NOI SS 1229137.pdf

75F40120Q00107

Notice of Intent to Sole Source for

Elucidation of Antimicrobial Resistance Pharmacogenetic Relationships for Organisms and Drug/Drug Classes of Critical/Serious Concern to Advance Regulatory Science and

Public Health

The Food and Drug Administration (FDA), the Office of Acquisitions and Grants Services (OAGS) intends to inform the public that the FDA anticipates issuing an award to procure the development of an unambiguous, comprehensive database/repository model that can allow for mapping and classifying evidence of the relationship between molecular (genotype) mechanism of resistance and phenotypic resistance for clinically relevant human bacterial pathogens. The services needed shall capture existing knowledge about phenotypic resistance and molecular detection, to make the results of an in vitro diagnostic device “actionable” when reporting results in the same manner as current phenotypic 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. The Period of Performance includes a one-year Base Period.

In accordance with FAR part 6.302-1, Jones Microbiology Institute, Inc. (JMI Labs) is the only known responsible source who can provide the required services as no other source has been identified who can provide the requirements listed below.

The FDA intends to award a purchase order to Jones Microbiology Institute, Inc. (JMI Labs) located at 345 Beaver Kreek Center, North Liberty, IA 52317.

This notice is not a request for competitive quotes. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued within approximately seven (7) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Please email responses to Janae Hughes at janae.hughes@fda.hhs.gov. No phone calls will be accepted.

mailto:janae.hughes@fda.hhs.gov