Solicitation No. 75F40126Q00046

REQUEST FOR QUOTE (RFQ)

Steris Laboratory Glassware Washer

i. This solicitation is an official RFQ from the U.S. Food and Drug Administration (FDA).

ii. The FDA intends to issue a commercial item Firm Fixed-Price delivery order that meets the requirements of the statement of need. This is a Brand Name or Equal solicitation.

iii. This RFQ is being conducted using commercial acquisition procedures in accordance with Federal Acquisition Regulation (FAR) Part 12, as implemented under the Revolutionary FAR Overhaul (RFO). The resultant contract will be a Firm-Fixed-Price (FFP) purchase order.

This acquisition is a Total Small Business Set-Aside in accordance with FAR 19.502-2.

The associated North American Industry Classification System (NAICS) code for this procurement is 333310 Commercial and Service Industry Machinery Manufacturing. The Small Business Administration (SBA) size standard for NAICS code 333310 is 1,000 employees.

SOLICITATION NO.: 75F40126Q00046

QUOTE DUE DATE: July 31, 2026 by 12:00 PM ET

All quotes must be submitted via email to the POC below.

Period for Acceptance of Offers: The quoter agrees to hold prices firm for 30 calendar days after the quote due date.

Point of Contacts: Min Jie Zeng at Minjie.Zeng@fda.hhs.gov

* Contracting Officer’s Representative (COR) and/or Technical Point of Contract (TPOC) will be provided at award.

Quoters that fail to submit all required information in accordance with the instructions, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. Quotes that do not provide the requested information may be deemed non-responsive.

The quote shall contain sufficient information to allow the Government to determine whether the quote is meeting all the requirements in the RFQ. Quoters shall clearly state product part number, product description, quantity, unit and extended prices, and period of performance for each proposed product.

Licensing Agreements: Quoters are notified that the Government will not sign any licensing agreement or similar user agreement provided by the Quoters. The Government may choose to incorporate an agreement into the contract resulting from this solicitation.

The Government reserves the right to include some or none of the quoters additional terms and conditions into any possible orders, especially when the quoter’s terms and conditions would conflict with the Federal Acquisition Regulation or any of the terms or conditions of the quoter’s award vehicles. Quoters are advised that additional terms and conditions submitted with their quotation that is in conflict of the terms and conditions of this solicitation may be deems as technically unacceptable and may not be considered for award.

Quoters shall ensure that their initial submission represents their best pricing and that all information is provided to determine technical acceptability. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation.

Equal To quotes must meet all the salient characteristics in order to be considered technically acceptable. Equal to quotes must submit a separate Technical Quote with a detailed point-by-point description of how the Equal To products meet all the salient characteristics of this SOW.

Equal To Quotes shall be required to operate seamlessly with all requirements of this solicitation.

The Equal To Quotes shall be clear, concise, and include sufficient detail for effective evaluation and for substantiating of the validity of stated claims. The Equal To Quotes shall not simply re-phrase or re-state the Government’s requirements, but rather shall provide convincing rationale to address how the Quoters intends to meet these requirements. Statements that the Quoters will provide a particular feature or objective without explaining how the Quoters proposes to meet that feature or objective are generally inadequate and may adversely impact the Government’s evaluation of the Quoters. Simply returning the solicitation may deem your quote to be non-responsive. Quotes providing the brand name product are not required to submit separate Technical Quotes. Technical Quotes shall not contain pricing information.

Compatibility: FDA is purchasing this software license on a “Brand Name or Equal” basis and the salient characteristics (physical, functional, or performance characteristic specified in this solicitation) have been provided. For the purposes of this RFQ, FDA defines compatible as meaning that there will be no communication, performance, maintainability issues in the interconnection of solutions with different configurations. A compatible solution is one that will allow for seamless integration in FDA’s current environment. Each alternate component proposed shall demonstrate:

• That there will be *no* communication, performance or maintainability issues in the interconnection of solutions with differing brand names.

• Seamless (no application change) any solution must be able to be installed with no change in application code or redevelopment. The ability to maintain service support without any changes in FDA environment.

• Performance compatibility of the component vs. the brand name provided.

• Equal to quotes shall include all pricing (installation, integration, training, etc.) related to ensuring the FDA maintains the current state of functionality with no disruption or degradation of service or support.

Equal To quotes shall include a breakdown of all costs associated with the integration of the proposed solution into FDA environment. These costs shall be incorporated in the overall cost to the Government.

For equal to quotations, Quoters will submit Section 508 Product Accessibility Templates (PAT) in full text with their quotations. For more information regarding PATs see:

https://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/

If Quoters fail to address this Section 508 PAT in their quotes, they may be deemed non-responsive and not considered for award.

The quote and any questions shall reference the solicitation number.

It is the quoter’s responsibility to monitor the release of an amendment to the request for quote.

The quoter shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an quoter to correct the document submission and the Government will not inform the quoter that their submission is non-responsive prior to award. It is the quoter’s responsibility to ensure all electronic documents are submitted without the use of macros.

v. SUBMISSION INSTRUCTIONS

The quoter must be an authorized distributor/reseller or manufacturer/provider for the quoted items in the schedule on the date of the quote submission. The FDA will verify the quoter’s authorized reseller status. Failure to meet the authorized reseller status may be deemed non-responsive.

Period of Performance Needed:

Base Year: 12 months

Submit all quotes with the following:

a) Quote – Schedule of items

Description Part # QTY Unit Price Sub-Total Price Delivery Steris Reliance 400XLS Laboratory Glassware Washer, including all the accessories and one-year warranty. Or Equivalent

FM40311.

Or Equivalent

1 $ $ Within 45 calendar days after award

Delivery, installation, demonstration, and Dispose

N/A 1 $ $ Within 45 calendar days after award

Total Cost:

vi. BASIS FOR AWARD

The Government will award an order resulting from this solicitation to the responsible quoter whose quote meets the requirements stated herein the solicitation and is the lowest priced quote received in response to this solicitation. Therefore, award will be made to quoter whose quote is determined to be Lowest Price Technically Acceptable.

A written notice of award or acceptance of a quote mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the quote, shall result in a binding contract without further action by either party. Before the quote’s specified expiration time, the Government may accept a quote (or part of a quote), whether or not there are communications after its receipt, unless a written notice of withdrawal is received before award.

vii. EVALUATION OF QUOTES

The following factors shall be used to evaluate quotes that are submitted timely

1) Submitted all schedule items in accordance with the solicitation.

2) Technical features meeting/exceeding requirements specified in the statement of need.

3) Total Price

In addition, each “or Equal” solution proposed shall demonstrate:

• A technical volume with detailed point-by-point description of how the equal to product meets all the salient characteristics of Statement of Need, specialized in Section 3.0.

• Completed Section 508 Product Accessibility Templates (PAT) in full text.

viii. PROVISIONS

1. FAR Provisions:

52.252-1: 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 offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address https://www.acquisition.gov/far-overhaul/far-part-deviation-guide

(End of provision)

Number Title Date

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions Sep 2024

52.203-18

Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation Jan 2017

52.204-7 System for Award Management—Registration

DEVIATION

DATE

52.204-7 with Alt I

System for Award Management—Registration, with Alternate I

DEVIATION

DATE

Number Title Date

52.204-90 Offeror Identification Deviation Date

52.207-6

Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts) Aug 2024

52.209-12 Certification Regarding Tax Matters Oct 2025

52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products Feb 2021

52.222-48

Exemption from Application of the Service Contract Labor Standards for Maintenance, Calibration, or Repair of Certain Equipment–Certification

Deviation

DATE

52.222-52 Exemption from Application of the Service Contract Labor Standards for Certain Services-Certification

Deviation

DATE

52.222-56 Certification Regarding Trafficking in Persons Compliance Plan

Deviation

DATE

52.223-4 Recovered Material Certification May 2008

52.225-2 Buy American Certificate Oct 2022

52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate

DEVIATION

DATE

52.225-6 Trade Agreements-Certificate Feb 202

52.240-90 Security Prohibitions and Exclusions Representations and Certifications

Deviation Date

2. HHSAR PROVISIONS:

The below Health and Human Services Acquisition Regulation (HHSAR) provision apply.

HHSAR Clauses can be viewed in full text at:

http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1-- InstructionsforUsingProvisionsandClauses

352.239-73: Electronic and Information Technology Accessibility Notice (Dec2015)

STATEMENT OF NEED

1. Background The Food and Drug Administration (FDA) Human Foods Program (HFP) seeks to procure a new lab glassware washer meeting or exceeding the salient characteristics below. A laboratory dishwasher is used to clean and sanitize labware used for sampling, media, reagents, and solutions. Equipment must automatically dispense liquid chemicals into the chamber pump during the desired treatment. A pre-wash, high-temperature wash (95C), rinse, pure water rinse to ensure all chemical residue is removed, and drying feature are needed. The unit must be able accommodate large items such as 20L carboys and tall flasks and cylinders. Deinstallation and installation must be included.

2. Objectives

The scope of this contract is to procure one (1) Laboratory glassware washer with the associated Warranty and Service/Maintenance Agreement to replace an existing unit that that is no longer manufactured and no longer supported.

3. Requirements

a. Salient Characteristics

The Contractor shall provide a Steris laboratory glassware washer, or equal, that meets the following salient characteristics:

1. The Laboratory Dishwasher shall feature be installable in fixed location:

a) The overall space where the laboratory dishwasher will be installed is 44”

(width) x 120” (height) x 36” (depth)

b) The unit must fit in the existing spot where the previous Steris Reliance 400 laboratory Dishwasher is currently installed as the laboratory does not permit any other space.

c) The unit must connect to the existing plumbing and water lines installed in the laboratory.

d) The Dishwasher shall be a single instrument that cleans, sanitizes, and dries labware free of residue.

High heat (95C) pre-wash and wash cycle with controlled chemical dispensing gravity cycle

e) The unit must be 208 Volt, 60 Hz, 3-Phase, 3-Wire

f) The unit must contain a non-vented drying system

g) The unit must contain a non-vented vapor condenser

h) The unit must contain a drain discharge cool down

i) The unit must contain non-recirculated heated pure water rinse system

j) The unit must contain a universal shelving system

k) The unit must contain an air compressor with 2 CFM 110 VAC/60 Hz

l) The Dishwasher shall be a single instrument that cleans, sanitizes, and dries labware free of residue.

High heat (95C) pre-wash and wash cycle with controlled chemical dispensing.Gravity cycle High heat (95C) rinse and pure rinse cycles (plumbing to the DI water system with a reservoir to ensure enough liquid is on hand to rinse)- These cycles must be adequate to remove all chemical residue from labware.

Drying cycle (adjustable heat for plastic ware) for labware that does not require sterilization but must be free from residue and sanitized for ready use.

2. The Dishwasher shall feature adjustable shelving to accommodate larger labware such as 20L carboys, tall flasks, and tall cylinders. A basket shall be included for labware lids, caps, and smaller lab utensils and implements.

3. The Dishwasher shall feature adjustable cycles for washes, rinses, and dries.

4. The Dishwasher shall feature a printable cycle log.

5. The Dishwahser shall include safety features to prevent a cycle from starting with the door/chamber open.

b. Task

The Contractor shall:

1. Uninstall an existing Steris Reliance 400 and dispose.

2. Deliver and install in the available space (mentioned above in Section 1) the new unit no more than thirty (30) calendar days after award.

3. Demonstrate the full operation of the selected unit after installation

c. Warranty

The proposed item:

1. Shall include a minimum of one (1) year original equipment manufacturer (OEM) warranty.

2. Stipulate that warranty coverage shall commence on the date of acceptance.

4. Deliverables and Delivery Location The Contractor shall deliver the following items that meet all the requirements delineated in Section 3 above.

Ref Description Part # QTY

Section 3.a Steris Reliance 400XLS Laboratory Glassware Washer, FM40311 1 and 3.c including all the accessories and one-year warranty. Or Equivalent

Or Equivalent

Section 3.b Delivery, installation, demonstration, and Dispose N/A 1

Delivery, Installation, and Maintenance/Service Location

US Food and Drug Administration 1 Iberville Drive Dauphin Islanda, AL 36528

POC for delivery: To be provided at time of award.

5. Period of Performance

The overall period of performance (POP) of this order is:

Base Period: 12 months

6. Inspection and Acceptance Criteria

The Contracting Officer’s Representative will inspect and accept the services delivered.

Inspection and acceptance will occur at the place of delivery. The Government will accept deliverables only if they conform to all terms and conditions of the contract, and satisfy the performance standards detailed within this SOW.

Government will accept goods and services only if they conform to all terms and conditions of this order. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

7. Contractor Performance Evaluation(s)

During the life of this contract, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov.

8. Contract Type

This is a Firm-Fixed Price.

9. Government Points of Contact (POC)

Contract Specialist (CS):

Min Jie Zeng

Office of Acquisition and Grants Services Food and Drug Administration Minjie.Zeng@fda.hhs.gov

Contracting Officer (CO):

TBD

Contracting Officer’s Representative (COR):

TBD

10. Authorized Reseller/Servicing Agent

The Contractor shall be the software Original Equipment Manufacturer (OEM), or, an authorized reseller/servicing agent of the software OEM.

The Contractor shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the OEM.

11. Contracting Officer Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

12. Order of Precedence

The Contractor shall follow the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4 of the underlying GSA contract. Any indemnification language indemnifying the Contractor of any liability and governing law language in the Contractor’s terms and conditions shall be invalid and shall be stricken and removed from this order. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from this order.

13. Invoicing Instructions

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

(a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

(c)

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov o phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to reregister.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

(d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

(e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

(f) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

1. List of all invoices submitted to date under the subject award, including the following:

a. invoice number, amount, & date submitted.

b. corresponding payment amount & date received.

2. total amount of all payments received to date under the subject contract or order and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

(g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

(h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

(j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

(k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

14. FAR / HHSAR Clauses

HHS FAR Deviations:

Note: To see the full details of the Class Deviations (CD), please go to Class Deviations.

HHSAR CD 2025-02 - This CD is necessary to immediately update HHSAR policies to comply with EOs issued on or after January 20, 2025, to implement President Trump’s agenda and priorities throughout the Executive Departments and agencies.

HHSAR CD 2025-01 - Supply Chain Risk Assessments.

HHSAR CD 2024-01 Amend. #1 - On the effective date of March 1, 2024, the prescribed contract language in Amendment 1 to Class Deviation 2024-01 supersedes the prescribed contract language in the HHS Policy for Information Technology Procurements - Security and Privacy Language. OCIO is in the process of updating their Policy.

HHSAR CD not numbered (2023-02) - Department of Health and Human Services (HHS) Class Deviation from the Health and Human Services Acquisition Regulation (HHSAR) – Implementation of the Make Personal Protective Equipment (PPE) in America Act Requirements. This HHSAR class deviation was issued with Acquisition Alert 2023-07.

HHSAR CD 2023-01 - HHSAR Class Deviation 23-01 HITECH Act Health IT Standards. This HHSAR class deviation was issued with Acquisition Alert 2023-05.

FAR CD 2025-02 Amend. #1 - Amendment 1 to Class Deviation (CD) No. 2025-02 from the Federal Acquisition Regulation (FAR) Regarding Section 2 of the Executive Order (EO) 14148, “Initial Rescissions of Harmful Executive Orders and Actions,” which revoked EO 14057 and Section 2 of EO 14208, “Ending Procurement and Forced Use of Paper Straws.” FAR CD 2025- 02, Amendment 1 – Attachment 1, FAR Deviation Text.

FAR CD 2025-01 Amend. #1 - lass Deviation 2025-01 from the FAR Regarding Executive Order (EO) 14173 and EO. 14168. FAR CD 2025-01 Attachment 1, FAR Deviated Text.

FAR CD 2024-03 - Class Deviation 2024-03 from the FAR Regarding Legal Challenges to EO 14026, Increasing Minimum Wage for Federal Contractors. CAAC Letter 2024-01, CAAC Consultation to Issue a Class Deviation from the FAR Regarding Legal Challenges to Executive Order 14026, Increasing the Minimum Wage for Federal Contractors

FAR CD 2024-01 - Class Deviation 2024-01 SBA 8(a) Program. CAAC Letter 2024-01 Regarding SBA Memorandum on use of the 8(a) Program.

FAR CD 2022-01 - Class Deviation 2022-01 Regarding Requirements for Nonavailability Determinations Under the Buy American Act. CAAC Letter 2022-01 Regarding Requirements for Nonavailability Determinations Under the Buy American Act.

FAR CD 2020-04 - Class Deviation (2020-04) from the Federal Acquisition Regulation to eliminate harp copy original documents, signatures, notarization, seal on bonds and other seals for certain contract requirements. CAAC Letter 2020-04.

FAR CD 2020-01 - Class Deviation from the Federal Acquisition Regulation Regarding Flexibilities for the Suspending or Disbarring Official's Correspondences with Contractors.

HHS FAR Class Deviation 2020-01 Attachment 1. Civilian Agency Acquisition Council (CAAC) Letter 2020-01.

FAR Clauses:

52.252-2: 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 address:

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide

(End of Clause)

52.203-6 with Alt I: Restrictions on Subcontractor Sales to the Government (Nov 2021) 52.203-17: Contractor Employee Whistleblower Rights (Nov 2023) 52.203-19: Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Jan 2017) 52.204-13: System for Award Management—Maintenance (DEVIATION DATE) 52.204-91: Contractor Identification (Deviation Date) 52.209-10: Prohibition on Contracting with Inverted Domestic Corporations (Deviation Date) 52.212-4: Contract Terms and Conditions – Commercial Items (Nov 2023) 52.219-6: Notice of Total Small Business Set-Aside (Deviation Date) 52.219-8: Utilization of Small Business Concerns (Deviation Date) 52.219-14: Limitations on Subcontracting (Deviation Date) 52.232-40: Providing Accelerated Payment to Small Business Subcontractors (Mar 2023) 52.222-3: Convict Labor (Deviation Date) 52.222-19: Child Labor—Cooperation with Authorities and Remedies (Deviation Date) 52.222-36: Equal Opportunity for Workers with Disabilities (Deviation Date) 52.222-40: Notification of Employee Rights Under the NLRA (Deviation Date) 52.222-50: Combating Trafficking in Persons (Deviation Date) 52.222-90: Addressing DEI Discrimination by Federal Contractors (Deviation Date) 52.225-1: Buy American—Supplies (Deviation Date) 52.226-8: Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.232-25: Prompt Payment (Jan 2017) 52.232-33: Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) 52.232-39: Unenforceability of Unauthorized Obligations (Jun 2013) 52.233-1: Disputes (Deviation Date) 52.233-3: Protest After Award (Deviation Date) 52.233-4: Applicable Law for Breach of Contract Claim (Deviation Date) 52.240-92: Security Requirements (Deviation Date) 52.244-6: Subcontracts for Commercial Products and Commercial Services (Deviation Date) 52.246-2: Inspection of Supplies—Fixed-Price (Aug 1996) 52.246-16: Responsibility for Supplies (Apr 1984) 52.247-34: F.O.B. Destination (Jan 1991)

FAR 52.222-54: Employment Eligibility Verification (Jan 2025)

(a) Definitions. As used in this clause-

Commercially available off-the-shelf (COTS) item—

(1) Means any item of supply that is—

(i) A commercial product (as defined in paragraph (1) of the definition of “commercial product” at Federal Acquisition Regulation (FAR) 2.101);

(ii) Sold in substantial quantities in the commercial marketplace; and

(iii) Offered to the Government, without modification, in the same form in which it is sold in the commercial marketplace; and

(2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Per 46 CFR 525.1 (c)(2), "bulk cargo" means cargo that is loaded and carried in bulk onboard ship without mark or count, in a loose unpackaged form, having homogenous characteristics. Bulk cargo loaded into intermodal equipment, except LASH or Seabee barges, is subject to mark and count and, therefore, ceases to be bulk cargo.

Employee assigned to the contract means an employee who was hired after November 6, 1986 (after November 27, 2009 in the Commonwealth of the Northern Mariana Islands), who is directly performing work, in the United States, under a contract that is required to include the clause prescribed at 22.1803. An employee is not considered to be directly performing work under a contract if the employee-

(1) Normally performs support work, such as indirect or overhead functions; and

(2) Does not perform any substantial duties applicable to the contract.

Subcontract means any contract, as defined in 2.101, entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime Contractor or another subcontractor.

United States, as defined in 8 U.S.C. 1101(a)(38), means the 50 States, the District of Columbia, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin Islands.

(b) Enrollment and verification requirements. (1) If the Contractor is not enrolled as a Federal Contractor in E-Verify at time of contract award, the Contractor shall-

(i) Enroll. Enroll as a Federal Contractor in the E-Verify program within 30 calendar days of contract award;

(ii) Verify all new employees. Within 90 calendar days of enrollment in the E-Verify program, begin to use E-Verify to initiate verification of employment eligibility of all new hires of the Contractor, who are working in the United States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph (b)(3) of this section); and

(iii) Verify employees assigned to the contract. For each employee assigned to the contract, initiate verification within 90 calendar days after date of enrollment or within 30 calendar days of the employee’s assignment to the contract, whichever date is later (but see paragraph (b)(4) of this section).

(2) If the Contractor is enrolled as a Federal Contractor in E-Verify at time of contract award, the Contractor shall use E-Verify to initiate verification of employment eligibility of-

(i) All new employees. (A) Enrolled 90 calendar days or more. The Contractor shall initiate verification of all new hires of the Contractor, who are working in the United States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph (b)(3) of this section); or

(B) Enrolled less than 90 calendar days. Within 90 calendar days after enrollment as a Federal Contractor in E-Verify, the Contractor shall initiate verification of all new hires of the Contractor, who are working in the United States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph (b)(3) of this section); or

(ii) Employees assigned to the contract. For each employee assigned to the contract, the Contractor shall initiate verification within 90 calendar days after date of contract award or within 30 days after assignment to the contract, whichever date is later (but see paragraph (b)(4) of this section).

(3) If the Contractor is an institution of higher education (as defined at 20 U.S.C. 1001(a)); a State or local government or the government of a Federally recognized Indian tribe; or a surety performing under a takeover agreement entered into with a Federal agency pursuant to a performance bond, the Contractor may choose to verify only employees assigned to the contract, whether existing employees or new hires. The Contractor shall follow the applicable verification requirements at (b)(1) or (b)(2) respectively, except that any requirement for verification of new employees applies only to new employees assigned to the contract.

(4) Option to verify employment eligibility of all employees. The Contractor may elect to verify all existing employees hired after November 6, 1986 (after November 27, 2009, in the Commonwealth of the Northern Mariana Islands), rather than just those employees assigned to the contract. The Contractor shall initiate verification for each existing employee working in the United States who was hired after November 6, 1986 (after November 27, 2009, in the Commonwealth of the Northern Mariana Islands), within 180 calendar days of-

(i) Enrollment in the E-Verify program; or

(ii) Notification to E-Verify Operations of the Contractor’s decision to exercise this option, using the contact information provided in the E-Verify program Memorandum of Understanding (MOU).

(5) The Contractor shall comply, for the period of performance of this contract, with the requirements of the E-Verify program MOU.

(i) The Department of Homeland Security (DHS) or the Social Security Administration (SSA) may terminate the Contractor’s MOU and deny access to the E-Verify system in accordance with the terms of the MOU. In such case, the Contractor will be referred to a suspending and debarring official.

(ii) During the period between termination of the MOU and a decision by the suspending and debarring official whether to suspend or debar, the Contractor is excused from its obligations under paragraph (b) of this clause. If the Contractor is not suspended, debarred, or subject to a voluntary exclusion, then the Contractor must reenroll in E-Verify.

(c) Web site. Information on registration for and use of the E-Verify program can be obtained via the Internet at the Department of Homeland Security Web site: https://www.e-

Verify.gov.

(d) Individuals previously verified. The Contractor is not required by this clause to perform additional employment verification using E-Verify for any employee-

(1) Whose employment eligibility was previously verified by the Contractor through the E- Verify program;

(2) Who has been granted and holds an active U.S. Government security clearance for access to confidential, secret, or top secret information in accordance with the National Industrial Security Program Operating Manual; or

(3) Who has undergone a completed background investigation and been issued credentials pursuant to Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors.

(e) Subcontracts. The Contractor shall include the requirements of this clause, including this paragraph (e) (appropriately modified for identification of the parties), in each subcontract that-

(1) Is for— (i) Services (except for commercial services that are part of the purchase of a COTS item (or an item that would be a COTS item, but for minor modifications), performed by the COTS provider, and are normally provided for that COTS item); or

(ii) Construction;

(2) Has a value of more than $3,500; and

(3) Includes work performed in the United States.

(End of clause)

HHSAR Clauses:

This contract incorporates one or more HHSAR clauses by reference, with the same force and effect as if they were given in full text. The full text of the HHSAR clauses may be accessed electronically at this address:

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

HHSAR 352.203-70: Anti-lobbying (Dec 2015) HHSAR 352.222-70: Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

HHSAR 352.224-71: Confidential Information (Dec 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: All data and analysis of FDA food supply chain activities within the 21 Forward system.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: Manufacturer data is commercial confidential data. Retail sales data is subject to review and clearance through each retail sales data company. All other data and analyses are for government use only; the analyses are pre-decisional intended to inform govt policy decisions and are not subject to FOIA or public release.

(iii) Written advance notice of at least 45 days shall be provided to the

Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

(End of Clause)

HHSAR 352.232-71: Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End Of Clause)

HHSAR 352.239-74: Information and Communication Technology (ICT) Accessibility

(DEC 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508.

The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

Must meet WCAG 2.0 A and AA E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) E208 Support Documentation and Services (Appendix A, Application and Scoping

Requirements) Chapter 6 Support Documentation and Services (Appendix C, Functional Performance

Criteria and Technical Requirements) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-filesaccessible/ index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards.

Instructions for documenting accessibility via the HHS Section 508.Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

HHSAR 352.223-70: Safety and Health (Dec 2015)

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the Federal, State, and local levels.

(1) In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR part 1910. These regulations are available at https://www.osha.gov/.

(ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C.