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/412a79a3c8554b9b8e4a2915c5647928/view
Timeline
    Description

    The Department of Health and Human Services (HHS) is seeking industry partners to provide information regarding domestic production capabilities related to anti-microbials under the Defense Production Act Title III Program. The objective of this Request for Information (RFI) is to identify gaps in the Public Health Industrial Base (PHIB) and enhance national defense resources by focusing on the production of essential medicines and medical countermeasures sourced domestically. Respondents are encouraged to share insights on their manufacturing processes, regulatory compliance, and infrastructure, as well as past supply chain disruptions and investment needs, with responses due by January 6, 2025, at 10 AM ET. Interested parties should submit their responses to Chris Newell at IBMSC-Submissions@hhs.gov.

    Point(s) of Contact
    Chris Newell
    IBMSC-Submissions@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.
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    Public Health Industrial Base Capabilities and Capacities: Anti-Microbials
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