SOLICITATION NOTICE
B -- Digital Gene Sequencing (mRNA)
- Notice Date
- 6/24/2013
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1119696
- Archive Date
- 7/5/2013
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) intends to award a Purchase Order on a sole source basis to LC Sciences, 2575 W. Bellfort St, Houston, TX 77054 for the services listed below. 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; no request for quote (RFQ) is available and a written solicitation will not be issued. Not withstanding, any firm that believes it is capable of providing the required items as stated herein may submit a capability statement to document its ability to provide the required item. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. In doing so, interested sources must submit technical capabilities, pricing, and other information that demonstrates their ability to meet the Government's needs to the point of contact located herein. A determination to compete this procurement based on a response to this notice is solely within the discretion of the government. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement under Simplified Acquisition Procedures. The solicitation number is 1119696. Sole source determination is based on the need for compatibility and consistency of study results based on previous mRNA testing conducted by LC Sciences. The Government believes a source change would yield inconclusive data and compromise the validity of research results if different controls, sample preparation and analysis procedures were used to perform the services. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66 effective April 1, 2013. The associated North American Industry Classification System (NAICS) Code is- 541380- Testing Laboratories; Small Business Size Standard is $14.0 million. The Food and Drug Administration intends to solicit and negotiate a Firm-Fixed Price order with only one source under the authority of FAR 13.106-1(b) for the following. Scheduled items include: mRNA Digital Gene Expression Sequencing Services 45 ea Scope: The cell substrates project has the need for using digital gene expression sequencing technology on forty-five (45) samples to determine biomarkers for virus activation in induced samples by comparing them to uninduced samples for cell substrate safety. The FDA will provide the company with total RNA from uninduced and induced samples. The contractor shall prepare a library, perform the high throughput sequencing, and perform comprehensive data analysis on the raw data. The contractor shall: • Perform cellular microarray service starting with Total RNA (provided by FDA) • Prepare sample from total RNA • Conduct library preparation • High-throughput sequencing using Illumina RNA-Seq technology • Run samples in triplicate • Filter data using standard filtering service and normalize • Provide comprehensive data analysis/gene expression profiling service with multiple comparison analyses • Provide a clear customer data report including a summary of methods and all differential expression analysis • Provide data/deliverables in text, excel, heatmaps, and proprietary sequencing files/formats. Associated raw data shall also be provided after running though the basic analyzer. Raw and Analyzed results and data shall be delivered to Bldg 29B, Room 4NN10, 8800 Rockville Pike, Bethesda, MD 20892 Contract shall be completed within 12 months from the date of contract award. The estimated date of sample shipment by the FDA will be within the 11 months after award. The contractor shall provide deliverables within 4 weeks of time from sample receipt. FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. Addenda to this provision are as follows: None The provision at FAR 52.212-2 Evaluation-Commercial Items (Jan 1999) is applicable to any responses received to this notice. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: (i) Technical capability of the service offered to meet the Government requirement without compromising the validity of research the results will be used in. (ii) Past Performance (iii) price. Technical capability and past performance are more important when compared to price. Technical capability will be determined by review of information submitted by the Offeror, which must provide a description in sufficient detail to show that the services quoted meet the Government's requirement, does not pose a validity issue with the data results and demonstrates successful performance of the service requested with the specific equipment stated in the requirements. The government is not responsible for locating or securing any information, which is not identified in the quote. 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 service, which demonstrates the capabilities of the Offeror. Furthermore, experience with RNA sample preparation, library preparation, high-throughput sequencing with Illimina RNA-Seq technology, running samples in triplicate, filtering data, gene expression profiling with multiple comparison analyses and performing data reports shall be included with offer. The Provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items (DEC 2012), applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (FEB 2012), applies to this acquisition. Addenda to this clause are as follows: Other Terms and Conditions Inspection and Acceptance 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. Invoice Submission Payment terms net 15 days after government acceptance of the supplies/services. Invoices shall be submitted to the attention of the Office of Financial Services identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. 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 Phone: (870) 543-7446 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy each to the Contracting Officer and Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov. The following clauses are incorporated by reference: • FAR 52.232-99, Providing Accelerated Payment to Small Business Subcontractors (DEVIATION) is applicable. • HHSAR Clauses: 352.222-70 and 352.231-71 are applicable to this solicitation. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JAN 2013), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: (b) 52.204-10, 52.209-6, 52.219-4, 52.219-28, 52.222-3, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3 II, 52.225-13 and 52.232-33. Offerors may submit a capability statement to document its ability to provide the required services, on or before July 3, 2013 by 9:00 am (Central Standard Time in Jefferson, Arkansas). The statements must reference solicitation number 1119696. The Offers are due in person, by postal mail, fax or email at the Food and Drug Administration, NCTR/OSS/OFFAS, HFT-320, 3900 NCTR Road, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Crystal McCoskey at (870) 543-7267, FAX (870) 543-7990 or email crystal.mccoskey@fda.hhs.gov.
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