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66 -- Deep Sequencing Service for Viral Vaccine

Notice Date
Notice Type
Combined Synopsis/Solicitation
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
Solicitation Number
Archive Date
Point of Contact
George Gonzalez, Phone: (301)-827-9361
E-Mail Address
Small Business Set-Aside
DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-33. The associated North American Industrial Classification System (NAICS) code for this procurement is 541711 for full and open competition. Background The FDA has developed a non-specific viral detection method using degenerated PCR and high through-put sequencing. Our non-specific viral detection method has been successfully used to detect viral containments in vaccine related products including cell substrates and viral vaccines. Our laboratory will use this service contract to further update our non-specific viral detection method and perform testing on vaccine related products. In the past few years, one or both of these services have been provided by Cogenics, Macrogren, NCI/SAIC, Operon (now Eurofins) and Bioreliance. Cogenics was not cost-effective at last use, and there were issues with timeliness of deliverables, however the results were most favorable. It is our understanding these issues may have been resolved. NCI/SAIC (via IAA) offered the lowest price but due to lowered priority of FDA, the project timeline was delayed significantly resulting in an adverse effect on the overall project and mission requirement. Bioreliance offers deep sequencing but not the type of analysis required for 454 sequencing. Macrogen offers both methods/technologies, has provided excellent response time, customer service, and consistently reasonable pricing to our other labs. The FDA intends to issue a firm fixed-price purchase order for both Roche 454 pyrosequencing, and Illumina ultra deep sequencing service for viral vaccine analysis that meets or exceeds the following specifications: Scope • The information will be used for discovery and quantification of viral contaminants in vaccine related products, including vaccines and cell substrates. • The main requirement is the maximum redundancy in sequencing, meaning that results for each sample must include tens of thousands of individual sequence determinations (reads) • Contractor shall utilize Roche's 454 instrument (also called pyrosequencing technology) AND • Illumina's Genome Analyzer (GA) IIx. • Both should be used in the aforementioned project for its different aspects, as regulation of vaccines and relation products requires evaluation of various methodologies/technologies. • Process user furnished DNA libraries using user furnished protocols and primers (PCR products with specific 454 or Illumina primers) for both deep sequencing/454 methodologies and provide sequencing data. • No library construction is required. Technical Requirements • Analyze samples of amplicons or DNA libraries prepared from vaccine samples and vaccine derived viruses utilizing Roche's 454 instrument (also called pyrosequencing technology) 8/8 plate AND • Illumina's Genome Analyzer (GA) IIx in both 1x36 bp and 2x101 bp format • Both deep sequencing methods shall be used concurrently in the aforementioned project for its different aspects, as both are required for regulatory evaluation of various methodologies/technologies used in vaccines/vaccine related products. • Process user furnished DNA libraries or amplicon with specific 454 or Illumina primers using user furnished protocols for both deep sequencing/454 methodologies and provide sequencing data. • Shall provide 5 runs of Roche 454 8/8 plate • Shall provide 3 LANES of Illumina 1x36 bp format (can be a single run) • Shall provide 1 run DNA sequencing 2x101 bp in Illumina format • Preferred overnight turn-around for delivery of data upon completion of runs/work, but not to exceed 48-72 turn around • Turnaround time from when FDA furnished samples are provided to furnishing of results should average approximately 4-6 weeks. • Vendor shall provide sequencing data results utilizing both methodologies/technologies via either secure web (FTP), CD and/or both. Deliver via secured web/internet connection (FTP) is preferred due to immediate access to results. • Entire project shall not exceed one year from date of award. (new sample sets may not be provided by user/FDA until results are provided from previous run) Deliverables Data results shall be provided by contractor via secure internet connection for immediate access upon completion of analysis may also be provided via CD/DVD Period of performance One year from date of contract award FDA Provided Materials FDA shall design and provide primers with MID (multiplex identifier) FDA shall provide direct PCR products (amplicon with specific 454 or Illuminia primers) or DNA libraries for them to sequence QUESTIONS DEADLINE: all questions must be received by email (george.gonzalez@fda.hhs.gov) before 1:00 pm (1300) EST on 23 July 2010. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," and 2) Price. Technical Capability is significantly more important than price. 3. Turn-around Time overnight, not to exceed 48-72 hours from each request. 4. Past Performance. 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 an option line item. Evaluation of Technical Capability shall be based on the requirements provided in the quotation. Offerors shall include the manufacturer, make and model of the product, manufacturer sales literature or other product literature which CLEARLY DOCUMENTS that the offered product meets or exceeds the specifications stated herein. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. This is a Combined Synopsis/Solicitation for Deep Sequencing Service for Viral Vaccine as defined herein. The Government intends to award a Firm Fixed-Price Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541711; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, 8800 Rockville Pike, Bethesda MD 20892. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 1:00 PM (1300) EST on 30 July 2010 to the attention of George Gonzalez, george.gonzalez@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
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