RFQ_2025130084.docx

RFQ 2025130084

The Division of Color Certification and Color Technology (DCCT) is requesting a new service agreement for the Axios WD-XRF that meets or exceeds the requirements/specifications listed below. Used or remanufactured instrumentation shall not be considered.

1. Contracting Office Address:

DHHS/FDA/OAGS/DAP

ATTN: Pamela Lee 11601 Lansdown Street 3WFN/13th Floor North Bethesda, MD 20852 Email: Pamela.Lee@fda.hhs.gov Telephone: 240- 402-3847

2. Solicitation Number: FDA-RFQ-2025130084

3. Subject: Maintenance of Laboratory Equipment and Service: Malvern PANalytical Axios Wavelength-Dispersive X-Ray Fluorescence Spectrometer

4. Classification Code: J066

5. NAICS Code: 811210

6. Response Date: September 12, 2025, 10:00 A.M. Eastern time due via email to the Primary Point of Contact listed in the sam.gov webpage for this combined synopsis-solicitation.

7. Name and Telephone Number of the Individual to Contact for Information Regarding the Solicitation: POC: Contract Specialist: Pamela Lee, pamela.lee@fda.hhs.gov Phone: 240-402-3847 Alternate POC: Contracting Officer: Madeline Bryant. Email address: Madeline,Bryant@fda.hhs.gov. Telephone: (240) 402-7611

8. Description: Service support for Axios Wavelength Dispersive X-ray fluorescence (Axios WD-XRF) spectrometer at the Division of Color Certification and Color Technology will end on September 13, 2025. X-ray fluorescence (XRF) spectrometry is used to analyze samples of color additives that are used in foods, drugs, cosmetics and medical devices for elements with limiting specifications listed in 21 CFR Part 74. XRF is the primary analysis used to determine levels within the range of 1 – 1000 ppm. XRF is also used for official sample analyses when elemental composition is being determined.

(i) This is a solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included below.

(ii) This acquisition is issued as a Request for Quote.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-05, August 7, 2025.

(iv) Evaluation Criteria - All evaluation factors other than cost or price, when combined, are approximately equal to cost or price.

Statement of Work Maintenance of Laboratory Equipment and Service: Malvern PANalytical Axios Wavelength-Dispersive X-Ray Fluorescence Spectrometer

Background:

Batch certification of color additives is a regulatory premarket enforcement function. The Color Certification Branch (CCB) evaluates physical appearance and chemically analyzes batch samples of color additives to determine whether each batch meets specifications described in 21 CFR Parts 74 and 82.

Service support for Axios Wavelength Dispersive X-ray fluorescence (Axios WD-XRF) spectrometer at the Division of Color Certification and Color Technology will end on September 13, 2025. X-ray fluorescence (XRF) spectrometry is used to analyze samples of color additives that are used in foods, drugs, cosmetics and medical devices for elements with limiting specifications listed in 21 CFR Part 74. XRF is the primary analysis used to determine levels within the range of 1 – 1000 ppm. XRF is also used for official sample analyses when elemental composition is being determined.

Description of Work:

The following is a request for the acquisition of a new service agreement for the Axios WD-XRF, which includes 48-hour on-site response time during normal business hours, unlimited labor and travel during normal business hours, and unlimited emergency calls.

Purpose:

The Axios WD-XRF instrument is used for high throughput sample determinations of specified elemental impurities in certifiable color additives to support the certification (or rejection) of color additives as required under 21 CFR Part 74. Additionally, the instrument will be used for research in developing methods for the Color Certification Program and for the analysis of regulatory samples of unknown composition.

Reliable and timely maintenance and repairs of the Axios WD-XRF is critical to the mission of the Color Certification Branch, which is to certify color additives for use in foods, drugs, and cosmetics.

Specifications necessary to meet the purpose/objectives:

The Division of Color Certification and Color Technology (DCCT) is requesting a new service agreement for the Axios WD-XRF that meets or exceeds the requirements/specifications listed below. Used or remanufactured instrumentation shall not be considered.

Specification being requested:

a. Service and support

i. The vendor shall offer a warranty on the spectrometer, including labor, parts, on-site service with travel and housing, phone, and on-line support for the one-year warranty.

ii. The vendor shall provide service and application support within 48 hours and on-site repairs within 7 days.

1. Provision of replacement parts with installation instructions through phone support. If Project Officer is unable to perform the installation of the replacement part(s), then Certified Engineer/Technician shall come on-site to perform repairs within seven days from the reported unsuccessful installation. Certified parts shall be used to restore the benchtop Axios WD-XRF to functional and operational specifications.

iii. At least one annual preventative maintenance (PM) shall be performed by the Contractor.

iv. Unlimited telephone and on-line support for hardware and software shall be performed by trained service Engineers/Technicians.

v. On-demand service during normal business hours between Monday through Friday, 8:00 am to 5:00 pm (excluding holidays) at one of the following options:

1. Unlimited telephone and on-line support with trained and certified service Engineers/Technicians.

vi. Repair parts (except the x-ray tube) are to be provided at no cost and will be covered under the contract for future replacement if necessary. Repair parts must be genuine Malvern PANalytical parts and be installed within 2 days of the service visit. All technicians both service and phone support must be Malvern PANalytical certified.

vii. On-site repairs at CPK2 location (Refer to the Section Location for further information).

Supplies and Services The Axios WD-XRF must include a maintenance service agreement that includes one on-site preventative maintenance service, unlimited service response within seven business days, unlimited software/firmware updates, parts, labor, and travel. All service conducted on the complete system, including maintenance and repairs, must be performed by qualified engineers/technicians that are trained and certified following manufacturer specifications to service the specific model offered and using original manufacturer parts. After servicing, the instrument must perform better or equal than when it was installed.

Location

1. The vendor shall provide service to the following location:

U.S. Food and Drug Administration University Station (CPK2) 4300 River Road College Park, MD 20740 Room 1098

· Service shall be scheduled with the Project Officers: To be provided at time of award.

· The Contractor shall perform service during the normal business hours (from 8:00 AM to 5:00 PM). Other times of performance shall be discussed and scheduled with the Project Officers: To be provided at time of award.

· Contractor shall perform maintenance and/or repairs as required by Project Officers: To be provided at time of award.

Evaluation of Vendors

Technical Experience Offeror shall demonstrate the ability to provide Malvern PANalytical certified engineers for both on site and phone support. On-site engineers must regularly perform on site repairs to Malvern PANalytical XRF equipment. Phone support technicians must provide unlimited technical phone support for Malvern PANalytical XRF equipment and SuperQ software.

Offeror shall demonstrate the ability to obtain genuine Malvern PANalytical or equivalent repair parts in a timely manner and will provide those parts with warrantees at no additional cost to the FDA.

Offeror shall demonstrate that it employs the requisite personnel to repair and maintain Malvern PANalytical XRF systems. The offeror shall name the participating personnel and show that they are Malvern PANalytical certified.

Inspection and Acceptance The inspection and acceptance of the service will be handled by Kristen Reese and Corina McClure.

Market Research Malvern PANalytical is the only source provider of factory parts and services required for the maintenance of the Axios Wavelength Dispersive X-ray Fluorescence spectrometer. Malvern PANalytical develops all service, preventive maintenance, parts, and calibration procedures. For further information, please see attached documents, FDA sole source letter and 2025 Malvern PANalytical sole source.

Overall Price The offeror shall provide the best overall value for the FDA in terms of cost, relevant experience and approach.

Period of Performance The performance period will be for option year #1 from 09/14/2025 to 09/13/2026.

Summary Statement of Urgency

Acquisition of a new service agreement contract for the Axios WD-XRF is urgent because the current service coverage expires on September 13, 2025, without an option for renewal.

Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

· New Year’s Day

· Martin Luther King Day

· President’s Day

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veteran’s Day

· Thanksgiving Day

· Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that contractor employees did not work due to any Government closure (e.g., applicable under a Labor Hour contract).

For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. If more than 40 hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the Contracting Officer.

*** Responses to this solicitation should not exceed 20 pages. ***

Additional Conditions, Provisions and Clauses

1. The Government intends to award a single, firm-fixed price order resulting from this RFQ.

2. The provision at 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023), applies to this acquisition.

3. The provision at FAR 52.212-3, Offeror Representations and Certification – Commercial Products and Commercial Services (May 2024)(DEVIATION FEB 2025). (and Alternate I – Feb 2024),

4. The clause at 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services (JAN 2025)(DEVIATION FEB 2025), applies to this acquisition.

5. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable:

52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) 52.219-11, Special 8(a) Contract Conditions (Jan 2017) 52.219-12, Special 8(a) Subcontract Conditions (Oct 2019) 52.219-28, Post Award Small Business Program Representation (Jan 2025) 52.222-3, Convict Labor (Jun 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2025) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) 52.222-50, Combating Trafficking in Persons (Nov 2021) 52.224-3, Privacy Training (Jan 2017) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018)

6. The following additional contract requirement(s) or terms and conditions apply:

a) https://www.acquisition.gov/far:

52.204-7, System for Award Management (Nov 2024) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

b) http://www.hhs.gov/policies/hhsar/:

352.203-70, Anti-Lobbying (Dec 2015) 352.208-70, Printing and Duplication (Dec 2015) 352.211-3, Paperwork Reduction Act (Dec 2015) 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223-70, Safety and Health (Dec 2015) 352.224-70, Privacy Act (Dec 2015) 352.224-71, Confidential Information (Dec 2015) 352.227-70, Publications and Publicity (Dec 2015) 352.233-70, Choice of Law (Overseas), (Dec 2015) 352.237-70, Pro-Children Act (Dec 2015) 352.237-71, Crime Control Act – Reporting of Child Abuse (Dec 2015) 352.237-72, Crime Control Act - Requirement for Background Checks (Dec 2015) 352.237-74, Non-Discrimination in Service Delivery (Dec 2015) 352.239-73, Electronic and Information Technology Accessibility Notice (Dec 2015) 352.239-74, Electronic and Information Technology Accessibility Notice (Dec 2015)

7. 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 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).

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR CHAPTER 3) CONTRACT CLAUSES

1) 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)

52.212-2 Evaluation—Commercial Products and Commercial Services. (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(i) technical requirements (ability to meet all salient requirements); and, (ii) price. Technical, is significantly less important than price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise 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.

(End of provision)