Public Health Industrial Base Capabilities and Capacities: Anti-Microbials
ID: 75A50121CType: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFOFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSEDEPT OF HEALTH AND HUMAN SERVICESELLICOTT CITY, MD, 21042, USA

NAICS

Medicinal and Botanical Manufacturing (325411)

PSC

DRUGS AND BIOLOGICALS (6505)
Timeline
    Description

    The Department of Health and Human Services (HHS) is seeking industry partners to provide information on domestic production capabilities related to anti-microbials as part of the Defense Production Act Title III Program. The objective is to gather insights that will help identify and address gaps in the marketplace, thereby enhancing the production and supply of essential medicines critical for public health and national defense. This initiative is particularly important in the context of responding to threats such as chemical, biological, radiological, and nuclear (CBRN) agents and infectious diseases. Interested parties are encouraged to submit their responses to Chris Newell at IBMSC-Submissions@hhs.gov, with all submissions treated as confidential to inform future funding and policy directions under the DPA Title III framework.

    Point(s) of Contact
    Files
    Title
    Posted
    The HHS Defense Production Act Title III Program has issued a Request for Information (RFI) to gather insights into the domestic production capabilities related to anti-microbials within the Public Health Industrial Base (PHIB). This initiative aims to address gaps in the marketplace and explore ways to enhance production capacities for essential medicines deemed critical for national defense. The document outlines the context of the RFI, highlighting the role of the Department of Health and Human Services in managing the production and distribution of health resources, particularly in response to threats such as CBRN agents and infectious diseases. Key details include a specific request for data on the production of various anti-microbials, including their active pharmaceutical ingredients (APIs) and finished dosage forms. Manufacturers are asked to provide technical and operational information, including U.S. regulatory approvals, manufacturing scales, processes, equipment used, supply chain vulnerabilities, and considerations for production expansion. This RFI emphasizes the need for maintaining robust domestic capabilities to ensure a timely response to public health needs while reinforcing the government's commitment to improving the U.S. industrial base for essential medical resources. Responses will remain confidential and aim to inform future funding and policy directions under the DPA Title III framework.
    Lifecycle
    Similar Opportunities
    BARDA Antibiotic for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia or Bloodstream Infections Caused by Drug-Resistant Bacteria or Biothreat Pathogens
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is issuing a Sources Sought Notice to gather information on antibiotics in development for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI) caused by drug-resistant bacteria. This initiative aims to enhance understanding of the antibiotic development landscape and prepare for future procurement to strengthen U.S. emergency response capabilities against CBRN threats and antibiotic resistance. BARDA is particularly interested in details regarding antibiotic candidates, including their clinical indications, development status, manufacturing plans, and commercialization strategies, with submissions due by November 29, 2025. Interested parties should contact Erin Greninger at erin.greninger@hhs.gov or Audrey Glover at audrey.glover@hhs.gov for further information.
    Rapid Pandemic Influenza and Emergency Infectious Disease Vaccine Development and Response Capability
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response (BARDA), is seeking proposals for the "Rapid Pandemic Influenza and Emergency Infectious Disease Vaccine Development and Response Capability" through a Special Notice. The objective of this procurement is to establish a long-term partnership focused on developing a flexible and rapid response capability for vaccine development against pandemic influenza and other priority pathogens, initially emphasizing influenza mRNA vaccine development. This initiative is critical for enhancing the nation's preparedness and response to emerging infectious diseases, ensuring readiness to pivot quickly in the face of public health threats. Interested parties can access the full Request for Project Proposals and additional consortium information at www.rrpv.org, and inquiries can be directed to Rebecca Harmon at rebecca.harmon@ati.org.
    Procurement of storage and stability services to maintain BARDA’s supply of Live Attenuated Influenza Virus Master and Working Seed Lots
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services (HHS), specifically the Biomedical Advanced Research and Development Authority (BARDA), is seeking to procure storage and stability services for maintaining its supply of Live Attenuated Influenza Virus Master and Working Seed Lots. The procurement aims to ensure that these seed lots remain within specification for use in clinical trials or commercial drug production, which is critical for pandemic preparedness. The contract will be awarded on a sole source basis to MedImmune, LLC, which has been performing these services under a previous indefinite-delivery, indefinite-quantity contract since 2016. Interested parties may submit capability statements or quotations for consideration, and inquiries can be directed to Deitra Williams at deitra.williams@hhs.gov or Corneilus Stephens at corneilus.stephens@hhs.gov.
    Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Partnership Solicitation
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting proposals for the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. This initiative aims to establish partnerships with organizations that provide decentralized healthcare services, such as retail pharmacies and telemedicine, to enhance clinical trial capabilities and support medical countermeasure development during public health emergencies. The program is critical for building a sustainable decentralized clinical research infrastructure, enabling efficient recruitment and participation in clinical studies within community settings. Proposals are due by December 9, 2024, at 12:00 PM EST, with an anticipated funding amount of up to $100 million distributed over a five-year performance period. Interested parties can direct inquiries to LaunchOfficeContracting@hhs.gov.
    Diagnostic Test Development and Production for Emergency Response
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking contractors for the development and production of diagnostic tests aimed at enhancing emergency response capabilities for public health threats. The procurement involves a range of tasks, including the rapid development and validation of Nucleic Acid Amplification Tests for selected pathogens, regulatory submissions for Emergency Use Authorization (EUA) or 510(k) approval, and the manufacturing of tests to meet outbreak demands. This initiative is critical for bolstering the national laboratory system's readiness and efficiency in addressing public health emergencies. Proposals are due by December 2, 2024, with a maximum contract value of $148 million and a minimum order of $10,000. Interested parties can contact Shayna Connery at xvj9@cdc.gov or (404) 498-0715 for further information.
    White Paper: Current State of Personal Protective Equipment Procurement by Make PPE in America Act Covered Agencies
    Active
    Health And Human Services, Department Of
    Special Notice: HEALTH AND HUMAN SERVICES, DEPARTMENT OF is seeking procurement of personal protective equipment (PPE) items in compliance with the Make PPE in America Act. This white paper provides insight into the PPE requirements, specifications, and anticipated demand of the covered agencies, including the U.S. Department of Homeland Security, U.S. Department of Health and Human Services, and the U.S. Department of Veterans Affairs. The Federal Government plans to gather feedback from industry through "industry convening" events to strengthen the domestic PPE supply chain and encourage innovation.
    Marburg virus (MARV) and Sudan virus (SUDV) Vaccines
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Biomedical Advanced Research and Development Authority (BARDA), is seeking information from potential partners regarding the development of vaccines for the Marburg virus (MARV) and Sudan virus (SUDV). This Sources Sought Notice (SSN) aims to gather insights on vaccine candidates, particularly those that are in or beyond Phase 2 clinical trials, to enhance BARDA's understanding of the current marketplace for these critical medical countermeasures. The development of effective vaccines against MARV and SUDV is vital for preparing for potential public health crises stemming from emerging infectious diseases. Interested parties are encouraged to submit concise responses, limited to ten pages, by November 18, 2024, and can direct inquiries to primary contact Yifan Yang at yifan.yang@hhs.gov or secondary contact Greg Smith at greg.smith1@hhs.gov.
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the 2026 NIAID DMID Omnibus Broad Agency Announcement (BAA) aimed at advancing medical countermeasures against infectious diseases. This opportunity encompasses two primary research areas: the development of therapeutics, vaccines, and diagnostics for antimicrobial-resistant pathogens, and the creation of direct acting antivirals targeting viruses with pandemic potential. The initiative is critical for enhancing public health responses to emerging infectious threats and includes funding estimates of up to $8.5 million for Research Area 001 and $20 million for Research Area 002, with proposals due to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) platform, starting around November 22, 2024. For further inquiries, interested parties may contact Swee L. Teo at teosl@niaid.nih.gov or Brian Madgey at brian.madgey@nih.gov.
    BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Office of Biomedical Advanced Research and Development Authority (BARDA), is soliciting proposals under the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which focuses on innovative medical countermeasures (MCMs) to address public health emergencies. The initiative invites submissions across various Areas of Interest (AOIs), including but not limited to vaccine development, diagnostics, and therapeutics for infectious diseases and chemical threats. This program is crucial for enhancing the nation's preparedness against health security threats, particularly in light of recent global health challenges. Interested parties must register on SAM.gov and adhere to specific submission deadlines, with multiple awards anticipated based on scientific merit and funding availability. For further inquiries, respondents can contact Aarati Singal or Lara Emmons at DRIVeAcquisitions@hhs.gov.
    RRPV Solicitation Summary: NextGen Oral Formulation Vaccines for COVID-19
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting proposals for the "NextGen Oral Formulation Vaccines for COVID-19" under the Rapid Response Partnership Vehicle (RRPV) Consortium. The objective of this initiative is to advance oral vaccine platforms and technologies into a proof-of-concept Phase 1 clinical trial, enhancing understanding of their potential and improving COVID-19 solutions to bolster preparedness against future health security threats. This effort is critical in the ongoing response to the COVID-19 pandemic and aims to develop innovative vaccine solutions. Interested parties should note that the proposal submission deadline has been extended to November 15, 2024, and can contact Rebecca Harmon at rebecca.harmon@ati.org for further information.