SOLICITATION NOTICE
66 -- Next-Generation Benchtop Sequencer System (NGS)
- Notice Date
- 6/28/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_13-233-1119656
- Archive Date
- 7/27/2013
- 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
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement herein under Simplified Acquisition Procedures. The solicitation number is FDA_13-233-1119656. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-68, June 26, 2013. The associated North American Industry Classification System (NAICS) Code is- 334516 - Analytical Laboratory Instrument Manufacturing; small business size standard is 500 in numbers of employees. This requirement is not being set aside for small businesses and any qualified, interested vendor may submit a quote. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 12, 2013 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov. The U.S. Food and Drug Administration's (FDA), Center for Biologics Evaluation and Research (CBER), Jefferson, AR requires a Next-Generation Sequencer (NGS). Statement of Work (SOW) The Laboratory of Method Development at U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), requires a Next-Generation Benchtop Sequencer System (NGS) capable of generating up to 15 Gb per run, that integrates amplification, sequencing, and data analysis in a single instrument. The system shall be used for rapid and high throughput generation of sequencing data. These data will be used for evaluation of the genetic consistency of viral vaccines. Technical Requirements: • Maximum 8 hours turnaround time from genomic DNA to data • Maximum 90-minute library prep with 15 minutes hands-on time • Maximum provide 1 hour of on-instrument clonal amplification • Maximum 3 hour of on-instrument sequencing run (1 x 36 bp) • Maximum 3 hours of on-instrument analysis for variant reporting • Shall have a single instrument to perform clonal amplification, sequencing, and data analysis • Shall not require emulsion PCR • Maximum 30 minutes total hand-on time from genomic DNA to analyzed data • Shall be hand-free, completely automated, on-instrument paired-end sequencing • Shall support at a minimum up to 2 x 250 bp read length • At a minimum shall provide greater than 7.5 Gb of high quality data passing filter per 2 x 250 bp run • Shall provide: >90% of bases with Q scores greater than 30 (1 x 36 bp) >90% of bases with Q scores greater than 30 (2 x 25 bp) >85% of bases with Q scores greater than 30 (2 x 100 bp) >80% of bases with Q scores greater than 30 (2 x150 bp) >75% of bases with Q scores greater than 30 (2 x 250 bp) • Shall have a fully optimized, highly multiplexed amplicon and sample assay for targeted resequencing • Shall provide at a minimum 7.5 Gb of output for multiplexed sequencing of viral and bacterial genomes in a single run • Shall provide accurate data quality • Shall provide wide application flexibility • Shall provide Data generation • Bench-top instrument (as small as possible as we have not enough space at lab). • Shall have the availability of used sequencing chemistry • Shall have short sequencing run time at a minimum: ~4.00 hours for a 1 x36 bp single-read sequencing run ~5.50 hours for a 2 x 25 bp paired-read sequencing run ~16.5 hours for a 2 x 100 bp paired-read sequencing run ~24.0 hours for a 2 x 150 bp paired-read sequencing run ~39.0 hours for a 2 x 250 bp paired-read sequencing run >39.0 hours for a 2 x 300 bp paired-read sequencing run • Shall have instrument control software • Shall have the ability of on-instrument data analysis, including alignment and variant calling with embedded touch screen monitor and on-instrument computer • Shall provide rapid genomic DNA sample libraries preparation • Shall have the availability of sample preparation kits to provide sequencing's fast, easy, and low input sample preparation • Ability to monitor data in real time, and view quality performance metrics from any mobile device. Service / Maintenance Agreement To begin upon expiration of initial warranty period and shall continue for a Base Period of 1-Year. In addition, the Government solicits four (4) 1-year Service and Maintenance Agreement Option Periods. Minimum Requirements for Preventative Maintenance Services : • Shall include one (1) planned preventative maintenance visits per contract year. • Shall include unlimited corrective/remedial maintenance visits within 3 business days of call for service • Shall include unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) • Shall include unlimited software and firmware updates. • All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using ne OEM replacement parts, components, subassemblies, etc. • All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. • 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. Item #1 New-Generation Sequencing System w/embedded touch screen monitor and on-instrument computer, dual surface imaging capability, Next-Generation Sequencing Software Suite, installation kits and standards, installation and training, and 12 months warranty (including parts and labor). Quantity: 1 Unit Price: ____________________ Extended Price: ________________ GSA Contract Number (if applicable): ________________________ Item #2 (1st Option Period) Service Maintenance Agreement To begin upon expiration of initial warranty period and shall continue for a Base Period of 1-Year Unit Price: ______________________ GSA Contract Number: __________________ (if applicable) Item #3 (2nd Option Period) Service Maintenance Agreement To begin upon completion of coverage provided under prior option period and shall continue for a Period of 1-Year Unit Price: ______________________ GSA Contract Number: __________________ (if applicable) Item #4 (3rd Option Period) Service Maintenance Agreement To begin upon completion of coverage provided under prior option period and shall continue for a Period of 1-Year Unit Price: ______________________ GSA Contract Number: __________________ (if applicable) Item #5 (4th Option Period) Service Maintenance Agreement To begin upon completion of coverage provided under prior option period and shall continue for a Period of 1-Year Unit Price: ______________________ GSA Contract Number: __________________ (if applicable) FOB Destination - U.S. Food and Drug Administration, 5516 Nicholson Lane, Kensington MD 20895. Contract Type - Commercial Item - Firm fixed price. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Contract clauses- The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (Jun 2013) The following addenda have been attached to the clause: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov/far/ FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper. (MAY 2011) FAR Clause 52.204-7 Central Contractor Registration. (DEC 2012) FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a)... within 1 day of contract expiration;.... at least 15 days before the contract expires... (c)...shall not exceed 4 years from date of initial one year warranty expiration. The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.202-1 Definitions JAN 2006 352.203-70 Anti-Lobbying JAN 2006 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009 352.223-70 Safety and Health JAN 2006 352.231-71 Pricing of Adjustments JAN 2001 352.242-71 Tobacco-Free Facilities JAN 2006 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contracting Officer for this order is: To be completed at time of award: Phone: Email: The COR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 2013 ), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 52.219-4, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.223-18, 52.225-3, 52.225-13, and 52.232-33.(c) 52.222-51 Solicitation provisions Contract Type: Commercial Item-Firm Fixed Price. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been attached to this provision: Addendum to Paragraph (b)(8) Representations and Certifications- In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48. Note: This solicitation is being issued under the premise that the Contractor will certify that the combination of equipment/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 05-2035 (Rev.-13): http://www.wdol.gov/wdol/scafiles/std/05-2103.txt?v=13 Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The government will award the purchase order to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government on a best value (tradeoff) evaluation basis, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical acceptability of the services offered to meet the Government's requirement. (ii) Price. Technical acceptability is more important when compared to price in determining the best value to the government; however, price remains a significant factor. Technical capability will be determined by review of information submitted by the respondent, which must provide a description in sufficient detail to show that proposed equipment and related PM services quoted meet the Government's requirements. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items (Dec 2012), applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically via http://www.acquisition.gov/far/. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at https://www.sam.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_13-233-1119656/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, 5516 Nicholson Lane, Kensington, Maryland, 20895, United States
- Zip Code: 20895
- Zip Code: 20895
- Record
- SN03103197-W 20130630/130628235202-081caf8de011b5fc20441cef54157712 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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