SOURCES SOUGHT
65 -- Reagents for Human miicroRNA PCR Array
- Notice Date
- 6/11/2014
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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
- FDA1134659
- Archive Date
- 7/3/2014
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 (NCTR) Office of Research (OR) requirement to procure reagents for human microRNA PCR Array. This is a Sources Sought Notice to determine the availability and capability of Small Business Manufacturers or Small Businesses capable of supplying a U.S. made product of a small business manufacturer or producer. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. General Introduction The OR requires reagents for miRNA for assessing microRNA (miRNA) expression changes in serum and plasma using quantitative Real-Time PCR (qRT-PCR) Array platform. Ultimately, the expression changes of the various miRNAs will be used as biomarkers of exposure and harm to tobacco products. A total of 120 samples (RNA from serum and plasma) will be analyzed so that the OR can compare the effect of tobacco on the circulating miRNA. Ultimately, the profiling of the various miRNAs will be used as biomarkers of exposure and harm to tobacco products. Background Tobacco use is the single largest preventable cause of death in the United States. Biomarkers would enhance the evaluation of new tobacco products with claims of reduced health risks. The limited number of biomarkers available today has yet to offer a comprehensive measure of total toxicant exposure or valid scientific prediction of cancer or other adverse health outcomes. Therefore, there is a need to develop new biomarkers of both exposure and harm from tobacco constituents. Scope Omics technologies have shown promise of not only discovering new biomarkers of harm to various types of products (e.g., drugs and general chemicals), but also providing more sensitive indicators of cellular injury. Various small molecule changes in a target tissue or cell often occur before clear phenotypic signs of injury are observed. For tobacco products, omics analyses should be able to detect subtle changes in cellular function in response to the many toxicants in tobacco smoke. The study for this requirement is being conducted for human biofluids with or without smoking history. The qRT-PCR approach will be used to directly assess miRNAs expression level in the human serum and plasma. The major goal is to identify biomarkers of harm by comparing the miRNA changes for the different study populations. Technical Requirements • The Contractor shall provide reagents and plates for miRNA profiling for 120 samples. • Shall be panels of miScript Primer Assays to detect miRNAs in serum and plasma • Shall be human genes (miRNA) • Shall be 384-well block used on ViiA 7 Real Time PCR instrument • Shall include spike-in controls for normalization of fluorescence and controls for cDNA synthesis • Shall provide supplies for at least 125 cDNA synthesis reactions • Shall provide gene-table for the 384-well plate design • Shall avoid pre-amplification step to decrease another variability Period of Performance Thirty (30) days after receipt of contract award The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offeror is capable of providing the required supplies identified above. Additionally, provide Business name, 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. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement. The government is not responsible for locating or securing any information, not identified in the response. Interested parties 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 June 18, 2014 by 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1134659. 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 Federal Business Opportunities. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1134659/listing.html)
- Place of Performance
- Address: National Center for Toxicological Research, 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN03392520-W 20140613/140611235633-e597c70dc83c9eb63606af70e8fa2fc4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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