Combined Synopsis for Aligent 1290.pdf

COMBINED SYNOPSIS/SOLICITATION FOR Agilent Infinity II 1290 or Equivalent

SOLICITATION NUMBER: FDA-RFQ-25Q1284011

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i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal

Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

ii. The solicitation number is FDA-RFQ-25Q1284011. This requirement is issued as Request for Quote

(RFQ).

The solicitation is issued as a Full and Open competition.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-07, Effective 08/29/2024.

iv. The associated North American Industry Classification System (NAICS) Code is 334516 with a small business size standard of $12.5 million.

v. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions submitted shall reference the solicitation number and name.

Quote Due Date & Time: 11 June 2025; 10 AM EST

Question Due Date &Time: 11 June 2025; 10 AM EST

Point(s) of Contacts: Warren Jackson; warren.jackson@fda.hhs.gov

Period for Acceptance of Quotes: The quoter agrees to hold the prices firm for 180 calendar days after quote due date.

Quotes that do not provide pricing for all line items may be deemed non-responsive.

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 mailto:warren.jackson@fda.hhs.gov

2 | P a g e award. It is the quoter’s responsibility to ensure all electronic documents are submitted without the use of macros.

QUOTE SUBMISSION INSTRUCTIONS

The quoter shall submit all quotes to the point(s) of contact listed by the due date and time indicated in the solicitation. Discounts are requested from the established GSA schedule prices.

All quotes shall be submitted with the following.

a) Pricing for all line items with the total price

b) Quote issue date and expiration date

c) Autoclave serial numbers and type

d) The information requested under section x of this solicitation.

A list of line-item number(s) and items, quantities, and/or units of measure (including option(s), as applicable) can be found in sections iv of the solicitation.

i. EVALUATION FACTORS

1. Technical features meeting/exceeding listed requirements

2. Total Price

ii. BASIS OF AWARD

The Government will award a contract resulting from this solicitation to the responsible quoter whose quote meets the requirements listed under this 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 an offer furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

iii. DESCRIPTION OF REQUIREMENT

1. Background

The Office of Pharmaceutical Quality Research (OPQR), part of CDER’s super Office of Pharmaceutical https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-pharmaceutical-quality

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Quality, protects the public health by assuring the quality and availability of drugs and biologics by conducting mission-relevant research that addresses current and future needs to support: Science- and risk-based quality assessments of regulatory submissions; Standard, guidance, and policy development;

Pharmaceutical quality surveillance, and Rapid responses to public health issues. The acquisition 1290 Infinity II LC System with ELSD will provide a robust high-performance liquid chromatography instrument suitable for a wide range of analytical applications.

2. Scope

To obtain an Agilent 1290 Infinity II LC System with DAD and ELSD or equivalent for use in DPQR- STL.

3. Requirement

The contractor shall provide (1) Agilent 1290 II LC System with DAD and ELSD or equivalent with the following salient characteristics:

• The Ultra-High Performance Liquid Chromatograph shall comply with the following quality requirements:

o ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html o ISO 9001:2008 https://www.iso.org/standard/46486.html o 21 CFR Part 11 Compliance https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm o USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin

• High Speed Pump o Settable flow range: Setpoints 0.001—5 ml/min, in 0.001 ml/min increments o Flow precision: ≤0.07 % RSD or 0.005 min SD, whatever is greater (0.2—5.0 ml/min) o Active Seal Wash: Included with sensor o Flow accuracy: 1 <±1.0 %

• Multisampler o Maximum load of 16 microplates and up to 6,144 samples for unmatched sample capacity o Integrated sample thermostat o Multi-wash capability.

o Dual needle injection

• Column Compartment o Compartment capacity up to 8 columns o Column Compartment Temperature Range 4 °C to 110 °C o Heat Exchanger o Column Tracing

• Diode Array Detector o RFID technology for flow cells o Simultaneous detection of up to eight signals for increased sensitivity and selectivity o Less baseline drift for more reliable and robust peak integration https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-pharmaceutical-quality https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/46486.html https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin

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• Pressure Range up to 1300 bar (18,855 psi)

• Full Audit Trail Capabilities

• Inside Delivery

• Installation, instrument configuration, and operational qualification

• Familiarization Training for 3-5 users

Trade and Service Specs

• Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.

• The Contractor shall provide a minimum of a one-year manufacturing warranty for all manufactured equipment and parts. The warranty shall be included with the equipment and not separately priced. The warranty shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

• Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

• The Contractor shall provide training and validation of the equipment and software on site at the time of installation. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided, such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training.

• The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/operation qualification (IQ/OQ) certification. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by an FDA representative before installation of the equipment and execution of protocols.

• Inside delivery, disposing pallets, boxes, and any associated garbage, and unpacking the equipment and inventory of parts with a lab representative.

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4. INSPECTION/ACCEPTANCE CRITERIA

Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement.

5. CONTRACT TYPE

This is firm fixed price.

6. PERIOD OF PERFORMANCE

The period of performance (POP) is for 180 days after award.

7. PLACE OF DELIVERY AND PERFORMANCE

U.S. Food and Drug Administration Office of Pharmaceutical Quality Research 645 Newstead Ave.

St. Louis, MO 63110 Attn: POC to be identified at time of the award.

HOURS OF OPERATION

Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays.

FEDERAL HOLIDAYS

The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/.

• New Year's Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Juneteenth National Independence Day

• Independence Day

• Labor Day https://www.opm.gov/

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• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

GOVERNMENT CLOUSURE

Government operating statuses for offices nationwide can be found on https://www.opm.gov/.

Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures. If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level.

In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status. If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO.

8. DELIVERABLES AND DELIVERY SCHEDULE

One (1) Agilent 1290 Infinity LC System with DAD and ELSD or equivalent meeting or exceeding the requirements stated above will be delivered, inside delivery required, in accordance with the following:

Description of Deliverable Quantity Due Date 1290 Infinity II Multicolumn Thermostat 1 Delivery within 60 days of award 1290 Infinity II Evaporative Light Scattering Detector

1 Delivery within 60 days of award

1290 Infinity II High-Speed Pump 1 Delivery within 60 days of award

1290 Infinity II Multicolumn Thermostat 1 Delivery within 60 days of award

1290 Infinity II Diode Array Detector 1 Delivery within 60 days of award

Open Lab Chem Station / software maintenance agreement license

1 Delivery within 60 days of award

Installation Within 30 days of delivery

Familiarization Training Within 30 days of delivery https://www.opm.gov/

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GOVERNMENT POINTS OF CONTACT

Contract Specialist Warren Jackson U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400 Beltsville, MD 20705 Phone: 301-796-7376 Email: warren.jackson@fda.hhs.gov

Contract Representative Officer (COR) Entered at Award

9. 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 of precedence.

10. INVOICING INSTRUCTIONS

Instructions for invoicing are indicated below.

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 mailto:warren.jackson@fda.hhs.gov http://www.ipp.gov/vendors/index.htm

8 | P a g e identified 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.

i. 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.

ii. 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 or phone (866) 973-3131.

iii. 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.

iv. If your company is already registered to use IPP, you will not be required to re-register.

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

• 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;

https://www.ipp.gov/

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

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

• 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;

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

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

• 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:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) 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

10 | P a g e 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.

viii. The provision at 52.212-2, Evaluation—Commercial Items (NOV 2021), is applicable to this requirement.

The government will award a contract resulting from this solicitation to the responsible quoter whose quote meets the requirements listed under the solicitation and is the lowest priced received in response to this solicitation. Therefore, award will be made to quoter is determined to be Lowest Price Technically Acceptable.

ix. The clause at 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2023), applies to this acquisition with the addenda for INVOICING provided under HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022) and invoicing instructions section.

viii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive

Orders—Commercial Items (JAN 2025), The additional FAR clauses cited in the clause that apply under this acquisition are indicated below.

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

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10

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(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) ( 31 U.S.C.

3903 and 10 U.S.C. 3801).

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

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

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

☐ 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN2020), with Alternate (NOV 2021) ☐ 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ☒ 52.203-17, Contractor Employee Whistleblower Rights (NOV 2023) ☐ 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) ☐ 52.204-14, Service Contract Reporting Requirements (OCT 2016) ☐ 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) ☒ 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) ☐ 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide

Acquisition Contracts, and Multi-Agency Contracts. (DEC 2023) ☐ 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (DEC 2023) ☐ Alternate I (DEC 2023) of 52.204–30.

☐ 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ☐ 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ☐ 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ☒ 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) ☐ 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ☐ Alternate I (MAR 2020) of 52.219-6.

☐ 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ☐ Alternate I (MAR 2020) of 52.219-7.

☐ 52.219-8, Utilization of Small Business Concerns (FEB 2024) ☐ 52.219-9, Small Business Subcontracting Plan (SEP 2023)

☐ Alternate I (NOV 2016) of 52.219-9.

☐ Alternate II (NOV 2016) of 52.219-9.

☐ Alternate III (JUN 2020) of 52.219-9.

☐ Alternate IV (SEP 2023) of 52.219-9.

☐ 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ☐ Alternate I (MAR 2020) of 52.219-13.

https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section3801&num=0&edition=prelim https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 https://www.acquisition.gov/far/part-52#FAR_52_203_6 https://www.acquisition.gov/far/part-52#FAR_52_203_13 https://www.acquisition.gov/far/part-52#FAR_52_203_17 https://www.acquisition.gov/far/part-52#FAR_52_204_10 https://www.acquisition.gov/far/part-52#FAR_52_204_14 https://www.acquisition.gov/far/part-52#FAR_52_204_15 https://www.acquisition.gov/far/part-52#FAR_52_204_27 https://www.acquisition.gov/far/part-52#FAR_52_204_28 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.acquisition.gov/far/part-52#FAR_52_209_6 https://www.acquisition.gov/far/part-52#FAR_52_209_9 https://www.acquisition.gov/far/part-52#FAR_52_219_3 https://www.acquisition.gov/far/part-52#FAR_52_219_4 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_13

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☐ 52.219-14, Limitations on Subcontracting (OCT 2022) ☐ 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ☐ 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business

(SDVOSB) Concerns Eligible Under the SDVOSB Program (FEB 2024) ☐ 52.219-28, Post Award Small Business Program Representation (FEB 2024) ☐ Alternate I (MAR 2020) of 52.219-28.

☐ 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned

Small Business Concerns (OCT 2022) ☐ 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible

Under the Women-Owned Small Business Program (OCT 2022) ☐ 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ☐ 52.219-33, Nonmanufacturer Rule (SEP 2021) ☒ 52.222-3, Convict Labor (JUN 2003) ☒ 52.222-19, Child Labor-Cooperation with Authorities and Remedies ☒ 52.222-21, Prohibition of Segregated Facilities ☒ 52.222-26, Equal Opportunity (SEP 2016) ☐ Alternate I (FEB 1999) of 52.222-26.

☒ 52.222-35, Equal Opportunity for Veterans (JUN 2020) ☐ Alternate I (JUL 2014) of 52.222-35.

☒ 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ☐ Alternate I (JUL 2014) of 52.222-36.

☒ 52.222-37, Employment Reports on Veterans (JUN 2020) ☐ 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) ☒ 52.222-50, Combating Trafficking in Persons (NOV 2021) ☐ Alternate I (MAR 2015) of 52.222-50 ☒ 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) ☐ 52.224-3 Privacy Training (JAN 2017) ☐ Alternate I (JAN 2017) of 52.224-3.

☐ 52.225-1, Buy American-Supplies (OCT 2022) ☐ Alternate I (OCT 2022) of 52.225-1.

☐ 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ☐ Alternate I [Reserved].

☐ Alternate II (DEC 2022) of 52.225-3.

☐ Alternate III (NOV 2023) of 52.225-3.

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

☐ 52.225-5, Trade Agreements (NOV 2023) ☒ 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) ☐ 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) ☐ 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) https://www.acquisition.gov/far/part-52#FAR_52_219_14 https://www.acquisition.gov/far/part-52#FAR_52_219_16 https://www.acquisition.gov/far/part-52#FAR_52_219_27 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_29 https://www.acquisition.gov/far/part-52#FAR_52_219_30 https://www.acquisition.gov/far/part-52#FAR_52_219_32 https://www.acquisition.gov/far/part-52#FAR_52_219_33 https://www.acquisition.gov/far/part-52#FAR_52_222_3 https://www.acquisition.gov/far/part-52#FAR_52_222_19 https://www.acquisition.gov/far/part-52#FAR_52_222_21 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_37 https://www.acquisition.gov/far/part-52#FAR_52_222_40 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_223_18 https://www.acquisition.gov/far/part-52#FAR_52_224_3 https://www.acquisition.gov/far/part-52#FAR_52_224_3 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_5 https://www.acquisition.gov/far/part-52#FAR_52_225_13 https://www.acquisition.gov/far/part-52#FAR_52_225_26 https://www.acquisition.gov/far/part-52#FAR_52_226_5

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☐ 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

☒ 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT2018) ☒ 52.239-1, Privacy or Security Safeguards (AUG 1996) ☒ 52.242-5, Payments to Small Business Subcontractors (JAN 2017) ☒ 52.242-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ☐ 52.222-41, Service Contract Labor Standards (AUG 2018) ☐ 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) ☐ 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) ☐ 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ☒ 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for

Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) ☒ 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain

Services-Requirements (MAY 2014) ☐ 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022) ☐ 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) ☐ 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)

x. Additional contract requirement(s) or terms and conditions

FAR 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/these address(es):

https://www.acquisition.gov/.

(End of Clause)

HHSAR CLAUSES

HHSAR

CLAUSE NO.

DESCRIPTION DATE

352.203-70 Anti-Lobbying DEC 2015 352.208-70 Printing and Duplication DEC 2015 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations

DEC 2015

352.227-70 Publications and Publicity DEC 2015

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

(a) Definitions. As used in this clause-https://www.acquisition.gov/far/part-52#FAR_52_229_12 https://www.acquisition.gov/far/part-52#FAR_52_232_33 https://www.acquisition.gov/far/part-52#FAR_52_239_1 https://www.acquisition.gov/far/part-52#FAR_52_242_5 https://www.acquisition.gov/far/part-52#FAR_52_242_5 https://www.acquisition.gov/far/part-52#FAR_52_222_41 https://www.acquisition.gov/far/part-52#FAR_52_222_42 https://www.acquisition.gov/far/part-52#FAR_52_222_43 https://www.acquisition.gov/far/part-52#FAR_52_222_44 https://www.acquisition.gov/far/part-52#FAR_52_222_51 https://www.acquisition.gov/far/part-52#FAR_52_222_53 https://www.acquisition.gov/far/part-52#FAR_52_222_55 https://www.acquisition.gov/far/part-52#FAR_52_222_62 https://www.acquisition.gov/far/part-52#FAR_52_226_6 https://www.acquisition.gov/

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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)

352.239-79 Information and Communication Technology Accessibility (FEB 2024) (Deviation)

(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 information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section- 508/accessibilitychecklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, http://www.ipp.gov/ https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html http://www.itic.org/policy/accessibility/vpat)

15 | P a g e products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section- 508/accessibility- checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)

FAR/HHSAR PROVISIONS

FAR 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 offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/.

(End of Provision)

FAR 52-211-6 Brand Name or Equal I (Aug 1999)

a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and http://www.hhs.gov/web/section-508/accessibility-http://www.hhs.gov/web/section-508/accessibility-https://www.acquisition.gov/

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(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

352.239-78 Information and Communication Technology Accessibility Notice (FEB 2024) (Deviation)

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html. The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility- checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail— whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether http://www.hhs.gov/web/section-508/index.html http://www.hhs.gov/web/section-508/accessibility-

17 | P a g e proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://Section508.gov/.

In order to facilitate the Government's determination whether proposed ICT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

Items delivered as electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(End of provision) https://section508.gov/ http://508.hhs.gov/