MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research's (NCTR) requirement for Micro Ribonucleic Acid (miRNA) Extraction Services. This sources sought notice is being issued to determine the availability of US small businesses capable of satisfying this requirement. The associated North American Industry Classification System (NAICS) Code is 541711- Research and Development in Biotechnology; Small Business Size Standard is 500 employees. Background: The FDA's NCTR requires services for miRNA extraction in conjunction with the Government's Study of Translational Biomarkers for Drug-Induced Liver Injury (DILI) with Next-Generation Sequencing (NGS). The mRNA extraction 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. The Illumina Hi Sequencing platform is required for the increased throughout and to ensure generated data is comparable with data obtained from previous projects utilizing the same platform, thereby reducing variations. The resulting miRNA sequence 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 the advantages and limitations of the strategies. It is anticipated that the new discovered miRNA, may be potential novel biomarkers, will be utilized to be more predictive for human specific DILI than conventional biomarkers, such as enzyme evaluation. Minimum Technical Requirements: - 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. The total RNA yield for each sample shall be more than 10ug and shall 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 shall be free of DNA contamination. - The contractor shall provide library preparation services using the total RNA for miRNA-Seq using Illumina labeling. The quality of library shall be recorded using high sensitive bioanalyzer chips. - The samples shall be processed, bar-coded, and indexed. The barcoded libraries shall be sequenced utilizing the Illumina Hi Sequence platform with single end 50 base pair reads. Different barcoded samples shall be pooled for a single lane. 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 reads for each sample shall be no less than 18 million reads. 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. Though this is not a request for quote, informational pricing for the service is encouraged. (see attached for deliverables) Period of Performance The Government will provide 512 samples within 30-days of contract issuance with deliverables due within 8 months of contractor receipt. 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 National Center for Toxicological Research Jefferson Laboratory 3900 NCTR Road Jefferson, AR 72079 Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in providing the required services. Though the target audience is small businesses, all interested parties may respond. At a minimum, responses shall include the following: - Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. - Past performance information for the service (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. - If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. - If a large business, provide if subcontracting opportunities exist for small business concerns. The government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before January 06, 2014 by 9:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Bldg 50, Rm 421 Jefferson, AR 72079-9502 or email
contact@example.gov. Reference FDA 1128162. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern.
