FDA-RFQ-1223331.pdf

FDA-RFQ-1223331

Comprehensive Preventive Maintenance for Steris Equipment’s

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-RFQ-1223331

Posted Date: January 17, 2020

Response Date: January 24, 2020

NAICS Code: 811219, Other Electronic and Precision Equipment Repair and Maintenance, Small Size Standard 1,000 Employees

Part 1 – Description

The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition

(CFSAN) require comprehensive preventive maintenance services for Steris equipment’s. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) 2020-04 dated January 15, 2020. The North American Industry

Classification System (NAICS) code for the proposed acquisition is 811219, Other Electronic and

Precision Equipment Repair and Maintenance, Small Size Standard 1,000 Employees. This is full and open competition solicitation.

This requirement is to provide “Comprehensive Preventive Maintenance and Repair for four (4) pieces Steris equipment’s.

Part 2 – Supplies or Services and Prices Purchase Order Type: Firm-Fixed Price

Base Year:

CLIN Service and Supply Description Quantity Total Price

Preventive Maintenance & Repair for:

Eagle 3000 Stage 3 20” Gravity Steam

SN # 011549214

Preventive Maintenance & Repair for:

Reliance 400, Steam, SPD, 120-208V, 3PH, 4 Wire

SN # 3603410009

Preventive Maintenance & Repair for:

Lab 250 Gravity Man VRT SLD SD R1W 120V 1PH

SN # 011640507

Preventive Maintenance & Repair for:

Amsco 250LS Man SD Cab STM Air Cool

SN # 030041917

Total Price

Option Period 1:

Preventive Maintenance & Repair for:

Eagle 3000 Stage 3 20” Gravity Steam

SN # 011549214

Preventive Maintenance & Repair for:

Reliance 400, Steam, SPD, 120-208V, 3PH, 4 Wire

SN # 3603410009

Preventive Maintenance & Repair for:

Lab 250 Gravity Man VRT SLD SD R1W 120V 1PH

SN # 011640507

Preventive Maintenance & Repair for:

Amsco 250LS Man SD Cab STM Air Cool

Option Period 2:

Preventive Maintenance & Repair for:

Eagle 3000 Stage 3 20” Gravity Steam

SN # 011549214

Preventive Maintenance & Repair for:

Reliance 400, Steam, SPD, 120-208V, 3PH, 4 Wire

SN # 3603410009

Preventive Maintenance & Repair for:

Lab 250 Gravity Man VRT SLD SD R1W 120V 1PH

SN # 011640507

Preventive Maintenance & Repair for:

Amsco 250LS Man SD Cab STM Air Cool

Option Period 3:

Preventive Maintenance & Repair for:

Eagle 3000 Stage 3 20” Gravity Steam

SN # 011549214

Preventive Maintenance & Repair for:

Reliance 400, Steam, SPD, 120-208V, 3PH, 4 Wire

SN # 3603410009

Preventive Maintenance & Repair for:

Lab 250 Gravity Man VRT SLD SD R1W 120V 1PH

SN # 011640507

Preventive Maintenance & Repair for:

Amsco 250LS Man SD Cab STM Air Cool

Option Period 4:

Preventive Maintenance & Repair for:

Eagle 3000 Stage 3 20” Gravity Steam

SN # 011549214

Preventive Maintenance & Repair for:

Reliance 400, Steam, SPD, 120-208V, 3PH, 4 Wire

SN # 3603410009

Preventive Maintenance & Repair for:

Lab 250 Gravity Man VRT SLD SD R1W 120V 1PH

SN # 011640507

Preventive Maintenance & Repair for:

Amsco 250LS Man SD Cab STM Air Cool

Total Price for the requirements base plus four (4) option years is: ________________________

Company Name: ________________________ DUNS Number: _______________________

Point of Contact: _______________________Tel: ____________E-mail: ___________________

Estimated Delivery Date: ________________ Country of Manufacturing: _____________

Payment is only authorized for the respective firm-fixed-price upon successful completion of the respective CLINs, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer’s Representative (COR) according to the Statement of

Work, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below.

Part 3 – Description/Specifications

3.1 Background

Scientists working at the Gulf Coast Seafood Laboratory (GCSL) requires clean and sterile media and labware to perform their experiments. Biowaste is accumulated as a result of these studies.

The glassware washer and each of the steam sterilizers are necessary to clean and sterilize the labware, media, and biowaste involved in the experimental process. Steris washers and sterilizers meet the stringent quality control requirements implemented by Center for Food Safety and

Applied Nutrition (CFSAN) and the National Shellfish Sanitation Program (NSSP) to prepare media and labware to ensure precise and accurate results.

The Steris sterilizers for labware, media, and biowaste here at the GCSL ensure the destruction of all living microorganisms, preventing contamination in sample processing. Because it is necessary to have clean and sterile components throughout the experimental process and with the complexity of the equipment, multiple inspections and preventative maintenance is imperative to ensure quality results.

3.2 Statement of Work

Requirements

Steris equipment in used at the Food and Drug Administration (FDA) GCSL for the cleaning and sterilization of labware, media, and biowaste involved in and as a result of studies performed at the GCSL. Because Steris sterilizers and dishwashers are industrial equipment, annual maintenance and calibration of this instrument is imperative to ensure quality results. Steris sterilizers and glassware washer systems which are well maintained will have the specific technological attributes:

• Eliminate living organisms, such as bacteria, fungi, viruses, and spores.

• Easy to program control, with full flexibility for basic and advanced lab applications.

• New STERI-Green® and STERI-Green Plus® water conservation systems and other energy saving options.

• Automated washing to clean lab glassware as well as clean critical components used.

• Wash chambers hold various sizes of laboratory glassware, reducing the number of loads needed to process daily requirements.

Specific Tasks for Sterilizer and Dishwasher maintenance agreement

1. Comprehensive (Platinum): Comprehensive service includes all parts and labor to perform

(i) scheduled preventive maintenance in accordance with STERIS’s then current

Preventive Maintenance Check List (“PMCL”), (ii) unscheduled repair visits with response within 24h, (iii) parts required during both preventative maintenance and unscheduled repair visits.

2. Priority Technical Support is also included in addition to Remote Monitoring if the covered equipment is capable and enabled with this technology.

3. Normal Working Hours – The Services for surgical equipment shall be performed

Monday through Friday, 8:00 A.M. to 8:00 P.M., local time, excluding federal holidays

(“Normal Working Hours”). The Services for infection prevention equipment will be performed Monday through Friday, 8:00 A.M. to 5:00 P.M., local time, excluding federal holidays (“Normal Working Hours”). Any Service not performed during Normal Working

Hours shall be billed at the then current applicable rate.

4. Overtime Coverage Options: Overtime coverage, unless included as part of a Service

Option and indicated on the Equipment List, will be charged at prevailing rates for any service performed outside Normal Working Hours.

5. Priority Technical Support: Priority Technical Support service for STERIS equipment for the term of the Agreement to include; unlimited calls to the service hotline, calls related to

STERIS equipment shall be placed ahead of calls related to equipment that is not registered for Priority Support coverage and shall route all calls to the appropriate

Technical Support resource based on the equipment serial number.

6. Block of Time: Subscriber agrees to purchase an annual prepaid retainer for a specific value of STERIS labor and travel.

7. Block of Parts: Subscriber agrees to purchase an annual prepaid retainer for a specific value of STERIS parts.

Part 4 –Performance and Deliverables

4.1 Delivery, Installation, Training, and Support: 52.247-34 F.O.B. Destination

The vendor is responsible to provide all the services for the specified above. The vendor is responsible for services and parts required for these equipment. The vendor will demonstrate upon services and repair that the equipment will meet all performance specifications of the manufacturer. The equipment will not be accepted until all performance specifications have been met. The project officer will perform inspection and acceptance of the equipment. The services and repair work must be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

The vendor shall cover all costs associated with the following:

• Crating and shipping of all parts shall be included in this proposal to the delivery address.

• On-site installation, hardware, software, and applications training shall be provided at the FDA site.

• All appropriate training manuals and literature must be supplied either electronically or in hard copy.

• Technical support shall be provided through common avenues: phone, web, fax, during standard business hours.

Place of Performance and Work Hours

Delivery and installation should be coordinated through the Contracting Officer Representative.

Work shall be conducted Monday through Friday, excluding federal holidays. The vendor is responsible for delivery and installation of the instrument to the laboratory facility.

The services and repair work shall be performed at:

U.S. Food and Drug Administration

Gulf Coast Seafood Laboratory (GCSL)

1 Iberville Drive

Dauphin Island, AL 36528

Tel: 251-406-8137

Inspection and Acceptance Criteria

After the delivery of the services, the Government shall have 30 working days to inspect and verify that the equipment is operational and functional. Acceptance to be made after completion of IQ/OQ.

Period of Performance

The period of performance for this contract is base period with four (4) one (1) year option periods.

Base period: February 1, 2020 to January 31, 2021 (Subject to change based on award date)

Option Period 1 February 1, 2021 to January 31, 2022 (Subject to change based on award date)

Option Period 2 February 1, 2022 to January 31, 2023 (Subject to change based on award date)

Option Period 3 February 1, 2023 to January 31, 2024 (Subject to change based on award date)

Option Period 4 February 1, 2024 to January 31, 2025 (Subject to change based on award date)

This is a standard procurement for a commercial product item. Period of performance will be the standard delivery after placement of the order, plus warranty and service contract coverage for one (1) year.

Warranty/Preventative Maintenance Service Agreement

Warranty: Vendor shall offer a minimum one-year warranty for parts and labor for repairs or defects.

Part 5 –Contract Administration

5.1 Administrative Points of Contract

Contracting Officer’s Representative’s

For this PART, (COR TBD) is the authorized representative of the Contracting Officer.

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment 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 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 is the following:

Richard Robinson

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Rd.

Beltsville, MD 20705

Richard.Robinson@fda.hhs.gov

Tel: 301- 796-6508

The contact information for the Contract Specialist is the following:

Ravi Chandan Palaniandy

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Rd.

Beltsville, MD 20705

Ravichandan.palaniandy@fda.hhs.gov

Tel: 301-796-4378

5.2 FDA Three-Way Match Invoicing Procedures

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

Office of Financial Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Phone: 301-827-3742

Email: FDAVendorPaymentsTeam@fda.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 To Be Determined

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses mailto:Richard.Robinson@fda.hhs.gov mailto:Ravichandan.palaniandy@fda.hhs.gov mailto:FDAVendorPaymentsTeam@fda.gov

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 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 (xii) 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 https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html

(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 6 – Contract clauses

6.1 HHSAR 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:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses.

352.203-70, ANTI-LOBBYING (DEC 2015)

352.215-70, LATE PROPOSALS AND REVISIONS (DEC 2015)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS (DEC 2015)

6.2 FAR Clauses Incorporated by Reference

52.204-16, Commercial and Government Entity Code Reporting (Jul 2016)

52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016)

52.204-22, Alternative Line Item Proposal (Jan 2017)

52.212-1, Instructions to Offerors—Commercial Items (Oct 2018)

52.212-4, Contract Terms and Conditions—Commercial Items (Oct 2018)

52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

6.3 FAR Clauses Full Text

52.204-21, Basic Safeguarding of Covered Contractor Information Systems

As prescribed in 4.1903, insert the following clause:

BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)

(a) Definitions. As used in this clause–

“Covered contractor information system” means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

“Federal contract information” means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

“Information” means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

“Information system” means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44

U.S.C. 3502).

“Safeguarding” means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract

Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

http://uscode.house.gov/ http://uscode.house.gov/

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

52.204-22 Alternative Line Item Proposal.

As prescribed in 4.1008, insert the following provision:

ALTERNATIVE LINE ITEM PROPOSAL (JAN 2017)

(a) The Government recognizes that the line items established in this solicitation may not conform to the Offeror’s practices. Failure to correct these issues can result in difficulties in acceptance of deliverables and processing payments. Therefore, the Offeror is invited to propose alternative line items for which bids, proposals, or quotes are requested in this solicitation to ensure that the resulting contract is economically and administratively advantageous to the

Government and the Offeror.

(b) The Offeror may submit one or more additional proposals with alternative line items, provided that alternative line items are consistent with subpart 4.10 of the Federal Acquisition

Regulation. However, acceptance of an alternative proposal is a unilateral decision made solely at the discretion of the Government. Offers that do not comply with the line items specified in this solicitation may be determined to be nonresponsive or unacceptable.

(End of provision)

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony

Conviction under any Federal Law.

As prescribed in 9.104-7(d), insert the following provision:

REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A FELONY

CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further

Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%204_10.html#wp1073826 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%204_10.html#wp1072814 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%209_1.html#wp1086248 subsequent appropriations acts, the Government will not enter into a contract with any corporation that—

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding

24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that—

(1) It is □ is not □ a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is □ is not □ a corporation that was convicted of a felony criminal violation under a

Federal law within the preceding 24 months.

(End of provision)

52.212-3 Offeror Representations and Certifications-Commercial Items.

As prescribed in 12.301(b)(2), insert the following provision:

Offeror Representations and Certifications-Commercial Items (DEC 2019)

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

(SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v)) of this provision.

(a) Definitions. As used in this provision—

“Covered telecommunications equipment or services” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment.

“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 https://acquisition.gov/content/12301-solicitation-provisions-and-contract-clauses-acquisition-commercial-items#i1113145 https://www.sam.gov/ https://www.acquisition.gov/content/52204-25-prohibition-contracting-certain-telecommunications-and-video-surveillance-services-or-equipment#id1989I600I4C 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.

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

(1) 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

(2) 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 domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“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 that http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim 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”—

“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

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 with13 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 at13 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

CFR124.104(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

“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 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

“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.

“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 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.

“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 least51 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.

(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 in SAM

(2) The offeror has completed the annual representations and certifications electronically in

SAM accessed through http://www.sam.gov. After reviewing SAM 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), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

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

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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 13CFR124.1002.

(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 50percent 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 Order11246-

(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 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

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.)

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(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 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 FAR52.225-3, 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”:

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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

[List as necessary]

(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph(g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements-Israeli Trade Act.” The offeror shall list as other foreign end products those end products manufactured in the

United States that do not qualify as domestic end 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.”

Other Foreign End Products:

Line Item No. Country of Origin

[List as necessary]

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

(2) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I. If

Alternate I to the clause at FAR52.225-3 is included in this solicitation, substitute the following paragraph(g)(1)(ii) for paragraph(g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements-

Israeli Trade Act”:

Canadian End Products:

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Line Item No. Country of Origin

[List as necessary]

(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II. If

Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph(g)(1)(ii) for paragraph(g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or

Israeli end products as defined in the clause of this solicitation entitled “Buy American-

Free Trade Agreements-Israeli Trade Act”:

Canadian or Israeli End Products:

Line Item No. Country of Origin

[List as necessary]

(4) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III. If

Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or

Peruvia…