SOURCES SOUGHT
66 -- Multiparameter Flow Cytometric Analyzer with Spectral Analysis capabilities
- Notice Date
- 3/14/2023 4:55:01 AM
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- FDA-SSN-117270
- Response Due
- 3/21/2023 11:00:00 AM
- Point of Contact
- Warren Dutter, Phone: 8705437577
- E-Mail Address
-
warren.dutter@fda.hhs.gov
(warren.dutter@fda.hhs.gov)
- Description
- THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE. The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources and other than small business sources capable of providing an Multiparameter Flow Cytometric Analyzer with Spectral Analysis including four (4) (1-year Post-Warranty Maintenance and Repair service option periods), meeting the requirements below. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all the minimum performance requirements. The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) requires a Multiparameter Flow Cytometric Analyzer with Spectral Analysis (Spectral Analyzer) capabilities for the CBER Flow Cytometry Core (CFCC) for the White Oak facility. This additional Spectral Analyzer will provide for both traditional and spectral analytical approaches and will replace current CFCC instrumentation soon to be retired. Traditional analyzers use a collection of optical filters to select / separate fluorescent signals. Thus, signals unique to the individual markers in an experiment are measured by excluding other signals. Error associated with spectral interactions (spillover) is corrected through compensation algorithms. In contrast, Spectral Analyzers use specialized spectral separation technology � Specialized Prisms or Coarse Wavelength Division Multiplexing -- to capture all fluorescence, then software deconvolution algorithms are used to separate signals for individual markers. The benefit of this process is that error associated with spillover is minimized, and measurements are more accurate. Further, adding new dyes to assays / expanding colors is facilitated since the new fluorescence signals are likewise separated through spectral analysis. This allows FDA investigators to expand parameters beyond our present limit of 20 parameters and provides for assays up to 48 different markers. This state-of-the-art analytical technology will greatly enhance the research capabilities in the Core. Further, the FDA will be better able to anticipate regulatory requirements for assays developed using spectral analysis technology. Minimum Technical Requirements: Shall have traditional analysis plus full spectrum unmixing. Shall Allow autofluorescence as a unique spectral plot which can be subtracted from sample. Shall include acquisition and analysis software. Shall be equipped with 5 spatially separated lasers, specifications as indicated below: Ultra-Violet Laser (60mW UV; 355nm) Violet Laser (200mW Violet; 405nm) Blue Laser (150mW Blue; 488nm) Yellow-Green (150mW YG; 561nm) Red Laser (140mW Red; 640nm) Emission optics shall be as indicated below: Minimum 60 fluorescence detectors Forward Scatter and Side Scatter Variable sample handling shall include: 5ml and multiwell plates. Installation, Training and Warranty: Upon delivery and installation, the Contractor shall coordinate with the Contracting Officer Representative (COR) to demonstrate functionality and schedule a training session with program office points of contacts to conduct the training. The training shall be detailed and capture full functionality of the machine. At the end of the training, the vendor shall transition over training aids, materials and technical guides to support utilization/maintenance of the machine. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA�s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s).� Post-Warranty Service Minimum Performance Requirements: The Contractor shall provide two (2) scheduled on-site planned preventive maintenance visits 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 the service engineers who are trained and certified by the Original Equipment Manufacturer (OEM). The service provider should follow the OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. The Contractor shall include software and firmware updates required during on-site instrument repair and instrument�s performance check during preventive maintenance during the coverage period(s). The Contractor shall provide factory-certified replacement parts. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and trouble-shooting with the equipment issues, Monday through Friday (excluding Federal Holidays) 8:00AM � 5:00PM Eastern Time. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc for the system. 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: Delivery, Installation and Training shall occur within 90 calendar days from date of award. 4 (1-year Post-Warranty Maintenance and Repair Option periods): Option Year 1: 12 consecutive months commencing upon expiration of initial warranty; 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; Option Year 4: 12 consecutive months commencing upon expiration of Option Year 3; Warranty shall commence upon acceptance of Multiparameter Flow Cytometric Analyzer system. Post-warranty Preventative maintenance and repair service, if exercised, shall commence, upon expiration of the warranty period and continue for a year, which may be extended in annual increments. 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, installation, and training), and the offered warranty period. Delivery Location: FDA-CBER Building 52, Room 1151 10903 New Hampshire Ave. Silver Spring, MD 20993 Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following: Business name and bio, unique entity identification (UEI) 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 to provide a service offered by another firm. Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client 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 UEI number and size status) if not the respondent. Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above. The offeror shall advise if the product and/or service is on a Best in Class contract. If applicable, the offeror shall clearly identify where the offered product is made. 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. If a large business, provide if subcontracting opportunities 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. Informational pricing is desired. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before March 21, 2023 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN-117270. 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). Additional Notes: 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/2ca8ccbad92d4f0eae3bde2be99e8c77/view)
- Place of Performance
- Address: Silver Spring, MD 20993, USA
- Zip Code: 20993
- Country: USA
- Zip Code: 20993
- Record
- SN06618459-F 20230316/230314230112 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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