Notice of Intent to Sole Source for Organisms and Drug/Drug Classes of Critical/Serious Concern to Advance Regulatory Science and Public Health

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Maryland
Level of Government: Federal
Category:
  • 11 - Nuclear Ordnance
Opps ID: NBD00159648152713324
Posted Date: Jul 30, 2020
Due Date: Aug 7, 2020
Solicitation No: 75F40120Q00107
Source: Members Only
Notice of Intent to Sole Source for Organisms and Drug/Drug Classes of Critical/Serious Concern to Advance Regulatory Science and Public Health
Active
Contract Opportunity
Notice ID
75F40120Q00107
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
FOOD AND DRUG ADMINISTRATION
Office
FDA OFFICE OF ACQ GRANT SVCS
General Information
  • Contract Opportunity Type: Presolicitation (Original)
  • All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
  • Original Published Date: Jul 30, 2020 03:52 pm EDT
  • Original Response Date: Aug 07, 2020 12:00 pm EDT
  • Inactive Policy: 15 days after response date
  • Original Inactive Date: Aug 22, 2020
  • Initiative:
    • None
Classification
  • Original Set Aside: Total Small Business Set-Aside (FAR 19.5)
  • Product Service Code: AZ11 - R&D- OTHER RESEARCH AND DEVELOPMENT (BASIC RESEARCH)
  • NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)
  • Place of Performance:
    Silver Spring , MD 20993
    USA
Description

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.

Attachments/Links
Contact Information
Contracting Office Address
  • 5630 FISHERS LANE HFA-500
  • ROCKVILLE , MD 20857
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Jul 30, 2020 03:52 pm EDTPresolicitation (Original)

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