RFQ_2025127285.docx

RFQ_2025127285 OC

The Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL) located in Atlanta, Georgia has a requirement for a service and qualification agreement for a Cerulean CETI-8 Electronic Cigarette (E-Cigarette) Smoking Machine.

The FDA intends to award a contract on a sole source basis to Cerulean upon the basis of the authority provided at FAR 13.106-1(b) and in accordance with the authority under FAR Part 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements.

The Contractor shall be capable of providing both the Service Agreement and Qualification Service for all systems specified in the Statement of Work “Brand Name or Equal” to that provided in a Cerulean service contract to ensure uninterrupted performance within manufacturer’s specification as well as complying with local qualification assurance and ISO 17025 certification.

Cerulean is the exclusive authorized agent and sole source representative of MPRD Ltd. t/a Cerulean in North America for Cerulean equipment including the CETI8.

Note: In order to be eligible for award of a Federal Government contract, vendors must be actively registered in the System for Award Management (SAM), have no active exclusions, and complete the FAR and DFARS representations and certifications.

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-2025130285

3. Subject: Cerulean CETI-8 Electronic Cigarette (E-Cigarette) Smoking Machin

4. Classification Code: J066

5. NAICS Code: 541990

6. Response Date: September 9, 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:

(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

Service Agreement and Qualification Service CERULEAN CETI-8 E-Cigarette Smoking Machine

Background

The Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL) located in Atlanta, Georgia has a requirement for a service and qualification agreement for a Cerulean CETI-8 Electronic Cigarette (E-Cigarette) Smoking Machine.

This instrument is an integral component that support the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. This E-cigarette instrument is needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products.

Salient Characteristics

The Contractor shall be capable of providing both the Service Agreement and Qualification Service for all systems specified in the Statement of Work “Brand Name or Equal” to that provided in a Cerulean service contract to ensure uninterrupted performance within manufacturer’s specification as well as complying with local qualification assurance and ISO 17025 certification.

All the following are minimum requirements.

Preventative Maintenance

· The E-Cig machine shall include a one (1) year full manufacturer’s warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum of 72 hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications.

· The contractor shall perform one (1) preventative maintenance inspection (PMI) for the CETI-8 E-Cigarette Smoking Machine during each one (1) year period of performance.

· The contractor shall perform one (1) operation qualification/performance verification (OQ/PV) for the CETI-8 E-Cigarette Smoking Machine during each one (1) year period of performance. The OQ/PV must include all supplies needed to perform that service.

· The contractor under the service agreement shall repair or replace any part or parts which prove to be defective at no additional charge to the government.

· The contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon timeframe.

· The contractor shall be responsible to obtain all new parts required for all repairs and maintenance.

· The Contracting Officer’s Representative (COR) or Point of Contact (POC) will contact the Contractor to schedule a mutually acceptable date and time for the preventive maintenance visit. All visits must be scheduled in advance with the COR or POC.

· Documentation of preventative maintenance duties performed must be provided.

· The PM service shall be performed by a Cerulean trained and certified engineer and must provide documentation that the instrument is functioning according to the manufacturer’s specifications.

Service Calls

· The Contractor shall respond within 2 business days after receipt of a service call.

· The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9-5 p.m. EST.

· All repairs must result in the instrument(s) serviced meeting the manufacturer specifications and must use factory new manufacturer replacement parts.

· Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information that the FDA may return the parts to the Contractor at the Contractor’s cost within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

· The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications.

Qualification Service

The Qualification service for each system shall include OQ/IPV to be performed after the planned preventative maintenance (PM) and in the event of a critical repair and shall include:

· The contractor shall provide documentation for calibrations and an instrument performance run.

· The OQ/IPV service shall be performed by a Cerulean trained and certified engineer and must provide documentation that the instrument is functioning according to the manufacturer’s specifications.

· Removal of any packaging materials shall be the responsibility of the Contractor.

Service Conditions

· To the maximum extent practicable, service must be rendered on-site at the FDA.

· In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the FDA, 60 8th ST.NE, Atlanta, GA. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The Contractor shall also provide a shipping account number to pay for the shipment.

· The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by the manufacturer.

Instruments for Preventative Maintenance and Qualification Service

Description/Serial Numbers

(1) CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

Warranty

All labor, replacement parts and components (excluding consumables) shall be warrantied.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

Deliverables

CLIN

DESCRIPTION

QTY

UNIT OF ISSUE

PRICE

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

EA

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

· CETI-8 E-Cigarette Smoking Machine (S/N: 0520-223835-5612)

Place of Performance

Food and Drug Administration Tobacco Products Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC: Lara Matthews

Period of Performance

The period of performance shall be for a base period of one year with four one-year option periods for Preventative Maintenance and Operation Qualification Services.

BASE YEAR - 09/30/2025 –09/29/2026

OPTION YEAR 1 – 09/30/2026– 09/29/2027

OPTION YEAR 2 – 09/30/2027 – 09/29/2028

OPTION YEAR 3 - 09/302028 – 09/29/2029

OPTION YEAR 4 - 09/30/2029 – 09/29/2030

Unless otherwise specified, services shall be performed Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Government Holidays

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.

January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) June (Juneteenth) December (Christmas Day) July (Independence Day)

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)