Inactive

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 Biological Evaluation and R... 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 Biological Evaluation and Research (CBER) requirement for a preventative maintenance, corrective/remedial maintenance repair service agreement on a PacBio Sequel IIe sequencer. 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 Background In the US, every year 1.5 million donated organ and tissue grafts are being transplanted to recipients. The existence of various pathogenic agents in these grafts from a single or several donors could likely cause complex and life-threatening illnesses in hundreds of recipients. To mitigate the risk of such transmissions, our laboratory is evaluating existing and developing new methodologies and technologies that involves short and long-read sequencing techniques for rapid detection and characterization of various emerging infectious pathogens that threaten the safe use of human cells, tissues, and cellular and tissue-based products (HCT/P's). We have procured PacBio Sequel IIe sequencer and is present in our lab. This service agreement will help us to maintain the sequencer quality over the years. The service contract will provide Sequel IIe system (SQ64469e) (warranty period October 29, 2022 to October 28, 2023) parts, labor, software and consumables required for repair and planned maintenance. The PacBio sequencer is critical to the function of CBER’s Office of Therapeutic Products’ (OTP) Research Program. Objectives OTP’s mission is to ensure the safety, potency, and effectiveness of a wide variety of products including purified and recombinant therapeutic proteins for hematology, cellular therapies, gene therapies, and tissue products, for the prevention, diagnosis, and treatment of human diseases. In support of OTP’s mission and to meet DCT2’s objectives of detecting pathogen variants with ultra-high confidence in cells and tissues used for therapy, we have purchased a PacBio Sequel IIe sequencer. This sequencing platform will also support the critical research needs of other research investigators in OTP who are working on improving upon the specificity of available CRISPR technologies, developing new recombinant adeno-associated virus (rAAV) vectors for cell and gene therapy. This equipment is required for the continuation of mission relevant research projects for several laboratories in the OCTHT. Scope This request details the information necessary for the servicing of the PacBio Sequel IIe instrument. This service agreement will help us to maintain the sequencer quality over the years. Place of Performance Work is to be performed at The U.S. Food and Drug Administration’s White Oak Campus (Government Site) located at 10903 New Hampshire Ave Center for Biologics Evaluation and Research (CBER), Bldg. 52, Rm 3256, Silver Spring MD 20903-1058 USA. Period of Performance Base Period: October 29, 2023 through October 28, 2024 Option Year 1: October 29, 2024 through October 28, 2025 Option Year 2: October 29, 2025 through October 28, 2026 Deliverables/Delivery Schedule Deliverables: The Vendor shall deliver the following to the FDA: The service contract will provide Sequel IIe system parts, labor, software and consumables required for repair and planned maintenance for the period mentioned in the quote. Hours of operation CBER’s hours of operation are from 7:00 am—4:30 pm. The contractor will work hours as necessary to accomplish the contract objectives. The subsequent contractor shall be required to meet the following performance requirements: 1. Minimum of one (1) planned preventative maintenance visit for the equipment each contract period. All costs for labor, travel, and parts required for preventative maintenance shall be included. 2. Unlimited phone and email support during the contractor’s normal operating hours. Initial response within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.). Emergency telephone consultation shall be available 24 hours per day, seven days a week. 3. 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. 4. Unlimited on-site corrective/remedial maintenance, service/repair visits which again includes all labor, parts, and travel costs. Provide on-site service response within three business days of notification if issue cannot be corrected remotely within 8 hours from call for service. 5. Proposed pricing for all necessary repairs and services shall be inclusive of labor, travel, replacement parts, components, unlimited replacement for x-ray tubes, subassemblies, etc. 6. Absolute adherence to and conformity with Original Equipment Manufacturer (OEM) specifications, manuals, bulletins, latest technical developments, PM procedures, application updates using OEM replacement parts, components, subassemblies etc. in performing all preventative maintenance and repair services. Each visit the provider shall check x-ray energy output, verify voltage output, check optical alignment, check multi-power supply, clean instrument, verify alignment system, verify full operation of the system and replace any defective parts. 7. Service shall include tracking and scheduling of required maintenance tasks; exchange of failed electrical and/or mechanical parts; care measures; adjustments to factory specifications; verification of specified performance and functionality; documentation and detailed protocol of system conditions. 8. Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. 9. System software and firmware updates required for reliability improvements and correction of any defects; 10. 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. 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. • Information on available service/maintenance plans available for the identified equipment; • 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. • 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 for both the purchase of the instrument and a lease of the instrument. 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 July 19, 2023 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CBER-2023-119443. 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).