SOURCES SOUGHT
66 -- Next-Generation Sequencing (NGS) System
- Notice Date
- 12/20/2016
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_17-223-SOL-1177416
- Archive Date
- 1/21/2017
- Point of Contact
- Howard Nesmith, Phone: 870-543-7459
- E-Mail Address
-
howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- 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) has issued this sources sought announcement on behalf of the National Center for Toxicological Research (NCTR), who requires a Next-Generation Sequencing (NGS) System. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. 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 vendor shall include information about the company which demonstrates they can meet all of the minimum requirements. The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. Background: The FDA/NCTR is currently conducting research on the development and evaluation of a novel in vitro epigenomic screening model system for the hazard identification of FDA-regulated products, new concepts in tumor mutational signatures of acrylamide and glycidamide, and genetics and epigenetics of susceptibility to non-alcoholic fatty liver disease (NAFLD): a comparative dietary study using collaborative cross mice. Statement of Need: The NGS System is required to perform genomic and epigenetic analysis to discover the biomarkers related to chemical toxicity and carcinogenicity in vivo and in vitro. The capability of the NGS technology will enable the quantitative genomic (Single Nucleotide Polymorphisms (SNPs) and mutations), epigenomic (DNA methylation and chromatin immunoprecipitation), transcriptomics (mRNA and small RNA expression) and metagenomics analysis. To maintain consistency and reproducibility with previously obtained data the system shall use sequencing by synthesis (SBS) chemistry and deliver 750 Gb and 2.5 billion reads per run. This capacity is required to process more samples per run and sequenced simultaneously at a greater depth, generating richer and more meaningful data. In addition to the NGS System the FDA requires Annual Post-Warranty Preventive and Corrective Maintenance Services (Base + 1 additional 1-year Maintenance Option period). Minimum Technical Specifications: - Shall be capable of sequence up to 6 human genomes, 50 transcriptomes, or 90 exomes per run, assuming 30× coverage of a human genome, 50 M reads per transcriptome, and 4 Gb per exome at 2 × 75 bp reads - Run throughput up to 750 Gb passing filter data per 2 × 150 bp, in single flow cell run mode. - Capable of greater than 200 Gb passing filter data per in single flow cell run mode up to 2.5 billion single reads passing filter in single flow cell mode. - Shall supported read lengths up to 2 x 150 bp. - Sequencing run time ranging from less than 1 day to 3.5 days, depending on read length. - Sequencing run times of less than 3.5 days for a 2 × 150 bp paired-end sequencing run. - Optical system shall consist of a 2-laser system with wavelengths at 532 nm (1 Watt maximum power) and 660 nm (1.2 Watt maximum power) for excitation of fluorophores. - Shall have Rapid Time Delayed Integration (TDI) line scanning with 4 Charge-Coupled Device (CCD) sensors. - Shall have dual surface flow cell imaging (top and bottom surface). - Instrument shall process 1 flow cell at a time. - Each flow cell substrate shall contain billions of ordered wells enabling optimal spacing of clusters and delivering high density. - Each flow cell shall be a substrate with 8 channels, providing physical separation of samples or to allow for multiplexing of more than 96 samples per flow cell. - Simplified loading of flow cells that provides clear and positive feedback to ensure vacuum and fluidics are engaged. - Flow cells shall be held in place by a reliable vacuum without the need for mechanical levers and locks. - Real-time processing shall takes place directly on instrument's control computer with no additional computer for image processing. - Shall have ready-to-use, premixed reagents drop into color-coded reagent racks - Ready-to-use kits shall be available to prepare samples for: - DNA sequencing (single or paired-end reads) - Exome sequencing - Transcriptome sequencing (mRNA-Seq and small RNA-seq) - Directional RNA sequencing - Sample multiplexing with up to 96 indexes per lane - Solid-phase isothermal amplification to produce clonal clusters shall be completely automated, requiring no user intervention without use of emulsion PCR. - Exclusion amplification shall deliver high percentage of wells with single template clusters. - The system shall utilize an automated system that creates clonal clusters from single molecules. - System Control Software shall provide a simple interface to configure, launch, and monitor runs. - Control Software shall include real-time analysis (RTA) - Control Software shall provide run-time feedback and generates base calls and quality scores as the run completes. - Sequencing analysis software shall be designed for Windows-based PCs, on or off the sequencing instrument with functionality available in the genomic cloud environment, to allow for web browser remote monitoring with applications supporting data analysis and sharing. - System Control Software shall allow for offline analysis. Installation - On-site installation shall include consumables to start running the sequencing system for confirmation and acceptance - On-site instruction and system training to include Assay, Software, and Bioinformatics at time of instrument installation Post Warranty Services & Preventative Maintenance Agreement - Shall include unlimited corrective/remedial maintenance visits within 3 business days of call for service - Shall provide unlimited technical support access Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Central Time. If the Government notifies the Contractor of a problem after 5:00 p.m. via the Internet or phone message, the vendor shall begin providing a solution to problem(s) reported within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.) - All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers. All repairs and PM services shall be performed following Original Equipment Manufacturer (OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.- Proposed pricing for unlimited on-site service, repairs, and Preventative Maintenance (PM) services shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. - The PM service plan shall include at least one (1) on-site visit for routine certification of the instrument per year. - Service plan shall include access to OEM technical developments, repair procedure bulletins, and unlimited software, firmware, and application updates. - 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 Destination- U.S. Food and Drug Administration National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079 Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in manufacturing Next-Generation Sequencing (NGS) Systems and shall demonstrate prior manufacturing experience of the same. Though the target audience is small business or small businesses capable of providing service from another small business, all interested parties may respond. At a minimum, responses shall include the following: - Business name and bio, DUNS 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 shall include date of manufacturing, 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 company (to include DUNS number and size status) if not the respondent. - Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing. - 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. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements in person, by e-mail, fax, mail or other delivery method before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on January 6, 2017 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Howard Nesmith, 3900 NCTR Road, Building 50, Room 424, Jefferson, AR 72079-9502 and Reference: FDA_17-223-SOL-1177416. 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 FedBizOpps. 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
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_17-223-SOL-1177416/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, National Center for Toxicological Research (NCTR), 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN04356776-W 20161222/161220235122-01045b469d82e2c72052ebd0cb61dcf7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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