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The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66, February 28, 2013.
The associated North American Industry Classification System (NAICS) Code is- 541380 - Testing Laboratories; Size standards $12 million. This combined synopsis/solicitation is set-aside for Small Business.
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 April 10, 2013 to [email protected], 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 [email protected].
The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), is soliciting quotes for services to sequence mRNA samples using an Illumina HiSeq200 platform.
Statement of Work (SOW)
The FDA/NCTR require services to sequence mRNA samples using an Illumina HiSeq200 platform for the Government's "Study of Translational Biomarkers for Drug-Induced Liver Injury with Next-Generation Sequencing" to elucidate the molecular mechanisms and processes modulated by mRNAs and their importance in DILI risk and phenotypes. The resulting mRNA-Seq data will be utilized to evaluate the impact of different drugs on genetics and epigenetic in rats. The data will also be utilized to identify biomarkers for safety and prognosis, and to develop NGS bioinformatics strategies and evaluate their advantages and limitations. It is anticipated that the new discovered mRNA, may be potential novel biomarkers, will be utilized to be more predictive for human specific DILI than conventional biomarkers, such as enzymes evaluation (to date, serum-based enzymes evaluation is the common practice in DILI research).
Technical Specifications:
1. Absorbance wavelength range of 200-1000 nm.
2. Wavelengths selected by monochromator, tunable in 1.0 nm increments.
3. Dual monochromators for fluorescence detection, tunable in 1.0 nm increments.
4. For fluorescence detection, wavelength range for excitation shall be 250-850 nm; for emission the wavelength range shall be 250-850 nm.
5. For luminescence, the wavelength range shall be 250-850 nm.
6. The reader shall be able to read 6, 12, 24, 48, 96 or 384 well plate formats.
7. The temperature control shall range from above ambient to 45˚ C; temperature shall be uniform and stable.
8. The reader shall have a shaker that can be set for up to at least 15 minutes.
9. The Contractor shall provide RNA extraction service from 10mg of rat liver. RNA concentration shall be measured using Picogreen RNA quantification kit and quality determined by Bioanalyzer. The total RNA yield of each sample shall be more than 10ug and fulfill the following criteria: Total RNA concentration >50ng/ul; 260/280 ratio>1.7; 260/230 ratio>1.5; 28S/18S ratio>1.5; RNA integration number (RIN)>7.8. All RNA samples v be free of DNA contamination.
10. The contractor shall provide library preparation services using the total RNA for RNA-Seq using Illumina TrueSeq Labeling Kit. The quality of library shall be recorded using high sensitive bioanalyzer chips.
11. The samples shall be processed and bar-coded using indexing, which enables the pooling of many samples into a single sequencing experiment. 24 barcode shall be used.
12. Barcoded libraries shall be sequenced utilizing the Illumina HiSeq2000 platform with single end 50 base pair reads. Different barcoded samples can be pooled for a single lane.
13. The sequencing data from HiSeq2000 shall be de-multiplexed and transformed to fastq data files. The reads for each sample shall be no less than 18 million reads.
14. The Contractor shall upload all sequence data onto a secure data server and make the data available for download by FDA investigators. The provided data shall be in fastq data files
Item #1
Sample preparation and Library Construction for mRNA-Sequencing w/ 24 Barcode Index
Quantity: 512
Unit Price: _____________________
Extended 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 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (Feb 2012)
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)
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 (Nov 2012), applies to this acquisition.
The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 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, 52.225-3, 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 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) Past Performance.
(iii) 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 acceptability will be determined by review of the technical approach proposed to meet the requirements of the SOW.
Past Performance will be determined by review of recent (within the past 3 years) and relevant Microarray Sequencing run on Illumina HiSeq2000 sequencer past performance and information submitted by the quoter. The Government reserves the right to look to other sources of information (e.g., the Past Performance Information Retrieval System (PPIRS), etc.) to support past performance evaluations.
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, 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/ . (Nov 2012)
An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.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).
Clauses and provisions incorporated by reference can be obtained at http://www.acquisition.gov/far