“Brand Name or Equal” Service Agreement and Qualification Service SM410-CV Cigar Smoking Machine The Food and Drug Administration (FDA), Center for Tobacco Product (CTP)

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation, and a written solicitation will not be issued.

“Brand Name or Equal product only”.  The following FAR Clause applies: Clause 52.211-6 - Brand Name or Equal (AUG 1999)

This requirement is “Subject to the Availability of Funds” The Following FAR Clause applies: AVAILABILITY OF FUNDS (52.232-18) (APR 1984)

This synopsis, NAICS code 334516, identified as REQ#1252189 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures.

Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the sam.gov website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request.

“Brand Name or Equal” Service Agreement and Qualification Service SM410-CV Cigar Smoking    Machine The Food and Drug Administration (FDA), Center for Tobacco Product (CTP)

Scope/Specifications:

The Southeast Tobacco Laboratory (STL) of Center for Tobacco Product (CTP) requires a service and qualification agreement for a SM410 Cigar Smoking Machine which is listed in detail below:

Description/Serial Numbers

       AGE

CURRENT WORKING CONDITION

DATE OF LAST SERVICE

KNOWN ISSUES

SM410-CV – Cigar Smoking Machine                                                      S/N:0716-21900-47969

     3 Years

    GOOD

     3/3/2021

      NONE

The SM410 Cigar Smoking Machine is an integral component that supports the Food and Drug Administration (FDA) ORA Southeast Tobacco Laboratory (STL) by simulating human cigar smoking under a variety of conditions and to collect smoke residues for further regulatory chemical analysis. The instrument is needed to continue to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under FDA regulatory jurisdiction and to establish FDA’s expertise in the analyses of tobacco products. The Contractor shall provide both the Service Agreement and Qualification Service for the system specified in the Statement of Work (SOW). The Contractor shall ensure uninterrupted performance of the system throughout the duration of the contract and, ensure that system operates within the original equipment manufacturer (OEM), GD USA Inc specifications.

Salient Characteristics/Technical Specifications:

Qualification Service for all systems specified in the Statement of Work to ensure uninterrupted performance within manufacturer’s specification.

Minimum Performance Requirements Preventative Maintenance (PM) & Repair:

• The contractor shall provide at least one (1) preventative maintenance inspection (PMI) service visit during each 12-month period of performance for each instrument. The Technical Point of Contact (TPOC) will contact the Contractor to schedule the PMI. All visits will be scheduled by the TPOC at least seven (7) business days in advance.
• The Preventative Maintenance Service shall be performed in accordance with the specifications contained in the original equipment manufacturer’s service manual.
• The PMI shall include all maintenance parts, repair parts, labor, and travel for remedial repair. 
• The contractor shall obtain all new parts required for all repairs and maintenance which meet the original equipment manufacturer’s specifications at no additional cost to the Government.
• The Contractor 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.
• The Contractor shall provide documentation of preventative maintenance duties performed. (See Records and Reports section).

Minimum Performance Requirements Qualification Service

• The Contractor shall provide Qualification Service after the planned PM and after any other repairs of the system. The Qualification Service shall include Operation Qualification/Instrument Performance Verification (OQ/IPV).
• The Contractor shall perform at least one (1) annual OQ/IPV verification for the systems that is equal to or exceeds the qualification requirements of the original equipment manufacturer.
• The OQ/IPV service shall be performed by a qualified engineer. The Contractor shall provide documentation that the system is functioning according to the original equipment manufacturer’s specifications.
• The OQ/IPV shall include all supplies needed to perform the service. Both the OQ and IPV shall be scheduled at a date approved by the TPOC or Alternate TPOC.

• The Contractor shall provide the TPOC documentation for temperature verification, calibrations, and an instrument performance run.
• If at any point during the Qualification Service, the system fails a test, the Contractor shall provide onsite service to remedy the failure and re-execute the Qualification Service to demonstrate to the TPOC that the system passed all the Functional Requirements Specification and the system is operating in accordance with OEM specifications.
• If parts are needed to re-execute the OQ, the Contractor shall schedule delivery of the necessary parts and perform a return service visit within 48 hours.

Service Calls

• The Contractor shall respond within two (2) business days after receipt of a service call from the TPOC.
• 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 shall result in the system serviced meeting the original equipment manufacturer specifications. All repairs shall use factory, new replacement parts.
• The Contractor shall perform a diagnostic test and document results and provide a narrative summary demonstrating that the system is meeting the original equipment manufacturer’s specifications
• Any parts or components removed for replacement shall be returned to the FDA unless the TPOC approves in writing for the parts or components to be disposed.  The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information so that the FDA may return the parts to the Contractor at no additional cost to the Government, no later than three (3) business days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

Service Conditions

• To the maximum extent practicable, service must be rendered on-site at the FDA.
• The Contractor is responsible for cleanup and removal of all shipping/packing materials at the time of service. Some shipping and packing material cannot be placed in the facility dumpster (e.g., pallets and/or crates) and must be removed by the contractor and at no additional cost to the Government.
• 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 Agilent with the Agilent system specified in this contract.

Warranty:

The Contractor shall provide warranty on all labor, replacement parts and components (excluding consumables) of the system for at least a 12-month period.

Deliverables:

The Contractor shall provide the following deliverables:

• 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.

Deliverable

Quantity

Delivery Date

Preventative Maintenance Inspection (PMI) Scheduled Visit

1

Annually during the Period of Performance (POP) at a date approved by the TPOC

Operation   Qualification/Performance Verification (OQ/PV)

 1

Annually during the POP at a date approved by the TPOC or after critical repair

Service Reports

Varies

No Later Than (NLT) 5th workday following the end of each month during any months which work is performed on the system.

Place of Performance:

 Food and Drug Administration

Southeast Tobacco Laboratory

60 Eighth Street NE

Atlanta, GA 30309

POC: To be identified at time of award

Period of Performance:

The period of performance of the contract shall be for 36-months which includes one (1) 12-month base period and two (2) 12-month option periods as outlined below:

BASE YEAR        – 04/01/2022 – 03/31/2023

OPTION YEAR 1 – 04/01/2023 – 03/31/2024

OPTION YEAR 2 – 04/01/2024 – 03/31/2025

OPTION YEAR 3 – 04/01/2025 – 03/31/2026

The Government will award a contract resulting from this solicitation to the responsible quoter as  a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method.Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial
quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.

FAR provisions can be found on the following website: http://Acquisition.gov

The following provisions apply to this acquisition:

FAR 52.212-1, Instructions to Offerors-Commercial Items;

52.225-2 Buy American Certificate;

52.212-4 Contract Terms and Conditions-Commercial Items;

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs:

52.222-3, Convict Labor

52.222-19, Child Labor-Cooperation with Authorities and Remedies

52.222-21, Prohibition of Segregated Facilities

52.222-26, Equal Opportunity

52.222-36, Affirmative Action for Workers with Disabilities

52.222-50, Combating Trafficking in Persons

52.225-1, Buy American Act--Supplies

52.225-13, Restrictions on Certain Foreign Purchases

52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration.

In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are Registered in SAM.gov under NAICS code; 334516 delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA.

FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email to Maryrose.nicol@fdahhs.gov  and be received by 5:00 PM (1700) on February 28, 2022 to the attention of Mary Rose A. Nicol, maryrose.nicol@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email.

ALL QUESTIONS REGARDING THIS SYNOPSIS/SOLICIATION MUST BE SUBMITTED IN WRITING NO LATER THAN 5:00 PM (1700) EST February 23, 2022.

FAX QUOTES SHALL NOT BE ACCEPTED