RFQ no. 75F40126Q00301

STATEMENT OF WORK

Gas module for an existing Inductively Coupled Plasma Mass Spectrometer (ICP-MS - ThermoFisher iCAP TQ)

1. Purpose The Office of Chemistry and Toxicology (OCT), Division of Bioanalytical Chemistry (DBC), Chemical Contaminants Branch (CCB) requires the purchase of a gas module to be coupled to an existing mass spectrometer to be used to measure toxic and nutritional elements in foods and dietary supplements.

2. Background The Chemical Contaminants Branch within the Office of Chemistry and Toxicology, Division of Bioanalytical Chemistry requires the purchase of a gas module for an existing instrument. The equipment requested will be used for the following applications:

1. Measuring toxic elements in foods and dietary supplements

2. Measuring elemental concentrations in foods with higher concentration of total dissolved solids

(TDS)

3. Reducing matrix effects in highly concentrated samples and in samples with higher carbon content

4. Reducing the need for dilutions to measure nutrient elements that are typically present in high levels (>1000 ppm - percent levels) in the foods

5. Maintaining acceptable stability throughout an entire analytical sequence

This instrument offers accurate, cost-effective benefits for mass spectrometric analysis and will ensure accuracy and stability. Additionally, this gas module will save time and resources otherwise wasted preparing additional dilutions of the samples. Upon installation of the gas module, the argon gas dilution capability for the iCAP TQ will enable the analysis of high matrix samples by diluting the nebulized sample stream, decreasing the sample load, and enabling tolerance of the direct analysis of a higher level of matrix compared to standard operating conditions. These applications are critical to the FDA’s mission to ensure the safety of the nation’s food supply and its proper and accurate labeling.

3. Objectives The purchase of this gas module is necessary to support several applications that are critical to the FDA’s mission. The major components of the acquisition plan shall have:

• Minimum requirements:

o Gas Module for iCAP Triple Quadrupole

1000 mL/min mass flow controller Tubing and connectors for the additional gas port o Installation and performance check of the gas module using the existing instrumentation (i.e., Thermo Fisher iCAP TQ), as well as any necessary software modifications to tune using the dilution gas

4. Technical Specifications

4.1. Technical Specifications

• Item: Gas Module for iCAP Triple Quadrupole

• Main component: 1000 mL/min mass flow controller

• Additional components: Y-connector to split the original argon line, any other tubing and connectors necessary

• Software compatibility: Adjustments to the Configurator software to reflect the new gas in Qtegra (the ICP-MS main software)

4.2. Performance Specifications

• Tuning requirements: The gas module shall pass tuning requirements using the auto-tune feature using the dilution gas

5. Delivery The vendor shall be responsible for delivery of the instrument and all components specified above to the FDA/HFP laboratory facility located at 5001 Campus Drive, College Park, MD 20740. The delivery shall be made to the loading dock and moved into location on the date of installation.

6. Installation and Set-up The vendor shall be responsible for installation and set-up, including initial calibrations.

7. Training and Documentation Installation shall include onsite training led by the contractor personnel on the day of the installation to make sure the user is familiar with how to use the system, and aware of any maintenance or troubleshooting of the module.

8. Warranty and Maintenance The instrument shall l be covered by a one (1) year warranty from the date of installation. The warranty shall cover all parts and labor with one preventative maintenance.

9. Inspection and Acceptance The instrument shall not be accepted until performance specifications have been met. The FDA project officer will perform inspection and acceptance of the instrument. The entire system shall be warranted for parts and labor for twelve (12) months from date of installation. Service shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

10. Quality Assurance The system shall be a newly manufactured unit, not used or refurbished, or previously used for demonstration. The instrument shall meet all the technical requirements specified above in Section 3.

(“Objectives”) and Section 4 (“Technical Specifications”) of this Request for Quote (RFQ).

11. Security Requirements Not Applicable

12. Environmental Considerations Not Applicable

13. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) Not applicable

14. Travel All travel charges will be in accordance with the Federal Travel Regulation. For additional reference, the contractor shall refer to the Federal Travel Regulation: https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation.

15. Contractor Provided Special Material Requirements Not Applicable

16. Place of Performance The vendor shall be responsible for delivery of the instrument and all components specified above to FDA/HFP laboratory facility. FDA/HFP, 5001 Campus Drive, College Park, Maryland, 20740. Delivery and installation should be coordinated through the HFP Project Officer. Work shall be conducted Monday through Friday, excluding federal holidays.

17. Period of Performance (POP)

The POP is anticipated to be twelve (12) months.

September 30, 2026 to September 29, 2027

18. Points of Contact Contracts Specialist (CS) Nam Nguyen Nam.Nguyen@fda.hhs.gov

Contracting Officer (CO) Maeve Xavier Maeve.Xavier@fda.hhs.gov

Contracting Officer’s Representative (COR)

TBD

Contractor POC

TBD

19. Contract Type It is anticipated that this will be a Firm-Fixed Price (FFP) type Purchase Order.

https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation mailto:Nam.Nguyen@fda.hhs.gov mailto:Maeve.Xavier@fda.hhs.gov

20. Invoicing The Contractor shall comply with FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services, with regard to Firm-Fixed-Price tasks/deliverables. The Contractor may submit invoices for one or more individual quantities of a deliverable after the successful delivery and acceptance of that individual quantity, not to exceed the individual unit Firm-Fixed-Price of each deliverable and not to exceed the total Firm-Fixed-Price of each period of performance.

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

a. All Invoice submissions for goods and or services must be mad e 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 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 or 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 re-register.

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).

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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;

• 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 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.

21. Availability of Funds The Government’s obligation for performance of this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

22. Clauses Federal Acquisition Regulation (FAR) clauses and provisions in full text may be accessed at the following electronic address: https://www.acquisition.gov/.

Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses in full text may be accessed at the following electronic address: https://www.acquisition.gov/hhsar. Unless specified otherwise, the following clauses and provisions are applicable at the IDIQ and task order level.

22.1. Federal Acquisition Regulation (FAR) Clauses

52.212-4 – Contract Terms and Conditions—Commercial Products and Commercial Services

(DEVIATION DATE)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights-

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the https://www.acquisition.gov/ https://www.acquisition.gov/hhsar

Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference.

The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include-

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer- Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act ( 31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and https://www.acquisition.gov/far/part-52#FAR_52_233_1 https://www.acquisition.gov/far/part-52#FAR_52_202_1 https://www.acquisition.gov/far/part-52#FAR_52_232_33 https://www.acquisition.gov/far/part-52#FAR_52_232_34 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3903&num=0&edition=prelim proceedings.

(i) Payment.-

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act ( 31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall-

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the-

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if–

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

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(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on-

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours https://www.acquisition.gov/far/part-32#FAR_32_608_2 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section1352&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section1352&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section431&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title40-chapter37&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU0MC1jaGFwdGVyMzctZnJvbnQ%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C.

chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation ( 31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an "I agree" click box or other comparable mechanism (e.g., "click-wrap" or "browse-wrap" agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of clause)

22.2. FAR Clauses Incorporated by Reference

The following clauses are incorporated by reference with the same force and effect as if they were given in full text.

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Clause Number Title Date 52.203-3 Gratuities APR 1984

52.204-13 System for Award Management Maintenance DEVIATION

DATE

52.237-3 Continuity of Services JAN 1991 52.242-15 Stop-Work Order AUG 1989 52.242-17 Government Delay of Work APR 1984

22.3. Health and Human Services Acquisition Regulation (HHSAR) Clauses

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)

23. Instructions to the Offerors The Contract Specialist, Nam Nguyen, is the main point of contact for this procurement. Questions (if any) pertaining to this RFQ. Oral communications are not permissible.

A quote shall be submitted electronically via email to Nam Nguyen, at Nam.Nguyen@fda.hhs.gov, by 9:00am (Eastern) on Wednesday July 22, 2026. By responding to the solicitation, the Offeror acknowledges validity through September 30, 2026.

Questions/clarifications regarding this requirement shall be submitted via email to Nam Nguyen, at Nam.Nguyen@fda.hhs.gov, as soon as possible.

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

Final issuance of award depends on the availability of funding.

The FDA is not responsible for any costs incurred in preparing the documents described in this RFQ.

Offeror employees responsible for preparing material that may be proprietary information must mark each page that the Offeror believes contains proprietary information with the legend “Proprietary Information.”

23.1. Technical Quote Instructions

The Technical Quote should include a brief narrative description demonstrating the Contractor’s understanding of and approach for performing all of the tasks and meeting all of the requirements written in this RFQ.

23.2. Business/Price Quote Instructions

The Business/Price Quote should include complete pricing to fulfil the requirements of this RFQ.

24. EVALUATION CRITERIA

The Government intends to issue a Firm-Fixed-Price Purchase Order (PO) as a result of this solicitation to the Offeror who is determined to be the best value to the Government. Best value will be obtained using a Lowest Priced Technically Acceptable (LPTA) source selection process, which does not permit tradeoffs and allows the Government to award on the basis of the lowest evaluated price of responses meeting or exceeding the acceptability standards for non-cost factors. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.

24.1. Technical Quote Evaluation Criteria

The Government will evaluate whether the technical quote complies with the tasks and goals described in the Statement of Work (SOW) as well as if the implementation approach described by the Offeror is technically sound, following standard practices while adhering to government guidelines and regulations.

The Government will determine an Offeror’s technical acceptability based on the information in their submitted quote. The following criteria will be used to determine technical acceptability:

• Technical Factor 1: Technical Capability: The Government will evaluate the extent to which the Offeror demonstrates a clear understanding of the requirements and provides a feasible, effective approach to successfully perform all tasks and meet the requirements outlined in the

SOW.

24.2. Business/Price Quote Evaluation Criteria

The Government will evaluate the Offeror’s business/price volume to ensure that it is complete and accurate and fully aligns with the technical volume; that the proposed unit prices and quantities are reasonable and in line with the solicitation; that any assumptions and all terms and conditions as listed are appropriate and do not provide any concerns to the Government; and that the price is considered fair and reasonable.