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U.S. FDA SOURCES SOUGHT NOTICE (SSN) Tissue specimen cassette labeler system SSN #: 75F40124R121764 Posted Date: March 4, 2024 Response Date: March 14, 2024, 2:00 pm CDT Classification: 6640 – Laborat... U.S. FDA SOURCES SOUGHT NOTICE (SSN) Tissue specimen cassette labeler system SSN #: 75F40124R121764 Posted Date: March 4, 2024 Response Date: March 14, 2024, 2:00 pm CDT Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 339113 – Surgical Appliance and Supplies Manufacturing, Small Business Size 750 employees MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of SAM.gov-registered small businesses capable of supplying the tissue cassette labeler system described herein. 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 339113 – Surgical Appliance and Supplies Manufacturing, Small Business Size 750 employees. Background and Requirement The U.S. Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS) presents this Sources Sought Notice (SSN) on behalf of the National Center for Toxicological Research (NCTR) to identify existing small businesses capable of providing scientific laboratory tissue cassette labeler systems meeting the technical requirements set forth below. NCTR requires a tissue cassette labeler for its necropsy lab to easily identify cassettes containing organ and tissue samples in accordance with scientific protocol processing. This labeling system will support all studies which require histopathology and will replace an existing labeler which is no longer functional. Since labeler malfunctions over time can cause delays in tissue processing and therefore potentially compromise the quality of tissues and the data obtained from them, three (3) option years of preventive maintenance for the labeler system are also required. Minimum technical requirements for a tissue cassette labeler system are as follows: *Shall be a “bench-top” tissue specimen labeler system with a footprint no larger than 30”x30”; *Capable of printing single cassette on demand and in batches, and 1D and 2D barcodes; *Shall be Windows 10 compatible and upgradable to later versions of Windows, i.e., W11 or later; *Shall be compatible with Document management system “Nice Label” and preclinical software platform “Pristima”; *Shall be capable of printing on any brand of cassette, with or without lids; *Shall have a per-label print speed of 3 seconds or less; *Shall include customizable templates; *Shall perform as described/advertised after 14 days of non-use; *Shall include a collection tray system that holds a minimum of 50 printed cassettes; *Shall include cassette printing PC software disk for text and barcodes and be capable of interfacing with a PC and/or LIS (Laboratory Information Systems); software shall be provided with system for initial loading of software and for reloading after a PC “crash;” *Shall include minimum cassette capacity of 400 cassettes utilizing a minimum of 6 cassette hoppers to allow for multiple cassette colors; *Shall be configured for AC power requirement of 220-240V; *Shall include installation and on-site training of FDA personnel; *Shall include a minimum two-year (24 months) full manufacturer’s warranty. Minimum technical requirements for each of three (3) option years of preventive maintenance and repair service are as follows: *Shall include one (1) planned on-site preventive maintenance for the labeler system to maintain optimal functionality; *On-site response time of 3 business days from receipt of FDA service request (repairs only); *Shall include unlimited on-site repair services by factory-trained technicians and/or certified engineers within 3-5 days of reported problem; *Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for remote technical assistance, *Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Eastern (Prevailing) Time; *All maintenance and repair service activities shall be performed by factory-trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.; *Software, firmware, and hardware upgrades and updates as required by the OEM; *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 and/or repair service 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 If your firm is considered a small business source under North American Industry Classification System (NAICS) 339113 – Surgical Appliance and Supplies Manufacturing, Small Business Size 750 employees, and believe that your firm is capable of providing these services, please submit a capability statement by e-mail to timothy.walbert@fda.hhs.gov. by the date and time specified above, providing all information as required below. Contract Type: Commercial Item-Firm Fixed Price Period(s) of Performance (Estimated based on agency acceptance of labeler system): Warranty: 24 months from date of delivery and acceptance of labeler system Option Year 1: 12 consecutive months commencing upon expiration of warranty period Option Year 2: 12 consecutive months commencing upon expiration of Option Year 1 Option Year 3: 12 consecutive months commencing upon expiration of Option Year 2 Delivery Address: U.S. Food and Drug Administration NCTR-Pathology Bldg. 5B, Room 5B-158 3900 NCTR Road Jefferson, AR 72079-9501 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing scientific cassette labeler systems and onsite preventive maintenance and repair services described herein and meeting all technical requirements set forth above. Although the target audience for this Notice are small businesses or small businesses capable of providing these labeler 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: Business name and bio, SAM Unique Entity Identifier (UEI), 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; Descriptive literature, brochures, marketing material, etc., detailing the scientific cassette labeler systems and preventive maintenance-repair services which the responding firm is regularly engaged in providing; Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and delivery time identified above can be met; 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 maintenance and repair services for these types of cassette labeling 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 SAM Unique Entity Identifier (UEI) and size status) if not the respondent. NOTE: In accordance with FAR provision 52.204-7, offerors are reminded that a firm shall be actively registered in the U.S. Government’s System for Award Management (SAM) when submitting an offer or quote, and shall continue to be registered until time of award, during performance and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation; If applicable, standard commercial warranty and payment terms; 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; If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns; 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; Respondent shall advise if the products and/or services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract. Respondent shall provide country (or countries) of origin for the products and/or services offered in response to this solicitation, and shall include any other applicable information to enable review and analysis pursuant to the requirements under the Buy American Act and requirements relating to Executive Order 14005 - Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request (submitted through the Made in America Office (MIAO) Digital Waiver Portal) is required. 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 March 14, 2024, to Tim Walbert, Contract Specialist, at the following address: timothy.walbert@fda.hhs.gov. 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 SAM/Federal Contract Opportunities (formerly FBO) at https://sam.gov/content/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).