MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for a preventative maintenance, corrective/remedial maintenance repair service agreement on a 3730xL genetic analyzer (a capillary DNA sequencer) and accessories for data acquisition and analysis. DNA Analyzer assigned Serial Number: 33295-004. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. 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- 811210 – Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million. Statement of Work I. Statement of Need : The 3730xL genetic analyzer is an instrument that performs capillary DNA sequencing. Scientists use genetic analyzers to determine sequences of DNA fragments of research interests such as: 1) confirming the authenticity of a DNA fragment amplified by polymerase chain reaction, (PCR); 2) verifying mutations introduced by mutagenesis; 3) validating the orientation of an inserted DNA fragment in an expression vector; 4) revealing sequences of isolated DNA fragments, etc. CBER scientists at FDA conduct research as well as perform regulatory functions. To meet the higher-volume sequencing demands of FDA scientists, FBR uses a high-capacity Applied Biosystems’ 3730xL sequencer and associated software programs for data acquisition and analysis. To maintain uninterrupted services to FDA scientists, this requisition is to purchase service contract for the 3730xL instrument and accessories. The equipment service contract expired on 3/10/2025. II. Statement of Work : Scientists at CBER are engaging in many aspects of biomedical research and conducting product reviewing relevant to drug and therapy efficacy and safety. DNA manipulations including PCR amplification of gene fragments, vector construction for gene expression, and mutagenesis of gene sequences are some of the routine tasks undertaken at CBER. These activities provide critical information for the identification of pathogenic strains involved in various diseases, or mutations that are responsible for phenotypes threatening the health and well-being of humans. Most DNA manipulations require sequence confirmation via DNA sequencing. Staff at FBR assists scientists in DNA sequencing using an Applied Biosystems’s 3730xL Genetic Analyzer. This instrument uses 48 or 96 capillaries that allow high throughput sequencing to meet increasing demands of CBER scientists’ needs for sequencing and data analysis. The requisition for a service contract ensures the instrument is maintained at optimal operation conditions for sequencing and data analysis which supports FDA scientists’ critical research and regulatory endeavors. Performance requirements -The contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year. The consumables required for PM visit shall be included in the contract. All costs for labor, travel, and parts required for preventative maintenance shall be included. -The contractor shall provide unlimited on-site corrective maintenance and repairs within 2 business days of call for service where problems cannot be resolved remotely after 2 business days. All costs for labor, travel, and parts shall be included. -The maintenance and repair activities shall be performed by the service engineers who are trained and certified, and the service provider should follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. -The contractor shall include unlimited software and firmware updates during the entire coverage period(s). -The contractor shall include unlimited technical support (via phone and email) on software and hardware related issues and trouble-shooting capabilities, Monday through Friday (excluding Federal Holidays). - Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance including software, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. -All maintenance and repair pricing must encompass costs for labor, travel, replacement parts, components, subassemblies, and any other necessary expenses related to the system. - Deliverables: Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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. Place of Performance CBER 10903 New Hampshire Ave., Room 1106, Bldg. 52/72 Silver Spring, MD 20993. Period of Performance Base Period: July 1, 2025 through June 30, 2026 Option Year 1: July 1, 2026 through June 30, 2027 Option Year 2: July 1, 2027 through June 30, 2028 FOB Point Destination. All items shall include shipping and handling to the destination identified herein. Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: Business name, SAM Unique Entity ID 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 products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. 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, 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 ID number and size status) if not the respondent. The offeror’s capability to initiate service on-site within the time specified above. Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call. 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. 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. Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). 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; 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; and Though this is not a request for quote, informational pricing is encouraged. Include the cost if there will be any reinspection fees/costs since the instrument is not currently covered by a service agreement. 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 14, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to
[email protected]. Reference CBER-2025-128782. 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 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).