SOURCES SOUGHT
66 -- Next Generation Sequencer
- Notice Date
- 4/27/2011
- 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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1086783
- Archive Date
- 5/19/2011
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including HUBZone firms; certified 8(a), Small Disadvantaged, veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. The U.S. Food and Drug Administration (FDA) is seeking capability statements from companies that are capable of providing a Next Generation Sequencer and a back-up Next Generation Sequencer. The responsibility of the Facility for Biotechnology Resources (FBR), Center for Biologics Evaluation and Research (CBER) is to contribute to the research and regulatory mission of the Center by providing biotechnology services to CBER scientists in support of their research and regulatory duties. The Facility for Biotechnology Resources is equipped with instrumentation and established scientific expertise to support the (i) synthesis of high quality DNA and peptide products, (ii) evaluation of a large variety of synthetic and native molecules and (iii) advice in assessing the quality and acceptability of chemistry, manufacturing and control (CMC) data for products seeking licensure from the Food and Drug Administration. Products synthesized by the Core Facility have been used both as research tools and as probes in evaluating the quality, purity and safety of licensed products. The Next Generation Sequencers will provide additional investigative tools to CBER in evaluating the quality and acceptability of chemistry, manufacturing and control (CMC) data for products seeking licensure. Specifications for a Next Generation Sequencer: • Number of Reads: Up to 3 billions single ends; up to 6 billions paired ends • Sequencing Run Time:< 8 hrs • Read Length: 100 bp uniform read length and 2 x 100 bp paired-end read • Throughput: ≥500 Gb high quality data per run and ≥50 Gb output per day • Quality of Data: highest achievable • Cost/Gb of Data: minimum Gb range • Chemistry: Chemistry must be well-established and proven Novel, unproven technology not acceptable Chemistry using error-prone processes not acceptable • Library Prep and Amplification Workflow: must require very little hands-on time • Workflow: Minimal opportunity for contamination ePCR not acceptable No clean room requirement • Ability to Detect Variants • Applications: as wide a selection as possible • Data storage and server requirement: must be available through instrument manufacturer • Track records: strength of chemistry and technology must be supported by publications • Space available in FBR: for benchtop instrument only: 6'2'' x 2'6'' x (LxW) • Installation requirement: must be minimal Specifications for a back-up Next Generation Sequencer: • Number of Reads: Up to3 billion single-end reads; up to 6 billion paired-end reads • Read Length: 100 bp uniform read length; 2 x 150 bp paired-end read • Throughput: Minimum 1 Gb of high quality data (2 x 150 bp run) • Quality of Data: highest quality achievable • Cost/Gb of Data: minimum Gb range • Time from DNA Purification to Direct Reporting of Variants: ~ 8 hrs acceptable • Instrument: small with integrated analysis server. Emulsion PCR not acceptable • Chemistry: proven chemistry required; minimal opportunity for error • Ability to Detect Variants • Applications (supported by peer-reviewed publications) • Space and Special Installation Requirements (must not require clean room or clean area) • Server: t not require a server The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing, Small Business Size Standard is 500 employees. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. Potential contractors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number, email address of point of contact. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. Capability statements must provide enough information to determine if the company can meet the requirement. At a minimum provide the following: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information corresponding to each item, which demonstrates the capabilities of the contractor to meet the requirement. Interested Contractors must respond with capability statements which are due in person, by postal mail, fax or email to the point of contact listed below on or before May 4, 2011, 1:00 pm (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Office of Acquisitions and Grants Services, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference solicitation number FDA1086783. 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 Federal Business Opportunities. 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)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1086783/listing.html)
- Record
- SN02434803-W 20110429/110427234835-cd576a1e8f193f569db372084786f662 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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