D CSS-C RFQ 75N95023Q00493.pdf

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Nanobody production against endocytic proteins

RFQ: 75N95023Q00493-RFQ

SAM.GOV: https://sam.gov/opp/8288a297d02d4b1982f3c202650eb1d1/view

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95023Q00493-RFQ and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

and FAR Part 12—Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date 06/02/2023.

(iv) The associated NAICS code is 541380 - Testing Laboratories and the small business size standard is $19M. This requirement has no set-aside restrictions.

(v) The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting, and making medical discoveries that improve people’s health and save lives.

The National Institute of Neurological Disorders and Stroke (NINDS) is one of 27 Institutes and Centers at the NIH, and its mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people.

The NINDS Synaptic Transmission Section (STS) combines physiological and cell-biological approaches to understand the mechanism and dynamics of cell membrane modulation during vesicle endocytosis. Various proteins orchestrate exo- and endocytosis in living cells at the nanometer scale. These events include vesicle docking and fusion, curvature generation, endocytosis, and others. NINDS STS characterizes these proteins, especially their spatial distribution and mechanisms of action in vivo with super-resolution imaging technique, and quantify several parameters related to their performance. Then NINDS STS wants to determine how these underlying mechanisms https://sam.gov/opp/8288a297d02d4b1982f3c202650eb1d1/view contribute to neurodevelopmental and neurodegenerative disorders, where synaptic signaling is severely impacted.

Single-molecule localization microscopy is the most advanced super-resolution fluorescence imaging technique to identify cellular components and quantify various parameters. Over more than 20 years, NINDS STS has invested efforts to understand the molecular underpinnings of the synaptic transmission process. The most critical aspect of understanding synaptic transmission and associated pathologies is to explore how the vesicle recycling process is regulated at the synapse. Previous studies from STS lab and others have shown the involvement of thousands of proteins at the presynaptic terminal to form specialized regions and facilitate vesicle fission and fusion by avoiding molecular crowding. However, the specialized arrangements have never been visualized at the nerve terminal at the single-nanometer resolution, which is the actual molecular resolution. Therefore, much of the mechanistic regulation has remained as speculative ideas.

While antibodies are the preferred choice of binders to identify endogenous proteins due to their simplicity and availability, the size of each antibody corresponds to about 8nm, while two antibodies used for immunocytochemistry would be around 16nm together.

The current microscope in the lab can resolve up to 1-3nm. The dual antibody staining method would create a much larger (16nm) localization error. In addition, two large antibodies would create substantial molecular crowding in the already crowded synaptic environment, thus, creating artifacts and affecting quantification. The answer to these problems lies with the nanobodies or single-domain antibody binders due to their tiny size (<3nm) and customizability. The nanobodies are produced in Camelids, such as Alpacas, and are the ideal molecules for Single-molecule localization microscopy (SMLM) using the microscope in the lab.

Thus, the nanobodies will be used to perform fluorescence imaging of endogenous proteins for identifying the nanoscale structures at the cell membrane and synaptic compartment and tracking the dynamics of a variety of cell-surface proteins regulating vesicle exocytosis and endocytosis in the cells during synaptic transmission and plasticity. Moreover, the nanobodies will be used to identify the nanoscale anatomy of endocytic machinery in chromaffin cells and nerve terminals. The nanoscale organization (also called the nano anatomy) of molecules and their spatial relationship regulate key aspects of vesicle fission-fusion and, thus, synaptic transmission. It is, therefore, essential to understand the operation of multiple proteins together in the cellular context to further the research on neurodevelopmental and neurodegenerative disorders.

(vi) The Statement of Work (SOW) with the general and specific requirements is included as an attachment to this Solicitation.

NINDS STS requires the production of nanobodies against five (5) major endocytic proteins expressed in neurons to further the research on neurodevelopmental and neurodegenerative disorders.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is twelve (12) months from award.

(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text.

Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)

• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

• FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial

Services (Mar 2023)

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

• FAR 52.214-34, Submission of Offers in the English Language (Apr 1991)

• FAR 52.214-35, Submission of Offers in U.S. Currency (Apr 1991)

• FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain

Activities or Transactions Relating to Iran—Representation and Certifications (Jun 2020)

• HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:

(End of clause) https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug

2020)

• FAR 52.212-4, Contract Terms and Conditions—Commercial Products and

Commercial Services (Dec 2022)

• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at FAR 52.204-24 and FAR 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

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

• FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Jun 2023)

• HHSAR 352.270-5a, Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (December 18, 2015)

• HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015)

• Invoice and Payment Provisions with and without IPP (Oct 2022 and Mar 2023)

(ix) The Government will perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to award a purchase order from this solicitation to the responsible offeror whose response meets the solicitation’s requirements and, as a whole, provides the best value, considering price and other factors in this solicitation.

The evaluation will compare: (a) Technical capability of the service offered to meet the Government requirement; (b) Price; and (c) Past Performance as defined under FAR 13.106-2(b)(3). If only one quotation is received it will be evaluated on the preceding basis.

Responses may exceed capability or performance characteristics of the solicitation’s requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation’s requirements if it provides a benefit to the Government; and the Government is not requesting or accepting alternate proposal(s).

(x) The Offerors to include a completed copy of the provision at FAR provision 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (Dec 2022), with its offer. If the offeror has completed FAR provision 52.212-3 at www.sam.gov , then the offeror does not need to provide a completed copy with its offer.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (Dec 2022) applies to this acquisition.

(xii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices.

The services under this contract involves live vertebrate animals. Quoters must have an active OLAW Animal Welfare Assurance. In addition, Quoters must include with its quotation:

1. Vertebrate Animal Section (VAS) (see below)

2. Institutional Animal Care and Use Committee (IACUC) project approval. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award.

Vertebrate Animals Section (VAS). The VAS should be no more than two (2) pages and must address the following criteria:

1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work.

2. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

4. Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.

The VAS Worksheet is provided as an attachment to this solicitation to assist in the preparation of the VAS.

http://www.sam.gov/ http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html

Animal Welfare. All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at:

http://grants1.nih.gov/grants/olaw/references/phspol.htm. In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the Contractor’s quotation.

FAR 52.212-4 – Addendum.

Please be advised that the National Institute of Neurological Disorders and Stroke (NINDS) is an Institute within the National Institutes of Health (NIH), which is a Federal agency. Your mass-market commercial sales and/or license agreement may include provisions that are customarily found in the commercial sector, but which are not appropriate for a contract with a Federal agency. Specifically, NINDS considers any provision in your mass-market commercial sales and/or license agreement to be inappropriate and unenforceable that:

(1) Contravenes a right granted NINDS under U.S. copyright law (e.g., fair use, right to archive, copying for interlibrary loan),

(2) Violated the Federal Acquisition Regulation or other Federal law (e.g., Antideficiency Act, Principles of Federal Appropriations Law),

(3) Departs from reasonable consumer expectations and was not disclosed by the Licensor prior to agreement, or

(4) Violates fundamental public policy.

NIH shall assume that you are in agreement with the statements herein if you submit a quotation/proposal and accept NIH's order/contract.

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

[To be specified at time of award]

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the http://grants1.nih.gov/grants/olaw/references/phspol.htm

Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the contract.

The Government may unilaterally change its COR designation in writing, any time during the contract’s period of performance.

(xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiv) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All questions must be received by 9 a.m., Eastern Time, on August 14, 2023, and reference Solicitation Number 75N95023Q00493-RFQ. Questions may be submitted electronically to Renato Gomes at renato.gomes@nih.gov.

All quotations must be received by 9 a.m., Eastern Time, on August 17, 2023, and reference Solicitation Number 75N95023Q00493-RFQ. Responses must be submitted electronically to Renato Gomes at renato.gomes@nih.gov.

Fax responses will not be accepted.

Attachments:

- Purchase Description (PD)

- FAR 52.204-24, Representation Regarding Certain Telecommunications and Video

Surveillance Services or Equipment (Nov 2021)

- FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation

(Oct 2020)

- FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or

Executive Orders—Commercial Products and Commercial Services (Jun 2023)

- HHSAR 352.270-5a and HHSAR 352.270-5b

- VAS Worksheet

- Invoice and Payment Provisions with and without IPP (Oct 2022 and Mar 2023) http://www.sam.gov/ mailto:renato.gomes@nih.gov mailto:renato.gomes@nih.gov

FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Nanobody production against endocytic proteins.

Statement of Need and Purpose:

The National Institute of Neurological Disorders and Stroke (NINDS), Synaptic Transmission Section (STS) requires the production of nanobodies against five (5) major endocytic proteins expressed in neurons to further the research on neurodevelopmental and neurodegenerative disorders.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting, and making medical discoveries that improve people’s health and save lives.

NINDS is one of 27 Institutes and Centers at the NIH, and its mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people.

The NINDS STS combines physiological and cell-biological approaches to understand the mechanism and dynamics of cell membrane modulation during vesicle endocytosis. Various proteins orchestrate exo- and endocytosis in living cells at the nanometer scale. These events include vesicle docking and fusion, curvature generation, endocytosis, and others. NINDS STS characterizes these proteins, especially their spatial distribution and mechanisms of action in vivo with super-resolution imaging technique, and quantify several parameters related to their performance. Then NINDS STS wants to determine how these underlying mechanisms contribute to neurodevelopmental and neurodegenerative disorders, where synaptic signaling is severely impacted.

Single-molecule localization microscopy is the most advanced super-resolution fluorescence imaging technique to identify cellular components and quantify various parameters. Over more than 20 years, NINDS STS has invested efforts to understand the molecular underpinnings of the synaptic transmission process. The most critical aspect of understanding synaptic transmission and associated pathologies is to explore how the vesicle recycling process is regulated at the synapse. Previous studies from STS lab and others have shown the involvement of thousands of proteins at the presynaptic terminal to form specialized regions and facilitate vesicle fission and fusion by avoiding molecular crowding. However, the specialized arrangements have never been visualized at the nerve terminal at the single-nanometer resolution, which is the actual molecular resolution. Therefore, much of the mechanistic regulation has remained as speculative ideas.

While antibodies are the preferred choice of binders to identify endogenous proteins due to their simplicity and availability, the size of each antibody corresponds to about 8nm, while two antibodies used for immunocytochemistry would be around 16nm together. The current microscope in the lab can resolve up to 1-3nm. The dual antibody staining method would create a much larger (16nm) localization error. In addition, two large antibodies would create substantial molecular crowding in the already crowded synaptic environment, thus, creating artifacts and affecting quantification. The answer to these problems lies with the nanobodies or single-domain antibody binders due to their tiny size (<3nm) and customizability. The nanobodies are produced in Camelids, such as Alpacas, and are the ideal molecules for Single-molecule localization microscopy (SMLM) using the microscope in the lab.

Thus, the nanobodies will be used to perform fluorescence imaging of endogenous proteins for identifying the nanoscale structures at the cell membrane and synaptic compartment and tracking the dynamics of a variety of cell-surface proteins regulating vesicle exocytosis and endocytosis in the cells during synaptic transmission and plasticity. Moreover, the nanobodies will be used to identify the nanoscale anatomy of endocytic machinery in chromaffin cells and nerve terminals.

The nanoscale organization (also called the nano anatomy) of molecules and their spatial relationship regulate key aspects of vesicle fission-fusion and, thus, synaptic transmission. It is, therefore, essential to understand the operation of multiple proteins together in the cellular context to further the research on neurodevelopmental and neurodegenerative disorders.

Period of Performance:

The period of performance shall be twelve (12) months from award.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the specific requirements of this Statement of Work.

Specific Requirements:

The Contractor shall perform the services in five (5) different phases as follows:

Phase 1. Feasibility study

a) The Contractor shall produce six different proteins for expression and purification in HEK cells.

b) The Contractor shall design vectors and synthesize genes for these proteins.

c) They subclone and sequence verify the vectors and prepare plasmids.

d) Express the proteins in HEK cells and harvest them for purification. Gel filtration and QC through the SDS page.

e) A written report would be generated mentioning whether all of the target proteins could be purified and how much of them could be produced (amount, concentration, and other biochemical properties) that will help NINDS judge which targets to be taken for the next phase.

Phase 2. Immunization

a) The Contractor shall husband and health care two alpacas.

b) Six immunizations would be done.

c) Test and final bleeding of animals would be performed.

d) An ELISA-based analysis would be used to test immune response.

e) Formal reporting is optional in this success or failure kind of situation. NINDS will report the nature of immunization, whether successful or failed, for each candidate.

Phase 3. Screening and Selection

a) The Contractor shall perform the screeding and selection of nanobodies by withdrawing blood from the two animals and making a target nanobody library for each candidate.

b) This library generation would include blood cell isolation, RNA extraction, and cDNA preparation.

c) The Contractor shall prepare a nanobody library from the animals and use them for screening through the phage display library.

d) The library shall be screened for nanobody candidates for each target.

e) The target nanobodies shall be subcloned for prokaryotic expression, and their interactions with target proteins will be checked through ELISA for specific interactions.

f) The Contractor shall further analyze the sequence of the best 24 candidate nanobodies for each target.

g) A detailed report of the screening and selection analysis shall be produced mentioning all the details (especially potential chance of validity, selectivity, affinity, stability, etc.) and communicated with the Government.

Phase 4. Validation

a) For validation of success, third-six (36) candidates combined from all six (6) targets will be tagged with FLAG-GFP construct and expressed and purified on a small scale. These will be sent to the NINDS for performance check. These processes include immunocytochemistry analysis in our labs, both in fixed and in live cells.

b) This stage will ensure which nanobodies are performing satisfactorily and the poorly performing ones can be removed. Also, among six candidates per target, one could be more suitable for one experimental purpose than the other. Therefore, all these decisions can be made in this stage by NINDS.

Phase 5. Production

a) Once the candidates are chosen by NINDS, they shall be subcloned in the existing production vectors for the addition of an ectopic cysteine residue for DNA conjugation later.

b) These candidates will be sequence-verified, and finally, these constructs will be used for intermediate-scale production and purification of five (5) different nanobodies.

c) These purified nanobodies, related constructs, sequences, and all other information will be provided to the NINDS.

GOVERNMENT RESPONSIBILITIES

The Government will not furnish property, facilities, workspace, computers, or other equipment.

Performance of the services shall be on-site at the Contractor’s facility. The Government will have the responsibility to review, approve, and accept the reports for each phase described in the SOW.

DELIVERY OR DELIVERABLES

The Contractor shall provide interim reports at the conclusion of each phase for review and approval by NINDS before moving to the next phase. The interim reports shall be sent electronically to the Contracting Officer Representative (COR).

The Contractor shall provide one (1) final report encompassing the results of all phases of the specific requirements of this Statement of Work as well as information on all nanobody sequences and corresponding plasmids including documenting their properties, quality control, and validation. The final report shall be sent electronically to the COR

Delivery of the purified nanobody products and plasmids is required within seven (7) months after award. Delivery shall be Freight on Board (FOB) Destination and shall be delivered to NIH/NINDS located at Building 35, Room number 2B 1008, 35 Convent Drive, Bethesda, MD, Zip 20892, USA.

REPORTING REQUIREMENTS

The Contractor shall provide by-weekly updates on the progress of the project, or more often as appropriate. Updates shall be provided electronically to the COR. The Contractor shall update about the progress after each stage through email and/or other forms of electronic communication accepted by NINDS.

OTHER CONSIDERATIONS

Data Rights:

FAR Clause 52.227-14, Rights in Data-General (May 2014) is included in the solicitation and resultant award. Under 52.227-14(c)(1), the Contractor must obtain approval from the contracting officer to assert copyright in any data first produced in performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. Under 52.227-14(d)(2), the Contractor must obtain approval from the contracting officer to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract.

In addition, the Contractor shall keep the results of the acquisition confidential.

52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

As prescribed in 4.2105(a), insert the following provision:

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 https://www.acquisition.gov/far/4.2105#FAR_4_2105 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 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 https://www.sam.gov

(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.

(End of provision)

Parent topic: 52.204 [Reserved]

Name of Authorized Individual Signature of Authorized Individual Date

Title Name of Organization

CERTIFICATION:

https://www.acquisition.gov/far/52.204

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

(a) Definitions. As used in this provision, "covered telecommunications equipment or services" and "reasonable inquiry" have the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) 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".

(c)

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

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

(End of provision)

CERTIFICATION:

Name of Authorized Individual Signature of Authorized Individual Date

Title Name of Organization https://www.acquisition.gov/far/part-4#FAR_4_2105 https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.sam.gov/

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(10)

(11)

(12)

52.203-6

52.203-13

52.203-15

52.204-10

52.204-14

52.204-15

52.209-9

52.219-3

Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L.

109-282) (31 U.S.C. 6101 note).

[Reserved].

Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L.

111-117, section 743 of Div. C).

Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L.

117-328).

Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

[Reserved].

Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C.657a).

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

✔ (9) 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) (31 U.S.C. 6101 note).

52.204-27

(19)

(20)

(21)

(22)

(23)

(13)

(14)

(15)

(16)

(17)

(18)

(24)

(25)

(26)

(27)

52.219-4

52.219-6

52.219-7

52.219-8

52.219-9

52.219-13

52.219-14

52.219-16

52.219-27

52.219-28

52.219-29

52.219-30

52.219-32

52.219-33

(i), Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[Reserved].

(i) Notice of Total Small Business Set-Aside (Nov 2020) of 52.219-6 (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-6.

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-7.

Utilization of Small Business Concerns (Oct 2022) (15 U.S.C. 637(d)(2) and (3)).

(i), Small Business Subcontracting Plan (Oct 2022) (15 U.S.C. 637(d)(4)).

(ii) Alternate I (Nov 2016) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Jun 2020) of 52.219-9.

(v) Alternate IV (Sep 2021) of 52.219-9.

(i) Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637(a)(14)).

Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) (15 U.S.C. 657 f).

Post Award Small Business Program Rerepresentation (Mar 2023) (15 U.S.C. 632(a)(2)). May require contractor completion.

(ii) Alternate I (Mar 2020) of 52.219-28.

Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

Nonmanufacturer Rule (Sep 2021)(15 U.S.C. 637(a)(17)).

(ii) Alternate I (Mar 2020) of 52.219-13.

(34)

(35)

(36)

(37)

(38)

(28)

(29)

(30)

(31)

(32)

(33)

(39)

(40)

(41)

(42)

(43)

(44)

(45)

(46)

52.222-3

52.222-21

52.222-26

52.222-35

52.222-36

52.222-37

52.222-40

52.222-50

52.222-54

52.223-9

52.223-11

52.223-12

52.223-13

52.223-14

52.223-15

52.223-16

52.223-18

52.223-20

Convict Labor (June 2003) (E.O. 11755).

Child Labor—Cooperation with Authorities and Remedies (Dec 2022) (E.O. 13126).

Prohibition of Segregated Facilities (Apr 2015).

(i) Equal Opportunity (Sept 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26. If this is checked, some terms have been waived.

(i) Equal Opportunity for Veterans (Jun 2020)(38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35. If this box is checked, some terms have been waived.

(i) Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(ii) Alternate I (July 2014) of 52.222-36. If this box is checked, some terms have been waived.

Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(i) Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O. 13627).

(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). Alt I requires CO completion.

Employment Eligibility Verification (May 2022). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

(i) Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Requires CO completion.

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Alt I requires contractor certification.

Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). Requires contractor completion.

Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

(i), Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Oct 2015) of 52.223-13.

(i) Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

(i), Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

Aerosols (JUN 2016) (E.O. 13693).

52.222-19

(47)

(48)

(49)

(50)

(51)

(52)

(53)

(54)

(55)

(57)

(58)

(59)

(60)

(61)

(62)

(63)

(64)

52.223-21

52.224-3

52.225-1

52.225-3

52.225-5

52.225-13

52.225-26

52.226-4

52.226-5

52.232-29

52.232-30

52.232-33

52.232-34

52.232-36

52.239-1

52.242-5

52.247-64

Foams (JUN 2016) (E.O. 13693).

(i), Privacy Training (JAN 2017) (5 U.S.C. 552a).

(ii) Alternate I (JAN 2017) of 52.224-3.

(i) 52.225-1, Buy American-Supplies (Oct 2022) ( 41 U.S.C. chapter 83).

(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

(ii) Alternate I [Reserved]

(iii) Alternate II (Dec 2022) of 52.225-3.

(iv) Alternate III (Jan 2021) of 52.225-3.

Trade Agreements (Dec 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). Requires CO completion.

Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 3805).

Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C.

4505, 10 U.S.C. 3805).

Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C.

3332).

Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). Requires CO completition.

Payment by Third Party (May 2014) (31 U.S.C. 3332).

Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

(i), Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (Nov 2021) of 52.247-64.

Tax on Certain Foreign Procurements—Notice and Representation (Feb 2021)(56) 52.229-12

(ii) Alternate I (Oct 2022) of 52.225-1.

(v) Alternate IV (Oct 2022) of 52.225-3.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services

[Contracting Officer check as appropriate.]

52.222-41 Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67). (1)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). Requires CO completion.

(2)

52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(3)

52.222-44 Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4)

52.222-51 Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C.

chapter 67).

(5)

52.222-53 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

(6)

52.222-55 Minimum Wages Under Executive Order 13658 (Jan 2022). (7)

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). (8)

52.226-6 Promoting Excess Food Donation to…