SOURCES SOUGHT
66 -- �Brand Name or Equal� Pacific Biosciences of California, Inc., Revio System
- Notice Date
- 4/12/2023 9:41:27 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-117826
- Response Due
- 4/19/2023 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 National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources and other than small business sources capable of providing �Brand Name or Equal� Pacific Biosciences of California, Inc. (PacBio), Revio System (Part Number: 102-090-600) 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. Background: The Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) requires a �Brand Name or Equal� PacBio, Revio System (Part Number: 102-090-600). At NCTR, the Division of Genetic and Molecular Toxicology (DGMT) has been using Error Corrected Next Generation Sequencing (ecNGS) on several projects over the past few years. ecNGS is able to measure rare changes in DNA sequence (mutations) in any tissue, cell or organ from which DNA can be extracted. The measurement of mutations is key to making safety decision of the carcinogenic potential of the products regulated by the FDA. Most of this work is currently being performed with a first generation PacBio Sequel II sequencer. PacBio sequencing analyzes DNA samples by Single Molecule, Real-Time (SMRT) sequencing, method that can independently and repeatedly analyze both strands from circular DNA molecules. We have discovered that the consensus reads generated by such approach (i.e., SMRT sequencing) can directly detect the mutations induced by mutagens. Precisely because of these accomplishments, the number of samples that we would like to analyze by PacBio sequencing has greatly increased and, as a result, we are now constrained by the output of our current PacBio sequencer, called the Sequel II. The PacBio Revio has 15x the sequencing capacity of the current Sequel II. Crucially, the Revio instrument also uses SMRT sequencing. These features mean the Revio would provide us with the increased sequencing capacity we require while also providing �compatibility� and �experimental continuity and reproducibility.� The Revio provides compatibility with our mutation detection technique because it analyzes DNA molecules in the exact same manner as the instrument we now use (i.e., SMRT sequencing). The Revio will also provide us with �experimental continuity and reproducibility� because its greater capacity will be used to analyze samples from studies whose analyses have already begun on the instrument we now use. The increased output of the Revio will enable us to expand the studies we are now undertaking and to reach for even more ambitious ones. This requirement is configured as Brand Name or Equal: Pacific Biosciences of California, Inc. (PacBio), Revio System (Part Number: 102-090-600) Minimum Technical Requirements: Shall be capable of holding and running/processing up to 4 SMRT Cell Trays simultaneously.� SMRT cell trays are a consumable part which are nanofabricated with 25 million ZMW (zero-mode waveguides) wells where prepared samples are loaded. Shall be capable of SMRT (Single Molecule, Real-Time) sequencing methodology. Shall be capable of independently and repeatedly analyze both strands from circular DNA molecules. Shall be a stand-a-lone, HiFi, high throughput native long-read sequencing system Shall be capable of producing data demonstrating small variants, structural variants, repeat expansions, methylation, and haplotype phasing from a single library and sequencing run Shall be capable of on instrument base calling. Shall be capable of on instrument BAM file generation. Shall be capable of on instrument methylation calling. Shall include one-year warranty to meet the following: The Contractor shall provide updates and upgrades for 12 months from date of installation. The Contractor shall provide access to technical support for this upgrade via email or telephone for 12 months from date of installation. Contractor shall provide the installation of the unit and ensure they meet or exceed original equipment manufacturer (OEM) operating standards. Contractor shall provide onsite training. 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 one (1) 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 free 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 Central 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 the �Brand Name or Equal� PacBio, Revio 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-NCTR 3900 NCTR Rd. Bld 14 Rm 1044 Jefferson, AR 72079 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 April 19, 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-117826. 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/b2114f4d8bcb42beb0b5b48c2ba5ec3c/view)
- Place of Performance
- Address: Jefferson, AR 72079, USA
- Zip Code: 72079
- Country: USA
- Zip Code: 72079
- Record
- SN06649092-F 20230414/230412230114 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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