SPECIAL NOTICE
99 -- Evaluation of the Relationship Between Phenotypic and Molecular Measures
- Notice Date
- 6/25/2021 6:32:45 AM
- Notice Type
- Special Notice
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- REQ1243130
- Response Due
- 7/2/2021 1:00:00 PM
- Archive Date
- 08/01/2021
- Point of Contact
- Todd Johnston
- E-Mail Address
-
todd.johnston@fda.hhs.gov
(todd.johnston@fda.hhs.gov)
- Description
- Sole Source Award Notice:�Jones Microbiology Institute, Inc. The purpose of this procurement is to develop an unambiguous, comprehensive model that can allow for the mapping and classifying the evidence of the relationship between molecular (genotype) mechanism of resistance and the resistance phenotype for clinically relevant human bacterial pathogens. There is a major need to capture existing knowledge about the resistance phenotype (accumulated through many years and form clinical drug studies) and the molecular detection to make the results of an in vitro diagnostic device �actionable� when reporting results in the same manner as a current phenotypic-based antimicrobial susceptibility test methods; this can only be accomplished by a �living� database, one that FDA, sponsors, and clinicians can use for regulatory and clinical practice. A notice of intent is issued a sole source to�Jones Microbiology Institute, Inc.�with authority of the FAR Part�12.603 (c)(2)(i), this is a combined synopsis/solicitation for commercial items prepared in accordance with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. and If there are no responses have received in response to the posting. Therefore, it was determined that no other sources are capable and willing to develop an unambiguous, comprehensive model that can allow for the mapping and classifying the evidence of the relationship between molecular (genotype) mechanism of resistance and the resistance phenotype for clinically relevant human bacterial pathogens�to�Center for Devices and Radiological Health/Office of In Vitro Diagnostics and Radiological Health. Estimated Value: $85,000.00 for a base year. In accordance with FAR Part 13.106-1(b), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available. For the reasons stated above, Jones Microbiology Institute, Inc. is the only source considered in this procurement.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/3208119b3eac4fd4867f5021c2188ff9/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06042969-F 20210627/210625230115 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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