FDA-RFQ-1199944.pdf

FDA-RFQ-1199944

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

Statement of Work (SOW)

Part 1 – Description This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, (STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation.

The solicitation is issued as a Request for Quote (RFQ), using FAR 12 Acquisitions of Commercial Items and the Simplified Acquisitions Procedures of FAR 13. The solicitations document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005-97. The Government reserves the right to issue an award without discussion.

The associated North American Industry Classification System (NAICS) Code is 541380 Testing Laboratories with a small business size standard of $15,000,000.00. This requirement is being set aside for small businesses.

Part 2: Items and Pricing

Pricing Table

The government anticipates a firm fixed-price type contract

CLIN Task Quantity Unit Price Total Firm Fixed-Price

1 Task 1-Kick Off Meeting

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

Task 3-Analysis of Official Samples

Task 4-Draft and Final Report of Analysis

Task 5-Return of samples to FDA

Invoices shall be submitted after successful completion of each deliverable but no more than once a month. Payments will be made after COR acceptance of deliverable.

Part 3-Statement of Work

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. FDA seeks to hire a contract laboratory to perform analyses with accuracy, repeatability, proficiency, which has the qualifications to support regulatory decision-making.

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 6 minerals including tremolite, anthophyllite and chrysotile can crystallize.

FDA is aware of reports of asbestos contamination in talc-containing cosmetics. However, the investigation of asbestos contamination in talc requires the use of sophisticated microscopy techniques not readily available within FDA. In order to investigate recent reports 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 transmission electron microscopy (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.

Objectives

The goal of this statement of work is to request an analysis of talc-containing cosmetic products and cosmetic talc using PLM and TEM:

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

• To obtain data describing fiber appearance/morphology (length, width, shape, etc.)

and thereby determine if such fibers can be characterized as being “asbestiform (mineral name) fibers” or simply “(mineral name) fibers”.

• To estimate the extent to which fibers of both types are found in cosmetic products.

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 V and VI 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

• Demonstrating the ability to satisfactorily perform the written procedures for analysis by PLM and TEM on four (4) samples and two (2) reference standards as if they are regulatory samples

• Analyzing actual regulatory samples in accordance with the written procedures

• Analyzing in triplicate all four (4) demonstration samples, two (2) reference standards, and regulatory samples

• Collecting and reviewing data and drawing conclusions from the results of sample analysis

• 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

Specific Tasks

Task 1 – Kick Off Meeting

Within ten (10) working days after the effective award, 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 National Voluntary Laboratory Accreditation Program (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 must 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 using a reference standard that is supplied by

FDA

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 The criteria applied to determine countable amphibole/serpentine fibers by PLM and TEM o The methods for determining length, width and morphology of each countable amphibole/serpentine fiber o The criteria for categorizing countable fibers into “asbestiform” and “non-asbestiform” fiber populations o The applicability to the categorization of well-characterized tremolite reference materials known as “Lone Pine Tremolite” and “NIEHS Tremolite” which will be provided by FDA o The method for calculating the number of fibers or making semi-quantitative estimates of the number of fibers in “asbestiform” and ‘non-asbestiform” populations

- 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 must include at a minimum:

o Methods for sample handling and disposition to include sample sealing 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 shall 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.

Task 2 – Analysis of Demonstration Samples

The Contractor shall follow the procedures for analysis in triplicate using up to four (4) demonstration samples and reference standards provided by FDA representing asbestiform and non-asbestiform tremolite as if they are official samples. The Contractor shall follow FDA procedures to provide complete documentation suitable for decision making purposes.

FDA will provide these procedures in association with Task 1 Kick Off Meeting. The complete documentation will be provided to FDA by the Contractor at the conclusion of the analysis.

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

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. The Contractor shall follow the analysis protocol and analyze the official samples provided by FDA.

Task 4 –Draft and Final Report of Analysis

The Contractor shall prepare a draft report of analysis in a mutually agreeable format that includes a tabulation of each countable fiber showing: mineral identity; fiber length and width; and description of fiber morphology noting whether fiber appears to be asbestiform.

The report must 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 report shall include a narrative containing the Contractor’s conclusions as to the extent to which asbestiform/ non-asbestiform, amphibole/serpentine fibers are present based on data obtained for countable fibers. If there were any deviations from the written procedures or equipment malfunctions, the report 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.

Draft report shall be reviewed by FDA COR and returned to contractor within 7 days for revisions. Contractor shall submit final report within 10 days of FDA approval of draft.

Task 5-Return of Samples, Temporary Files and/or Draft Documents and Worksheets to FDA

The Contractor shall return all samples, temporary files and/or draft documents and worksheets to FDA upon acceptance of the final report of analysis while ensuring proper chain of custody.

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 Contracting Officer’s Representative (COR). All deliverables shall become the permanent property of FDA.

Task Deliverable and Format Estimated Time to Delivery Task 1-Kick Off Meeting Within ten (10) working days after effective award date FDA to provide to Contractor: chain of custody protocol; four (4) demonstration samples; and two (2) reference materials.

Within ten (10) working days after kick off meeting.

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

Task 3-Analysis of Official Samples Within four (4) months after effective award date

Task 4-Draft and Final Report of Analysis

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

Task 5-Return of samples to FDA Within ten (10) days of acceptance of final report

Performance

Satisfactory performance of this contract shall be deemed to occur upon successful delivery of the task described in PART 3 Statement of Work and upon acceptance by the COR, of the deliverables.

Unless otherwise specified, deliveries shall be made to the delivery location specified above, Monday through Friday (excluding Federal Holidays) between the hours of 8:30 a.m. and

5:30 p.m. EASTERN TIME only. Supplies or services scheduled for delivery on the Federal holidays listed below shall be made the next business day.

January (New Year’s Day) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) July (Independence Day) September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving) December (Christmas Day)

Place of Performance

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

Period of Performance

The period of performance shall be twelve (12) months from the award date.

Packing, Marking and Shipping

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name.

Inspection and Acceptance

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of services to be provided.

For the purpose of this PART, the COR (to be determined upon contract award), is the authorized representative of the Contracting Officer.

Inspection and acceptance will be performed at: the location identified in Part 5.

Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or the COR within 30 days of receipt.

Contract Administration Data

REPRESENTATIVES

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials and services to be provided.

The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer (CO) is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer Representative is the following:

To Be Determined

The contact information for the Contracting Officer is the following:

Matthew Bucher U.S. Food and Drug Administration

Office of Acquisitions and Grants Services Matthew.Bucher@fda.hhs.gov;

(240) 402-7570

The contact information for the Contract Specialist is the following:

Priscilla Harrison

U.S. Food and Drug Administration Office of Acquisitions and Grants Services

Priscilla.harrison@fda.hhs.gov;

(240) 402-7609

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

FDA will provide a chain of custody protocol, four (4) demonstration samples, two (2) reference materials, and approximately fifty (50) official samples. FDA will also provide procedures for complete documentation suitable for decision making purposes

Security

The Contractor shall maintain security including a documented chain of custody for all samples according to procedures approved by FDA. The Contractor shall also maintain strict confidentiality in all communications and work products.

The COR responsible for drafting requirements must also identify the security level required to support the effort. The security level required to support the effort is Level 5, Moderate Risk.

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;

Discuss any other unique requirements or considerations, e.g. – 508 standards, animal welfare, packaging, etc.

mailto:Priscilla.harrison@fda.hhs.gov

Invoice Submission

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.

(End of clause)

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. The COR is (TBD)

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 Contract Line Item/Funding line item 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) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(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 FDA Payment Office at the e-mail address provided above in Section A.

CONTRACT CLAUSES

FAR Clauses Incorporated By Reference (Feb 1998)

52.252-2 Clauses Incorporated by Reference.

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): https://www.acquisition.gov/?q=browsefar:

52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014)

52.212-4 Contract Terms and Conditions-Commercial Items (2017) 52.213-2 Invoices (APR 1984) 52.217-5 Evaluation of Options (July 1990)

FAR CLAUSES INCORPORATED IN FULL TEXT

52.212-2 Evaluation—Commercial Items (Oct 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical Capability Relevant Experience Price

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

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

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision) https://www.acquisition.gov/?q=browsefar

52.212-3 Offeror Representations and Certifications—Commercial Items.

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for

Award Management (SAM) website located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision.

(a) Definitions. As used in this provision—

“Administrative merits determination” means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“Arbitral award or decision” means an arbitrator or arbitral panel determination that a labor law violation occurred, or that enjoined or restrained a violation of labor law. It includes an award or decision that is not final or is subject to being confirmed, modified, or vacated by a court, and includes an award or decision resulting from private or confidential proceedings. To determine whether a particular award or decision is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“Civil judgment” means–

(1) In paragraph (h) of this provision: A judgment or finding of a civil offense by any court of competent jurisdiction.

(2) In paragraph (s) of this provision: Any judgment or order entered by any Federal or State court in which the court determined that a labor law violation occurred, or enjoined or restrained a violation of labor law. It includes a judgment or order that is not final or is subject to appeal. To determine whether a particular judgment or order is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“DOL Guidance” means the Department of Labor (DOL) Guidance entitled: “Guidance for

Executive Order 13673, ‘Fair Pay and Safe Workplaces’”. The DOL Guidance was initially published in the Federal Register on August 25, 2016, and significant revisions will be published for public comment in the Federal Register. The DOL Guidance and subsequent versions can be obtained from www.dol.gov/fairpayandsafeworkplaces.

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Enforcement agency” means any agency granted authority to enforce the Federal labor laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of

Federal Contract Compliance Programs, and Occupational Safety and Health https://www.sam.gov/portal https://www.acquisition.gov/sites/default/files/current/far/html/www.dol.gov/fairpayandsafeworkplaces

Administration), the Equal Employment Opportunity Commission, the Occupational Safety and Health Review Commission, and the National Labor Relations Board. It also means a

State agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations. The enforcement agencies associated with each labor law under E.O. 13673 are–

(1) Department of Labor Wage and Hour Division (WHD) for–

(i) The Fair Labor Standards Act;

(ii) The Migrant and Seasonal Agricultural Worker Protection Act;

(iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act;

(iv) 41 U.S.C. chapter 67, formerly known as the Service Contract Act;

(v) The Family and Medical Leave Act; and

(vi) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for

Contractors);

(2) Department of Labor Occupational Safety and Health Administration (OSHA) for–

(i) The Occupational Safety and Health Act of 1970; and

(ii) OSHA-approved State Plans;

(3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for–

(i) Section 503 of the Rehabilitation Act of 1973;

(ii) The Vietnam Era Veterans’ Readjustment Assistance Act of 1972 and the

Vietnam Era Veterans’ Readjustment Assistance Act of 1974; and

(iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity);

(4) National Labor Relations Board (NLRB) for the National Labor Relations Act; and

(5) Equal Employment Opportunity Commission (EEOC) for–

(i) Title VII of the Civil Rights Act of 1964;

(ii) The Americans with Disabilities Act of 1990;

(iii) The Age Discrimination in Employment Act of 1967; and

(iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act).

“Forced or indentured child labor” means all work or service—

(6) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(7) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following:

ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees. “Inverted domestic corporation”, means a foreign incorporated entity that meets the definition of an inverted http://uscode.house.gov/ domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Labor compliance agreement” means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters.

“Labor laws” means the following labor laws and E.O.s:

(1) The Fair Labor Standards Act.

(2) The Occupational Safety and Health Act (OSHA) of 1970.

(3) The Migrant and Seasonal Agricultural Worker Protection Act.

(4) The National Labor Relations Act.

(5) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act.

(6) 41 U.S.C. chapter 67, formerly known as the Service Contract Act.

(7) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity).

(8) Section 503 of the Rehabilitation Act of 1973.

(9) The Vietnam Era Veterans’ Readjustment Assistance Act of 1972 and the Vietnam

Era Veterans' Readjustment Assistance Act of 1974.

(10) The Family and Medical Leave Act.

(11) Title VII of the Civil Rights Act of 1964.

(12) The Americans with Disabilities Act of 1990.

(13) The Age Discrimination in Employment Act of 1967.

(14) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors).

(15) Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are OSHA-approved State Plans, which can be found at www.osha.gov/dcsp/osp/approved_state_plans.html).

“Labor law decision” means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

“Manufactured end product” means any end product in product and service codes (PSCs)

1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/www.osha.gov/dcsp/osp/approved_state_plans.html that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment

Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets

Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the

President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on http://uscode.house.gov/ http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

Government contracts, and qualified as a small business under the criteria in 13 CFR

Part 121 and size standards in this solicitation.

“Small disadvantaged business concern”, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR

124.105) by—

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding

$750,000 after taking into account the applicable exclusions set forth at 13 CFR

124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at

38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

“Successor” means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

“Women-owned business concern” means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program” (in accordance with 13 CFR part 127), means a small business concern that is at least 51 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United

States.

Note to paragraph (a): By a court order issued on October 24, 2016, the following definitions in this paragraph (a) are enjoined indefinitely as of the date of the order:

“Administrative merits determination”, “Arbitral award or decision”, paragraph (2) of “Civil judgment”, “DOL Guidance”, “Enforcement agency”, “Labor compliance agreement”, “Labor laws”, and “Labor law decision”. The enjoined definitions will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(b)(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website.

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through http://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (t) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it □ is, □ is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it □ is, □ is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

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(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that—

(i) It □ is,□ is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each

WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB

Program and other small businesses that are participating in the joint venture: __________.]

Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern.

[Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB

Program in (c)(6) of this provision.] The offeror represents that—

(i) It □ is, □ is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each

EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that—

(i) It □ is, □ is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and

(ii) It □ is, □ is not a HUBZone joint venture that complies with the requirements of

13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: __________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the

HUBZone representation.

(d) Representations required to implement provisions of Executive Order 11246—

(1) Previous contracts and compliance. The offeror represents that—

(i) It □ has, □ has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It □ has, □ has not filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that—

(i) It □ has developed and has on file, □ has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the

Secretary of Labor (41 cfr parts 60-1 and 60-2), or

(ii) It □ has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352).

(Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of

Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of

1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of

Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation

(FAR) 52.225-1, Buy American—Supplies, is included in this solicitation.)

(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1192900 products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item” “component,” “domestic end product,” “end product,”

“foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American—Supplies.”

(2) Foreign End Products:

Line Item No. Country of Origin

[List as necessary]

(3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.

(g)(1) Buy American—Free Trade Agreements—Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph

(g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than

COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms “Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product,” “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” “Free

Trade Agreement country,” “Free Trade Agreement country end product,” “Israeli end product,” and “United States” are defined in the clause of this solicitation entitled “Buy

American—Free Trade Agreements–Israeli Trade Act.”

(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled

“Buy American—Free Trade Agreements—Israeli Trade Act”:

Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

Line Item No. Country of Origin

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(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this…