Document_Type_rfq_talc_testing.pdf

Document Type: Request for Quote Solicitation Number: FDA RFQ 1213893 Subject: Analyze official samples of talc-containing cosmetics Posted Date: 9 Sept. 2019 Questions Date: 16 Sept. 2019 Response Date: 11 Sept. 2019 NAICS Code: 541380 Testing Laboratories

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 to analyze official samples of talc-containing cosmetics for the presence of asbestos in support of the Food and Drug Administration (FDA) regulatory decision-making.

Contract Type: Commercial Item: Firm Fixed Price

Part 2: Prices/Cost Clin Deliverable Estimated Time of Delivery Total Price

BASE YEAR

0001 Task 1 -Kick off Meeting

Within ten (10) working days after the effective award date.

0002 FDA to provide to Contractor: chain of custody protocol; four (4) demonstration samples; and two (2) reference materials

Within ten (10) working days after the kickoff meeting.

0003 Task 2 – Analysis of Demonstration Samples and shall follow FDA procedures to provide complete documentation suitable for decision making purposes.

Within two (2) months after effective award date.

0004 Task 3 – Analysis of Official Samples

Within four (4) months after effective award date.

0005 Task 4 – Draft and Final Report of Analysis

Draft report due within one (1) month after completion of Task 3. Final report due within ten (10) days of FDA acceptance of draft report

0006 Task 5 – Return of samples to

FDA

Within ten (10) days of acceptance of final report

TOTAL

BASE YEAR

OPTION

YEAR

1001 Task 1 -Kick off Meeting

Within ten (10) working days after the effective award date.

1002 FDA to provide to Contractor: chain of custody protocol; four (4)

Within ten (10) working days after the kickoff demonstration samples; and two (2) reference materials meeting.

1003 Task 2 – Analysis of Demonstration Samples and shall follow FDA procedures to provide complete documentation suitable for decision making purposes.

Within two (2) months after effective award date.

1004 Task 3 – Analysis of Official Samples

Within four (4) months after effective award date.

1005 Task 4 – Draft and Final Report of Analysis

Draft report due within one (1) month after completion of Task 3. Final report due within ten (10) days of FDA acceptance of draft report

1006 Task 5 – Return of samples to

FDA

Within ten (10) days of acceptance of final report

TOTAL

OPTION

YEAR

TOTAL

CONTRACT

VALUE

PART 3: SOW: Title: Testing of Official Samples of Talc Containing Cosmetics for Asbestiform Fibers

1. Purpose

The purpose of this requirement is to analyze official samples of talc-containing cosmetics for the presence of asbestos in support of Food and Drug Administration (FDA) regulatory decision-making. Because the FDA does not currently have the technical capability to conduct asbestos testing, the FDA seeks to hire a suitably qualified contract laboratory to perform asbestos analyses with demonstrable proficiency and repeatability, to support regulatory decision-making and possible enforcement action.

2. Background

Talc has many uses in cosmetics and personal care products. Firms mining ores used to produce cosmetic talc exercise caution to avoid excavating tremolite, anthophyllite and chrysotile which may be found adjacent to or commingled with talc deposits since these minerals can exhibit the physical and chemical characteristics of asbestos, a known carcinogen. Asbestos refers to the fibrous “asbestiform habit” in which six (6) minerals including tremolite, anthophyllite and chrysotile can crystallize.

Using the services of a private laboratory with National Voluntary Laboratory Accreditation Program (NVLAP)-accreditation for testing of bulk asbestos, FDA was recently able to confirm independent lab reports of asbestos contamination in talc-containing cosmetics. It is now apparent that detection of asbestos in cosmetics demands using the most sensitive asbestos testing methods available and requires the expertise of laboratories with a documented history of asbestos analysis of bulk materials using transmission electron microscopy (TEM). Thus, to further its investigation of asbestos contamination in marketed cosmetic products, FDA requires the services of a laboratory with the capability and credentials to use polarized light microscopy (PLM) and TEM to analyze talc-containing cosmetic products and cosmetic talc identified as the most likely source of any plausible asbestos contamination. TEM encompasses transmission electron microscopy, energy dispersive X-ray spectroscopy, and selected area electron diffraction, for the identification and quantification includes asbestiform and non-asbestiform fibers of minerals in the amphibole and serpentine families.

3. Objectives The objective is to request the analysis of samples of talc-containing cosmetic products and cosmetic talc provided by FDA using PLM and TEM combined with energy dispersive X-ray spectroscopy, and selected area electron diffraction.

1- To determine if silicate mineral fibers1 are present composed of the minerals tremolite, anthophyllite or chrysotile based on the determination of fiber chemical composition using energy dispersive X-ray spectroscopy.

1 As used in this document the term “fiber” is defined as a particle exhibiting a length at least 3x its diameter or width.

2- To obtain data describing appearance/morphology (length, width, shape, etc.) of populations of fibers that may include the asbestos and non-asbestos types of the amphibole and serpentine minerals.

3- To provide the data in a report containing a description of the methods used, tabulations of detected fibers and images/spectra of fibers suitable for FDA to use to determine if, and the extent to which, asbestos fibers are present in cosmetic products.

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:

• Identifying appropriate laboratory analytical methods applying the techniques of PLM and TEM for the analysis of <1% (w/w) asbestos in talc-containing cosmetic products.

• Data demonstrating the ability to satisfactorily perform the written procedures for analysis by PLM and TEM on at least four (4) samples of cosmetic products and provide documentation of the findings in a manner suitable for FDA regulatory action

• Analyzing all samples in accordance with the written procedures

• Analyzing all samples in triplicate

• Collecting and reviewing data and discussing findings to support FDA’s assessment pertaining to whether and the extent to which asbestos is present

• Preparing a written report of the work conducted and the results obtained

• Providing full and complete documentation requested by FDA such as raw data, method validation and verification, calibration logs, instrumentation and software employed, instrumental parameters, identification of reagents and supplies used, and documentation of the chain of custody and handling of samples

• Participating in periodic status updates and discussions of data and conclusions with

FDA

5. Specific Tasks

5.1 Task 1 – Kick Off Meeting to provide ISO/IEC 17025:2017 documentation, NVLAP accreditation documentation, proposed testing methods, and procedures for maintaining chain of custody of samples for FDA review.

The Contractor shall meet with the assigned Contracting Officer’s Representative (COR) and provide documentation demonstrating that they comply with ISO/IEC 17025:2017 and have accreditation with the NVLAP for the analysis of asbestos in bulk materials.

• The Contractor shall also provide the proposed PLM and TEM procedures for the analysis of asbestos in talc-containing cosmetic products in adequate detail for review by FDA. These procedures for PLM and TEM shall include at a minimum:

o Suitable methods to prepare samples of cosmetics for analysis by PLM and TEM to mitigate interference from inorganic and organic substances, as needed for the detection of asbestos;

o For PLM methods, the capability to identify amphibole and serpentine mineral fibers based on optical properties;

o For TEM methods, the capability to apply X-ray spectroscopy and electron diffraction to determine chemical composition and crystal structure of amphibole and serpentine mineral fibers;

o References to applicable public standards, and as applicable, detailed description of/justification for any modifications made to public standards o The criteria/boundaries for length, width and morphology that will be used to determine whether to count/record data for amphibole/serpentine fibers found by PLM and TEM, including criteria denoting when a satisfactory number of fibers will have been counted;

o The formulae to be used for calculating the number of fibers and/or making semi-quantitative estimates of the content (i.e., mass and/or number) of fibers in “asbestiform” and ‘non-asbestiform” populations.

• The Contractor shall also state how the reliability of the data is ensured. This shall include a description of applicable reference materials and how such reference materials will be used (e.g., in proficiency testing or in establishing system suitability).

• The Contractor shall also provide the procedures to be followed that ensure proper chain of custody is maintained for all cosmetic product samples. These procedures shall include at a minimum:

o Methods for sample handling and disposition to include sample sealing o Methods for assigning sample identifiers allowing for the blinding and decoding of blinded samples o Methods for documentation o Methods to maintain security of samples

The Contractor’s site is subject to FDA audit as a part of this task. FDA will review documentation provided in accordance with this task and findings of any audit, dictate any necessary modifications to documentation and/or procedures, and determine suitability to proceed to the next task.

The Contractor shall meet with the FDA, in person or by teleconference, on a regular basis, as needed, or as requested by the COR.

5.2 Task 2 – Analysis of Demonstration Samples

At the discretion of FDA after review of the Contractor’s qualifications, the Contractor shall be directed to follow the procedures for analysis in triplicate of demonstration samples provided by FDA as if they are official samples. The Contractor shall provide a full documentation package suitable to support a regulatory decision making for FDA review.

Upon review of this documentation, FDA will determine suitability to proceed to the next task.

5.3 Task 3 – Analysis of Official Samples

Upon successful completion of Task 2 and being given authorization to proceed to Task 3 by FDA, the Contractor shall analyze in triplicate approximately fifty (50) official samples provided by FDA sent in batches of approximately ten (10) official samples. The Contractor shall follow the analysis protocol and analyze the official samples provided by FDA.

5.4 Task 4 – Draft, Interim, Final Reports of Analysis

The draft, interim, and final reports of analysis shall be in a mutually agreeable format that includes a tabulation of each countable fiber showing: mineral identity; fiber length and width. The reports shall also include: optical characterization data obtained using PLM; X-ray spectral and electron diffraction data obtained using TEM; and images representing viewing of individual fibers by PLM and TEM. The reports shall include a narrative summarizing the Contractor’s observations pertaining to the morphological characteristics of the population of countable fibers. If there were any deviations from the written procedures or equipment malfunctions, the reports shall provide a full explanation of the nature of the deviation or malfunction and the ensuing investigation determining whether there was any impact on the validity of the data obtained.

The Contractor shall revise each draft, interim, or final report as requested by the COR. The Contractor shall make provisions to ensure that each subsequent report conforms to FDA’s expectations for being complete.

5.4.1 Task 4a – Draft Reports for Each Batch or Sequence of Batches The Contractor shall prepare a complete draft report of analysis for every batch received or, if agreed to or requested by the COR, a sequence of batches.

5.4.2 Task 4b – Interim Reports for Each Batch or Sequence of Batches After the COR has accepted a draft report, the Contractor shall submit the accepted draft as the interim report for the batch or sequence of batches analyzed.

5.4.3 Task 4c – Final Report

After completion of the last interim report, the Contractor shall prepare a final report, which shall summarize all work performed and findings obtained under this statement of work.

5.4.4 Task 5 – Return of Samples to FDA

The Contractor shall return all samples to FDA upon completion of the corresponding interim report while ensuring proper chain of custody.

6. Deliverables

The Contractor shall provide electronic copies of the deliverables listed below in Microsoft Office Suite. All deliverables shall be transmitted via hard copy and electronically via email to the COR. All deliverables shall become the permanent property of FDA.

Task Deliverable and Format Estimated Time to Delivery

5.1 Task 1 - Kick Off Meeting review proposed testing methods, and internal procedures including those for maintaining chain of custody and ensure the contractor can address relevant concerns in a timely manner.

Within ten (10) working days after effective award date.

5.2Task 2 - Analysis of Demonstration Samples and full documentation package suitable to support a regulatory decision making

(At the discretion of the FDA) Within two (2) months after effective award date.

5.3 Task 3 - Analysis of official samples Within two (2) months after receipt of each batch and no later than ten (10) months after effective award date.

Task 4a - Draft reports for each batch or sequence of batches Within ten (10) working days after completion of analysis of official samples (including resolution of all FDA’s requested revisions).

Task 4b - Interim reports for each batch or sequence of batches Within ten (10) working days of FDA’s acceptance of each draft report (including resolution of all FDA’s requested revisions).

Task 4c - Final report Within ten (10) working days of acceptance of the last interim report (including resolution of all FDA’s requested revisions).

Task 5 - Return of samples to FDA Within ten (10) working days of FDA’s acceptance of each corresponding interim report.

7. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

FDA will provide the chain of custody protocol and approximately fifty (50) official samples. At the discretion of the FDA, FDA will also provide up to four (4) demonstration samples and two

(2) reference materials. The COR will review each draft, interim, or final report and, when necessary, return it to the Contractor for revisions.

FDA to provide to Contractor: chain of custody protocol; four (4) demonstration samples; and two (2) reference materials.

FDA to provide to Contractor: approximately fifty (50) official samples in batches of approximately ten (10) official samples

8. Organizational Conflict of Interests

As a regulatory agency charged with protection of public health, the FDA must maintain public confidence in the integrity of its decisions. The Center for Food Safety and Applied Nutrition (CFSAN) in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that cosmetic products are safe and properly labeled.

The Center regulates over $60 billion worth of cosmetics sold across state lines. This regulation takes place from the products' point of U.S. entry or processing to their point of sale. There are over several thousand cosmetic firms. FDA’s responsibility in the area of cosmetics covers all domestic and imported products.

The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. In contracting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offerors performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor.

(a) The purpose of this section is to ensure that the Contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests, which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language of this section applies to performance or participation by the

Contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest Conflict of interest means that because of other activities or relationships with other persons, entities or organizations (hereinafter “person”), a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501).

(d) Contractor’s Conflict of Interest Responsibilities The individual contractor must be free of interest prior to performing under this contract.

Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the Contracting Officer and Contracting Officer Representative. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it.

The contractor shall not commence or continue working on the contract until directed by the Contracting Officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The Contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5 and in 45 CFR Part 94, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The Contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

The Contractor shall be performing lab analysis of cosmetic products and providing that analysis to FDA to inform regulatory decision making. The contractor must thoroughly disclose any relevant information regarding financial relationships with private entities that may be affected by this contract. If such financial relationships exist, the Contractor shall provide a statement as to whether it believes the relationships present a potential or actual conflict of interest and the basis for that determination. If the Contractor has identified a potential or actual conflict of interest, a plan for mitigating the conflict of interest must be submitted.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities. – The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor shall obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the Contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the Contractor agrees that the Contractor shall be required to eliminate the subcontractor from its team, at the Contractor's own risk. The Contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The Contractor shall seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

9. Other Considerations

Contractor shall provide relevant documentation pertaining to: quality systems as required by ISO/IEC 17025:2017; applicable procedures for maintenance and calibration of equipment and instrumentation used in asbestos testing and metrology; custodial procedures that ensure that chain of custody of all samples is maintained;

10. Place of Performance

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

11. Period of Performance

The tasks shall be performed under a twelve (12) months base with a twelve (12) months option period.

12. Contracting Officer’s Representative

TBD

Part 4: 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 5.2.

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, 52.246-3 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 5: Place of Performance

Performance Location: Contractor’s facility

Part 6. 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 mailto:howard.yablon@fda.hhs.gov

6.2 Invoice Submission

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 7. 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) http://farsite.hill.af.mil/VFHHSARA.HTM http://www.acquisition.gov/

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.

52.217-8 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.

52.232-40 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.]

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

_ _ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (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]

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

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

644).

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

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

_X__ (16) 52.219-8, Utilization of Small Business Concerns (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)).

__X_ (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.

_X__ (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.

_X__ (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.

_X__ (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).

_X__ (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).

_X__ (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…