SERVICE AND QUALIFICATION AGREEMENT FOR A CERULEAN CETI-8 ELECTRONIC CIGARETTE (E-CIGARETTE) SMOKING MACHINE

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

0001

Base Year - Maintenance Agreement for:

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

1

EA

0002

Base Year Qualification Service for:

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

1

EA

0003

Option Year 1 - Maintenance Agreement for:

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

1

EA

0004

Option Year 1 Qualification Service for:

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

1

EA

0005

Option Year 2 - Maintenance Agreement for:

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

1

EA

0006

Option Year 2 Qualification Service for:

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

1

EA

0007

Option Year 3 - Maintenance Agreement for:

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

1

EA

0008

Option Year 3 Qualification Service for:

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

   

    1

   EA

0009

Option Year 4 - Maintenance Agreement for:

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

         1

    EA

0010

Option Year 4 Qualification Service for:

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

        1

   EA

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)