SOLICITATION NOTICE
A -- MicroRNA sequencing in conjunction with the Government’s Study of Translational Biomarkers for Drug-Induced Liver Injury (DILI) with Next-Generation Sequencing (NGS) - Combined Synopsis/Solicitation
- Notice Date
- 4/10/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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-14-223-SOL-1128162
- Archive Date
- 5/10/2014
- Point of Contact
- Sondea R Blair, Phone: 8705437469
- E-Mail Address
-
sondea.blair@fda.hhs.gov
(sondea.blair@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Attachment 1 Subcontracting Plan Combined Synopsis/Solicitation 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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures and FAR 13.5 Test Program for Certain Commercial Items. The solicitation number is FDA-14-223-SOL-1128162. 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 dated January 31, 2014. The associated North American Industry Classification System (NAICS) Code is 541711- Research and Development in Biotechnology; Small Business Size Standard is 500 employees. This acquisition is issued as full and open competition. Contract Type: Commercial Item - Firm Fixed Price. REQUIREMENTS Part I: General Information (Introduction/Background/Scope) Background: The US Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR) requires services for miRNA sequencing in conjunction with the Government's Study of Translational Biomarkers for Drug-Induced Liver Injury (DILI) with Next-Generation Sequencing (NGS). The project requires microarray services to sequence microRNA samples, using an Illumina Hi Sequencing platform, to elucidate the molecular mechanisms and processes modulated by non coding RNAs (including miRNAs) and their importance in DILI risk and phenotypes. An original pilot study conducted in 2013 generated miRNA-seq data using an Illumina Hi Sequencing Platform, specifically HiSeq2500. To ensure future data is scientifically comparable with data from the previous study, identical platforms, equipment, and methods across studies are necessary to the integrity of the sequencing quality, as well as the downstream analysis. The resulting miRNA sequence data will be utilized to evaluate the impact of different drugs on genetics and epigenetic effects correlated to DILI. The data will also be utilized to identify biomarkers for safety and prognosis of DILI, and to develop NGS bioinformatics strategies and evaluate the advantages and limitations of the strategies. It is anticipated that the new discovered miRNA, may be potential novel biomarkers, and will be utilized to be more predictive for human specific DILI than conventional biomarkers, such as enzyme evaluation. Part II: Work Requirements A. Technical Requirements At a minimum the Contractor shall: -Provide RNA extraction service from 10mg of rat liver tissues. RNA concentration shall be measured using Picogreen RNA quantification and quality determined by a Bioanalyzer using RNA 6000 Nano chips. The total RNA yield for each sample shall be more than 10ug and shall fulfill the following criteria: Total RNA concentration >200ng/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 shall be free of DNA contamination. -Provide Next Generation Sequencing library preparation services from 1ug of the above extracted total RNA for miRNA-Seq using Illumina TruSeq Small RNA Sample Prep Kit. The quantity of each library shall be measured by Picogreen DNA quantification and the quality of library shall be recorded using high sensitive DNA chips on bioanalyzer. -The library preparation shall be processed in a batch of 48 samples per run using 48 indexed adaptors. Each sample shall be processed individually by adding special bar-coded adaptors and reverse transcript and amplified. 48 samples shall be pooled by mixing equal amount of DNA from each library based on the concentration measured by Picogreen. The recovered miRNA library pool from 48 samples shall have a yield of no less than 20ng. - The barcoded libraries shall be sequenced utilizing the Illumina HiSeq2500 platform (or higher) for single end 50 base pair reads. Each pool of 48 different barcoded samples shall be evenly uploaded onto 4 flowcell lanes. a. The sequencing data shall be de-multiplexed and transformed to FASTQ format data files. FASTQ files are ASCII text files that encode both nucleotide calls as well as quality information, which provides information about the confidence of each nucleotide). The final reads passed filter shall be no less than 10 million reads for each sample. b. 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 format, and shall be able to offer an alternative method of data transformation upon request by the Government. Schedule of Items Line Item 0001 MiRNA Extraction Services to include the following: Extraction of total RNA including microRNA from Rat liver tissues including quantification and quality control using bioanyalzer. Library construction for microRNA-Sequences using bar coding index. MicroRNA Deep Sequencing using resulting in a minimum of 18,000,000 reads/samples. Est. Qty 120 EA Price ____________ Option Items Line Item 1001 Option Period One - one year period of service to commence upon conclusion of base contract period. MiRNA Extraction Services to include the following: Extraction of total RNA including microRNA from Rat liver tissues including quantification and quality control using bioanyalzer. Library construction for microRNA-Sequences using bar coding index. MicroRNA Deep Sequencing using resulting in a minimum of 18,000,000 reads/samples. Est. Qty 444 EA Price __________ Line Item 2001 Option Period Two - one year period of service to commence upon conclusion of base contract period. MiRNA Extraction Services to include the following: Extraction of total RNA including microRNA from Rat liver tissues including quantification and quality control using bioanyalzer. Library construction for microRNA-Sequences using bar coding index. MicroRNA Deep Sequencing using resulting in a minimum of 18,000,000 reads/samples. Est. Qty 528 EA Price __________ Line Item 3001 Option Period Three - one year period of service to commence upon conclusion of base contract period. MiRNA Extraction Services to include the following: Extraction of total RNA including microRNA from Rat liver tissues including quantification and quality control using bioanyalzer. Library construction for microRNA-Sequences using bar coding index. MicroRNA Deep Sequencing using resulting in a minimum of 18,000,000 reads/samples. Est. Qty 528 EA Price ______________ Total Price all Option Items _______________ Grand Total All Items _________________ Part III: Supporting Information A. Period of Performance The period of performance is estimated at 12-months from date of contract award. The Government will provide 120 samples within 30-to 90-days of contract issuance with deliverables due within 9 months of contractor receipt. B. Place of Performance Work shall be performed on-site at the contractor location with deliverables sent to the following Government location: US Food and Drug Administration Point of Contact will be provided at time of award. National Center for Toxicological Research Jefferson Laboratory 3900 NCTR Road Jefferson, AR 72079 FOB Point destination. All items shall include delivery to the destination identified herein. Solicitation Provisions The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (July 2013) applies to this solicitation. The following addenda have been added to this provision: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the 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 (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (i) Technical Capability (ii) Past Performance (iii) Price When combined, technical capability, past performance, and small business subcontracting opportunities are more important than price in determining the best value to the Government. If the Government determines non-price factors to be essentially equal, price becomes more important as the discriminating factor. Technical Capability Technical capability will be determined by review of information submitted by the offeror demonstrating corporate ability and experience in conducting miRNA sequencing by describing instrumentation, expertise with that instrumentation and operational integrity of the required instrumentation to conduct the proposed miRNA sequencing, RNA extraction, library preparation, and MicroRNA Deep Sequencing services. Describe in detail the existing facility and equipment that will be dedicated to successful performance of the required services identified above. Address the professional qualifications and experience of key staff who may be assigned in the production of the materials and delivery of services. Discuss specific software that will be used in data acquisition, statistics, quality control, data storage and archiving. Recent and Relevant Past Performance Identify all ongoing and completed work (within the last 3 years from date of this solicitation) relevant to these requirements in terms of type, scope, complexity, and size. For each of these past performance references, provide a detailed description of the work, the period of performance, the dollar value of the work, your role and responsibilities as either a prime or subcontractor, the client name and address and client point of contact name, phone number, and email address. Any relevant past performance and/or collaborative research with major universities and/or federal agencies involved in publishing results in miRNA sequencing. Small Business Subcontracting As prescribed by FAR 19.708(b), because the total contract price is expected to exceed $650,000, the Offeror shall submit with its proposal, a subcontracting plan as prescribed in FAR 52.219-9(d). If the Offeror determines that there will not be subcontracting opportunities, the Offeror shall still submit a subcontracting plan and include a statement of circumstances supporting this determination. Small business firms are exempt from this requirement (See attachment 1). The Small Business Subcontracting factor will be evaluated based on the Offeror's proposed subcontracting plan related to this effort. Evaluation will reflect the extent to which the contractor has committed to utilizing small businesses. All subcontracting plans must be approved by the Contracting Officer. Failure to submit and negotiate an acceptable subcontracting plan by the time of award shall render the Offeror ineligible for award of a contract. The subcontracting plan will become part of the contract. Offerors shall provide pricing, clearly delineating the applicable performance period, using the above schedule format for each period of performance. Offerors shall provide detailed costs supporting their firm fixed price, ensuring that the price proposal is consistent with the technical proposal in all respects since the price proposal may be used as an aid to further determine the Offeror's understanding of the technical requirements. 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 Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of 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, offerors must furnish as part of their proposal all descriptive material necessary for the government to unequivocally determine whether the service meets the technical requirements. The Government reserves the right to make an award without discussions. The Provision at FAR 52.212-3, Offeror's Representations and Certifications - Commercial Items, applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items applies to this acquisition. The following addenda have been added: Inspection and Acceptance The deliverables and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the deliverables 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. Invoice Submission Invoices shall be submitted to the address identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Purchase order/award number; (iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading, if applicable; (vi) Terms of any discount for prompt payment offered, if applicable; (vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer identification number (TIN); (x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (xi) name and telephone number of the FDA contracting officer representative or other program center/office point of contact, as referenced on the purchase order; and (xii) Any other information or documentation required by the purchase order/award. II. An original and two (2) copies shall be submitted to: FDA/OC/OA/OFO/OFS Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor suite 616 Jefferson, AR 72079 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy to the Contracting Officer Representative or other program center point of contact/office designee, clearly marked "courtesy copy only": To be completed at time of award by Government. III. Questions regarding invoice payments should be directed to the FDA payment office at (870) 543-7446 or (870) 543-7042 or electronically at nctrinvoices@fda.hhs.gov The following clauses are incorporated by reference: • 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. • HHSAR Clauses: 352.202-1, 352.203-70, 352.222-70, 352.223-70, 352.231-71, 352.242-71 • FAR Clause 52.217-9 Option to Extend the Term of the Contract (a)... within 1 day of contract expiration;.... at least 15 days before the contract expires... (c)...shall not exceed 3 years, past the end period of performance date under item 1. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items apply to this acquisition. The following additional FAR clauses cited in this clause are applicable: (b): 52.203-6 Alt I, 52.204-10, 52.209-6, 52.219-4, 52.219-8, 52.219-9, 52.219-16, 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, 52.222-54, 52.223-18, 52.225-13, and 52.232-33. (c): 52.222-53. Additional Information Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. It is the offeror's responsibility to monitor FedBizOpps.Gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc. All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number FDA-14-223-SOL-1128162. The offers are due in person, by postal mail or email to the point of contact listed below on or before April 25, 2014 before 9:00 am (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Building 50, Room 421, 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 Sondea Blair by e-mail at sondea.blair@fda.hhs.gov no later than 9:00 AM CST on April 22, 2014.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-223-SOL-1128162/listing.html)
- Place of Performance
- Address: National Center for Toxicological Research, 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03335751-W 20140412/140410235254-7cd8082f04f8337bfc38f42ee2eb7bb2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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