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FBO DAILY ISSUE OF MAY 17, 2009 FBO #2729
SOURCES SOUGHT

A -- Nanoscale Multiplex Real-time PCR Detection of Pathogens in Blood

Notice Date
5/15/2009
 
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
HHS-FDA-SS-09-003
 
Archive Date
6/5/2009
 
Point of Contact
Tara R. Hobson, Phone: 3018279691, Doreen Williams , Phone: 301-827-3366
 
E-Mail Address
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
Response Date: May 21 at 4:30pm local time via e-mail to Contracting Specialist Contracting Office Address: Food and Drug Administration, Tara Hobson, Contract Specialist Description: Nanoscale Multiplex Real-time PCR Detection of Pathogens in Blood This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and woman-owned small businesses) to develop and test a platform that can perform real-time PCR on a nucleic acid sample extracted from blood testing for the presence of 10 or more pathogens simultaneously in a volume less than 25ul. The platform must be optimized to achieve the greatest degree of sensitivity possible while achieving the highest possible level of multiplicity. This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA). No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future a official solicitation is released, there is no guarantee that sources responding to this will be included on the source list No telephone inquiries will be accepted. Objectives: NAT assays targeted to specific blood borne pathogens are comprised of oligonucleotide primer pairs and a set of reaction conditions that have been optimized to give the most efficient amplification of the target. Such NAT assays have been developed by scientists in the Division of Emerging and Transfusion Transmitted Diseases for at least ten different blood borne pathogens individually. The contractor will take these primer pairs and associated reaction conditions and combine them into a Nanoscale Multiplex platform that can perform real-time PCR with at least 10 reactions simultaneously. The platform will also incorporate internal standards to provide quantitative and QA/QC for each test. The FDA investigators will provide nucleic acid samples extracted from the various pathogens as well as nucleic acid extracted from blood samples that have been spiked with pathogens. The contractor will use these samples to evaluate and optimize the performance of the Nanoscale Multiplex platform. The contractor will report the data on limits of detection of each pathogen when assayed on the Nanoscale Multiplex platform. The FDA anticipates a labor hour type contract with a base year with four one year options. The NAICS code for this is 541711. Interested parties shall provide the following: Part A. Capabilities and Technical Experience – Provide a capability statement describing how your company would develop and test a platform that can perform real-time PCR on a nucleic acid sample extracted from blood testing for the presence of 10 or more pathogens simultaneously in a volume less than 25ul. The platform must be optimized to achieve the greatest degree of sensitivity possible while achieving the highest possible level of multiplicity. Part B. Size of Business- Please provide your business size and submit copies of any documentation such as letters or certificates to indicate the firm’s status. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of Nanoscale Multiplex Real-Time PCR Detection of Pathogens in Blood. Part D. Cost Estimate - Provide a cost estimate for the services (i.e. hourly rates, hours/days) and the number of hours in the performance of activities to develop and test a platform that can perform real-time PCR on a nucleic acid sample extracted from blood testing for the presence of 10 or more pathogens simultaneously in a volume less than 25ul. Part E. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of activities to develop and test a platform that can perform real-time PCR on a nucleic acid sample extracted from blood testing for the presence of 10 or more pathogens simultaneously in a volume less than 25ul. Part F. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation on Subcontracting. Responses shall be: identified with the Sources Sought number ; no more than five (5) pages in length; not submit marketing materials; submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. Respond to this Sources Sought Notice by email to: Tara.Hobson@fda.hhs.gov
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/HHS-FDA-SS-09-003/listing.html)
 
Record
SN01819583-W 20090517/090516161217-e10667f1e447dc193515d1911338fbaa (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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