FDA Solicitation 75F40123Q115946.pdf

75F40123Q115946

Document Type: Combined Synopsis/Solicitation

Solicitation Number: 75F40123Q115946

Posted Date: January 24, 2023

Title: Hardware-software upgrades and preventive maintenance for Cozzoli vial filling machine

Response Date: February 7, 2023 2:00 PM Central Time

NAICS Code: 333993 – Packaging Manufacturing Machinery

Product or Service 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 75F40123Q115946. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through are those in effect through Federal Acquisition Circular (FAC) 2023-01 effective December 30, 2022.

The associated North American Industry Classification System (NAICS) code for this acquisition is 333993 – Packaging Manufacturing Machinery, Small Business Size: 500 employees. This requirement is solicited as a total small business set-aside.

Background and Requirement

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC), serves as a Standards Preparation facility for CBER. DBSQC maintains a well-equipped Standards Preparation capacity to both (1) prepare standards for potency testing and (2) share them with manufacturers and other regulatory agencies. Standards are also used to test assay validity for vaccine products, and an important part of DBSQC laboratory activities involves testing influenza vaccines for potency and identity. An integral component of this testing is a Cozzoli Vial Filling Machine, which dispenses an exact volume of biological standards into vials for lyophilization and subsequent distribution. This filling machine is critical to the accurate, consistent preparation of Standards and to the mission of CBER, since the standards prepared support testing for licensing, lot release, and other regulatory decisions.

This instrument requires both hardware and software upgrades to its computer processor and Human- Machine Interface (HMI), a replacement set of weight cells (scales), and a base year and four (4) option periods of preventive maintenance for the system once the HMI and weight scales have been integrated.

Schedule of Items:

Line Item 1 Hardware and software upgrades to its Human-Machine Interface (HMI) system to include computer processor, display panel, and software, as well as a replacement set of four (4) weight cells (scales), for a Cozzoli vial filling machine, S/N: CR200i-CWS- 69, to include all labor, travel, freight charges (FOB Destination), installation, staff familiarization, and meeting the minimum technical requirements set forth below.

Quantity: 1

Unit: Each

Unit Price (each): ____________________________

Extended Price: ____________________________

GSA Contract Number (if applicable): ____________________________

Line Item 2 On-site preventive maintenance for Cozzoli vial filling machine and components, S/N’s: CR200i-CWS-69, UT36-975, BT15-75; period of performance shall be 12 consecutive months commencing from date of upgrades described on Line Item 1 above; estimated period of performance is 7/18/2023 – 7/17/2024:

Quantity: 1

Unit: Year (12 months)

Annual Price: ____________________________

GSA Contract Number (if applicable): ____________________________

Line Item 3 Option Year 1 - On-site preventive maintenance for Cozzoli vial filling machine and components, S/N’s: CR200i-CWS-69, UT36-975, BT15-75; period of performance shall be 12 consecutive months commencing from expiration of base year; estimated period of performance is 7/18/2024 – 7/17/2025:

Quantity: 1

Unit: Year (12 months)

Line Item 4 Option Year 2 - On-site preventive maintenance for Cozzoli vial filling machine and shall be 12 consecutive months commencing from expiration of Option Year 1;

estimated period of performance is 7/18/2025 – 7/17/2026:

Quantity: 1

Unit: Year (12 months)

Line Item 5 Option Year 3 - On-site preventive maintenance for Cozzoli vial filling machine and shall be 12 consecutive months commencing from expiration of Option Year 2;

estimated period of performance is 7/18/2026 – 7/17/2027:

Quantity: 1

Unit: Year (12 months)

Line Item 6 Option Year 4 - On-site preventive maintenance for Cozzoli vial filling machine and shall be 12 consecutive months commencing from from expiration of Option Year 3;

estimated period of performance is 7/18/2027 – 7/17/2028:

Quantity: 1

Unit: Year (12 months)

GRAND TOTAL-Lines 1-6 above: ____________________________

Minimum Technical Requirements shall include the following for a Human-Machine Interface (HMI) system to include computer processor, display panel, and software, as well as a replacement set of four (4) weight cells (scales), for Cozzoli vial filling machine, S/N:

CR200i-CWS-69:

HMI Computer:

*All parts, hardware, and software shall be OEM required as described below;

*Upgrade to Windows 10 HMI operating system;

*Rockwell Automation touch display 6181P HMI industrial computer w/15.6 inch display, AC poer source, 4:3 stainless steel bezel, RSLinx software (new or upgrade) w/existing license, 256GB MLC solid state drive, Microsoft Office LTSC Standard 2021 w/license;

*Sytech XLReporter V14.3 or higher (new or upgrade) w/license;

*Configuration of HMI computer for seamless integration with existing Cozzoli filler identified above;

*On-site installation and qualification service to include labor, travel, parts, subassemblies;

*Qualification service shall demonstrate no change in functionality in filler line after upgrades;

*System familiarization training on system for FDA staff;

*Minimum one-year full manufacturer warranty commencing from date of acceptance and functionality.

Weight Cells (Scales):

*All parts, hardware, and software shall be OEM required as described below;

*Quantity of four (4) weight cells system upgrade for Cozzoli vial filling machine, S/N: CR200i-CWS- 69;

*Each weight cell measuring range of 50g, maximum dead-load 50g, display value (d) 0.0005g, with Class IP44 protective housing;

*Stainless steel 316L connected to separate electronics box;

*Interface 1: ethernet/IP; Interface 2: RS232; power supply 24V DC;

*On-site installation and qualification service to include labor, travel, parts, subassemblies;

*Qualification service shall demonstrate no change in functionality in filler line after upgrades;

*System familiarization training on system for FDA staff;

*Minimum one-year full manufacturer warranty commencing from date of acceptance and functionality.

Installation, Training and Additional System Requirements:

*Hardware shall be newly manufactured, not used or refurbished, or previously used for demonstration;

*System upgrades shall be delivered with all necessary supplies and accessories required for full use;

*Shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting. All manuals and documentation shall be provided in hard copy and/or electronic format;

*The contractor shall provide any necessary guidance on pre-installation site requirements;

* Phone and email technical support shall be included for a minimum of one (1) year.

Minimum Technical Requirements shall include the following for preventive maintenance service for Cozzoli vial filling machine and components, S/N’s: CR200i-CWS-69, UT36-975, BT15-75:

*The preventive maintenance plan shall include at least one (1) planned on-site visits for routine certification of the instrument per year; PM plan shall include all periodic maintenance services as described and required for annual system health checks;

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

*Corrective or repair visits shall occur within 3-5 business days of call for service (for issues that can’t be resolved remotely via phone or Internet); troubleshooting activities shall include spare parts replacement where required and allowed by contractor; service plan shall also include FDA Technical Representative access to OEM technical developments as required;

*Shall include software and firmware updates, where applicable;

*Unlimited technical support Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern Time, and shall begin working on a solution to the problem within 8 business hours of contact for assistance;

*Proposed pricing shall provide Preventive Maintenance service(s) inclusive of shipping, labor, travel, replacement parts, components, subassemblies, etc.

*NOTE: Base period preventive maintenance shall be performed at time of system upgrades described in Line Item 1 above.

Deliverables: Service Records and Reports:

The Contractor shall, commensurate with the completion of each service call or preventive maintenance visit, provide the end-user of the equipment and the Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

Preventive maintenance or repair visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Delivery Terms - Upgrades FOB Destination approximately 20-24 weeks of receipt of award.

Period(s) of Performance for Preventive Maintenance Periods of Performance for the base and four (4) optional years of preventive maintenance are estimated as follows:

Base Year: 07/18/2023 through 07/18/2024 Option Year 1: 07/18/2024 through 07/17/2025;

Option Year 2: 07/18/2025 through 07/17/2026;

Option Year 3: 07/18/2026 through 07/17/2027;

Option Year 4: 07/18/2027 through 07/17/2028;

The periods of performance for the base and option years of preventive maintenance in any resultant award will be estimated based on (1) successful delivery, installation and acceptance of the hardware and software system upgrades as described in Line Item 1 above, and (2) and performance of the base

(initial) preventive maintenance service. Periods of performance for the 4 option years shall then be documented and incorporated into the contract by bilateral contract modification.

Contract Type: Commercial Products and Commercial Services-Firm Fixed Price

Place of Delivery/Performance U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg 52/72, 5th Floor Sterility Suite 10903 New Hampshire Ave.

Silver Spring, MD 20993-0002

POC: Will be provided at time of award

FDA Attestation and COVID-19 Testing Screening Procedures for Onsite Work at an FDA Facility

On April 22, 2022, HHS posted a notice to SAM.gov outlining procedures for access control regarding onsite contractor attestation of vaccination or evidence of negative COVID-19 test results and can be found here: https://sam.gov/opp/b85251f1555c40dfae55adf651e18f5a/view. The notice outlines the use of the Contracting Officer Representative (COR)/Technical Point of Contact (TPOC) or his/her designee to facilitate this process.

FDA has developed a process that should be followed in FDA facilities based upon medium or high COVID-19 Community Levels in an area.

The COR/TPOC or Designee should validate compliance prior to any Contractor or visitor reporting on-site at an FDA facility.

Similar to FDA’s face covering/mask policy, each individual is responsible for checking the current CDC COVID-19 Community Level for their respective FDA facility and implementing this compliance check for contractors who will be working on-site if the facility CDC COVID-19 Community Level is Medium or High.

The Contractor shall maintain a copy of either their Certification of Vaccination form or result of a negative COVID-19 test within the last 72 hours and must always have it available with them to present to the COR/TPOC or Designee upon request.

Onsite Contractors who are not yet fully vaccinated, unvaccinated, or decline to disclose their vaccination status and who are unable to show proof of a negative test within the last 72 hours, may be asked to leave the facility. The COR/TPOC or Designee shall then notify their Contracting Officer (CO) that this action was taken.

Solicitation Provisions

52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) https://sam.gov/opp/b85251f1555c40dfae55adf651e18f5a/view

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) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-17 Ownership or Control of Offeror (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.

52.217-5 Evaluation of Options (July 1990)

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 Products and Commercial Services (Nov 2021) applies to this solicitation. The following addenda apply:

Paragraph (b)(4). Offerors shall provide sufficient technical information necessary for the government to conclusively determine that the offered upgrades and preventive maintenance services for an existing Cozzoli vial filling machine, S/N: CR200i-CWS-69 meet all the technical requirements herein, to include descriptive material, literature, brochures and other information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered equipment and services. The Government is not responsible for locating or securing any information which is not identified in the quote; however, the Government reserves the right to obtain information for use in https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html the evaluation from any sources including sources outside of the Government. The Government reserves the right to request additional information at any time.

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).

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.

The price(s) proposed must be detailed and shall represent the offeror’s response to the schedule of supplies/services above. Pricing shall be detailed and supported by an itemized but practical list of all items required for system operation. NOTE: Offerors shall fill in the schedule above with the total system price AND provide a detailed quote in their own format.

Proprietary and/or confidential information shall be clearly marked. Respondent’s SAM Unique Entity Identifier (UEI) number shall be included with quote.

Paragraph (b)(8) Representations and Certifications- In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's proposal shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48 as follows:

NOTE: This solicitation is being issued under the premise that the offeror will certify that the combination of equipment maintenance/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If the Contractor certifies that the company is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will be applicable to the resulting order. In the event that a contractor does not make this certification, 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 2015-4269 (Rev. 21), 12/27/2022, and can be accessed at the following link: https://sam.gov/wage-determination/2015- 4269/21.

The provision at FAR 52.222-48 Exemption from Application of the Service Contract Act 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— https://www.itic.org/policy/accessibility/vpat http://www.itic.org/policy/accessibility https://sam.gov/wage-determination/2015-4269/21 https://sam.gov/wage-determination/2015-4269/21

(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 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.

Paragraph (c). Period for Acceptance of Offerors. FAR Clause 52.232-18 applies to this acquisition.

Pricing shall remain valid through September 30, 2022.

The option year service agreement periods will not be funded at time of award. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option period shall be priced accordingly.

Paragraph (j) Unique entity identifier. Due to the ongoing delays in the System for Award Management (SAM) beyond the control of, and related to, entities and their ability to activate or re-activate their firm’s registration(s) in SAM, the determination has been made that it is in the best interests of the Government to accept offers from entities not actively registered at the time offers are submitted.

Once an awardee is apparent, the contract officer shall notify the apparent awardee of the date by which the entity must be active in SAM. If that date passes and the entity is still not actively registered in SAM.gov, the Contracting Officer will award to the next otherwise successful SAM.gov-registered Offeror.

Microsoft Suite Documents Containing Macros The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, 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 all electronic documents are submitted without the use of macros.

Buy American Act and Executive Order 14005 If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required.

The provision at 52.212-2 Evaluation-Commercial Products and Commercial Services (Nov 2021) is applicable to this solicitation.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. For the purposes of this solicitation, “Most advantageous to the Government” is defined as lowest price technically acceptable (LPTA). Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first.

If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.

Technically acceptability will be determined by review of information submitted by the Offeror which shall provide all descriptive material necessary for the government to conclusively determine that the equipment and services offered will satisfy the Government’s requirements and demonstrate successful performance of the products described herein.

Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. For services, quotes shall also include a brief description of service performed, contract number(s), client points of contact names, and client points of contact, email addresses, and phone numbers. The government is not responsible for locating or securing any information, which is not identified in the proposal.

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

(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 Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (Dec 2022) 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— 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

(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.

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

(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.

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 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 http://www.sam.gov/ submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, 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.]

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). 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 https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201

(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.

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(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.”

(2) Foreign End Products:

Line Item No. Country of Origin

[List as necessary]

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

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

(i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product," "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," "Free Trade Agreement country," "Free Trade Agreement country end product," "Israeli end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements–Israeli Trade Act."

(ii) The Offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements- Israeli Trade Act."

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

Line Item No. Country of Origin https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-25#FAR_Part_25 https://www.acquisition.gov/far/part-25#FAR_Part_25 https://www.acquisition.gov/far/part-52#FAR_52_225_3

Line Item No.