Posted Date: July 3, 2019
Response Date: July 10, 2019 no later than 2:00 pm CDT
Classification: 6640 - Lab Supplies

NAICS Code: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing

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 instrument rental and preventive maintenance and repair service 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 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing; Small Business Size standards - $32.5 million.

Requirement and Background
The U.S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR), Division of Systems Biology (DSB) Personalized Medicine Branch (PMB) requires an instrument to measure concentrations of high-sensitivity cardiac disease markers (such as troponin T and NT-proBNP) in plasma from cardiotoxicity studies, using sophisticated and highly-sensitive immunoassays manufactured by Roche Diagnostics.

These immunoassays are a critical part of current research to discover and identify novel biomarkers of early cardiotoxicity induced by anthracyclines. These early markers may prove valuable in identifying cancer patients or survivors at risk of heart damage, optimizing treatment regimen and/or designing new interventions to minimize cardiotoxicity tailored to susceptible sub-population and enhancing the FDA's mission to protect and promote individual health. Additionally, these early biomarkers will allow accurate prediction of cardiotoxic events and minimize the risks associated with FDA-regulated products.

The current requirement consists of rental and preventive maintenance for a base period and two option years of a Roche Diagnostics e411 Rack Analyzer or equal immunoassay analyzer.

Minimum Technical Requirements - Roche Diagnostics Cobas e411 Rack or equal Immunoassay Analyzer:
Salient physical, functional, or performance characteristics that an "equal" product shall meet are as follows:

1. fully automated immunoassay analyzer capable of measuring cardiac troponin T and NT-proBNP in biological samples;
2. Capable of analyzing immunoassays manufactured by Roche Diagnostics;
3. include multiple channels (reagent slots) for multiple tests;
4. Capable of analyzing biological samples, including serum, plasma and urine, provide automated sample dilution upon request, and capable of detecting clot and liquid level in the sample cup;
6. Include both Disk and Rack models with a minimum of 30 positions for samples (Disk), calibrators and controls, and 15 racks with 5 samples each (Rack);
7. Capable of drawing 10-50 µl from sample cup for the assay;
8. Adequate digital memory to enable analyzer and software to function together;
9. Capable of lot calibration, reagent pack calibration and reagent calibration;
10. Adequate data storage to accommodate separate data files for reagents, samples, calibrations, quality, and operating parameter(s) reagent applications);
11. Capable of performing individual and cumulative quality controls with pre-programmable controls;
12. Capable of multiple operator ID's;
13. Water and liquid waste containers on the instrument.

Period(s) of Performance (instrument rental)
Base Period: 12 consecutive months from date of award;
Option Period 1: 12 consecutive months from expiration of base period;
Option Period 2: 12 consecutive months from expiration of Option Period 1.

Minimum Technical Requirements - Preventive Maintenance for Roche Diagnostics Cobas e411 Rack or equal Immunoassay Analyzer:
Preventive maintenance for a Roche Diagnostics Cobas e411 Rack or equal Immunoassay Analyzer shall include and meet the following technical requirements:

*minimum of one (1) planned on-site preventive maintenance visit for routine certification, calibration and temperature verification per contract year;
* On-site corrective/remedial maintenance/repair visits which includes parts, labor, and travel;
*response time within 3 business days after receipt of service call if issue cannot be corrected remotely within 8 hours from call for service;
* 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 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 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 service visit, 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 COR and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Period(s) of Performance
Base Period: 12 consecutive months from date of award;
Option Period 1: 12 consecutive months from expiration of base period;
Option Period 2: 12 consecutive months from expiration of Option Period 1.

Delivery Address:
U.S. Food and Drug Administration
National Center for Toxicological Research
3900 NCTR Road
Jefferson, AR 72079

Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing Roche Diagnostics Cobas e411 or equal instruments and the required preventive maintenance and repair service for same, meeting the technical requirements set forth above. Although the target audience is small businesses or small businesses capable of providing these systems 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 an instrument offered by another firm;
2. Descriptive literature, brochures, marketing material, etc. detailing the instruments and equipment (to include consumables) which the responding firm is regularly engaged in providing;
3. Information on available service/maintenance plans for the identified equipment;
4. Three (3) years of past performance service information, if not the manufacturer of the equipment identified herein, where the respondent has provided same or substantially similar service solutions on the same or near-same brand name equipment. For each past performance reference include the date of sale and service, description of service provided and the manufacturer name, model and serial number(s) of the equipment serviced, dollar value of those services, client names, client addresses, client point of contact names, client point of contact mailing address (if different from that provided for client), client point of contact phone numbers, and client point of contact email address;
5. 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.
6. 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.
7. If a large business, provide documentation if subcontracting opportunities exist for small business concerns;
8. Though this is not a request for quote, informational pricing is encouraged.
9. 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, in person, by e-mail, fax, mail or other delivery method before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on July 11, 2019 to [email protected], fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Tim Walbert, 3900 NCTR Road, Building 50, Room 426, Jefferson, AR 72079-9502. Reference the following on the outside packaging: FDA_SSN_1214075.

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 solicitation may be published in Federal Business Opportunities. 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).

Note: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.