SOLICITATION NOTICE
B -- Deep Sequencing
- Notice Date
- 6/25/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- 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-RFQ-1119688
- Archive Date
- 7/23/2013
- 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-RFQ-1119688. 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) 2005-66, April 1, 2013. The associated North American Industry Classification System (NAICS) Code is- 541380 - Testing Laboratories; small business size standard is $12 million. 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 of their complete proposal and any additional documents before 1:00 pm (Local Prevailing Time in Jefferson, Arkansas) on July 8, 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, 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. The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is soliciting quotes for services to provide Deep Sequencing using GS-FLX 454 Titanium Chemistry with Annotated Bioinformatics. Statement of Work (SOW) The FDA/CBER requires services for Deep Sequencing using GS-FLX 454 Titanium Chemistry with Annotated Bioinformatics. GS-FLX 454 Titanium chemistry platform enables the long reads capability that is required for this project. Deep Sequencing provides for evaluation for the presence of unknown adventitious viruses in vaccine cells using Massively Parallel Sequencing (MPS) or deep sequencing using a curated virus database and providing bioinformatics analysis and annotated data along with other curated and publicly available databases as identified by the offerer. The evaluation for the presence of unknown adventitious viruses in vaccine cells is critical for product safety. Massively parallel sequencing (MPS), also called deep sequencing, can generate transcriptome sequences. This new technology has been reported to identify novel viruses. The FDA will need to use this approach to investigate the presence of unknown viruses in novel cells for new vaccines. Materials (cell-free lysates, cell culture supernatant, cell or viral pellets, RNA or DNA) will be provided for cDNA synthesis for Massively Parallel Sequencing (454-deep sequencing platform). For all samples the FDA requires full bioinformatics analysis with annotation using a curated virus database along with other curated and publicly available databases as identified by the offerer. FDA shall provide cell culture supernatant, cell-free lysates, cell or viral pellets, RNA or DNA. Performance Requirements • The Contractor shall construct a full-length cDNA library and perform Massively Parallel sequencing using GS-FLX 454 Titanium chemistry. • The Contractor shall perform whole transcriptome (RNA) analyses from submitted samples. • Each sample requires a ½ plate run. • For each sample, the average read length shall be at a minimum of 350-450 bases and >400,000 - 500,000 reads. • Comprehensive bioinformatics analysis with annotation and statistics shall be conducted using curated viral databases, Blastn against the nt/nr database along with other curated and publicly available databases as identified by the offerer. • The Contractor shall provide all of the data including reads, contigs, and analysis of sequences generated from the sample and comply with NCBI text output: FASTA and quality scoring files of all single reads and of all clusters; a contig survey; and raw data in *.sff format via FTP and on DVDs. • Bioinformatics with gene expression differential analysis. • Final Report. • Contractor turnaround time for 2 samples shall be no more than 4 weeks after receipt of the samples. Item #1 Deep Sequencing using GS-FLX 454 Titanium Chemistry with Annotated Bioinformatics Quantity: 5 Unit Price: _____________________ Extended Price: _________________ GSA Contract Number (if applicable): ________________________ FOB Destination - U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda, MD 20892. 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, 52.219-4, 52.219-28, 52.222-3, 52.222-21, 52.222-26, 52.222-36, 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, 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 and past performance, when combined, are 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 and relevant projects (completed by the Contractor within the last 3 years), where the Contractor demonstrates that it has performed services related to Deep Sequencing using GS-FLX 454 Titanium Chemistry with Annotated Bioinformatics. 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 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). Clauses and provisions incorporated by reference can be obtained at http://www.acquisition.gov/far
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_13-233-RFQ-1119688/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03099048-W 20130627/130625235136-9124600f342a20cc2c3b15c24c608d48 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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