicable) via oral, dermal (including perineal area), and inhalation.

• Conclusions in terms of the objectives of the scoping review.

• Implications of the scoping review. The scoping review is expected to identify data gaps and make recommendations for necessary research, identify a number of potential topics for a more focused systematic review, and propose a scope for three systematic review(s) on talc safety, in particular, as it relates to cancer-related endpoints.

• Documentation of any deviations to the protocol (under section 5.3).

• Discussion of limitations of the scoping review.

5.6 Task 6. Development of the Systematic Review Protocol Examining the Possible Association between Talc Use and Cancer-related Endpoints

5.6.1 Contractor shall develop a protocol, based on published and justified guidelines for performing systematic reviews. The protocol shall include, but not limited to the following key sections:

• Scoping and problem formulation – summary of the scope of the review and specific question to be answered through the systematic review.

• Population, Exposure, Comparison, and Outcome (PECO) criteria statement.

• Systematic literature search strategies including databases searched, manual search of citations from review articles or non-peer reviewed data such as published positions on talc from national such as EPA and international regulatory agencies in the EU, Health Canada, and Japan.

• Literature screening process including inclusion & exclusion criteria, how studies will be selected.

• A framework for judging the quality of included studies including data extraction strategy from selected studies relevant for addressing the question, and study evaluation strategies including evaluation of animal studies, human epidemiological studies and in vitro mechanistic studies.

• A framework for selecting publications by authors not conflicted by participating in past, present or future litigation cases.

• A plan for organization and synthesizing the identified evidence.

• A plan for presenting data and results.

• A framework for integrating results and drawing conclusions.

5.7 Task 7. Revised and Final Systematic Review Protocol Examining the Possible Association between Talc Use and Cancer-related Endpoints

5.7.1 Contractor shall meet with the COR and OCAC, in person or via telecom, to discuss the protocol and possible revision.

5.7.2 Contractor shall revise protocol for the systematic review based on input from COR and

OCAC.

5.7.3 After receipt of the COR’s acceptance of the revised protocol for the systematic review, the Contractor shall submit the final protocol for the systematic review.

5.8 Task 8. Conduct of Systematic Review.

5.8.1 Contractor will conduct a systematic review according to the protocol developed under

Section 5.7 (Task 7) to identify, evaluate, extract, synthesize, integrate, and interpret the data regarding the possible association between talc exposure and cancer-related endpoints. This systematic review shall include, but not limited to:

• Background information.

• Methods for identification of studies as detailed in the protocol (section 5.7).

• Characteristics of the identified studies including epidemiological (human) and toxicological (experimental animal) studies on cancer risk from exposure to talc.

• Evaluation of mechanistic studies associated with talc exposure to information the toxicities in animals and health effects in human, focusing on cancer.

• Evaluation of risk of bias and quality of individual included studies.

• Extraction of data on relevant cancer outcomes from animal studies and epidemiological studies, respectively.

• Rating of the strength/confidence in the body of evidence by applying published recommendations.

• Synthesis of the evidence across studies (with same or similar toxicological endpoints or health outcomes) relevant to the cancer endpoint of interest to FDA.

• Synthesis and incorporation of the mechanistic data with relevant endpoints and health outcomes.

• Conduct a quantitative synthesis (a meta-analysis) of the evidence.

• Overall conclusions based on the evidence regarding the link between talc exposure and cancer risk.

• Cancer risk estimates (if the available data support).

• Characterization of uncertainties, identification of data gaps and research needs.

• Documentation of any deviations to the protocol (under section 5.7).

• Discussion of limitations of the systematic review.

5.9 Task 9. Create and present PowerPoint slides summarizing scoping review and systematic review to OCAC

5.10 Task 10. Bi-weekly meetings (via telecom) with COR and OCAC to report the progress and clarify any questions.

5. Deliverables:

Contractor shall provide electronic copies of the deliverables listed in the table below in Microsoft Word, Excel, or Power Point, or PDF as appropriate. All deliverables shall be transmitted via email to the COR and shall become the permanent property of FDA/OCAC.

PLEASE NOTE THE FOLLOWING:

The base year shall include Deliverables 1-5 and 9-10.

The option year shall include Deliverables 1-2, and 6-10.

Task Number

Task Deliverables: Estimated time period to delivery

Period of Performance

5.1.1 Draft work plan.

Two (2) weeks after contract award and when option year begins

Base Year, Option Year

5.1.2 Kickoff meeting with

COR and OCAC, either in-person or via telecom, to discuss and revise work plan.

Three (3) weeks after contract award and when option year begins.

Base Year, Option Year

5.2 Revised and final work

plan.

Five (5) weeks after contract award and when option year begins.

Base Year, Option Year

5.3 Draft protocol for

conducting a scoping review.

Two (2) months after contract award.

Base Year

5.4 Meeting with COR and

OCAC, either in-person or via telecom, to discuss and revise draft protocol for scoping review;

Two (2) months and two (2) weeks after contract award.

Base Year

Revised and final protocol for scoping review.

5.5 Scoping review of

scientific literatures on the toxicological endpoints, human health effects, and mechanisms of action of cosmetic talc;

All references reviewed, full text, in pdf, along with a reference list.

Seven (7) months after contract award.

Base Year

5.6 Draft protocol for

systematic review.

Seven (7) months and two

(2) weeks after option year begins.

Option Year

5.7 Meeting with COR and

OCAC, either in-person or via telecom, to discuss and revise draft protocol for systematic review;

Revised and final protocol for systematic review.

Eight (8) months after option year begins.

Option Year

5.8 A systematic review on

the association between talc exposure and cancer-related endpoints;

All literatures evaluated, full text, in pdf, along with a reference list.

Twelve (12) months after option year begins.

Option Year

5.9 Create and present

PowerPoint slides to OCAC. Slides shall be

Twelve (12) months after contract award and when option year begins.

Base Year, Option Year delivered by email and

CD.

5.10 Bi-weekly meeting (via

telecom) with COR and OCAC to report the progress and clarify any questions.

Every two (2) weeks after kick-off meeting until acceptance of all deliverables or twelve (12) months after contract award and when option year begins.

Base Year, Option Year

Part 6: Inspection and Acceptance:

The Contractor’s Officer’s Representative (COR) will perform inspection and acceptance of the mass spectrometer system.

4.1 For the purpose of this part, the COR, TBD is the authorized representative of the Contracting Officer

4.2 Inspection and acceptance will be performed at the location identified in in the Statement of Work Acceptance is communicated in writing unless otherwise indicated in writing By the Contracting Officer or COR within 30 days of receipt

4.3 This contract incorporates the following Clause, 52.246-4 Inspection of Services-Fixed Price (Aug 1999) by reference with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available

Part 7: Place of Performance

Performance Location: The work shall be performed at the Contractor’s site.

Delivery or Performance-Period Requirements.

The performance period will be twelve (12) months from the time of award and a twelve

(12) month option period.

Part 8. Contract Administration Data:

6.1 CONTRACTING OFFICERS REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract: TBD 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.

6.1.1 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 Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

6.1.2 The contact information for the Contracting Officer:

Matthew Bucher 4041 Powder Mill Road Beltsville, MD 20705 matthew.bucher@fda.hhs.gov Tel: 240-402-7570

6.1.3 The contact information for the Contracting Specialist is:

Howard S. Yablon 4042 Powder Mill Road Beltsville, MD 20705 howard.yablon@fda.hhs.gov Tel: 240-402-7630

6.2 Invoice Submission

mailto:howard.yablon@fda.hhs.gov

FDA THREE-WAY-MATCHING INVOICE CLAUSE

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is (insert name and email address.)

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other

Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and

Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742);

or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Part 9. HHSAR AND FAR CLAUSES

7.1 HHSAR CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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: http://farsite.hill.af.mil/VFHHSARA.HTM.

HHSAR Clause Description Date

352.203-70 Anti- Lobbying 12/18/2015

352.208.70 Printing and Duplication 12/18/2015

352.222-70 Contractor Cooperation in Equal 12/18/2015 Employment Opportunity Investigations 352.239-73 Electronic Information and Technology 12/18/2015 Accessibility Notice

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 this/these address(es): www.acquisition.gov

52.212-1 Instructions to Offerors-Commercial Items (OCT 2018) 52.212-2 Evaluation-Commercial Items (OCT 2014) 52.212-4 Contract Terms and Conditions-Commercial Items

52.217-5 Evaluations of Options (July 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement.

Evaluation of options will not obligate the Government to exercise the option(s).

http://farsite.hill.af.mil/VFHHSARA.HTM http://www.acquisition.gov/ https://www.acquisition.gov/content/part-17-special-contracting-methods#i1103099

52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days.

52.217-9 Option to Extend the term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice anytime prior to contract expiration. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 2 years.

52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (DEC 2013)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (AUG 2019)

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

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

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

L. 115-91).

(3) 52.204-25, 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, 108-78 (19 U.S.C. 3805 note)).

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

[Contracting Officer check as appropriate.]

___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_ __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

_X__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

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

_X__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

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

___ (10) [Reserved]

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C.

644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

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

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637 (d)(4)).

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

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

___ (iv) Alternate III (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Aug 2018) of 52.219-9.

_X__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

__X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_X__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X__ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

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

_X__ (28) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

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

___ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

___ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

___ (ii) Alternate I (July 2014) of 52.222-36.

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X__ (33) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

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

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA- Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

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

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

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

_X__ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

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

___ (46) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (47) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

___ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X__ (55) 52.232-33, Payment by Electronic Funds Transfer--System for Award Management (Oct 2018) (31 U.S.C. 3332).

___ (56) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C.

637(d)(13)).

___ (60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

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

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

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

[Contracting Officer check as appropriate.]

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

___ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67.).

___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C.

206 and 41 U.S.C. chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C.206 and 41 U.S.C.

chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O.

13658).

___ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

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

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

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

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jan 2019) (41 U.S.C. 3509).

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

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

L. 115-91).

(iv) 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).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

(viii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(ix) 52.222-35, Equal Opportunity for Veterans (Oct 2019) (38 U.S.C. 4212).

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

(xi) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(xii) 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.

(xiii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).

(xiv) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (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 E.O. 13627).

(xv) 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.)

(xvi) 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)

(xvii) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xviii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xix) 52.222-62, Paid sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xx) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

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

(xxii) 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.

(xxiii) 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)

Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and

(c) of this clause”.

Alternate II (Aug 2019). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d) (1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(A) 52.203–13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

(C) 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).

(D) 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).

(E) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(G) 52.222–26, Equal Opportunity (Sep 2016) (E.O. 11246).

(H) 52.222–35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

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

(J) 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.

(K) 52.222–41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(L) ____ (1) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

____ (2) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(M) 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).

(N) 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).

(O) 52.222–54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989).

(P) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(Q) 52.222-62, Paid sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(R) (1) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(2) Alternate I (Jan 2017) of 52.224-3

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

(T) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).