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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 07, 2013 FBO #4213
SOURCES SOUGHT

B -- Multi-Disciplinary Research Efforts

Notice Date
6/5/2013
 
Notice Type
Sources Sought
 
NAICS
541990 — All Other Professional, Scientific, and Technical Services
 
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
1119148
 
Archive Date
6/15/2013
 
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
MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses to provide multi-disciplinary research efforts in nationally recognized research programs. The associated North American Industry Classification System (NAICS) Code is‐ 541990 All Other Professional, Scientific and Technical Services; Small Business Size Standard is $14.0 million. Part I: General Information Background: The U.S. Department of Health and Human Services, Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Systems Biology, Innovative Safety and Technologies Branch has a requirement for collaboration on multi-disciplinary research efforts in nationally recognized research programs in support of FDA's mission. Bladder cancer is the fourth most common cancer in the United States and cigarette smoking is the leading risk factor for the development of bladder cancer. Recent epidemiological studies have strengthened the association of cigarette smoking with bladder cancer. Objective: The FDA's hypothesis is that microRNA (miRNA) may be a reliable biomarker to identify patients with bladder cancer and potentially distinguish between bladder cancer that occurs in smokers vs. NEVER smokers. Since some miRNAs are expressed in a tissue-specific manner, they may also be more specific than existing biomarkers of bladder cancer. It is hypothesized that miRNA expression patterns found in blood and/or urine could mirror the miRNA changes in bladder tumors and be potentially used as noninvasive biomarkers for bladder cancer diagnosis. Part II: Work Requirements Scope: The main research aspect is to determine if biofluids miRNA can serve as early molecular biomarkers for tobacco smoking-induced bladder cancer. The researcher shall hold a Ph.D. degree in Physiology and Biophysics or Oncology. Contractor activities shall include, but not be limited to: • Isolation of RNA from human tissues, analysis of Next-Generation Sequencing data, use of bioinformatics tools to elucidate the mechanisms and confirm miRNA biomarkers using Real-Time Polymerase Chain Reaction (qRT-PCR). • Development of circulating miRNA biomarkers for smoking-related bladder cancer, analysis of miRNA profiling in body fluid by qRT-PCR array. Deliverables and Milestones: The following are deliverables/milestones for the base period: 1. RNA extraction: Extraction of serum, urine and tissue samples for miRNA profiling analysis. An estimated total of one-hundred and twenty (120) RNA samples, including miRNA fraction, shall be isolated by Trizol method. The quality and quantity of the RNA shall be assessed by Nanodrop with data results submitted to the Contracting Officer's Representative (COR) electronically in spreadsheet format. Due Date: Within 30 business days from start of the period of performance. 2. microRNA profiling: An estimated sixty (60) tissue RNA samples shall be provided to external vendors for Next-Generation sequencing analyze. An estimated sixty (60) urinary microRNA samples shall be analyzed using qRT-PCR array. The microRNA expression data shall be submitted to the COR electronically in spreadsheet format to include threshold cycles (Ct) values. Due Date: Within 60 business days from date of milestone 1 completion. 3. Processing and storage of miRNA-seq results. The estimated sixty (60) sample Next-Generation sequencing data shall be uploaded to ArrayTrack. Upon completion, the COR shall be notified in order to verify the data input into ArrayTrack. Due Date: Within 60 business days from date of milestone 2 completion. 4. Analysis of miRNA-seq results. Once the data is uploaded to ArrayTrack, comparisons between the cancer, an estimated thirty (30) samples, and control, an estimated thirty (30) samples shall be made to identify miRNA changes that associated with bladder cancer. Contractor shall provide a complete list, electronically to the COR, of all miRNA checked for changes. Due Date: Within 90 business days from date of milestone 3 completion. 5. Confirmation of miRNA biomarkers. Once the list of biomarkers has been identified from Next-Generation sequencing and/or qRT-PCR array, secondary confirmation of the results shall be conducted. Specifically, qRT-PCR single reaction confirmation of the biomarker changes shall be conducted for existing samples. miRNA targets and the related biological pathway shall be predicted using different computational algorithms. A final results report shall be submitted to the COR. Due Date: Within 120 business days from date of milestone 4 completion. The contractor shall use the same technical approach as the base period to provide similar deliverables/milestones in the option period. The sample type may change, i.e. to human lung RNA. Period of Performance: Base year: July 1, 2013 through June 30, 2014 Option Year1: July 1, 2014 through June 30, 2015 Place of Performance: U.S. Food and Drug Administration National Center for Toxicological Research (NCTR) 3900 NCTR Road, Bldg 5B (Laboratory) Jefferson, AR 72079 Security and Privacy: It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contract personnel will not divulge or release information or data developed or obtained with performance of this contract, unless made public by FDA or upon written approval by NCTR. The Contractor shall complete the following steps for badging/access to the NCTR Facility: Step 1: Complete the Office of Personnel Management Electronic Questionnaire for Investigations Processing Initiation (e-QIP) form which will be provided by the COR. Step 2: When completed, the form shall be e-mailed to the COR. Step 3: Within 24 hours, the contractor will be contacted by an FDA Security Specialist with instructions on granting access to the appropriate e-QIP Web pages for completion of background investigation forms. Step 4: Once the contractor completes the online forms, they will be prompted to print out signature pages. These signature pages shall be brought to the Regulatory Compliance and Risk Management Office in Building 50 when fingerprinting is scheduled. Step 5: Upon arriving at NCTR, the contractor shall complete the computer-based New Employee Safety Orientation Program. When the orientation program is completed, an e-mail is generated to the Security Specialist. Step 6: The Contractor shall present two forms of acceptable identification in accordance with the Homeland Security Presidential Directive 12 (at least one form of ID must be a photo ID). Step 7: The Contractor will be escorted by the COR until their fingerprint results return with a favorable designation [the timeframe varies depending on the workload of the FDA Security Office (usually 2 to 4 weeks). At that time, a permanent badge is requested. Step 8: The Contractor will not obtain a computer network account until a favorable fingerprint is received. Contractor Conformance with Applicable Laws, Regulations, Polices and Standards: The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, polices and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). These can be found at or through Federal CIO Council website at : http://www.cio.gov. HHS documents are found at : http://www.cdc.gov. List of Government Furnished Property: - Samples - Real-time qPCR Instrument - Nanodrop Spectrophotometer - Lab computer with Internet access - The contractor will be provided with a Personal Identification Verification (PIV) Card for both the physical (building) and logical (computer) access to FDA facilities and information systems. Although the Government will provide the Contractor with the items, the Contractor is responsible for accurate analysis results. The COR shall be notified immediately in the event of equipment failure or inaccuracy. All items will remain the property of the Government and shall be returned in the same condition as received upon project completion. Part III: Instructions to Prospective Respondents Responses to this sources sought shall unequivocally demonstrate that respondent has the capability, education, publications and experience to perform the 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, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Three (3) years of past performance information for the service of same or substantially similar projects, to include date of services, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (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; • Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing; • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Although this is not a request for quote, informational pricing is encouraged; • The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. 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 14, 2013 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT‐320, Jefferson, AR 72079‐9502 or email crystal.mccoskey@fda.hhs.gov. Reference #1119148 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open 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 combined synopsis/solicitation (No. 1119148) may be published via 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).
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1119148/listing.html)
 
Record
SN03081315-W 20130607/130606002501-ae8700fa95f35a889b96163a6e4bc151 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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