Inactive Total Small Business Set-Aside (FAR 19.5)

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Systems Biology requires... MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Systems Biology requires renting an automated immunoassay analyzer capable of measuring concentration of cardiac disease markers to allow identification of early predictive biomarkers of doxorubicin-induced cardiac damage. Anthracyclines are the potent anti-cancer drugs used in the treatment of different types of cancer in children and adults. However, a long-term clinical use of these drugs is limited by the serious adverse effect of cardiotoxicity which can occur during therapy or many years after cessation of treatment. Currently, there is a lack of biomarkers or technologies that can predict future heart damage in cancer patients or survivors. Thus, there is a need for identification of novel biomarkers of early cardiotoxicity induced by anthracyclines. To accomplish these goals, it is important to utilize assays with the greatest sensitivity for measurement of cardiac disease markers, such as cardiac troponin T and NT-proBNP to verify if there is any heart damage in patients after anthracycline treatment. Therefore, an automated immunoassay analyzer is needed to measure concentration of cardiac disease markers (cardiac troponin T and NT-proBNP) in plasma samples collected from cardiotoxicity studies using highly sensitive immunoassay kits manufactured by Roche Diagnostics. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 or fewer employees. One (1)-Year Rental of “Brand Name or Equal” Cobas e 411 analyzer by Roche Diagnostics automated immunoassay analyzer system that meets the following salient characteristics: The analyzer shall be fully automated and capable of measuring cardiac troponin T and NT-proBNP in biological samples using highly sensitive immunoassay kits manufactured by Roche Diagnostics, Indianapolis, IN. The analyzer shall offer maximum of 18 channels (reagent slots) for 18 tests. The analyzer shall run up to 86 tests per hour. The analyzer shall be capable of analyzing biological samples, such as serum, plasma and urine, shall have capability of automated sample dilution upon request, and shall be capable of detecting clot and liquid level in the sample cup. The analyzer shall have Disk model to provide 30 positions for samples, calibrators and controls. The analyzer shall have Rack model of 15 racks with 5 samples each (total of 75 samples capacity). The analyzer shall be capable of drawing 10 – 50 µl from the sample cup for the assay. The analyzer shall have adequate memory to contain data files necessary for the analyzer and software to work together. The analyzer shall have adequate data storage capacity: For reagent data files for up to 300 reagent packs For sample data files for storage of up to 2000 test records (samples and controls). For calibration data file for storage of up to 160 calibrators. For quality data file of capacity of up to 100 controls. For operating parameter data file for storage of up to 305 reagent applications. The analyzer shall be able to perform individual and cumulative quality controls and shall have capacity of up to 100 pre-programmable controls. The analyzer shall be capable of lot calibration, reagent pack calibration, and reagent calibration. The analyzer shall have capacity of up to 20 operator IDs. The analyzer shall have water and liquid waste containers on board. Service Minimum Performance Requirements: The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days. The Maintenance and Repair activities shall be performed by formally trained and certified technicians/engineers, following absolute adherence to and conformity with Original Equipment Manufacturer (OEM) specifications, manuals, service bulletins, latest technical developments, PM procedures, application updates, using OEM-certified replacement parts, components, subassemblies, etc. The Contractor shall include unlimited software and firmware updates during the coverage period(s). The Contractor shall guarantee technical support Monday through Friday (excluding Federal Holidays) 8:00AM - 5:00PM Central Time. All maintenance/repair 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 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. Period of Performance: Base Year: July 2020 – July 2021 Option Year 1: July 2021 – July 2022 Option Year 2: July 2022 – July 2023 Option Year 3: July 2023 – July 2024 Option Year 4: July 2024 – July 2025 Delivery shall be made within 30 days of award. Rental period will begin on date of acceptance and continue for a period of one year. If/when Option Period 1 is exercised; the periods of performance for all options will be firmed via bilateral modification. The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery of the system, inclusive of inside delivery. Place of Delivery: 3900 NCTR Rd Jefferson, AR 72079 The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered product/services meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying services of a small business, all interested parties may respond. At a minimum, responses shall include the following: Business name, 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 if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered service can meet the above requirements. All descriptive material necessary for the government to determine whether the service offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. If a large business, identify the subcontracting opportunities that would exist for small business concerns; Standard commercial warranty and payment terms; and Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 4, 2020 by 1:00 PM (Central Time in Jefferson, Arkansas) to warren.dutter@fda.hhs.gov, Reference: FDA-SSN-1227027. Notice of Intent Responses to this sources 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 FedBizOpps. 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).