FDA_SSN_1249751.pdf

U.S. FDA SOURCES SOUGHT NOTICE (SSN)

# FDA_SSN_1249751 Preventive maintenance (PM) and repair service for Yokogawa CellVoyager

(CV) 8000 Imaging System

SSN #: FDA_SSN_1249751

Posted Date: November 29, 2021 Response Date: December 10, 2021 Classification: J066 – Maintenance, Repair, and Rebuilding of Equipment-Instruments and Laboratory Equipment NAICS Code: 811219 – Other Electronic and Precision Equipment Repair and

Maintenance

MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the Spectral Analyzing Cell Sorter instrument system described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible.

The appropriate NAICS code for the acquisition is 811219 – Other Electronic and Precision Equipment Repair and Maintenance, Small Business Size Standards – $22.0 million.

Requirement and Background The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) requires a preventive maintenance (PM) and repair agreement for its Yokogawa CV8000 imaging system, serial number LSTR-CV8000-A074. This system is heavily used in numerous research activities by researchers at CBER and CDER. It is covered under an existing agreement through 12/31/2021. A base year and two (2) option years of PM are required.

Minimum Technical Requirements are as follows for the base year and two (2) option years of preventive maintenance and repair service for the Yokogawa CV8000 imaging system, serial number LSTR-CV8000-A074:

*Two (2) planned on-site preventive maintenance visits for routine certification and calibration per contract year; preventive maintenance visits shall cover the microscope itself and all internal systems, both dependent and independent;

*Unlimited on-site corrective/remedial maintenance/repair visits which includes parts, labor, and travel;

*Response time within 24 hours after receipt of service call, and on-site corrective/remedial maintenance/repair visits executed within two (2) business days after receipt of service call;

*in the event repairs to lasers, lenses and other parts cannot be made on-site, loaner items shall be installed as available until repairs are finished; shipping containers and arrangements shall be provided by offeror;

*Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument;

* Software, firmware, and application updates as required by the OEM;

*Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern (Prevailing) Time;

*All maintenance activities shall be performed by formally trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.;

*All preventive maintenance and repair service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Service Records and Reports *The Contractor shall, commensurate with the completion of each preventive maintenance or repair service visit (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, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Point of Contact (TPOC) and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Preventive maintenance shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Contract Type: Commercial Item-Firm Fixed Price

Period(s) of Performance (Estimated) Base Year: 1/1/2022 through 12/31/2022;

Option Year 1: 1/1/2023 through 12/31/2023;

Option Year 2: 1/1/2024 through 12/31/2024;

Delivery/Service Address U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72, Room 1108 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the multi-parameter spectral analyzing cell sorter instrument system and preventive-corrective maintenance services described herein and meeting the technical requirements set forth above. Although the target audience for this Notice are small businesses or small businesses capable of providing these stocks from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following:

1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding with the capability of providing these services offered by another firm;

2. Descriptive literature, brochures, marketing material, etc. detailing the preventive-corrective maintenance services which the responding firm is regularly engaged in providing, including services for CellVoyager CV8000 imaging systems. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and delivery time identified above can be met;

3. Provide recent (within the last three (3) years) and relevant past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar preventive-corrective maintenance services for CellVoyager CV8000 imaging systems.

For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested.

5. If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns;

6. Though this is not a request for quote, informational pricing is encouraged.

7. The Government is not responsible for locating or securing any information, not identified in the response.

Interested parties shall respond with Capability Statements, as described above, by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on Friday, December 10, 2021, to Tim Walbert, Contract Specialist, at the following address:

timothy.walbert@fda.hhs.gov. Please include the following in the Subject Line of the e-mail:

FDA_SSN_1249751 .

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and/or combined synopsis-solicitation may be published on Federal Contract Opportunities (formerly FBO) at https://beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

mailto:timothy.walbert@fda.hhs.gov https://beta.sam.gov/