SOLICITATION NOTICE
66 -- Next Generation Sequencer System plus post-warranty Preventative Maintenance (PM) Services
- Notice Date
- 3/17/2014
- 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_13-233-1130736
- Archive Date
- 4/8/2014
- 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 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 using Simplified Acquisition Procedures in accordance FAR 13.5-Test Program for Certain Commercial Items. The solicitation number is FDA_13-233-1130736. 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) 2005-72, January 30, 2014. The associated North American Industry Classification System (NAICS) Code is- 334516 Analytical Laboratory Instrument Manufacturing SB Size status: 500 employees. This combined synopsis/solicitation is a Total 100% small business set-aside. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method of their complete proposal and any additional documents before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on March 24 2014 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, Building 50, Room 424, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not 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. Background The FDA/NCTR/DGMT uses TK6 and WTK1 cells in several mutagenicity assays. However, it is unclear how the genetic background of these cells compares to a normal human transcriptome and genome-information crucial to assess the validity of the findings obtained from these cells. To better understand the genetic background of TK6 and WTKl cells, DGMT seeks to sequence their transcriptome and whole genome. To that end, DGMT needs a massively parallel sequencing platform that can rapidly and affordably sequence and analyze entire human transcriptomes and genomes. DGMT also routinely employs the Pig-a assay for in vivo mutagenicity studies. A massively parallel sequencing platform will allow DGMT to rapidly and affordably identify mutations in the Pig-a gene in lymphocytes, erythroid precursors, and other blood cell progenitors-in complex mixtures and without need of clonal expansion. Such findings and capabilities will greatly enhance the value of the Pig-a assay. Requirement The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology (DGMT), is soliciting quotes for a Next Generation Sequencer System plus post-warranty Preventative Maintenance (PM) Services. Minimum Technical Specifications: -The instrument shall perform clonal amplification, sequencing, paired-end tum, and data analysis as single, integrated platform. -The instrument shall have the necessary hardware and software integrated to analyze genomes on its own and without the need to access the Internet or any website outside of the FDA. -The technology used by the instrument shall not rely on ancillary amplification systems or other burdensome procedures, such as emulsion PCR. -The instrument shall be able to generate at least 350 million reads per run with Q scores greater than 30 for at least 75% of the bases sequenced. -For greater confidence in the sequencing quality, the instrument shall use competitive nucleotide addition with reversible terminator technology. -The instrument shall be able to sequence through homopolymeric regions. -The instrument shall be able to generate single-read and paired-end runs. Post-Warranty Service Maintenance Agreement Post-Warranty Service Maintenance Agreement(s) to begin upon expiration of initial warranty. The Government is interested in acquiring PM services for up to an additional four (4) one-year option periods that the Government may exercise unilaterally on an annual basis. Minimum Requirements for Preventative Maintenance Services: • At least one on-site Performance Maintenance (PM) visit per year • Shall include unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Time. If a call is received outside of normal business hours, the Contractor shall begin working on a solution within 8 business hours of message receipt (e.g., telephone-based, email-based, website-based, etc.) • Shall include unlimited software and firmware updates • All Performance Maintenance shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. • All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. • 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 Next Generation Sequencer System Quantity: 1 (one) Unit Price: ______________________ Make: __________________________ Model: _________________________ Part Number: ____________________ GSA Contract Number: __________________ (if applicable) PRICE QUOTES MUST INCLUDE SHIPPING & HANDLING Item #2 (1st Option Period) Service Maintenance Agreement- Services to be performed in accordance with Minimum Requirements for Preventative Maintenance Services section. To begin upon expiration of initial warranty period and shall continue for a period of 1-year Unit Price: ______________________ GSA Contract Number: __________________ (if applicable) Item #3 (2nd Option Period) Service Maintenance Agreement- Services to be performed in accordance with Minimum Requirements for Preventative Maintenance Services section. To begin upon expiration of the previous 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- Services to be performed in accordance with Minimum Requirements for Preventative Maintenance Services section. To begin upon expiration of the previous 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- Services to be performed in accordance with Minimum Requirements for Preventative Maintenance Services section. To begin upon expiration of the previous 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, National Center for Toxicological Research, 3900 NCTR Rd., Jefferson, AR 72079. 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 FAR 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. 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 / 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... FAR Clause 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Deviation) 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: (870) 543-XXXX Email: xxxx 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 COR for this order is: to be completed at time of award. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 Alt I, 52.203-17, 52.204-10, 52.209-6, 52.219-6, 52-219-8, 52-219-14, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52-222-40, 52.223-18, 52.225-13, and 52.232-33. Solicitation provisions The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. Addendum Paragraph (c) Period for acceptance of offers. The offeror shall state on its quote that the quoted prices in its offer firm until September 30, 2014. 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 a 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 Capability of the instrumentation/services offered to meet the Government's requirement. (ii) Price. When combined, Technical Capability 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: • The degree to which the proposed instrument meets or exceeds the requirements of the SOW and the associated value of any additional benefits that may be derived in cases where the proposed instrument exceeds the minimum requirements. • The degree to which the proposed PM services plan meets or exceeds the minimum performance requirements and the value associated with any additional benefits that may be derived where the offered plan exceeds the minimum requirements. • A review of the Offeror's certification/training program for their technicians. The technical requirements as indicated above are minimal requirements only; offerors may offer additional instrumentation/services as part of their quote that exceeds these requirements. The offeror shall note any additional instrumentation/services that are being offered in excess of the minimum requirements and shall provide a detailed explanation as to what the additional instrumentation/services are and how they will be of benefit to the Government. 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. Price Price proposed must be detailed and represent the offeror's response to the schedule of items above. The cost of operating the equipment is a significant component of the price evaluation. Operating costs are primarily driven by the cost per kit required to sequence an entire human genome in a single run with a depth equal to 30x. Sequencing kits are not part of this requirement. However, offerers must provide detailed information regarding which kit(s) they recommend be used to perform this type of run on their proposed instrument. This information will assist the Government in determining the operating cost of the instrument which will be used as part of the total price analysis. Options: The Government will evaluate offers for award purposes on a total price basis. Total price shall consist of the price of the instrument + estimated operational costs for the base + 4 option year period + the price for PM services during the option years. Operational costs are comprised of the cost per kit x 25 (the Government's expected number of runs per year). The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, 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 https://www.sam.gov/portal/public/SAM/#1. If an offeror has not completed the annual representations and certifications electronically at the website, the offeror shall complete only paragraphs (c) through (o) of this provision. This solicitation is being issued under the premise that the offeror will certify that the combination of equipment maintenance/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 the Contractor certifies that the company is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will be applicable to the resulting order. In the event that a contractor does not make this certification, the 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.-14) http://www.wdol.gov/wdol/scafiles/std/05-2035.txt?v=14 FAR CLAUSE 52.222-48 EXEMPTION FROM APPLICATION OF THE SERVICE CONTRACT ACT TO CONTRACTS FOR MAINTENANCE, CALLIBRATION, OR REPAIR OF CERTAIN EQUIPMENT CERTIFICATION (a) The offeror shall check the following certification: CERTIFICATION The offeror [ ] does [ ] does not certify that- (1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations; (2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment. (i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. (ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and (3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, will not be included in any resultant contract awarded to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. 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_13-233-1130736/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Rd., Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03312333-W 20140319/140317234248-694850fd8cf880df79d51d9b04b1c1c5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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