1333ND21QNB640296 CELL BANKS COMBINED SYNOPSIS-SOLICITATION.pdf

FBO ANNOUNCEMENT: COMBINED SYNOPSIS/SOLICITATION

ACTION CODE: <COMBINED>

CLASSIFICATION CODE: Q3 – MEDICAL - LABORATORY TESTING

SUBJECT: MANUFACTURING AND TESTING OF A MASTER CELL BANK AND WORKING

CELL BANK

SOLICITATION NO.: 1333ND21QNB640296

RESPONSE DATE: 19 Aug 2021

CONTACT POINTS: Randy Schroyer, Contract Specialist; 301/975-6314 (T)

Andrea Parekh, Contracting Officer; 301/975-6984 (T)

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN

ACCORDANCE WITH THE FORMAT IN FEDERAL ACQUISITION REGULATION (FAR)

SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR

COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED

IN THIS NOTICE. FAR PART 13 SIMPLIFIED ACQUISITION PROCEDURES ARE UTILIZED

IN THIS PROCUREMENT. THIS ANNOUNCEMENT CONSTITUTES THE ONLY

SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION

DOCUMENT WILL NOT BE ISSUED.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06 effective 12 Jul 2021.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325414 with a small business size standard of 1,250 employees.

This acquisition is unrestricted and all interested Offerors may submit a firm fixed-price quotation in accordance with the specifications included herein and inclusive of F.O.B Destination shipping.

The National Institute of Standards and Technology (NIST) intends to issue a Firm Fixed Priced (FFP) purchase order for the manufacturing and testing of (1) master cell bank (MCB) and (1) working cell bank (WCB) IAW the Statement of Work (SoW) included as an attachment to this solicitation.

Responsible quoters shall provide a quotation which includes all of the following line items:

LINE ITEM NO. (LIN) 0001

QTY: 200 VIALS

Manufactured Master Cell Bank Vials

LINE ITEM NO. (LIN) 0002

QTY: 1 JOB

Testing of LIN 0001 Master Cell Bank

LINE ITEM NO. (LIN) 0003

QTY: 800 VIALS

Manufactured Working Cell Bank Vials

LINE ITEM NO. (LIN) 0004

QTY: 1 JOB

Testing of LIN 0003 Working Cell Bank

DELIVERY: Delivery of (200) Master Cell Bank vials and (800) Working Cell Bank vials shall be completed within 24 mos. after award.

Delivery terms shall be FOB Destination. FOB DESTINATION MEANS: The Contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of an/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. All shipping costs to Gaithersburg, MD shall be included in the total firm-fixed price.

Formal acceptance of the MCB and WCB Reports of Analysis will be given at the time that NIST determines all criteria described in the SoW Section VII 1.1-1.5 and 2.1-2.4 have been met. NIST will have 15 working days following receipt of the MCB and WCB Reports of Analysis from the Contractor to review and verify findings. NIST reserves the right to address scientific or quality questions to the Contractor and to pause the 15 working day review period while awaiting Contractor response.

Formal acceptance of the set of “Copies of Quality Documentation for MCB Manufacture, MCB Testing, WCB Manufacture and WCB Testing” will be given within 15 business days following receipt from the Contractor. NIST reserves the right to address scientific or quality questions to the Contractor and to pause the 15 working day review period while awaiting Contractor response.

Formal acceptance of the MCB and WCB deliverable units will be given at the time that NIST determines all criteria described in the SoW Section VII 3.1-3.4 and 4.1-4.4 have been met. NIST will have 2 business days of officially receiving the MCB units to verify by visual inspection the MCB units were manufactured and labeled IAW Section III 10-14 of the SoW.

NIST will have 2 business days of officially receiving the WCB units to verify by visual inspection the WCB units were manufactured and labeled IAW Section III 36-40 of the SoW. Using Contractor furnished protocol(s) and a sample of ≤ 5 MCB units and ≤ 10 WCB units, NIST will have 20 working days to verify the post-freeze recoverable cell viability of the MCB units and

WCB units is >90% by thawing, culturing and assaying these samples. NIST reserves the right to address scientific questions regarding cell characteristics to the Contractor and to pause the 20 working day confirmation period while awaiting Contractor response.

PAYMENT: Partial payments will be considered and must be proposed at time of quotation submission and shall be made pending receipt of a proper invoice. Otherwise, one aggregate payment shall be made pending receipt of a proper invoice.

A proper invoice will be approved for payment IAW net 30-day payment terms IAW the Contractor’s payment schedule, if proposed at time of quotation submission and accepted by the Government; otherwise, IAW net 30-day payment terms upon receipt and acceptance of all Master Cell Bank and Working Cell Bank vials, receipt and acceptance of all required reporting and documentation, and completion of the visual inspection of, and random sampling by the Government of, the Master Cell Bank (MCB) and Working Cell Bank (WCB) vials.

If invoicing in the aggregate, the invoice will not be approved if any items are outstanding, and/or have been rejected during the visual inspection and random sampling phases.

This is an Open-Market Combined Synopsis/Solicitation for commercial manufacturing of Master and Working Cell Banks as defined herein. The Government intends to award a Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL quotations shall include a statement regarding the terms and conditions herein as follows:

The Offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

OR

The Offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:

Offeror shall list exception(s) and rationale for the exception(s).

Offerors that fail to furnish required representations or information or reject the terms and conditions of the solicitation may be excluded from consideration.

Please note that this procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an Offeror submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Purchase Order, not the terms and conditions of the Offeror’s FSS or GWAC contract, and the statement required above shall be included in the quotation.

Prior to contract award, NIST will provide the Contractor with certain terms governing the use of the cell substrate and RCB in order to ensure that the Contractor will fully comply with such terms.

ADDENDUM TO FAR 52.212-1

QUOTATION PREPARATION INSTRUCTIONS

All offerors shall submit the following:

Each quotation shall consist of two (2) separate electronic files: (a) Technical Quotation (Vol.

I); and, (b) Business/Pricing Quotation (Vol. II). Incomplete quotations may be considered non-compliant and removed from further consideration.

Quotations shall be clearly and concisely written as well as being neat, indexed (cross-indexed as appropriate) and logically assembled. All pages of each part shall be appropriately numbered and identified with the name of the offeror, the date, and the solicitation number. A one-page transmittal letter signed by an individual authorized to commit the organization shall be transmitted with the quotation to the Government. Each quotation shall be on 8.5” x 11” paper, in a commercially standard font, not smaller than 12-point font. Each page in the quotation shall be separately numbered.

Overall Arrangement of Documents

VOLUME I: TECHNICAL

NIST will evaluate quotations, based on the information submitted in support of the following factors:

Factor 1A Technical Approach

The organization shall provide sufficient information to demonstrate its understanding of the requirements by providing a concise, detailed, and thorough discussion of its approach in terms of the proposed technical procedures to be followed to successfully manufacture and test the Master Cell Bank (MCB) and the Working Cell Bank (WCB) fully compliant with all requirements defined in the SoW.

At a minimum, demonstration of technical approach shall include: a) a narrative description (not exceeding 2 pages) of the process that the organization will perform to manufacture, test, store and ship the MCB and WCB, b) description of the facilities, including cold storage facilities, the organization possesses or has access to that will be used throughout production and storage of the MCB and WCB including documentation and/or copies of certification(s) that facilities used for manufacturing that meet the b.1) cleanroom, b.2) animal-origin free (AOF), and b.3) single-product requirements described in the SoW; c) a milestone plan for deliverables; d) any cell culture expansion and/or tests required by the organization to be performed on the Research Cell Bank (RCB) prior to the start of MCB manufacture and hence included in the quotation; e) a list and/or table of procedures, methods, tests and/or assays to be used including, for each entry, e.1) a descriptive title, e.2) compendial “yes/no”, e.3) compendial citation, if applicable, e.4) validated “yes/no”, and e.5) documentary basis (e.g.: standard, guidance, “Points to Consider”, etc.) for validation, if applicable; and, f) a discussion of any perceived risks associated with production and testing and how these risks will be mitigated.

If the organization is utilizing a subcontractor for any work, the same information must be provided for the subcontractor relevant to the work the subcontractor will perform.

The organization shall not simply state they will meet the requirement; evidence must be provided.

Factor 1B Documentation Required by NIST

The organization shall provide documentation of compliance with the Common Rule for the Protection of Human Subjects (15 C.F.R. Part 27), as follows:

i. If the organization will use human cell lines without identifying information that they currently own, or plans to purchase human cell lines from a vendor without identifying information, the use of human subjects may be not research or not a human subjects use as defined in 15 C.F.R. 27.102 or exempt from the requirement of review by an Institutional Review Board (IRB) 15 C.F.R. 27.104.

The organization must submit a written justification of their determination that each use of human materials meets one of these requirements. THE WRITTEN JUSTIFICATION MUST ACCOMPANY THE QUOTATION. An official determination as to whether the research is not research, not a human subjects use, or exempt will be made by NIST as part of the review process for the quotation.

ii. If the organization proposes to collect human materials themselves or obtain the human materials lines via a custom collection specifically for this project, the protocol for the human materials collection must be reviewed and approved by an appropriate IRB. The organization must submit a copy of the protocol and informed consent forms approved by the IRB, documentation of the IRB’s approval of the protocol, and the IRB’s Federal-wide assurance number from the Dept. of Health and Human Services

Factor 2 Experience

The organization shall describe its experience performing three (3) recent and relevant MCB and WCB production and testing efforts performed IAW current good manufacturing practices (cGMP), and the national and international safety and quality guidance, and biopharmaceutical industry standards of practices referenced throughout the SoW.

If the organization is utilizing a subcontractor for any work, the same information must be provided for the subcontractor.

Factor 3 Past Performance

The organization shall describe and provide references for at least one (1) but no more than three (3) past projects with federal, state or local governments and/or commercial customers that were similar in scope, size, and complexity to the work defined in the SoW. All projects must have been completed or substantially completed within the past three (3) yrs. of the solicitation closing date.

The description of each contract/order shall not exceed one-half (1/2) page in length. For each contract/order, the quoter shall provide the following information:

• Contract number

• Client’s name and address and point of contact, including telephone number and e-mail address

• Dollar value

• Period of performance

• Narrative describing the requirement and its relevance to the current requirement

• Name of contracting officer or point of contact, telephone number and e-mail address

If the organization intends to subcontract with another firm for part of this requirement, that firm’s past performance information shall also be provided.

If the organization has no relevant past performance, it may include a statement to that effect in its quotation. If the organization considers relevant past performance information to be confidential, it may include a statement to that effect in its quotation.

The Government reserves the right to consider data obtained from sources other than those described by the organization in its quotation.

VOLUME II: BUSINESS/PRICING

The price quotation shall be separate from the technical portion of the quotation.

The price quotation shall include the following:

i. Organizations Alternative Payment Schedule, if commercial practice is other than payment in the aggregate

ii. Completed FAR Provisions: 52.204-17, 52.204-20, 52.204-26, 52.209-2, 52.209-11, 52.222-22, 52.222-25, 52.223-22 and 52.225-18 (included elsewhere in this solicitation)

iii. The organizations Dun and Bradstreet Number (DUNS) linked to their active System for Award Management (SAM) registration. If the organization’s representations and certifications do not reflect the NAICS code governing this solicitation, the organization must submit documentation of their business size under the NAICS code governing this solicitation

iv. Place of Manufacture (e.g., city/state/country)

v. Price – firm, fixed-price, FOB Destination, for each LIN 0001-0004 covering the required manufacturing and testing of (1) Master Cell Bank yielding 200 units and

(1) Working Cell Bank yielding 800 units

To be eligible for award, the organization must have an active registration in the System for Award Management (sam.gov/SAM/)

The Government anticipates that the resultant purchase order will be awarded based upon adequate price competition. However, in order to determine that prices are fair and reasonable, the Government reserves the right to request the organization provide further cost breakdown to support quoted prices.

ADDENDUM TO FAR 52.212-2

EVALUATION AND BASIS FOR AWARD

The Government intends to make a single award and reserves the right to make no award as a result of this solicitation.

The Government intends to evaluate quotations and award a purchase order without discussions. Therefore, the organization’s initial quotation should contain the organization’s best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary.

The Government may reject any and or all quotations if such action is in the public interest;

accept other than the lowest price quotation; and waive informalities and minor irregularities in quotations received.

The Government will award a purchase order resulting from this solicitation that will include the terms and conditions that are set forth herein to the responsible organization whose quotation, conforming to the solicitation, will provide the best value to the Government, price and other factors considered.

The Government will evaluate quotations based on the following criteria: a) technical approach; b) experience; c) past performance; and, d) price

Technical approach, experience, and past performance shall be equal in importance to each other. When combined, technical approach, experience, and past performance shall be equal in importance to price. As the quality and merit of quotations received become more equivalent among quoters, price shall become more of a determining factor.

Factor 1A Technical Approach

Evaluation of technical approach will be based on the information provided in the quotation.

The Government will evaluate the organizations: a) overall approach to determine the extent of its understanding of the requirements, including the credibility of the proposed methodology (e.g., steps to manufacture and test) to effectively meet and comply with the processes and specifications outlined in the SoW; b) ability to provide adequate facilities for accomplishing the SoW requirements; c) the logic and progress represented in the deliverables milestone plan to ensure on-time delivery of the MCB and WCB vials; d) http://www.sam.gov/ credibility of any pre-manufacturing expansion or testing of the RCB that is proposed; e) solution for ensuring compliance with cGMP and ICH Q guidelines; and, f) credibility of planned approach for risk mitigation

Factor 1B Documentation Required by NIST

The Government will evaluate the documentation submitted by the organization establishing how the organization will satisfy the need for compliance with the Common Rule for the Protection of Human Subjects (15 C.F.R. Part 27)

Experience

The Government will evaluate the depth and breadth of the organization’s experience examples submitted, including proposed subcontractor examples, to determine the extent to which the organization demonstrates an ability to produce and test MCB and WCB’s IAW current good manufacturing practices (cGMP), national and international safety and quality guidance, and biopharmaceutical industry standards of practice;

Past Performance

For past performance, NIST will evaluate the extent to which the organizations, including proposed subcontractor, past projects are relevant to the current requirements and the extent to which the organization, including proposed subcontractor, successfully completed relevant contracts in the past three (3) yrs. In assessing past performance, NIST will evaluate the quality and timeliness of delivery of goods/services, level of communication between the contracting parties, and customer satisfaction. NIST reserves the right to assess the past performance of proposed subcontractors. NIST will use its discretion to determine the sources of past performance information used in the evaluation. Information may be obtained from references provided by the organization, the agency’s knowledge of Contractor performance, other Government agencies or commercial entities, or past performance databases.

If an organization does not have a history of relevant contract experience, or if past performance information is not available, the organization will receive a neutral past performance rating.

Price

The Government will evaluate the Offeror’s proposed pricing for reasonableness, accuracy, and completeness.

Price will not be evaluated for quotations that are determined technically unacceptable.

***APPLICABLE PROVISIONS AND CLAUSES***

The full text of a FAR provision or clause may be accessed electronically at http://acquisition.gov/far/index.html

The following FAR provisions apply to this acquisition:

http://acquisition.gov/far/index.html

52.204-7 System for Award Management (OCT 2018);

52.204-16 Commercial and Government Entity Code Reporting (AUG 2020);

52.204-17 Ownership or Control of Quoter (AUG 2020);

OWNERSHIP OR CONTROL OF OFFEROR (AUG 2020)

(a) Definitions. As used in this provision–

Commercial and Government Entity (CAGE) code means–

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

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.

(b) The Offeror represents that it □ has or □ does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (c) and if applicable, paragraph (d) of this provision for each participant in the joint venture.

(c) If the Offeror indicates "has" in paragraph (b) of this provision, enter the following information:

Immediate owner CAGE code: ____________________

Immediate owner legal name: ______________________

(Do not use a "doing business as" name)

Is the immediate owner owned or controlled by another entity?: □ Yes or □ No.

(d) If the Offeror indicates "yes" in paragraph (c) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:

Highest-level owner CAGE code: ___________________

Highest-level owner legal name: ___________________

(Do not use a "doing business as" name)

(End of provision)

52.204-20 Predecessor of Offeror (AUG 2020)

PREDECESSOR OF OFFEROR (AUG 2020)

(a) Definitions. As used in this provision–

Commercial and Government Entity (CAGE) code means–

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

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.

(b) The Offeror represents that it □ is or □ is not a successor to a predecessor that held a Federal contract or grant within the last three years.

(c) If the Offeror has indicated "is" in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):

Predecessor CAGE code: (or mark "Unknown").

Predecessor legal name: .

(Do not use a "doing business as" name).

(End of provision)

52.204-22 Alternative Line Item Proposal (JAN 2017);

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

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)

52.209-2 Prohibition on Contracting with Inverted Domestic Corporations – Representation

(NOV 2015);

PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS-REPRESENTATION

(a) Definitions. “Inverted domestic corporation” and “subsidiary” have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10).

(b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.

(c) Representation. The Offeror represents that-

(1) It □ is, □ is not an inverted domestic corporation; and

(2) It □ is, □ is not a subsidiary of an inverted domestic corporation.

https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.sam.gov/ https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062680 https://www.acquisition.gov/content/part-9-contractor-qualifications#i1116407 https://www.acquisition.gov/content/part-9-contractor-qualifications#i1116422

(End of provision)

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction Under any Federal Law (FEB 2016)

REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A FELONY CONVICTION

UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that—

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Quoter represents that—

(1) It is □ is not □ a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is □ is not □ a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

(End of provision)

52.212-1 Instructions to Quoters – Commercial Items (JUN 2020);

52.212-2 Evaluation—Commercial Items (OCT 2014);

52.212-3 Quoters Representations and Certifications- Commercial Items (FEB 2021);

In accordance with FAR 52.212-3 Quoter Representations and Certifications – Commercial Items, quoters must complete annual representations and certifications on-line at sam.gov/SAM/ and be actively registered to be eligible for award. If paragraph (j) of the provision applies, a written submission is required.

52.222-22 Previous Contracts and Compliance Reports (FEB 1999);

http://www.sam.gov/

The quoter represents that— It □ has, □ has not participated in a previous contract or subcontract subject to the Equal

Opportunity clause of this solicitation;

It □ has, □ has not filed all required compliance reports; and Representations indicating submission of required compliance reports, signed by proposed subcontractors, will be obtained before subcontract awards.

(End of provision)

52.222-25 Affirmative Action Compliance (APR 1984);

AFFIRMATIVE ACTION COMPLIANCE (APR 1984)

The offeror represents that-

(a)It □ has developed and has on file, □ has not developed and does not have on file, at each establishment, affirmative action programs required by the rules and regulations of the Secretary of Labor (41 CFR 60-1 and 60-2); or

(b)It □ has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(End of provision)

52.223-22 Public Disclosure of Greenhouse Gas Emissions and Reduction Goals – Representation (DEC 2016);

PUBLIC DISCLOSURE OF GREENHOUSE GAS EMISSIONS AND REDUCTION GOALS-REPRESENTATION (DEC

2016)

(a) This representation shall be completed if the Offeror received $7.5 million or more in Federal contract awards in the prior Federal fiscal year. The representation is optional if the Offeror received less than $7.5 million in Federal contract awards in the prior Federal fiscal year.

(b) Representation. [Offeror is to check applicable blocks in paragraphs (1) and (2).]

(1) The Offeror (itself or through its immediate owner or highest-level owner) □ does, □ does not publicly disclose greenhouse gas emissions, i.e., make available on a publicly accessible website the results of a greenhouse gas inventory, performed in accordance with an accounting standard with publicly available and consistently applied criteria, such as the Greenhouse Gas Protocol Corporate Standard.

(2) The Offeror (itself or through its immediate owner or highest-level owner) □ does, □ does not publicly disclose a quantitative greenhouse gas emissions reduction goal, i.e., make available on a publicly available website a target to reduce absolute emissions or emissions intensity by a specific quantity or percentage.

(3) A publicly accessible website includes the Offeror’s own website or a recognized, third-party greenhouse gas emissions reporting program.

(c) If the Offeror checked "does" in paragraphs (b)(1) or (b)(2) of this provision, respectively, the Offeror shall provide the publicly accessible website(s) where greenhouse gas emissions and/or reduction goals are reported:________________.

(End of provision)

52.225-18 Place of Manufacture (AUG 2018);

PLACE OF MANUFACTURE (AUG 2018)

(a) Definitions. As used in this provision—

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except-

(1) FPSC 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.

(b) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly-

(1) □ In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or

(2) □ Outside the United States.

(End of provision)

52.225-25 Prohibition on Contracting with Entities Engaging in Sanctioned Activities Relating to Iran – Representation and Certifications (JUN 2020);

52.252-1 Solicitation Provisions Incorporated by Reference

SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The quoter is cautioned that the listed provisions may include blocks that must be completed by the quoter and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the quoter may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://acquisition.gov/far/index.html

The following FAR clauses apply to this acquisition:

52.203-12 Limitation on Payments to Influence Certain Federal Transactions (JUN 2020);

52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (JUN 2020);

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011);

52.204-13 System for Award Management Maintenance (OCT 2018);

52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020);

52.204-19 Incorporation by Reference of Representations and Certifications (DEC 2014);

52.212-4 Contract Terms and Conditions – Commercial Items (OCT 2018);

52.217-8 Option to Extend Services.

OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within any time prior to purchase order expiration.

52.227-14 Rights in Data – General (MAY 2014);

52.232-8 Discounts for Prompt Payment (FEB 2002);

52.232-39 Unenforceability of Unauthorized Obligations (JUN 2013);

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS [(DEVIATION APR 2020)]

(a)[(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 2307, u]Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract [in accordance with the accelerated payment date established], to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, [with a goal of 15 days] after receipt of a proper invoice and all other required documentation from the small business subcontractor [if a specific payment date is not established by contract.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor].

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of clause)

52.242-13 Bankruptcy (JUL 1995);

52.247-34 F.o.b. Destination (NOV 1991);

52.252-2 Clauses Incorporated by Reference (FEB 1998);

CLAUSES 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): http://acquisition.gov/far/index.html

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders (JAN 2021) — Commercial Items including subparagraphs:

52.203-6 Restrictions on Subcontractor Sales to the Government (JUN 2020);

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020);

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020);

52.219-28 Post Award Small Business Program Rerepresentation (NOV 2020);

52.222-3 Convict Labor (JUN 2003);

52.222-19 Child Labor – Cooperation with Authorities and Remedies (JAN 2020);

52.222-21 Prohibition of Segregated Facilities (APR 2015);

52.222-26 Equal Opportunity (SEP 2016);

52.222-35 Equal Opportunity for Veterans (JUN 2020);

52.222-36 Affirmative Action for Workers with Disabilities (JUN 2020);

52.222-37 Employment Reports on Veterans (JUN 2020);

52.222-50 Combatting Trafficking in Persons (OCT 2020);

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020);

52.225-13 Restriction on Certain Foreign Purchases (FEB 2021); and 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (OCT 2018)

The following Department of Commerce (CAR) provisions and clauses apply to this acquisition. The CAR can be accessed online at http://www.ecfr.gov/cgi-bin/text-idx?SID=6b3121d28d772a0296241b81d731dbf1&mc=true&node=pt48.5.1352&rgn=div5

PROVISIONS:

1352.215-72 Inquiries (Apr 2010)

Quoters must submit all questions concerning this solicitation in writing to randy.schroyer@nist.gov within seven (7) calendar days of the posting. All responses to the questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the question responses included in the amendment to the solicitation will govern performance of the contract.

1352.233-70 Agency Protests (Apr 2010)

(a) An agency protest may be filed with either: (1) the contracting officer, or (2) at a level above the contracting officer, with the appropriate Protest Decision Authority. See 64 Fed. Reg. 16,651 (April 6, 1999)

(b) Agency protests filed with the Contracting Officer shall be sent to the following address: NIST/Acquisition Management Div.

Attn: Andrea Parekh, Contracting Officer 100 Bureau Dr., M/S 1640 Gaithersburg, MD 20899

(c) Agency protests filed with the agency Protest Decision Authority shall be sent to the following address: NIST/Acquisition Management Div.

Attn: Head of the Contracting Office (HCO) 100 Bureau Dr., M/S 1640 Gaithersburg, MD 20899

(d) A complete copy of all agency protests, including all attachments, shall be served upon the Contract Law Division of the Office of the General Counsel within one day of filing a protest with either the Contracting Officer or the Protest Decision Authority.

(e) Service upon the Contract Law Division shall be made as follows:

U.S. Department of Commerce Office of the General Counsel Chief, Contract Law Division http://www.ecfr.gov/cgi-bin/text-idx?SID=6b3121d28d772a0296241b81d731dbf1&mc=true&node=pt48.5.1352&rgn=div5 http://www.ecfr.gov/cgi-bin/text-idx?SID=6b3121d28d772a0296241b81d731dbf1&mc=true&node=pt48.5.1352&rgn=div5 mailto:randy.schroyer@nist.gov

Room 5893 Herbert C. Hoover Building 14th Street and Constitution Avenue, NW Washington, DC 20230

FAX: 202/482-5858

1352.235-70 Protection of Human Subjects (APR 2010).

(a) Research involving human subjects is not permitted under this award unless expressly authorized in writing by the Contracting Officer. Such authorization will specify the details of the approved research involving human subjects and will be incorporated by reference into this contract.

(b) The Federal Policy for the Protection of Human Subjects (the “Common Rule”), adopted by the Department of Commerce at 15 CFR part 27, requires contractors to maintain appropriate policies and procedures for the protection of human subjects in research. The Common Rule defines a “human subject” as a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information. The term “research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The Common Rule also sets forth categories of research that may be considered exempt from 15 CFR part 27. These categories may be found at 15 CFR 27.101(b).

(c) In the event the human subjects research involves pregnant women, prisoners, or children, the contractor is also required to follow the guidelines set forth at 45 CFR part 46 subpart B, C and D, as appropriate, for the protection of members of a protected class.

(d) Should research involving human subjects be included in the proposal, prior to issuance of an award, the contractor shall submit the following documentation to the Contracting Officer:

(1) Documentation to verify that contractor has established a relationship with an appropriate Institutional Review Board (“cognizant IRB”). An appropriate IRB is one that is located within the United States and within the community in which the human subjects research will be conducted;

(2) Documentation to verify that the cognizant IRB possesses a valid registration with the United States Department of Health and Human Services' Office for Human Research Protections (“OHRP”);

(3) Documentation to verify that contractor has a valid Federal-wide Assurance (FWA) issued by OHRP.

(e) Prior to starting any research involving human subjects, the contractor shall submit appropriate documentation to the Contracting Officer for institutional review and approval.

This documentation may include:

(1) Copies of the human subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms approved by the cognizant IRB;

(2) Documentation of approval for the human subjects research protocol, questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB;

(3) Documentation of continuing IRB approval by the cognizant IRB at appropriate intervals as designated by the IRB, but not less than annually; and/or

(4) Documentation to support an exemption for the project from the Common Rule [Note: this option is not available for activities that fall under 45 CFR part 46 subpart C].

(f) In addition, if the contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed consent form approved by the cognizant IRB, the contractor shall submit a copy of all modified material along with documentation of approval for said modification by the cognizant IRB to the Contracting Officer for institutional review and approval. The contractor shall not implement any IRB approved modification without written approval by the Contracting Officer.

(g) No work involving human subjects may be undertaken, conducted, or costs incurred and/or charged to the project, until the Contracting Officer approves the required appropriate documentation in writing.

CLAUSES:

1352.201-70 Contracting Officer’s Authority (Apr 2010)

The Contracting Officer is the only person authorized to make or approve any changes in any of the requirements of this contract, and, notwithstanding any provisions contained elsewhere in this contract, the said authority remains solely in the Contracting Officer. In the event the contractor makes any changes at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract terms and conditions, including price.

1352.201-72 Contracting Officer’s Representative (COR) (Apr 2010)

(a) TBD is hereby designated as the Contracting Officer's Representative (COR). The COR may be changed at any time by the Government without prior notice to the contractor by a unilateral modification to the contract. The COR is located at:

Phone Number: TBD E-mail: TBD

(b) The responsibilities and limitations of the COR are as follows:

(1) The COR is responsible for the technical aspects of the contract and serves as technical liaison with the contractor. The COR is also responsible for the final inspection and acceptance of all deliverables and such other responsibilities as may be specified in the contract.

(2) The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the contract price, terms or conditions.

Any contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the express written prior authorization of the Contracting Officer. The Contracting Officer may designate assistant or alternate COR(s) to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the contractor.

1352.209-73 Compliance with the Laws (Apr 2010)

The contractor shall comply with all applicable laws, rules and regulations which deal with or relate to performance in accord with the terms of the contract.

1352.209-74 Organizational Conflict of Interest (Apr 2010)

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The restrictions described herein shall apply to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the activities covered by this clause as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity. For the purpose of this clause, affiliation occurs when a business concern is controlled by or has the power to control another or when a third party has the power to control both.

(c) Warrant and Disclosure. The warrant and disclosure requirements of this paragraph apply with full force to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement at any tier expected to exceed the simplified acquisition threshold. The terms “contract,” “contractor,” and “Contracting Officer” shall be appropriately modified to preserve the Government's rights.

(f) Prime Contractor Responsibilities. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507-1 and shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational…