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)

Original Source

https://sam.gov/opp/a28ed348ae5645d8ac5874a89c20cb88/view
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 data that will enhance the understanding of the Public Health Industrial Base (PHIB) and identify gaps in the marketplace that can be addressed through Title III authorities, which incentivize domestic production. This initiative is crucial for ensuring a reliable supply of essential health resources necessary for national defense and public health, particularly in light of the recent Presidential Determination 2024-03. Interested parties are invited to submit their responses by January 22, 2025, at 10 AM ET, to Chris Newell at IBMSC-Submissions@hhs.gov or Christopher.Newell@hhs.gov.

    Point(s) of Contact
    Chris Newell
    IBMSC-Submissions@hhs.gov
    Chris Newell
    Christopher.Newell@hhs.gov
    Files
    Title
    Posted
    HHS DPA T3 RFI_Antimicrobials - Clean copy 11-7-24 (002).docx
    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.
    HHS DPA T3 RFI_Antimicrobials - Clean copy 12-3-24 (002).docx
    The Department of Health and Human Services (HHS) is conducting a Request for Information (RFI) under the Defense Production Act Title III Program to gather insights on domestic production capabilities related to anti-microbials. This RFI aims to identify gaps in the Public Health Industrial Base (PHIB) and enhance national defense resources, following Presidential Determination No. 2024-03. The initiative emphasizes the production of essential medicines and medical countermeasures, focusing solely on domestic sources as defined by the Defense Production Act. Responding entities are encouraged to provide information regarding their production capabilities, regulatory compliance, manufacturing processes, and existing infrastructure related to a specified list of anti-microbials. Additionally, insights on past supply chain disruptions, modernization prospects, and investment requirements are sought. The information gathered will inform potential future investments and facilitate the enhancement of domestic supply chains in a critical sector for public health. Responses to this RFI are confidential and must adhere to specified formatting guidelines, with a submission deadline of January 6th, 2025.
    HHS DPA T3 RFI_Antimicrobials - Updated POC 1-22-25.docx
    The HHS Defense Production Act Title III Program has issued a Request for Information (RFI) targeting domestic production capabilities related to anti-microbials identified in Presidential Determination 2024-03, signed on December 27, 2023. This RFI aims to gather data on the Public Health Industrial Base (PHIB) to enhance the production and supply of essential health resources crucial for national defense. The HHS Department seeks to identify gaps in the market that could be addressed through Title III authorities, which allow for incentivizing domestic production capabilities. The RFI requests detailed information from industry partners regarding their ability to produce various key components and active pharmaceutical ingredients (APIs) listed in the document, along with insights on manufacturing processes, regulatory holdings, production scales, and capacity challenges. The initiative focuses on maintaining a viable domestic supplier network for anti-microbials and aims to support new or modernized facilities for large-scale manufacturing. By encouraging industry feedback, the HHS DPA Title III Program intends to ensure the reliability and growth of the domestic health industrial base to meet evolving demands for anti-microbials in public health and national defense.
    Lifecycle
    Title
    Type
    Public Health Industrial Base Capabilities and Capacities: Anti-Microbials
    Currently viewing
    Sources Sought
    Similar Opportunities
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the 2026 DMID Omnibus Broad Agency Announcement (BAA) aimed at advancing research and development of medical countermeasures against antimicrobial-resistant pathogens and viruses with pandemic potential. The BAA encompasses two primary research areas: Research Area 001 focuses on developing therapeutics, vaccines, and diagnostics for antimicrobial-resistant bacterial and fungal pathogens, while Research Area 002 targets the creation of Direct Acting Antivirals for viruses of pandemic potential. This initiative is critical for addressing public health challenges related to infectious diseases, with an estimated funding of $28.5 million available for awards in fiscal year 2026. Proposals for Research Area 001 are due by February 21, 2025, and for Research Area 002 by January 21, 2025; interested parties can contact Swee L. Teo at teosl@niaid.nih.gov or Brian Madgey at brian.madgey@nih.gov for further information.
    Access to Outpatient Longitudinal Drug Utilization Data
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified small businesses to provide access to outpatient longitudinal drug utilization data through a Sources Sought notice. The primary objective is to acquire existing, HIPAA-compliant data resources that will enhance drug safety evaluations, support post-market surveillance, and inform regulatory decisions, rather than developing new databases. This initiative is crucial for monitoring medication utilization trends, particularly in areas such as opioid surveillance, and aims to improve public health outcomes through rigorous analyses of drug safety data. Interested firms must submit their responses by January 23, 2025, including their business size status and DUNS number, and can direct inquiries to Telisha Wilson at telisha.wilson@fda.hhs.gov.
    Milliflex Rapid 2.0
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking responses for a Sources Sought Notice regarding the acquisition of the Milliflex Rapid 2.0 microbial detection system. This procurement aims to enhance quality control testing for bioburden contamination in pharmaceutical products, necessitating a system that is compatible with the existing Milliflex Oasis filtration pump currently in use. The initiative is critical for ensuring compliance with quality control standards in pharmaceutical manufacturing, thereby bolstering the FDA's capabilities in evaluating rapid microbial detection methods. Interested vendors must submit their responses by January 30, 2024, at 12:00 PM ET, directed to Contract Specialist Iris Johnson at Iris.Johnson1@fda.hhs.gov and Contracting Officer Maria Finan at Linda.Finan@fda.hhs.gov.
    2025 HHS Industry Summit
    Health And Human Services, Department Of
    The Department of Health and Human Services (HHS) is hosting its inaugural Industry Summit on February 10-11, 2025, at the National Institute of Health’s Natcher Conference Center in Bethesda, Maryland. This free hybrid event aims to connect industry stakeholders, HHS acquisition personnel, and academic institutions interested in federal procurement opportunities, featuring specialized tracks in Training, Innovation, and Procurement. Attendees will have the chance to network with HHS officials, learn about upcoming procurement opportunities for Fiscal Year 2025, and participate in matchmaking sessions for one-on-one meetings. Registration is open online, and for further inquiries, interested parties can contact the HHS Industry Liaison at IndustryLiaison@hhs.gov.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services to support the development of drug products. The objective of this procurement is to ensure the delivery of high-quality formulated drug products for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic development. This opportunity encompasses a wide range of services, including formulation development, manufacturing under current Good Manufacturing Practices (cGMP), and necessary testing to meet regulatory standards. Proposals are due by February 3, 2025, with a contract period extending from September 30, 2025, to July 31, 2031, and a maximum funding amount of $49,885,703. Interested parties can contact Michelle Cecilia at michelle.cecilia@nih.gov or Valerie Whipple at valerie.whipple@nih.gov for further information.
    In Vitro Assessments of Antimicrobial Activity
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals for the In Vitro Assessments of Antimicrobial Activity (IVAAA) program through solicitation RFP 75N93024R00024. This initiative aims to support in vitro testing to evaluate the therapeutic potential of compounds against over 270 infectious agents, facilitating the development of vaccines, therapeutics, and diagnostics for infectious diseases. The program is critical for enhancing public health preparedness and response capabilities, particularly in addressing emerging health threats such as bioterrorism and infectious diseases. Proposals are due by March 10, 2025, with a funding range of $2,500 to $15 million available through January 14, 2033. Interested parties can direct inquiries to Alexander Beraud at alexander.beraud@nih.gov or Brian Madgey at brian.madgey@nih.gov.
    CIVICs Data Management and Coordinating Center (DMCC)
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide services for the renewal of the CIVICs Data Management and Coordinating Center (DMCC). The DMCC will support the CIVICs program by managing data, conducting analyses, and facilitating communication and coordination among various stakeholders, with a focus on advancing influenza vaccine research and development. This initiative is critical for enhancing the immunogenicity and durability of seasonal influenza vaccines and involves the operation of a scalable data management system, maintenance of public and private portals, and comprehensive program coordination. Interested parties must submit their tailored Capability Statements by 3:00 PM (Eastern Time) on January 23, 2025, to Maribel Miranda at maribel.miranda@nih.gov, with the anticipated contract award date around July 2026.
    Pre-Solicitation FY 2025 CDC OS Emerging Public Health Priorities BAA
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is preparing to issue a Fiscal Year 2025 Broad Agency Announcement (BAA) for Applied Research aimed at addressing Emerging Public Health Priorities. This initiative seeks innovative research proposals in various areas, including infectious disease surveillance, wastewater surveillance, and substance use disorder recovery, to enhance public health strategies and responses to emerging threats. The BAA will be open for full and open competition, with a tentative issuance date of December 30, 2024, and a due date for concept papers set for January 30, 2025. Interested contractors must ensure they are registered in the System for Award Management (SAM) to be eligible for award, and further details will be available on SAM.gov.
    BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting innovative research proposals under the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which is open until October 18, 2027. The initiative aims to address high-risk biomedical challenges related to public health emergencies, with specific Areas of Interest (AOIs) including drug repurposing, at-home diagnostics, and vaccine development. This program is crucial for enhancing the nation’s preparedness against emerging infectious diseases and other health threats, emphasizing the importance of innovative solutions in medical countermeasures. Interested parties must have active registration with SAM.gov and are encouraged to schedule pre-submission calls; key deadlines for abstract submissions vary by AOI, with multiple awards anticipated based on scientific merit and alignment with program goals.
    Office-Wide Innovative Solutions Opening for Proactive Health Office (PHO)
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting innovative research proposals aimed at enhancing health outcomes via the Proactive Health Office (PHO). The initiative focuses on developing solutions that prioritize disease prevention, early intervention, and scalable wellness-promoting behaviors, moving away from traditional reactive healthcare models. This opportunity is significant for entities capable of delivering transformative health solutions, with proposals evaluated based on scientific merit and relevance, and funding potentially awarded through Other Transactions or Cooperative Agreements. Interested parties must submit a mandatory solution summary by March 3, 2029, and can direct inquiries to the designated contact via the provided submission platforms.