SOURCES SOUGHT
A -- Micro Ribonucleic Acid Sequencing Validation and Confirmation Services - Sources Sought
- Notice Date
- 5/6/2014
- Notice Type
- Sources Sought
- 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
- 1131336
- Archive Date
- 6/5/2014
- 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
- Sources Sought 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) Sequencing Validation and Confirmation Services inclusive of up to two (2) one- year option periods. 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. Part I: General Information (Introduction/Background/Scope): The FDA's NCTR requires miRNA Sequencing Validation and Confirmation Services for profiles and expressions of miRNAs specific to carcinogen exposure, for use in identifying carcinogens biomarkers. The library construction, miRNA sequencing, and data mapping Recent studies demonstrate that miRNAs play an important role in chemical carcinogenesis and are involved in the early stage of tumor development, suggesting that miRNAs could be useful biomarkers for the detection of potential carcinogens. Our previous studies show that there are changes in expression for a large number of miRNAs following carcinogen exposure and that these expression changes occur in tissue and chemical specific manners. Many of the miRNAs deregulated by carcinogens are involved in the regulation of genes that are important for the key pathways of chemical carcinogenesis, including xenobiotic metabolism, DNA repair, apoptosis, cell proliferation, tumor suppression, cell transformation, and tumor progression. The previous aforementioned studies generated miRNA sequenced data using an Illumina Hi Sequencing Platform. To ensure future data is scientifically comparable with data from the previous studies, identical platforms across studies are necessary to the integrity of the sequencing quality, as well as the downstream analysis. The resulting miRNA data will be utilized to evaluate miRNA profiles and changes in miRNA expression following carcinogen exposure, thereby resulting in potential biomarkers for identifying carcoinogens. Part II: Work Requirements A. Technical Requirements At a minimum the Contractor shall provide: I. Library Construction • 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. • 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 the samples shall a yield of no less than 20ng. • 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 a bioanalyzer. II. miRNA Sequencing • The barcoded libraries shall be sequenced utilizing the Illumina HiSeq2500 or above platform for single end 50 base pair reads. • Each pool of 48 different barcoded samples shall be evenly uploaded onto 4 flowcell lanes. III. Data Collection, Management, Analysis and Processing (CMAP) • 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. • 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. Though this is not a request for quote, informational pricing for the service is encouraged. Schedule of Items (See Attached) Period of Performance The Government will provide 100 samples within 90-days of contract issuance with deliverables due within 9- 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 May 21, 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 sondea.blair@fda.hhs.gov. Reference FDA 1131336. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1131336/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, National Center for Toxicological Research, Jefferson Laboratory, 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03358245-W 20140508/140506234746-c76061049a91764c0d21f1e27d875ccc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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