FDA-RFQ-1238565-Amendment A00001 Upgrade Checkpoint Hardware.pdf

FDA-RFQ-1238565

AMENDMENT A00001

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-RFQ-1238565 Posted Date: February 12, 2021

Title: Upgrade temperature monitoring system hardware from CheckPoint to ViewPoint

Original Response Date: February 25, 2021 12:00 PM CT

Amendment Date: March 1, 2021

Revised Response Date: March 4, 2021 1:00 PM CT

Amendment Notes: Amended information is highlighted by a thick bold line in the left margin of the document.

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

Classification Code: 6640 – Laboratory Equipment and Supplies

Contracting Office Address

FDA/OO/OFBA/OAGS/DAP

National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation is being issued in conjunction with FAR Part 13 - Simplified Acquisition Procedures. The solicitation number is FDA- RFQ-1238565. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-03 effective February 16, 2021.

The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1000 Employees. This requirement is solicited as a Total small business set-aside; only small businesses under the applicable NAICS may submit a quote.

Background and Requirement

The U.S. Food and Drug Administration’s (FDA), Office of Regulatory Affairs (ORA) requires upgrades to its wireless Temperature Monitoring System. The Arkansas Laboratory (ARKL) currently uses the Mesa Laboratory Inc, ViewPoint Temperature Monitoring System Software, which provides automated wireless temperature monitoring of refrigerators, freezers, incubators, water baths, and ovens to meet requirements for monitoring analytical critical control points in accordance with its ISO/IEC 17025:2017 and the Association of Official Analytical Chemists (AOAC) guidelines and Office of Regulatory Science’s (ORS) Quality Management System. The associated Mesa Labs/TempSys CheckPoint hardware currently in use is approaching its life expectancy and will no longer be supported. The Government has a requirement to replace the temperature monitoring system hardware that can be used with all or most of the software currently owned and installed in the ORS laboratories. The FDA’s Office of Regulatory Science, ARKL, requires that the new hardware be compatible with the ViewPoint software which is currently in use. The new hardware, in conjunction with the ViewPoint software will allow for increased point of use temperature monitoring, increased storage of temperature readings, and offers an immediate view of temperatures during any power outage. These upgrades are necessary for the monitoring system to be able to function in today’s technological environment and to meet new and ever-increasing stringent regulatory concerns.

The Offeror shall provide all resources necessary to accomplish the tasks and deliverables described herein. The Offeror shall provide hardware that is compatible to existing ViewPoint software to standardize temperature monitoring across ORS and the Office of Information Management and Technology (OIMT). The Offeror shall provide installation, conduct all Initial Qualification/Operation Qualification (IQ/OQ) and provide training as required on the upgraded equipment. As ARKL currently has the ViewPoint software associated with the temperature monitoring system, no software is required with this procurement. Vendor shall provide all hardware identified in the equipment list, install all hardware necessary for the system to function as intended, and conduct functionality verification check(s) as required. This acquisition also includes the requirement for four (4) years of post-warranty maintenance on the hardware or system, depending on what is quoted.

Schedule of Supplies or Services and Prices/Costs. Pricing shall be inclusive of shipping and installation to the ARKL at 3900 NCTR Rd, Building 26, Jefferson AR 72079.

Upgrade TempSys CheckPoint temperature monitoring system hardware, as set forth herein, which shall include the following parts and services.

While the items below are indicative of the parts and services the government estimates are required to upgrade the system in use at the Arkansas labs, this is only an estimate of what will be required for the system upgrade. Offerors/quoters are afforded the opportunity to inspect the existing equipment and site, at their own expense, prior to the date set for receipt of quotes by contacting the Contract Specialist/Contracting Officer identified herein to schedule an appointment. Failure to inspect the site will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered.

Line Item 1: System Upgrade/Equipment Items: While ViewPoint hardware is specified, offerors/quoters may propose “or equal” hardware as long as it is compatible with and will seamlessly integrate with the laboratory’s existing ViewPoint software.

VPx or equal, 900 MHz Access point. Item #: CM-000252, QTY: 26

VPx or equal, 900 900MHz, Sensor LCD - RTD, KIT. Item #: CM-000261, QTY: 134

VPx or equal, 900 900MHz, Sensor with LCD - DUAL RTD, KIT. Item #: CM-000301 QTY: 19

VPx or equal, 900 900MHz, Sensor LCD - CRYO RTD, KIT. Item #: CM-000264: QTY: 5

VPx or equal, 900 900MHz, Sensor LCD - I2C Snap TEMP/HUMIDITY, KIT - Low Power.

Item #: CM-000262: QTY: 1

VPx or equal, 900 900MHz, Sensor LCD - PYRO RTD. Item #: CM-000366, KIT: QTY: 9

VPx or equal, 900 Cable, Door Switch / Motion / Alarm Contact. Item #: CM-000183, QTY: 158

Cable, Power, Extension, 14.0', 2.1x5.5mm. Item #: CM-000065: QTY: 168

Continuous Monitoring (CM) Protocol: QTY: 1

Technical Support and Warranty: QTY: ALL (168)

Total Equipment Price: $ _____________________

Line Item 2: Travel

Travel is from contractor’s place of business to the Delivery/Performance location listed herein:

Total Travel Cost: $ _______________________

Line Item 3: Installation and Training

On-Site Technician (per day):

Price per day: $ ____________ Approx Qty: 12 days Total Install/Training Cost: $ ________________

Line Item 4: Post-Warranty Maintenance and Calibration Service Agreement, Base Year.

Quantity: 1 Unit: EA

Price: _____________________

Line Item 5: Post-Warranty Maintenance and Calibration Service Agreement, Option Year 1.

Line Item 6: Post-Warranty Maintenance and Calibration Service Agreement, Option Year 2.

Line Item 7: Post-Warranty Maintenance and Calibration Service Agreement, Option Year 3.

Quantity: 1 Unit: EA

Price: _____________________

TOTAL PRICE:

(Equipment plus travel & installation/training + 4 years of Post-Warranty Maintenance/Service Agreement): ______________________________________

GSA Contract Number: __________________ (if applicable)

Minimum Technical Requirements/Salient Characteristics:

1. Contractor shall be ISO/IEC 17025:2017 accredited.

2. Hardware shall be compatible with Mesa Labs ViewPoint software version 1.3.

3. Hardware shall be capable of continuous monitoring and at a minimum collect data at 15 minimum intervals from each individual sensor.

4. Hardware probes must provide visual temperature readout at point of use.

5. Hardware shall have the capability to capture and store all wireless temperature probes transmissions to sufficient specificity/sensitivity of ±0.2°C of the specified set monitoring temperature value.

6. Hardware must be scalable to address the needs of the laboratory as it continues to expand and shall be able to accommodate changing technologies with minimal changes required to the wireless temperature monitoring system infrastructure.

7. Hardware shall provide the capability to program a wide range of wireless temperature sensing probes that are capable of monitoring temperatures associated with freezers, ultra-low freezers, refrigerators, water baths, ovens, and incubators.

8. Vendor is required to provide all hardware identified in the equipment list, install all hardware necessary for the system to function as intended, and conduct functionality verification check(s) as required

9. The system must be sufficient to operate within the FDA/ORA’s multi-floor laboratory facility

10. The system must remain scalable to address the needs of the laboratory as it continues to expand, and adaptable (upgradeable) to accommodate changing technologies

Probe Requirements:

Temperature range to be monitored:

Calibrated probes are required for this system and must include calibration certificate(s) with traceability to the US National Institute of Standard (NIST). System must provide a range of wireless temperature sensing probes that are capable of monitoring temperatures associated with Ultra low freezers to environmental chambers between -82° C and 125° C and humidity range 10-70%. All wireless temperature probes must be of sufficient specificity/sensitivity to calibrate to ±0.2° C of the specified set temperature monitoring value and must have Certificate of Calibration that conforms to ISO/IEC 17025 requirements.

Trade and Service Specifications

1. Equipment shall have at least a minimum one (1) year OEM-warranty for parts and labor;

2. Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.

3. Equipment shall be delivered with all necessary supplies and accessories required for installation and start-up.

Post Warranty Maintenance/Service Agreement: Agreement shall include and meet the following technical requirements:

1. Minimum of one (1) planned on-site preventive maintenance visit for routine certification, calibration of each probe per contract year;

2. 24x7 phone support and extended service plan covering replacement parts for manufacturing defects only;

3. Response time within 1 business days after receipt of service call if issue cannot be corrected remotely within 8 hours from call for service;

4. Annual Support Plan per device. 1 year support plan that includes 24x7 phone support and extended support plan covering replacement parts for for manufacturing defects only;

5. Access by the FDA Technical Point of Contact (TPOC) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

6. Software, firmware, and application updates as required by the OEM;

7. Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern Time;

8. All maintenance activities shall be performed by formally trained and Original Equipment Manufacturer (OEM) -certified technicians and/or engineers, following OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.;

9. All preventive maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Service Records and Reports

1. Provide Calibration Report fulfilling the requirements of ISO/IEC17025:2017 for each temperature probe at time of installation

2. The Contractor shall, commensurate with the completion of each service visit, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Contract Type: Commercial Item - Firm fixed price

Delivery Terms:

Delivery/Installation/Calibration/IQ/OQ: Must be performed NLT Sept 29, 2021.

Period(s) of Performance for Post-Warranty Maintenance/ServicePlan. Base Year plus four (4) one-year Option Years.

Manufacturer’s Warranty: 12 consecutive months from installation and training (anticipated to be no later than Sept 29, 2021);

Warranty Period: anticipated on/about Sept 30, 2021 – Sept 29, 2022 Base Year: anticipated on/about Sept 30, 2022 – Sept 29, 2023 Option Year 1: anticipated on/about Sept 30, 2023 – Sept 29, 2024 Option Year 2: anticipated on/about Sept 30, 2024 – Sept 29, 2025 Option Year 3: anticipated on/about Sept 30, 2025 – Sept 29, 2026

The period of performance for the Option years in any resultant award will be estimated based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period. If/when Option Year 1 Post-Warranty Service/ maintenance is exercised, the periods of performance for all post-warranty Options will be firmed via bilateral modification.

Delivery/Performance Location

US FDA/ARKL

3900 NCTR Rd. BLDG 26 Jefferson AR 72079 POC: Will be provided at time of award

Solicitation Provisions 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/browse/index/far and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Provisions 52.204-7 System for Award Management (Oct 2018) https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) (fill-in appropriate boxes below):

(d) Representation. The Offeror represents that—

(1) It ☐ will, ☐ will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It ☐ does, ☐ does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)

(c) (1) Representation. The Offeror represents that it ☐ does, ☐ does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it ☐ does, ☐ does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

52.211-6 Brand Name or Equal (Jan 1999)

HHSAR Provisions 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

Shall meet the level of conformance of the delivered service/items to the 508 standards identified in HHSAR Clause 352.239-74(c) herein.

FAR Full Text Provisions

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (June 2020) applies to this solicitation. The following addenda apply:

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) beta.sam.gov for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications or reject the terms and conditions of the solicitation may be excluded from consideration.

Offerors are afforded the opportunity to inspect the existing equipment and site, at their own expense, prior to the date set for receipt of quotes by contacting the Contract Specialist/Contracting Officer identified herein to schedule an appointment. Failure to inspect the site will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered.

Paragraph (b)(4). Technical Capability: It is incumbent that offerors unequivocally demonstrate that offered equipment meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, scientific publications where the proposed solution has been used for same or similar purposes, and other information which demonstrates the acceptability/technical capability of the offered equipment/services. Contractor quotes shall clearly identify and quantify the components and configuration of what their proposed system shall include if it differs from the FDA’s equipment list identified herein.

Offerors are also permitted to propose a new laboratory monitoring system for both hardware and software equal to that of the current system hardware and software; however, it is believed that proposals lending themselves to this strategy will likely be prohibitively expensive compared with just purchasing the hardware upgrade.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). For this requirement we anticipate only deliverables/reports and invoices to be applicable to the requirement unless software becomes part of the purchase package.

NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

Offerors shall submit the following information for MAT List approval:

• Version/Model number of the proposed software.

• Description of what your software does (if the software contains a suite of products, please provide the function of each product contained within the suite).

• Website URL for Software

Paragraph (b)(10). Past Performance: Contractor shall provide references to at least two previous projects where a same or similar temperature control system was sold and installed. For each project, include a thorough description of the project and the name, telephone number, email address of someone who has knowledge of the project and would be available to answer any follow-up questions the Government might have.

Past performance information shall clearly demonstrate recent (within the past 3 years) and relevant experience in providing same or similar products and services, to include a brief description of service performed, contract number(s), dollar value, client points of contact names, and client points of contact email addresses and phone numbers. The Government reserves the right to look to other sources of information (e.g., the Contractor Performance Assessment Reporting System (CPARS), etc.) to support past performance evaluations.

Price: Price(s) proposed shall represent the offeror’s response to the schedule of supplies/services above. Price shall be detailed and supported by a breakdown of all items required for system operation.

(Offerors shall fill in the schedule above with the total system price and provide a detailed quote in their own format.) Offeror shall indicate any discounts offered.

Proprietary and/or confidential information shall be clearly marked. Respondent’s DUNS number shall be included with quote.

The Contractor’s quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48.

Note: The solicitation is being issued under the premise that the Offeror certifies that the service it will propose to fulfill this requirement are exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). Based on this premise that the Offeror certifies that its proposed services are exempt under the terms and conditions of 52.222-48, FAR clause 52.222-51-Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements will be applicable to the resulting order. In the event that an Offeror determines its proposed services do not meet the exemption, they are to expressly notify the Contracting Officer in their quotation and the traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 2015-5121 (Rev. 13) Revision date: 12/21/2020. The applicable wage determination can be located here: https://beta.sam.gov/wage-determination/2015- 5121/13?index=wd&keywords=&is_active=tru

The provision at FAR 52.222-48 Exemption from Application of the Service Contract to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) applies as follows:

(a) The offeror shall check the following certification:

CERTIFICATION

The offeror [ ] does [ ] does not certify that-

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available https://beta.sam.gov/wage-determination/2015-5121/13?index=wd&keywords=&is_active=tru https://beta.sam.gov/wage-determination/2015-5121/13?index=wd&keywords=&is_active=tru for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

(ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and

(3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act-

(1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or

(2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-- Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis.

(c) If the offeror does not certify to the conditions in paragraph (a) of this provision-

(1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements, will not be included in any resultant contract awarded to this offeror; and

(2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation.

(d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.

Microsoft Suite Documents Containing Macros The offeror or applicant shall submit all electronic documents created by Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure that all electronic documents submitted do not contain or otherwise use macros.

The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation.

The following subparagraph (a) factors apply:

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

(1) Technical Capability (see FAR Provision 52.212-1 (b)(4) and addenda thereto)

(2) Past Performance (see FAR Provision 52.212-1 (b)(10) and addenda thereto)

(3) Price

Technical Capability (i.e., how well the proposed products/services will meet or exceed the Government’s requirements) and past performance (i.e., when, what, and how well), when combined, are relatively equal in value and collectively more important than price in determining the best value to the government, although price remains a significant consideration. If the Government determines non-price factors to be essentially equal among competing offerors, price becomes more important as a discriminating factor. The Government is more concerned with obtaining superior performance capability rather than lowest overall price. However, the Government will not make an award at a significantly higher overall price to achieve only slightly superior performance.

Technical Capability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered equipment and/or services meet or exceed the technical requirements identified herein. Contractor quotes shall clearly identify and quantify the components and configuration of what their proposed system shall include if it differs from the FDA’s equipment list identified herein.

The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure the equipment and services meet the FDA’s stated need.

Past Performance: Contractor’s Past Performance will be evaluated to determine the likelihood of success a contractor will have in satisfactorily performing this requirement to upgrade the temperature monitoring system hardware at the Arkansas Labs.

(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.

The government is not responsible for locating or securing any information which is not identified in the proposal/quote; the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (February 2021)(DEVIATION 2020-05), applies to this acquisition.

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 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 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.

https://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.acquisition.gov/far/part-52#FAR_52_204_25 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 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

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 veteransor, 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—

(1) 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.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

https://www.acquisition.gov/far/part-52#FAR_52_204_25 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

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 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(s) applicable to the NAICS code(s) 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.

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.] http://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201

(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 CFR124.1002.

(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, [ ] s 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 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/ 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.)

(i) The Offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product.

(ii) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products.

(iii) The terms "domestic end product," "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Supplies.”

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_1

(2)…