RFQ 75F40123Q00210_A00001.pdf

Solicitation No. 75F40123Q00210_A00001 Revised on May 12, 2023 Original Date: May 8, 2023

Question with Answers posted and no further changes.

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) 2023-02.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION

WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00210 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 Full and Open Competition.

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 procure one (1 each) High Resolution

Ion Mobility (HRIM) - High Resolution Mass Spectrometer (HRMS) System

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

Description: Statement of Work

1. Scope of Work

To purchase and install a high-resolution ion mobility (HRIM) – high resolution mass spectrometer

(HRMS) system to expand and augment the capacity and capability of Food and Drug Administration

(FDA) to ensure pharmaceutical safety, efficacy, and high quality. In particular, this system will offer a wealth of multi-attribute information that can enable comprehensive analysis of complex biologics, peptide and oligonucleotide therapeutics and other complex drug products, thus promoting an in-depth understanding of the advanced manufacturing methods employed in the production of these complex therapeutic drug products.

2. Background:

High resolution mass spectrometer (HRMS) is essential in the characterization of emerging complex and biological drugs including peptides, proteins, oligonucleotides, and other complex mixtures. The accurate mass provided by HRMS needs to be obtained to confidently identify active ingredients, isoforms, and impurities. The high resolution and high sensitivity by HRMS are needed to differentiate all the components including structurally-similar ones and to detect low-level species such as modifications and impurities, which are commonly present and are critical quality attributes in these highly complex and heterogeneous systems. Additionally, physical separation of highly heterogeneous complex drug products including impurities is needed prior to HRMS analysis and is often achieved with high performance liquid chromatography (HPLC). However, advanced separation techniques such as ion mobility (IM) technology can allow separation of chromatographically coeluting ions such as by their molecular shape and mobility. This additional dimension of separation in addition to HPLC enables a higher resolving power and can thus address the analytical challenges posed by the complexities of those drug products. The high-resolution ion mobility (HRIM) can further enhance the resolving power to separate structurally similar components that are not separated by LC, MS or low-resolution IM. The LC-HRIM-HRMS system permits the analysis of multiple critical quality attributes on a single analytical platform, enables complete process and product characterization, and offers the potential for drug manufacturers to gain deep understanding of their manufacturing processes, particularly the biopharmaceutical and complex product manufacturing.

** Important **

**The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

**The Vendor shall explain why and how their system meets or exceeds each detailed technical requirement and include supportive data and descriptions.

**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.

3. Instrument Requirements and Deliverables:

Technical Requirements

The instrumentation shall meet the following minimum salient characteristics.

The LC-HRIM-HRMS system must consist of a high-resolution ion mobility (HRIM) – high resolution mass spectrometer (HRMS) system coupled to a liquid chromatography (LC) with appropriate software for control of the instruments, data acquisition and basic data processing.

a. Mass spectrometer performance characteristics:

1) Have an upper resolving power not less than 50,000 FWHM at high mass (m/z 2,700+).

2) Provide high MS accuracy defined as measured m/z for reserpine protonated ion (positive mode) or chloramphenicol deprotonated ion (negative mode) < 0.8 ppm RMS using an internal mass reference in 10 replicates.

3) Provide high MS sensitivity defined as S/N for 1 pg injection of reserpine (positive mode) or chloramphenicol (negative mode) > 500:1 RMS while maintaining maximum mass resolution in 10 replicates.

4) Provide high MS/MS accuracy defined as measured m/z for reserpine product ion (positive mode) or chloramphenicol product ion (negative mode) < 2.5 ppm RMS in 10 replicates using an internal mass reference.

5) Provide high MS/MS sensitivity defined as S/N for 1 pg injection of reserpine monitoring the most intense top 4 product ions > 1,500:1 RMS while maintaining maximum mass resolution in 10 replicates.

6) Provide high dynamic range on coeluting components up to 5 decades.

7) Provide high spectral acquisition rate of 50 spectra/second for MS and 30 spectra/second for

MS/MS while maintaining maximum mass resolution.

8) Provide mass range 50-30,000 m/z or wider.

9) Have automated delivery of calibrant and tuning and calibration to simplify the process and reduce the burden and time spent on instrument maintenance.

10) Be benchtop compatible to accommodate space restrictions.

11) Vacuum Isolation valve to allow removal of the capillary without venting the system to minimize downtime.

b. Ion mobility spectrometer performance characteristics:

1) Provide high ion mobility spectrometry (IMS) resolving power > 250 in collision cross section space and across the entire m/z 300-2,700 mass range in a lossless manner in a single experiment.

2) Provide high IMS sensitivity defined as LOQ < 10 pg.

3) Provide high IMS reproducibility < 0.25% RSD.

4) Have mass accuracy in HRIM mode < 5 ppm.

5) The low end of mass range must be not more than 300 m/z.

6) The high end of mass range must be not less than 3000 m/z and configurable up to 10,000 m/z.

7) Be benchtop compatible while connecting with the mass spectrometer.

c. LC system specifications and requirements:

1) An autosampler that can control the sample temperature between 4 – 37 °C or a wider range and be compatible for both vials and plates with the capacity of over 300 2ml vials and greater than

4 well plates.

2) One or multiple binary or quaternary pumps that can deliver a flow rate range of 0.001 – 5 mL/min or wider with a high-pressure limit of not less than 1300 bar.

3) Biocompatible flow path with no stainless steel in contact with solvent.

4) A column compartment with temperature control in the range of 10 – 80 °C or wider.

5) A diode array detector with both light sensitive flow cell optimized for photolabile species and standard flow cell for small molecules and peptides, a wavelength range of 190 – 600 nm or wider, and upper limit of acquisition rate of not less than 200 Hz.

6) A mechanism to enable high throughput studies across multiple methods, such as solvent selection valves and a column switching valve to allow switching solvents and columns without operator intervention.

d. Software Requirements

1) Instrument operating software: capable of operating the LC, IMS and MS components

2) The software and all specified modules shall be able to communicate with each other and through a network.

3) Compatible software and tools must be included to enable advanced data analysis and interpretation for both small and complex molecules, including, but not limited to, automated workflows for intact mass measurements, peptide sequence mapping, glycan profiling, oligonucleotide purity/impurity analysis, and oligonucleotide MS/MS-based structure confirmation.

e. Services Requirements

The Vendor shall have the ability to provide technical support and service for this system to include demonstrated that the Vendors Service Department has been adequately staff in past years or other methods to include customer endorsements.

1. The vendor must perform and document Installation and Operational Qualification (IQ/OQ) including installation and testing of LC, IMS, MS and software.

2. The vendor must provide software / hardware familiarization and 2-3 day on-site training course for 3-4 scientists at the place of performance (OTR).

3. Unlimited technical support for the life of the instrument: phone AND internet

4. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance. FDA must be able to reasonably expect service and technical support from the vendor during its lifecycle.

5. The vendor shall provide service agreement option consisting of at least 1 annual preventative maintenance (PM) for three (3) one-year periods following warranty end.

Option for comprehensive maintenance plan, if available and in best interest of government, may be considered. The vendor must also be capable of servicing the instrument through the extended warranty or service contract. This information shall not obligate FDA to purchase an extended warranty.

A. Training

Training class for at least 4 FDA personnel, installation and familiarization on site.

B. Warranty

The entire system must be warranted for parts, travel and labor for 12 months from the date of

Installation and Operational Qualification (IQ/OQ) completion.

The instrument shall be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance. OTR must expect service and technical support from the vendor during its lifecycle.

The entire system shall be warrantied for parts and labor for at least 12 months from the date of installation. Software updates shall be furnished at no additional cost during the warranty period.

Technical support shall be furnished at no additional cost during the warranty period. The

Contractor shall provide servicing of the instrument through the extended warranty or service contract.

Complete system shall have a ten-year value guarantee such that vendor shall have ten years guaranteed parts and comprehensive service available or give residual value credit for replacement.

C. Delivery and Installation

The Contractor shall deliver all hardware to the FDA St. Louis Campus, unless otherwise instructed via contract modification.

Location of installation and Place of Performance:

FDA/CDER/OPQ/OTR

645 S Newstead Ave., St. Louis, MO 63110

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.

Acceptance Criteria

FOB: Destination Inspection/Acceptance: Destination

Partial acceptance is made upon delivery of all the parts. Full acceptance is made after completion of Installation and Operational Qualification (IQ/OQ) by the contractor that the system meets all the specifications and requirements.

Reporting Requirements and Deliverables

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

Period of Performance

Delivery of Instrument: TBD

Three Option Periods (12 months) from expiration of Manufacturer Warranty.

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 at OTR-St. Louis 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

Description Qty Unit Price

Total Price

1 LC-HRIM-HRMS

system in line with technical requirements to include 12 month warranty

1 EA - $

3. Training/User Training Course within 60 days after Installation

3 Installation and Instrument Qualification

4 Delivery/Shipping

FOB DESTINATION

7. Option Period One Preventative

Maintenance and Repair of (12

MONTHS)

8 Option Period Two Preventative Maintenance and Repair of (12

MONTHS)

9 Option Period Three Preventative Maintenance and Repair of (12

MONTHS)

TOTAL $

Provide a fixed price quote in accordance with the Statement of Work identified above.

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.

Government Holidays

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

(1) New Year's Day (7) Labor Day

(2) Martin Luther King's Birthday (8) Columbus Day

(3) President’s Day (9) Veterans' Day

(4) Memorial Day

(5) Juneteenth (10) Thanksgiving Day

(6) Independence Day (11) Christmas 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 May 11, 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 May 19. 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 (Nov 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 52.217-5 Evaluation of Options (July 1990) FAR 52.232-18 Availability of Funds.(Apr 1984) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Nov 2021)

By Full Text

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) mailto:patricia.natividad@fda.hhs.gov https://www.acquisition.gov/far https://www.acquisition.gov/hhsar

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— https://www.acquisition.gov/far/part-52#FAR_52_204_26 https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-52#FAR_52_204_26 https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-52#FAR_52_204_25

(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 https://www.sam.gov/

(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).

https://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.ecfr.gov/current/title-13/part-127 https://www.ecfr.gov/current/title-13/part-127 https://www.ecfr.gov/current/title-13/section-127.300 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

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;

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

(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— 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

(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.

https://www.ecfr.gov/current/title-13/part-121 https://www.ecfr.gov/current/title-13/part-121

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.

https://www.ecfr.gov/current/title-13/part-127 https://www.ecfr.gov/current/title-13/section-127.300 http://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201 https://www.acquisition.gov/far/part-19#FAR_Part_19 https://www.acquisition.gov/far/part-19#FAR_19_000

(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.

https://www.ecfr.gov/current/title-13/section-121.103#p-121.103(h) https://www.ecfr.gov/current/title-13/section-125.8#p-125.8(a) https://www.ecfr.gov/current/title-13/section-125.8#p-125.8(b) https://www.ecfr.gov/current/title-13/section-125.18#p-125.18(b)(1) https://www.ecfr.gov/current/title-13/section-125.18#p-125.18(b)(1) https://www.ecfr.gov/current/title-13/section-125.18#p-125.18(b)(2) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(a) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(a) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(c) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(a) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(c)

(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, https://www.ecfr.gov/current/title-13/section-126.200 https://www.ecfr.gov/current/title-13/section-126.616#p-126.616(a) https://www.ecfr.gov/current/title-13/section-126.616#p-126.616(a) https://www.ecfr.gov/current/title-13/section-126.616#p-126.616(c) http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 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:

Line Item No. Country of Origin Exceeds 55% domestic content (yes/no)

[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.

https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-25#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:

Line Item No. Country of Origin

[List as necessary]

(iii) The Offeror shall list those supplies that…