Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)
ID: BAA-23-100-SOL-00004Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFOFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSEBARDA - ASPR / DAAPPO / BARDA DCMAWASHINGTON, DC, 20515, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; EXPERIMENTAL DEVELOPMENT (AN13)

Original Source

https://sam.gov/opp/65e6d7784edd4eb083840c3794dc8d47/view
Timeline
    Description

    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting proposals under the Broad Agency Announcement (BAA) BAA-23-100-SOL-00004 for advanced research and development of Medical Countermeasures (MCMs) aimed at addressing public health threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, as well as emerging infectious diseases and pandemic influenza. The initiative seeks to foster public-private partnerships to enhance the development and responsiveness of life-saving MCMs, emphasizing the importance of technological maturity, regulatory compliance, and manufacturing standards in the evaluation process. This opportunity is critical for strengthening national health security and improving preparedness for future public health emergencies, with an open submission period running until September 25, 2028, at 4:30 PM Eastern Time. Interested parties can direct inquiries to BARDA-BAA@hhs.gov for further information.

    Point(s) of Contact
    BARDA-BAA@hhs.gov
    BARDA-BAA@hhs.gov
    Files
    Title
    Posted
    Amendment_1_Changes_Table.pdf
    Amendment_1_Changes_Table.pdf
    The document details Amendment 1 (dated November 9, 2023) for the BARDA Broad Agency Announcement (BAA) BAA-23-100-SOL-00004, outlining significant updates across various sections concerning research and development opportunities. Key revisions include an updated overview of the application process, specific changes to proposal instructions, and adjustments in evaluation criteria related to past performance. Areas of interest have been updated, such as new requirements in medical countermeasures for burn and blast injuries, biothreat diagnostics, and COVID-19 therapeutics. Notably, Area of Interest #11 concerning COVID-19 immune assay development has been suspended. The updates aim to refine the submission process and enhance the alignment of projects with stated objectives, emphasizing BARDA's commitment to medical innovation and readiness. This amendment signifies the agency’s responsive approach to evolving public health challenges and the importance of adaptive measures in federal grant proposals.
    Amendment_2_Changes_Table.pdf
    This document outlines two amendments for the BARDA Broad Agency Announcement (BAA-23-100-SOL-00004). Amendment 1, issued on November 9, 2023, includes updates to various sections such as the overview of research opportunities, application processes, contract information, proposal instructions, and evaluation criteria. Noteworthy updates involve changes to Areas of Interest, including modifications to diagnostics related to influenza and biothreat agents, and the introduction of a new area on COVID-19 monoclonal antibody therapeutics for treatment. Amendment 2, released on December 22, 2023, suspends Area of Interest 9.4 for COVID-19 monoclonal antibody therapeutics. Additionally, it highlights the importance of the recent changes made to improve clarity and streamline submission processes for potential applicants in the medical countermeasures domain. The document serves as a vital resource for grant applicants and enhances the Department of Health and Human Services' efforts in improving public health responses. Overall, the amendments reflect a responsive and adaptive approach to evolving health threats and the need for timely updates in government-funded research.
    Amendment_2_Changes_Table.pdf
    Amendment_3_Changes_Table.pdf
    The document outlines a series of amendments to the BARDA BAA-23-100-SOL-00004, detailing updates across various Areas of Interest (AOIs). Amendment 3, dated March 29, 2024, includes significant revisions to AOI 3 concerning antimicrobial resistance, AOI 5 related to chemical medical countermeasures, and AOI 6 focusing on burn and blast trauma management. New areas have been introduced, such as advanced imaging technologies, while some areas have been suspended or updated, particularly in diagnostics and trauma management. Amendment 2 from December 22, 2023, suspended a specific AOI related to COVID-19 monoclonal antibody therapeutics. Amendment 1, issued on November 9, 2023, includes updates to various sections of the overview information, submission process, and proposal instructions, as well as adding to or updating other AOIs, including therapeutics related to infectious diseases. These amendments highlight the evolving focus of BARDA on addressing current public health threats, including antimicrobial resistance and trauma care, indicating a proactive approach to research and development in medical countermeasures. The document serves as an update for potential applicants in the federal grants and RFPs context, ensuring alignment with ongoing and emerging health challenges.
    Amendment_4_Changes_Table.pdf
    The document outlines a series of amendments to the BARDA BAA-23-100-SOL-00004, which focuses on the development of diagnostics and therapeutics for biological threats and emergencies. It details changes made across four amendments from November 2023 to May 2024. Key areas of interest (AOIs) include updates to diagnostic tests for filovirus, bacterial antimicrobial resistance, and influenza, as well as advancements in medical countermeasures for diverse threats such as antimicrobial resistance and traumatic injuries. Specific amendments include updated technology readiness level (TRL) requirements and the suspension of outdated guidelines related to COVID-19 monoclonal antibodies. Overall, these amendments aim to refine research priorities, enhance proposal instructions, and clarify application processes to ensure robust responses to public health threats. The document serves as a guide for stakeholders involved in federal grants and proposals, emphasizing the need for adaptive strategies in medical research and development.
    Amendment_5_Changes_Table.pdf
    The document outlines Amendment 5 of the BARDA Broad Agency Announcement (BAA-23-100-SOL-00004), detailing significant updates to various sections regarding development and technical objectives in medical countermeasures. Key revisions include updates to the Detection, Diagnostics, and Devices Infrastructure (DDDI) Division's language, enhancements to the Manufacturing Development Activities, and the inclusion of new attachments such as Supply Chain Risk Assessment and specific procurement guidelines for synthetic nucleic acids. Suspensions of several Areas of Interest (AOIs) related to needle-free technologies, COVID-19 therapeutics, and some diagnostics are noted. Additionally, various AOIs covering CBRN vaccines, antivirals, chemical countermeasures, and burn and blast medical countermeasures received updates. The amendments aim to enhance proposal evaluation criteria, emphasizing supply chain risk assessments and the importance of diagnostics, especially concerning biothreat agents and antimicrobial resistance. Overall, the amendment underscores BARDA's ongoing commitment to advancing research and development in critical health responses and improving contractor eligibility standards through structured updates and evaluations.
    BAA-23-100-SOL-00004 Amendment 1.pdf
    BAA-23-100-SOL-00004 Amendment 1.pdf
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Broad Agency Announcement (BAA) BAA-23-100-SOL-00004 to solicit proposals for advanced research and development (R&D) of medical countermeasures (MCMs) against various public health threats, including chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. The BAA aims to modernize and streamline the proposal process to enhance responsiveness and efficiency within its partnerships with private and public sectors. Eligible offerors include diverse organizations and academic institutions, emphasizing inclusion of historically marginalized groups. The submission process consists of three stages: preliminary market research discussions, detailed abstract submissions, and formal proposals, focusing on the required technological maturity and regulatory strategies for the proposed MCMs. The document outlines expectations regarding proposal handling, submission formats, and evaluation criteria, which include scientific relevance, technical merit, and capabilities of the offerors. BARDA emphasizes the need for robust partnerships to tackle health security issues effectively, and encourages participation through a TechWatch program to optimize alignment with its strategic objectives.
    BAA-23-100-SOL-00004 Amendment 2.pdf
    The Office of Biomedical Advanced Research and Development Authority (BARDA) issued the Broad Agency Announcement (BAA) BAA-23-100-SOL-00004 to solicit proposals for advanced research and development (R&D) of medical countermeasures (MCMs) against public health threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, emerging infectious diseases, and pandemic influenza. The BAA aims to enhance efficiency in partnering and responsiveness to the increasing demands for MCM development. It outlines eligible offerors, including private sector entities, academic institutions, and encourages participation from historically marginalized groups. Proposals must address predetermined Areas of Interest (AOIs) for MCMs, covering various aspects of development, regulatory approach, and manufacturing standards. The application process consists of three stages: initial inquiries, a Market Research Abstract submission, and a detailed proposal. Evaluations will consider scientific merit, relevancy, and the offeror's capabilities, with awards depending on proposal quality and available funding. The BAA supports a coordinated governmental effort for health security, emphasizing public-private partnerships to tackle urgent health threats efficiently.
    BAA-23-100-SOL-00004 Amendment 2.pdf
    BARDA BAA-23-100-SOL-00004.pdf
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued the Broad Agency Announcement (BAA) BAA-23-100-SOL-00004, dated September 26, 2023, to solicit proposals for advanced research and development (R&D) of Medical Countermeasures (MCMs) addressing Chemical, Biological, Radiological, Nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. This BAA aims to accelerate partnerships, enhance responsiveness, and modernize the award process for developing life-saving MCMs critical for national health security. Eligible offerors, which include private organizations, government laboratories, and academic institutions, may submit proposals through a three-stage process: preliminary inquiries and market research, followed by detailed proposals based on favorable assessments. Technological maturity, regulatory compliance, and manufacturing standards are pivotal to the evaluation criteria. The announcement emphasizes BARDA's commitment to improving public health preparedness, leveraging public-private partnerships to expedite the development of MCMs, and addressing gaps highlighted during public health emergencies like COVID-19. Interested parties are encouraged to monitor updates on platforms such as SAM.gov and Grants.gov, with an open submission period running until September 25, 2028.
    BARDA BAA-23-100-SOL-00004.pdf
    BARDA FY23 Modernized BAA Solicitation - Amendment 3.pdf
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued the Broad Agency Announcement (BAA) BAA-23-100-SOL-00004 to solicit proposals for advanced research and development (R&D) of Medical Countermeasures (MCMs) against public health threats, including CBRN agents and emerging infectious diseases. The BAA focuses on fostering innovation and public-private partnerships to expedite MCM development and regulatory approval. Eligible participants include private sector organizations, government labs, and academic institutions, with encouragement for diverse representations, such as minority institutions and small businesses. The solicitation outlines a three-stage application process: Stage 1 involves pre-submission calls for initial guidance, Stage 2 requires submission of a Quad Chart and Market Research Abstract, and Stage 3 entails full proposal submission. It emphasizes the importance of compliance with regulations and reporting requirements, and it allows various award types, including contracts and grants. The deadline for submissions is September 25, 2028. This initiative reflects BARDA's commitment to enhancing national preparedness for health crises and aligns with strategic plans for health security and biodefense.
    BARDA FY23 Modernized BAA Solicitation - Amendment 4.pdf
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued a Broad Agency Announcement (BAA-23-100-SOL-00004) to solicit proposals for the advanced research and development of Medical Countermeasures (MCMs) addressing threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, along with pandemic influenza and emerging infectious diseases. This BAA aims to catalyze innovation and accelerate the development process, particularly in light of lessons learned from the COVID-19 pandemic. Eligible offerors include private sector organizations, government laboratories, academic institutions, and various small business concerns. The submission process occurs in three stages: initial inquiries, submission of a Quad Chart and Market Research Abstract, and a formal proposal for selected candidates. Multiple awards are anticipated based on the scientific merit of the proposals and available funding. Key areas of interest span developments in CBRN vaccines, antivirals, diagnostics, and therapeutics. The objective is to enhance the knowledge and technological maturity of potential MCMs while ensuring that regulatory standards and product quality are maintained throughout the development process. By leveraging public-private partnerships, BARDA seeks to improve national preparedness against public health emergencies.
    BARDA FY23 Modernized BAA Solicitation - Amendment 5.pdf
    The Office of Biomedical Advanced Research and Development Authority (BARDA) issued Broad Agency Announcement (BAA) BAA-23-100-SOL-00004 to solicit proposals for advanced research and development (R&D) of Medical Countermeasures (MCMs) targeting chemical, biological, radiological, and nuclear threats as well as emerging infectious diseases. This BAA is intended to accelerate the development of MCMs through innovative public-private partnerships, particularly in light of lessons learned from the COVID-19 pandemic. The announcement outlines several areas of interest for R&D, including vaccines, therapeutics, diagnostics, and manufacturing processes, with an emphasis on technological maturity and the ability to achieve FDA approvals. The application process is structured in three stages: pre-submission calls for guidance, submission of a Quad Chart and Market Research Abstract, and a full proposal invitation based on favorable assessment of Stage 2 submissions. Awards may be in various contract forms, with multiple awards anticipated based on scientific merit and funding availability. Overall, this BAA reflects BARDA’s commitment to enhancing national health security through effective MCM development against existing and emergent public health threats.
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