75F40123Q00464 Combined Synopsis_Solicitation.docx

Solicitation No. 75F40123Q00464 Date: August 15, 2023

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00283 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516- Analytical Laboratory Instrument Manufacturing. The small business size standard for NAICS 334516 is 1000 employees. The requirement will be awarded as Firm-Fixed Price and Small Business Set-Aside. Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Sam.Gov. The Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value to the Government and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA), has a need to purchase 1 each benchtop quadrupole-orbital trapping high resolution mass spectrometer with liquid chromatograph

**************************BRAND NAME OR EQUAL ***************************

Description: Statement of Work

1. Scope of Work The purpose of this requirement is to purchase a benchtop quadrupole-orbital trapping high resolution mass spectrometer with liquid chromatograph for the Office of Regulatory Science (ORS), Division of Analytical Chemistry (DAC), Methods Development Branch (MDB).

Background:

ORS/DAC requires the purchase of a benchtop quadrupole-orbital trapping high resolution mass spectrometer (HRMS) with liquid chromatograph for the research and development of qualitative and semi-quantitative methods for emerging contaminants in food and contact materials, such as per and poly-fluorinated alkyl substances (PFAS). A quadrupole-orbital trap mass spectrometer is necessary to provide the flexibility, speed, accuracy, and resolving power to properly detect and identify a range of contaminants whose identity and presence (by definition) is not already known. Past work in this area has shown that quadrupole-orbital trapping mass spectrometers are uniquely positioned to provide this identification power, but existing equipment fails to achieve this power with flexibility and identification from complex samples at time-scales supportive of timely agency action and decision making.

** Important ** **The Vendor shall indicate if the minimum salient characteristics have been met, and how their system meets or exceeds (point by point from RFQ) each detailed technical requirement and include supportive data and descriptions to be considered responsive for this requirement

**The Vendor shall demonstrate the system offered is used successfully by the pharmaceutical industry for applications with similar technical demands.

** Ease of use of the instrument and software to include export data, and images to other programs.

Provide a Country of Origin for all system components.

2. Instrument Requirements and Deliverables:

Technical Requirements The objective of this requirement is to purchase a quadrupole-orbital trap high resolution mass spectrometer that is critical to support the Agency’s mission of ensuring food safety. This purchase is necessary to facilitate the identification of, and development of analytical methods for PFAS and other emerging contaminants and generate data to support safety assessments.

The major components of this acquisition plan are as follows:

1. Quadrupole-Orbital Trapping High Resolution Mass Spectrometer Including:

a. Integrated computer-based data system capable of controlling the instrument and associated, user selected, liquid chromatograph system, for acquiring data, and performing subsequent basic data analysis.

b. Software capable of automating instrument acquisition settings/experiments to maximize the success of non-targeted and comparative analyses.

c. A 6 port, 2 position LC diversion valve

d. Ion source with HESI and APCI capability.

e. A source of post-spray, internal mass calibrant ions.

f. A collisional dissociation cell after the quadrupole mass filter.

g. All necessary rough/mechanical pump(s).

h. Instrument pre-installation kit.

i. Any necessary UPS’s and power conditioners.

j. At least three full days of on-site active use training (post installation) by manufacturer trained/certified application specialists/engineers. Contractor shall provide a three (3) day on-site training that shall cover basic instrument-unique operation/maintenance, updates to basic software, and how-to use non-targeted/comparative analyses automated instrument acquisition/experiment software.

k. A system warranty for parts and labor for twelve (12) months from date of installation. Service shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. System includes one (1) preventative maintenance (PM) visit during one-year warranty period.

1) The Contractor shall provide an integrated Ultra High-Pressure Liquid Chromatograph (UHPLC) from the same vendor as the mass spectrometer.

2) The system shall be a newly manufactured unit, not used or refurbished, or previously used for demonstration. The instrument shall meet all of the technical and hardware specifications below.

3) The Contractor shall deliver and install the instrument. The CFSAN project officer will perform or assign inspection and issue acceptance (or not) of the system.

4) The Contractor shall demonstrate upon installation that the system shall meet all performance specifications by the manufacturer.

5) The Contractor shall demonstrate compatibility of operation, including system communication and hardware/software configuration, between the liquid chromatograph, the mass spectrometer, and the integrated computer-based data system.

2. Quadrupole-Orbital Trapping Mass Spectrometer The instrument shall be capable of operating as a high-resolution mass spectrometer (HRMS) and as MS/HRMS (or tandem HRMS, HRMS2), with scan-to-scan programable resolution/scan type, utilizing a quadrupole filter and a high-resolution orbital trapping mass sensor. The instrument shall be capable of operating/acquiring the following types of scans:

a. Adjustable Resolution/Speed Full HRMS scans

1) Full HRMS scans from at least m/z 40-3000.

2) Full HRMS scans of resolution >180,000 FWHM (m/z 200) at ≥ 2Hz.

3) Full HRMS scans with mass errors ≤ 1 ppm over the course of a day

4) (using internal or lock mass), and ≤ 3 ppm via external calibration.

5) Sequential positive & negative ion full HRMS scans (≥ 60,000 FWHM, m/z 200) at > 1Hz (polarity switching).

6) Adjustable Full HRMS scans at resolutions < 20000 to > 180000.

7) MS/HRMS (tandem HRMS, HRMS2)

8) MS2 scans from at least m/z 40-3000.

9) MS2 scans of ≥ 120k/15k FWHM at ≥ 10Hz.

10) MS2 scans (>10k FWHM) at ≥ 20Hz.

11) MS quadrupole precursor isolations of ≤ 0.5 Da widths (≤ 400 Da).

12) Multiplexing >10 MS2 spectra simultaneously.

b. Collision cell energetics must be available in both normalized and absolute settings, and at fixed or stepped values.

c. Ionization Sources: The instrument shall have the capability to perform and switch between electrospray ionization and atmospheric pressure chemical ionization in both the positive and negative ion modes without breaking vacuum. ESI source shall be capable of liquid flows 1-1000 µL/min, APCI as low as 50 µL/min.

d. Accuracy: The instrument’s HRMS spectra shall be able to routinely maintain < 1ppm mass error across the course of a day (internal/lockmass permitted) and < 3ppm across a work week without full re-calibrations. Calibrations should require ≤ 15 minutes for both ion polarities.

e. Must be capable of detecting < 400 fg of reserpine with a signal to noise ratio of ≥ 100:1 and yield linear response ranges (R2 > 0.99) for 5 orders of magnitude of concentration.

f. Capable of executing data dependent acquisitions (DDA) where the mass spectrometer acquisition types are varied from scan to scan based on the data acquired in a previous scan. Instrument DDA methods shall:

1) Not be strictly limited to triggering on just “top N” number of ions, but also be able to factor-in/maintain acquisition speeds.

2) Allow DDA Top N of ≥ 100.

g. The instrument shall be robust and easily maintained by users without frequent service calls or vacuum breaks. Specifically:

1) Entrance capillaries/ion transfer tubes shall be user replaceable/cleanable without breaking vacuum.

2) Entrance optics and quadrupoles shall be easily user removable/cleanable

a. Without violating warranty

b. Via training/guides freely available upon demand.

h. The instrument shall permit all specifications to be met when laboratory conditions include:

1) Temperature 65-80 °F, RH 25-75%

2) Maximum Benchtop space of 40”h x 32”d x 38”w.

i. The instrument shall have an integrated data system capable of controlling the instrument and associated liquid chromatographs via entirely software-controlled settings, acquiring data and performing subsequent basic data analysis.

j. Software capable of automating instrument acquisition settings/experiments for non- targeted and comparative analyses shall be capable of:

1) Updating method acquisition parameters between experiment sample injections without manual selection.

2) Automating acquisition exclusion ion lists from negative control samples.

3) Updating inclusion ion lists from positive control samples.

4) Iterating updates to inclusion ion lists upon replicate or subsequent positive controls/samples to avoid redundancy in MS2 spectral collection.

3. Ultra-high Pressure Liquid Chromatograph

a. Advanced UHPLC pump with an extended pressure range (up to 100 MPa/14,500 PSI). Compatible with mobile phase pH range ≤ 2 to ≥ 12.

b. A dual piston pump with pulsation <2% or <0.5 MPa and online degasser.

c. Includes an automatic purge/rinse capability.

d. The solvent delivery system is capable of controlling flow rates between < 2 µL/min to > 4 mL/min with accuracy of < ± 0.2% and steps of ≤ 5 µL/min.

e. Includes a high efficiency, < 250 µL delay volume, high pressure solvent-mixer with high pressure gradient proportioning (± ≤ 0.25% accuracy/precision).

f. Includes column compartment, with integrated software-controlled temperature programable between ≤ 5°C and ≥ 100°C, and mobile phase pre-heater.

g. Column compartment heats and cools between 20°C and 50°C in <20 minutes.

h. Column compartment can fit 300 mm L x 10 mm o.d. columns and contains software- controlled column switching valves if >1 column rack is present.

i. Includes a high throughput autosampler capable of:

1) Auto-Sampling from ≥ 96 1.2mL vials, and/or ≥ 48 1.5mL vials.

2) Programable sample temperature control from ≤ 5°C to ≥ 40°C.

3) Injection volumes of ≤ 0.1 to ≥ 50 µL with ≤ 0.5% accuracy & repeatability.

4) Minimum sample consumptions as low as 5 µL.

5) Void volumes of ≤ 150 µL.

j. Contains no fluorinated polymer in the sample flow path.

k. Allows real-time pressure monitoring in software & run monitoring graphical interface.

l. Shall match the vendor of the mass spectrometer to enable seamless connection.

Delivery Instrument shall be shipped within TBD of placing order.

FOB: Destination Food and Drug Administration - CFSAN 5001 Campus Drive College Park, MD 20740 If the Contractor is not installing on the day of delivery, the delivery shall be made to the loading dock and moved into location on the date of installation. The contractor shall demonstrate upon installation that the item shall meet all performance specifications by the manufacturer. The instrument will not be accepted until those performance specifications have been met. The CFSAN project officer will perform inspection and acceptance of the mass spectrometer system. The entire system shall be warranted for parts and labor for 1 year from date of installation. Service and installation shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

A three (3) day on-site training for FDA users will be arranged by the CFSAN project officer. Work shall be conducted Monday through Friday, excluding federal holidays.

Acceptance Criteria FOB: Destination Inspection/Acceptance: Destination Full acceptance is made after completion of Installation and Operational Qualification by the contractor that the system meets all the specifications and requirements.

The delivery or services must be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM Central Time (CT), excluding holidays.

Installation The system shall be installed by the Contractor and meet contract specifications TBD. Installation, at a minimum, shall include uncrating/unpackaging of all equipment, rigging, set-up and hook-up of the system, demonstration of all specifications, and removal of trash. Onsite installation and demonstration shall be done at the Harvey Wiley Building, 5001 Campus Drive, College Park, MD 20740.

Training A three (3) day on-site training for FDA users will be arranged by the CFSAN project officer. Work shall be conducted Monday through Friday, excluding federal holidays. The training shall provide a thorough demonstration of all system/solution functions, maintenance, data administration, basic troubleshooting, and hardware/software operation. The training shall be completed immediately after installation/set-up and demonstration of performance specifications but shall be completed no later than tbd days after installation.

Warranty The contractor shall warrant the entire system for a period of at least one (1) years from acceptance. The warranty shall include unlimited telephone/e-mail support for questions regarding operation. All costs including parts, labor, travel, and other expenses necessary to repair the system will be borne solely by the contractor at no additional cost to the U.S. Government.

Documentation, Reporting Requirements and Deliverables The quadrupole orbital trapping high resolution mass spectrometer shall include an operations and maintenance manual covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy, electronic format, or both).

The contractor shall provide 30-day notice prior to shipping. All reports for installation and qualification shall be provided (electronic format preferred). Acceptance will be made by the government within 30 days following completion of instrument installation and qualification The work cannot be done remotely; work shall be done at the Government site where the equipment is to be located.

Security: Supervision of install engineer upon arrival will be required. All software required must be approved on FDA’s Product Catalog and comply with OIMT requirements. Software not already on the FDA Product Catalog may be considered but must be approved on FDA Product Catalog prior to award.

Line Items and Prices The Contractor shall provide the following deliverables:

NOTE: The Contractor shall complete the pricing table below.

Line Item

Price Total Price

The offeror shall state the commercial delivery schedule.

TOTAL

Provide a fixed price quote in accordance with the Statement of Work identified above and country of origin of all components.

IT Purchasing Requirements:

NOTE to Contractor: Before the Purchase Order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware (rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the Vendor will use in fulfilling this Purchase Order.

This list will need to include:

1. IT hardware: manufacture, nomenclature and model number

2. Software (all types): manufacture, nomenclature and version number Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

Other Considerations:

No prototypes, demonstration models, used or refurbished systems will be considered

Government Holidays

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(4) Memorial Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this award.

Instructions to Offeror for Proposal Submission FAR 52.212-1 Instructions to Offerors—Commercial Items (MAR 2023)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

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.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Patricia Natividad, email: patricia.natividad@fda.hhs.gov no later than August 18, 2023, 10:00 a.m. Eastern Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

QUOTES DUE: All quotes are due, no later than August 24. 2023, 10:00 a.m. Eastern Time.

NOTE: Quotes shall be valid for 90 days.

Evaluation of Award:

FAR 52.212-2 Evaluation-Commercial Items (Dec 2021) Lowest Priced, Technically Acceptable (LPTA), Provisions and Clauses FAR 52.252‐2 Solicitation Provisions Incorporated by Reference (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/far and https://www.acquisition.gov/hhsar.

The Following Provisions and clauses apply:

FAR CLAUSES AND PROVISIONS

By Reference:

FAR 52.211-6 Brand Name or Equal (Aug 1999) FAR 52.212‐4 Contract Terms and Conditions‐Commercial Products and Commercial Services (Dec 2022) FAR 52.232-18 Availability of Funds(Apr 1984) By Full Text FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "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" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Products or Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision— Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) ( https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(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.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

FAR 52.212‐3, Offeror Representations and Certifications‐Commercial Products and Commercial Services (December 2022) 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, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. 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.

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

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

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, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300.

(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 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—

(i) It □ is, □ is not a small business concern; or

(ii) It □ is, □ is not a small business joint venture that complies with the requirements of 13 CFR 121.103(h) and 13 CFR 125.8(a) and (b). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.]

(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—

(i) It □ is, □ is not a service-disabled veteran-owned small business concern; or (ii)It □ is, □ is not a joint venture that complies with the requirements of 13 CFR 125.18(b)(1) and (2). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.] Each service-disabled veteran-owned small business concern participating in the joint venture shall provide representation of its service-disabled veteran-owned small business concern status.

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

(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 joint venture eligible under the WOSB Program. The offeror represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.]

(7) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The offeror represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.]

(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, as having been certified by SBA as a HUBZone small business concern in the Dynamic Small Business Search and SAM, and will attempt to maintain an employment rate of HUBZone residents of 35 percent of its employees during performance of a HUBZone contract (see 13 CFR 126.200(e)(1)); and

(ii) It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13 CFR 126.616(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.] Each HUBZone small business concern participating in the HUBZone joint venture shall provide representation of its HUBZone status.

(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.)

(1) (i) The Offeror certifies that each end product and that each domestic end product listed in paragraph (f)(3) of this provision contains a critical component, 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. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select “no”.

(iii) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(iv) The terms “commercially available off-the-shelf (COTS) item,” “critical component,” “domestic end product,” "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Supplies."

(2) Foreign End Products:

[List as necessary]

(3) Domestic end products containing a critical component:

Line Item No. ___ [List as necessary]

(4) 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) (A) The Offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (iii) of this provision, is a domestic end product and that each domestic end product listed in paragraph (g)(1)(iv) of this provision contains a critical component.

(B) The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product," "commercially available off-the-shelf (COTS) item," "critical 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:

(iii) The Offeror shall list those supplies that are…