FDA-SSN-1253115.pdf

High-performance Electrochemiluminescence Imager Sources Sought Notice

FDA-SSN-1253115

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing a High-performance Electrochemiluminescence Imager

The appropriate NAICS code for the acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size standards – 1,000 employees.

Background:

The FDA/NCTR, Office of Research, Division of Systems Biology (DSB) requires a High-performance Electrochemiluminescence Imager to perform measurements of cytokines in the perfusing culture medium of human liver non-parenchymal cells (npcs) maintained in a liver microphysiological system (mps) for the purpose of biomarker discovery for individual susceptibility and adaptation to drug-induced liver injury.

This requirement is as Brand Name or Equal configuration:

1. Meso Scale Discovery, MESO QuickPlex SQ 120MM Reader, part # AI1AA-0, 1 - Each

Minimum Technical Requirements:

1. Shall have electrochemiluminescence detection capabilities with 3 to 5 log dynamic range using 96-well plates.

2. Shall have the multiplex capabilities and high sensitivities for the detection of cytokines using less than 100 μl of cell culture medium.

3. Shall have the capacity to complete the reading of one 96-well plate in about 3 minutes.

4. Shall include at least a 1-year warranty covering parts and labor.

Minimum Performance Requirements:

Three (3) option years of Preventative Maintenance & Repair Services shall include:

1. The High-performance Electrochemiluminescence Imager.

2. Minimum of one (1) planned preventative maintenance visits per contract period.

3. Preventative maintenance shall include all labor, travel, and parts.

4. Unlimited on-site corrective/remedial maintenance/repairs maintenance, service and repairs shall include all labor, travel, and parts; Provide service response time with quote.

On-site repair service shall be inclusive of all labor, travel, certified replacement parts, components, subassemblies, etc. needed to return the system to operational capacity.

5. Performance by formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.

6. Access by the FDA Contracting Officer’s Representative (COR), 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.

7. System software and firmware updates required for reliability improvements and correction of any defects

8. Unlimited phone and email support during the contractor's normal operating hours.

9. Service 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. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Delivery/Period of Performance:

FOB Point Destination. Shipping, handling, installation qualifications shall be no later than 60 calendar days after receipt of contract award. The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery, installation, and offered warranty period of the systems. If/when Option Year 1 is exercised, the periods of performance for all options will be firmed via bilateral modification.

Place of Delivery/Performance:

U. S. FDA – NCTR

Division of Systems Biology 3900 NCTR Road Jefferson, AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing a High-performance Electrochemiluminescence Imager. Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, unique entity ID SAM, 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 to provide a service offered by another firm.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical and performance requirements identified above.

3. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near same applications for High-performance Electrochemiluminescence Imager. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, dollar value, client name, client address, client 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 company (to include DUNS number and size status) if not the respondent.

4. Documentation, if not the manufacturer of the equipment identified herein, of technical competency on the operation and repair of the brand name equipment. Such documentation should include certification from the original equipment manufacturer or other training certificates within the past calendar year.

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

6. If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on.

7. If a large business, provide if subcontracting opportunities exist for small business concerns.

8. Standard commercial warranty and payment terms.

9. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

10. Though this is not a request for quote, informational pricing for the service would be helpful.

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

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before March 30, 2022 by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA-SSN-1253115.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether 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 solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

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).

Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern.