Public Health Industrial Base Capabilities and Capacities: Anti-Microbials

Background
The HHS Defense Production Act (DPA) Title III Program, under the Department of Health and Human Services (HHS), aims to enhance domestic production capabilities for essential health resources, particularly anti-microbials.

This initiative is part of a broader mission to protect the civilian population from health threats, including chemical, biological, radiological, and nuclear agents. The program seeks to identify gaps in the marketplace that can be addressed through HHS's delegated Title III authorities, following the Presidential Determination No. 2024-03 signed on December 27, 2023.

Work Details
The RFI requests information on domestic production capabilities related to a list of specific anti-microbials essential for national defense. Key products include:
- Amoxicillin
- Ampicillin
- Azithromycin
- Cefepime
- Ceftazidime
- Ceftriaxone
- Doxycycline
- Penicillin G
- Piperacillin/Tazobactam
- Trimethoprim/Sulfamethoxazole
- Vancomycin
- Amikacin
- Amphotericin B
- Ceftazidime – Avibactam
- Ciprofloxacin HCl
- Clindamycin
- Daptomycin
- Fluconazole
- Imipenem
- Linezolid
- Levofloxacin
- Meropenem
- Metronidazole
- Micafungin
- Moxifloxacin HCl
- Omadacycline
- Rifampin
- Voriconazole
- Tigecycline
- Tobramycin Ophthalmic solution 0.3%. The RFI seeks detailed responses regarding U.S. regulatory holdings (e.g., DMF), production scales (pilot or commercial), manufacturing processes and equipment used (including Manufacture Readiness Level), operating capacities at facilities (warm-base and surge capacity), and any existing customer bases that sustain current manufacturing capabilities.

Place of Performance
The focus is on domestic sources within the United States; however, it also considers companies from Canada, the United Kingdom, or Australia that meet the expanded definition of 'domestic source' as per the DPA.