FDA-Presolicitation Notice-1223694.doc

FDA-Pre-Solicitation Notice-1223694 BAA – Breakpoint Studies

Part 1 – Description

The purpose of this pre-solicitation notice is to provide additional context and awareness of the FDA’s scientific need identified in the Broad Agency Announcement (FDABAA-20-00123), which is available on www.beta.sam.gov. This is not a request for proposal. The purpose of this pre-solicitation notice is to inform interested entities of a solicitation opportunity through the FDA BAA Program and to outline a more detailed program need.

Part 2 - Purpose FDA is interested in advancing regulatory science to facilitate the development of novel antibiotics against carbapenemase-resistant strains. As one may anticipate some uncertainties in a clinical trial specifically targeting carbapenemase-resistant strains, such as prior antibiotic treatment or concomitant antibiotic treatment, data from animal models may provide informative data. Validating the predictive ability of animal models of ventilator-associated pneumonia against susceptible and resistant strains would increase the utility of animal models in predicting a human clinical response.

Objectives:

FDA has identified specific funding sources for this area of interest and will prioritize White Papers submitted in response to the FDA Broad Agency Announcement by the 2 March 2020 deadline (preferably sooner; (see link https://www.fda.gov/media/133769/download) that provide a rationale for why data to support updating of breakpoints for a particular drug-bacteria combination is a high priority, propose to synthesize or obtain relevant microbiologic data, propose to utilize relevant human pharmacokinetic data and animal model studies to conduct probability of target attainment analyses, incorporate any clinical response data available in the public literature or other sources to justify any proposal for updating of breakpoints based on the research findings. Proposals to obtain data for older antibacterial drugs are encouraged.

Part 3 – Instructions for Response Responses: All interested parties should go to https://beta.sam.gov/opp/1c2db86ed5b2440a9ef5b4fc2d5a5c09/view

The contact information for the Contract Specialist is the following:

Christine Russman U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Road Beltsville, MD 20705 Christine.Russman@fda.hhs.gov 2 | Page