BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)
ID: DRIVeEZBAA22100SOL00003Type: 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)
Timeline
    Description

    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.

    Point(s) of Contact
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    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 001 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which introduces new Areas of Interest (AOIs) related to medical countermeasures (MCMs) against various health security threats. The amendment details specific research areas, including drug repurposing, home diagnostic technologies, digital health tools, and host-directed therapeutics. Key objectives involve requesting abstract submissions for projects focusing on effective responses to chemical threats, innovative at-home health testing platforms, and development of digital tools for health monitoring. There are also calls for advancements in therapies aimed at mitigating the impacts of infectious diseases, particularly those that allow for efficient patient management beyond conventional treatments. Priority will be placed on proposals that demonstrate significant innovation and effectiveness while ensuring equitable access. The submission deadline varies by AOI, and pre-submission consultation is strongly encouraged for interested parties. This amendment reflects BARDA's commitment to advancing public health preparedness by fostering innovative solutions that address current and emerging health threats.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 002 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, focusing on the new Area of Interest (AOI #24: REPAIR) related to medical countermeasures for Acute Radiation Syndrome (ARS). This initiative aims to repurpose existing FDA-approved therapeutics for treating various injuries from ionizing radiation exposure, including cell death, vascular injury, bleeding, and ischemia. Abstract submissions are invited from entities with applicable therapeutics that have shown efficacy in relevant clinical trials and can be made available quickly in emergency scenarios. The closing date for submissions is set for 12:00 PM ET on February 28, 2023, and applicants must have active registration on SAM to be eligible. The amendment also corrects an administrative error regarding the evaluation of abstract submissions, clarifying that decisions will be based solely on content. Multiple awards are anticipated depending on the merit of submissions and funding availability. Successful applicants will be required to share de-identified data to further research and development in the field. This opportunity reflects BARDA's commitment to enhancing preparedness for radiological and nuclear events through advanced therapeutics.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) is issuing Amendment 003 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, focusing on a revised Area of Interest (AOI #19): Healing Lungs. This amendment invites submissions for innovative technologies to address acute respiratory distress syndrome (ARDS), a critical condition characterized by severe lung inflammation and compromised gas exchange. The key objectives involve developing alternative methods for oxygen delivery and enhancing the safety and accessibility of veno-venous extracorporeal membrane oxygenation (VV-ECMO). CRDIVE seeks solutions including new oxygen carriers that maintain high oxygen saturation and minimize toxicity, and technologies that improve ECMO's anticoagulation management and integration of system components. Notable requirements for proposals include demonstrated efficacy in animal models, compliance with technology readiness standards, and no reliance on mechanical ventilation. Proposals must include a detailed project description, preliminary data, and regulatory strategies, with submissions due by February 3, 2023. This initiative underscores BARDA's commitment to advancing medical technologies critical for managing severe ARDS, particularly in resource-intensive and high-stakes healthcare environments.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 004 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003 to extend the closing date for Area of Interest (AOI) #21: Vaccines on Demand to February 28, 2023, at 12:00 PM ET. This opportunity is open to all responsible entities with an active registration on sam.gov, with a strong recommendation for potential respondents to schedule a pre-submission call for guidance. Multiple awards are anticipated based on the scientific merit of submissions and program priorities, subject to available funding. Moreover, awarded respondents must share any collected data to further the field, while also being encouraged to commercialize their technologies in compliance with federal standards. The submission process aligns with standard EZ-BAA procedures outlined in prior documents. This initiative reflects the government's commitment to advancing vaccine development through structured collaboration with the private sector.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) issued Amendment 005 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, primarily to pause research under Area of Interest (AOI) #15, known as ReDIRECT. This amendment allows all responsible sources eligible under the EZ-BAA to submit abstracts, provided their registrations on https://sam.gov are current at the time of submission. The closing date for abstract submissions for AOI #15 is set for February 15, 2023. Multiple awards are expected, depending on the submissions' scientific merit, alignment with program goals, and available funding, which may change at the government's discretion. Award recipients must share de-identified data to further the field and are encouraged to commercialize their findings, maintaining compliance with relevant regulations. The amendment's structure aligns with standard submission processes, and interested vendors are urged to engage with the program early to ensure alignment and successful submission. Overall, this amendment reflects the government's ongoing commitment to advancing biomedical research while ensuring responsible management of public funding.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 006 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, focusing on updating closing dates and revising Areas of Interest (AOIs) related to healthcare innovations. This includes AOIs #16 "Lab at Home," #17 "Digital MCMs," and #19 "Healing Lungs." The main objective of AOI #16 is to seek proposals for technologies enabling on-demand detection of multiple health biomarkers at the point of need, avoiding traditional lab testing delays. Applicants are encouraged to propose novel platforms that can perform quantitative measurements in home or low-skill settings, focusing on non-invasive sample collection. The amendment emphasizes clinical relevance, comparison to laboratory standards, and multiple biomarker detection, while prioritizing submissions from U.S.-based developers. Closing dates for abstract submissions are set for February 6, 2024, for AOIs #16 and #17, and June 30, 2023, for AOI #19. Limited funding and multiple expected awards highlight the competitive nature of this initiative. The document reiterates that awarded respondents must share de-identified data for research purposes, ensuring alignment with BARDA’s objective to enhance public health through innovative diagnostics.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 007 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, specifically updating the closing date for Area of Interest (AOI) #24: REPAIR. This amendment invites all responsible sources to submit research abstracts, contingent upon their active registration at https://sam.gov. The new submission deadline is set for June 1, 2023, at 12:00 PM ET. BARDA anticipates multiple awards based on the merit of submissions and available funding. Respondents are encouraged to conduct pre-submission calls and must agree to share de-identified data collected with the government, maintaining alignment with BARDA’s mission. The application process adheres to the standard submission and review protocols outlined in the EZ-BAA. This initiative aims to foster innovative research in the field, highlighting the importance of commercialization and collaboration with government entities to advance biomedical solutions.
    The Amendment 008 to the Easy Broad Agency Announcement (EZ-BAA) by the Office of Biomedical Advanced Research and Development Authority (BARDA) introduces a new Area of Interest (AOI #25) focusing on developing a nucleic acid-based platform known as FASTx for antiviral therapies. BARDA aims to improve readiness for emerging viral threats through adaptable therapeutic platforms that can quickly respond to diverse viral families. Submissions should target key features including delivery, efficacy, manufacturability, and safety, while providing evidence of mechanism and proof of concept efficacy. In addition, the Amendment updates the review processes for submissions, clarifying expectations for proposed projects. The closing date for abstract submissions for AOI #25 is set for October 15, 2024. The Amendment is open to all qualified respondents, with a strong encouragement for interested vendors to engage in pre-submission consultations. Multiple funding awards are anticipated, depending on the merit of submissions and available funding, aligning with BARDA’s mission to address public health emergencies caused by viral diseases.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 009 to reopen Area of Interest (AOI) #21: Vaccines on Demand under the EZ-BAA BAA-22-100-SOL-00003. This initiative aims to enhance vaccine production capabilities in response to emerging biological threats and public health emergencies. BARDA seeks submissions for technologies that enable decentralized, on-demand manufacturing of next-generation COVID-19 vaccines, addressing inefficiencies observed during the pandemic, such as bottlenecks in large-scale manufacturing and lengthy regulatory processes. Key criteria for proposals include easy-to-source inputs, minimal release testing, in-line formulation capabilities, and compact logistical footprints. The goal is to produce over 1,000 doses within a week of receiving a pathogen's genetic information. Eligible respondents must be registered on SAM.gov and are encouraged to participate in pre-submission calls. Multiple awards are anticipated based on scientific merit and alignment with funding availability. This solicitation represents a critical step towards improving the U.S. pandemic preparedness posture by fostering innovation in vaccine manufacturing technologies while ensuring that any data collected through awarded contracts is shared with BARDA for further government advancement.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 010 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, focusing on Area of Interest (AOI) #24: Repurposing and Advancing Innovations Against Rad/Nuc Threats (REPAIR). This amendment revises the AOI to seek abstracts for medical countermeasures (MCMs) that treat Acute Radiation Syndrome (ARS) resulting from ionizing radiation exposure. Solutions should ideally be FDA-approved or in advanced clinical stages, with mechanisms targeting cell death, vascular injury, bleeding, coagulation disorders, or ischemia. The program aims to collect proof-of-concept data for potential treatments and requires candidates to demonstrate safety profiles and rationales for effectiveness post-exposure. The submission deadline for this AOI is December 1, 2023, 12:00 PM ET. Awards will be based on scientific merit and funding availability, with expectations for awarded projects to share de-identified data. This initiative highlights BARDA's commitment to enhancing preparedness for radiological events by developing effective therapeutic options for emergency medical response.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 011 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which outlines updates to specific Areas of Interest (AOIs). This amendment announces the closure of AOI #18 (Host-Directed Therapeutics) and AOI #23 (Host-Based Diagnostics). Additionally, it updates the closing date for AOI #19 (Healing Lungs) to October 4, 2023. Eligible entities must be registered on the System for Award Management (SAM) to have their abstract submissions considered. The amendment encourages interested vendors to reach out for a pre-submission call and includes specific contact information for the respective AOIs. Multiple awards are anticipated for qualifying submissions based on program priorities and funding availability. Respondents who secure contracts will be required to share de-identified data with BARDA to further knowledge and advancement in the field, aligning with BARDA’s mission. This streamlined process allows for targeted innovation in biomedical research while ensuring compliance with federal standards governing data use and funding. Overall, this amendment is aimed at refining the focus of BARDA’s research initiatives and enhancing collaborative efforts in biomedical advancement.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) released Amendment 012 for its Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, focusing on research proposals in various Areas of Interest (AOIs) related to health diagnostics. This amendment updates submission deadlines for AOIs #16 (Lab at Home), #17 (Digital MCMs), and #19 (Healing Lungs), and introduces a new AOI #26 (Agnostic Diagnostic). The primary goal for AOI #16 is to develop technologies for the on-demand detection of multiple health markers at home, improving timely healthcare access. Proposals must demonstrate innovation in technological capabilities and feasibility for effective use by untrained individuals in non-invasive settings. AOI #26 seeks advances in metagenomic next-generation sequencing for viral pathogendetection. Interested parties must submit abstracts by specified deadlines and are encouraged to register on the government website. Awarded proposals are expected to comply with data-sharing requirements to further enhance public health diagnostics. Funding availability is variable, emphasizing the need for timely engagement with BARDA before submission.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 013 to pause its Area of Interest (AOI) #20, titled "DRIVe Forward," as part of the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003. This amendment is open to all eligible respondents who comply with EZ-BAA requirements, specifically noting that abstract submissions from entities lacking an active registration at https://sam.gov will be rejected. Interested vendors are encouraged to schedule pre-submission calls before abstract submission. The revised closing date for submissions is September 15, 2023, at 12:00 PM ET, with plans to reopen the AOI later in the year. Multiple awards will be granted based on scientific merit and alignment with AOI goals, subject to funding availability. Awardees must share de-identified data collected under government funding to advance research in the field, with an emphasis on commercialization of technologies. Overall, the amendment reflects BARDA's commitment to fostering innovation while adhering to federal standards and regulations.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 014 to its Easy Broad Agency Announcement (EZ-BAA) concerning Area of Interest (AOI) #21: Vaccines on Demand. This amendment announces a pause in submissions for this AOI, effective immediately. Respondents must ensure they have an active registration at SAM.gov to have their abstracts reviewed and are encouraged to schedule pre-submission calls for guidance. The closing date for abstract submissions was set for September 28, 2023; however, submissions for AOI #21 will reopen at a later date. Multiple awards are anticipated based on program priorities and submission merit, though funding amounts may vary. Notably, awarded respondents are required to share any de-identified data collected during their research with BARDA to further advance knowledge in the field. This amendment likens to previous procedures outlined in the EZ-BAA, stressing the importance of alignment with government regulations and BARDA's mission to enhance public health through scientific innovation.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 015 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, focusing on two Areas of Interest (AOIs): ReBoot and FASTx. The amendment updates closing dates and revises these AOIs to enhance research on antiviral therapeutics targeting filoviruses and developing flexible therapeutic platforms for emerging viral threats. AOI #22: ReBoot encourages submissions for candidate antivirals previously advanced in clinical trials but effective against filoviruses, stipulating criteria such as demonstrated efficacy against these viruses and acceptable safety profiles. AOI #25: FASTx seeks proposals for adaptable therapeutic platforms capable of addressing diverse viral outbreaks, with an emphasis on nucleic acid-based approaches and specific targets like filoviruses and coronaviruses. Abstract submissions must ensure they meet the outlined requirements and are due by March 1, 2024. The amendment anticipates multiple awards contingent on scientific merit and funding availability. Interested parties are urged to engage in pre-submission discussions with BARDA to refine their proposals. This initiative exemplifies the government's strategy to bolster public health preparedness through targeted research funding and innovation in therapeutic solutions.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 016 to its Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which pauses Area of Interest (AOI) #24: REPAIR. This amendment invites responsible entities to submit research abstracts adhering to the EZ-BAA guidelines. Eligible respondents must register with SAM.gov, and non-compliance will result in rejection of submissions. The revised closing date for abstract submissions for AOI #24 is set for November 1, 2023, with indications that it may reopen in the future. BARDA expects multiple awards based on abstract merit, alignment with AOI goals, and funding availability. Respondents must share de-identified data to advance knowledge, emphasizing the commercialization of their technologies. The application process aligns with existing EZ-BAA procedures, reinforcing BARDA's commitment to scientific innovation while adhering to federal regulations and standards. This effort underscores a strategy to engage high-quality research early in the fiscal year, balancing project priorities and resource allocation.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 017 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, specifically reopening and revising Area of Interest (AOI) #20: DRIVe Forward. This initiative aims to address the ongoing threat of infectious diseases and public health emergencies by soliciting abstract submissions for innovative products, technologies, and capabilities that can enhance vaccine efficacy, develop portable viral diagnostic platforms, and create computational models for rapid development of medical countermeasures (MCMs) during outbreaks. Respondents must have active registrations on the SAM.gov platform for their submissions to be considered. The closing date for submissions is March 15, 2024. Multiple awards are expected, contingent on scientific merit and available funding. Importantly, awarded respondents must share de-identified data to advance public health knowledge, aligning with BARDA’s mission. The document underscores the importance of early engagement with DRIVe to encourage high-quality submissions as it aims to foster high-risk, high-reward innovations that fill existing gaps in current public health approaches.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 018 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003. This amendment updates and revises Areas of Interest (AOIs) related to biomedical research, notably AOI #16: Lab at Home, which seeks proposals for innovative technologies enabling simultaneous detection of multiple health markers in non-invasive settings. The aim is to improve healthcare access and efficiency by allowing point-of-need testing, thus alleviating delays associated with traditional laboratory methods. The amendment pauses AOI #17: Digital MCMs and updates the closing dates for AOIs #16 and #19: Healing Lungs. Eligible respondents must be registered with the System for Award Management (SAM) and are encouraged to engage with BARDA before submitting proposals. Funding for selected projects will be based on their scientific merit, alignment with AOI goals, and budgetary considerations, while all awarded projects must share de-identified data to advance research in the field. This solicitation signifies the government's focus on fostering innovative health solutions that enhance rapid diagnostics and patient care.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #019 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, reopening and revising Area of Interest #15: ReDIRECT (Repurposing Drugs In Response to Chemical Threats). This opportunity aims to solicit abstract submissions for the repurposing of FDA-approved or late-stage investigational therapeutics as medical countermeasures (MCMs) against chemical threats like cyanide, opioids, and nerve agents. Candidates for this initiative must demonstrate a known safety profile and potential efficacy as MCMs, particularly for diverse populations, including children and pregnant women. The document encourages submissions targeting treatments for various chemical agents that can be quickly administered during mass-casualty situations. Proposals should be distinct from conventional uses and require an active FDA Investigational New Drug application. The closing date for abstract submissions is May 3, 2024. The amendment emphasizes the importance of pre-submission consultations and clarifies that multiple awards may be granted depending on the merit of submissions and available funding. Overall, the amendment reflects the government’s commitment to enhancing public health readiness against chemical threats while promoting innovative therapeutic solutions.
    Amendment #020 to EZBAA-22-100-SOL-00003 by the Office of Biomedical Advanced Research and Development Authority (BARDA) primarily pauses Area of Interest (AOI) #26: Agnostic Diagnostic and introduces new topics under AOI #20: DRIVe Forward. This amendment seeks innovative proposals that enhance vaccine efficacy, develop portable diagnostic platforms for remote settings, create computational models for medical countermeasure deployment, and explore detection methods for prion diseases. The objective is to foster high-risk, high-reward technologies that can significantly improve public health responses to emerging infectious diseases and pandemics. Eligible respondents are required to submit abstracts, emphasizing scientific and impact attributes. The closing date for submissions for AOI #20 is April 15, 2024, while AOI #26 closes on January 15, 2024. Multiple awards will be granted based on scientific merit and program fit, with a focus on commercialization and sharing de-identified data to advance knowledge within the field. This initiative underscores BARDA's commitment to addressing biomedical threats through innovative solutions.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) issued Amendment #021 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003), focusing on Area of Interest (AOI) #27: Stopping Secondary Spread (S3). This AOI seeks proposals for pharmaceutical medical countermeasures aimed at interrupting the transmission of respiratory viruses, particularly influenza and SARS-CoV-2. Current strategies mainly utilize non-pharmaceutical approaches, necessitating the development of innovative transmission-blocking agents that can reduce virus spread and prevent infections in exposed individuals. The ideal products should have a direct delivery route to the upper respiratory tract, immediate activity, minimal side effects, and ideally be available over-the-counter. Abstract submissions will be evaluated based on alignment with the Target Product Profile and must demonstrate compelling preclinical evidence in relevant animal models. Proposals focusing on vaccine candidates, non-pharmaceutical interventions, or using murine models are deemed out of scope. This announcement is open to all responsible sources registered on SAM.gov, with submissions closing at 12:00 pm ET on May 3, 2024. Multiple awards are anticipated based on the scientific merit of submissions and available funding. Concurrently, awarded entities must share collected data with BARDA, reinforcing collaboration towards advancing field knowledge on respiratory virus transmission.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #022 to its Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003). The primary purpose of this amendment is twofold: it pauses Area of Interest (AOI) #27 on "Stopping Secondary Spread" and removes Topic #4 from AOI #20 "DRIVe Forward," specifically regarding portable diagnostics for prion diseases. Instead, DRIVe is currently seeking abstract submissions for innovative proposals aimed at addressing emerging infectious diseases and enhancing preparedness capabilities. The new topics under AOI #20 include: enhancing vaccine efficacy for vulnerable populations, creating mobile viral diagnostic platforms for remote settings, and developing computational models for optimal medical countermeasure deployment during outbreaks. All submissions must meet outlined scientific and impact criteria, and interested parties should engage in a pre-submission call. The closing date for abstract submissions is April 15, 2024, with multiple awards anticipated based on the merit and alignment of proposals with program goals. This structured approach reflects BARDA's mission to advance public health emergency responses through high-risk, high-reward innovations.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has amended its Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) to reopen Area of Interest (AOI) #26, focusing on "Agnostic Diagnostic" research. This amendment encourages submission of abstracts for innovative diagnostic solutions, with a submission deadline of May 15, 2024, at 12:00 PM ET. All interested entities must be registered with sam.gov to qualify for review. The amendment anticipates multiple awards based on the scientific merit of submissions and funding availability. Respondents must adhere to established submission processes, and any data collected under awarded contracts will be shared with BARDA for further advancement of the field. Interested vendors are advised to engage in pre-submission consultations to enhance the quality of their proposals, reflecting a structured approach to seeking innovative solutions in biomedical research and development.
    The document presents Amendment #024 to the Easy Broad Agency Announcement EZBAA-22-100-SOL-00003 issued by the Office of Biomedical Advanced Research and Development Authority (BARDA). The amendment updates the closing dates for two Areas of Interest (AOIs): ReBooT (AOI #22) and FASTx (AOI #25) to May 31, 2024, at 12:00 PM ET. It invites eligible respondents to submit research abstracts, highlighting the necessity for active registration on SAM.gov. Pre-submission calls with relevant contacts are encouraged for interested vendors to clarify project objectives. The amendment anticipates multiple award selections based on scientific merit and alignment with program goals, noting that funding is limited and subject to government discretion. Awarded respondents must share de-identified data collected during funded projects with BARDA to further public knowledge and advance the field. Overall, the document emphasizes BARDA's strategic approach to secure innovative solutions while fostering collaboration and data transparency in the biomedical research sector.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #025 for the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) to reopen and revise Area of Interest (AOI) #24: Repurposing and Advancing Innovations Against Rad/Nuc Threats (REPAIR). This initiative aims to develop medical countermeasures (MCM) effective for treating Acute Radiation Syndrome (ARS) resulting from ionizing radiation exposure. BARDA seeks abstracts that propose repurposing FDA-approved or clinical-stage therapeutics through label expansion, addressing mechanisms of action (MOA) related to cell death, vascular injury, bleeding/coagulation, or ischemia. Eligible respondents must hold FDA-approved drugs or those in Phase 2 trials with established safety profiles. The submission deadline for abstracts is May 15, 2024, and multiple awards may be granted based on merit and funding availability. Successful respondents will be required to share de-identified data as part of the collaboration. This initiative emphasizes the rapid availability and deployment of effective treatments in emergency scenarios involving radiation exposure.
    Amendment #026 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) by the Office of Biomedical Advanced Research and Development Authority (BARDA) updates the submission deadlines for two Areas of Interest (AOI): #16 (Lab at Home) and #19 (Healing Lungs). The amendment specifies that the closing date for abstract submissions for these AOIs is set for 12:00 PM ET on May 15, 2024. Eligible respondents must have active registration with the System for Award Management (SAM) for submissions to be reviewed. The amendment anticipates multiple awards depending on scientific merit and funding availability, encouraging interested vendors to contact program representatives ahead of submission. Following the established EZ-BAA process, awardees must share any collected de-identified data with BARDA to support the advancement of knowledge in these fields. This document reflects the government’s ongoing commitment to foster research and technological innovation in biomedical science while ensuring compliance with regulations and promoting data sharing for public benefit.
    Amendment #027 of the Easy Broad Agency Announcement EZBAA-22-100-SOL-00003 outlines significant updates from the Office of Biomedical Advanced Research and Development Authority (BARDA) under the Division of Research, Innovation & Ventures (DRIVe). It reopens Area of Interest #20: DRIVe Forward and modifies its topic areas by removing two specific topics related to viral diagnostics and computational models while introducing a new area focusing on next-generation tourniquets for civilian use. The key objectives are to enhance vaccine efficacy, particularly for vulnerable populations, and to develop user-friendly tourniquets that improve civilian response in traumatic injury situations. The submission process requires interested parties to schedule a pre-submission call to discuss their technology and must comply with specific eligibility and submission criteria outlined in the EZ-BAA. Abstracts are due by May 31, 2024, with multiple awards anticipated based on merit and funding availability. The initiative aims to promote high-risk, high-reward innovations to strengthen public health preparedness and response strategies in anticipation of emerging infectious diseases and health emergencies.
    Amendment #028 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) from the Office of Biomedical Advanced Research and Development Authority (BARDA) updates key areas of interest for medical countermeasures (MCMs) research. It extends submission deadlines for AOI #15 (ReDIRECT) and AOI #26 (Agnostic Diagnostic), and reopens AOI #17 (Digital MCMs), which focuses on innovative computational technologies, including AI, to develop MCMs against health security threats such as CBRN events and pandemics. Proposals must demonstrate innovation, feasibility, user accessibility, and equity for underserved populations. Non-responsive submissions include incremental improvements and internal infrastructure projects without R&D components. Aiming for multiple awards, the initiative seeks abstracts while encouraging pre-submission calls for guidance. Funding levels may vary at the government’s discretion, and awarded respondents must share de-identified data to foster further research. The amendment underscores BARDA's commitment to advancing health security through innovative research and its collaborative approach with interested parties in refining health response technologies.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #029 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003), focusing on significant updates to its Areas of Interest (AOIs). Notably, AOI #16: Lab at Home is paused, while the closing date for AOI #19: Healing Lungs is extended. The Healing Lungs initiative targets innovative solutions for patients with acute respiratory distress syndrome (ARDS), emphasizing the development of non-extracorporeal membrane oxygenation methods and enhancements to veno-venous extracorporeal membrane oxygenation (VV-ECMO) technologies. Funding is available for technologies that can maintain oxygen saturation at 95% or higher and improve safety and accessibility in ECMO procedures. The amendment outlines the submission process, encouraging interested parties to schedule pre-submission calls. Multiple awards are expected based on scientific merit and alignment with program goals. Awardees must share relevant data and may commercialize their technology, adhering to federal regulations. This document encapsulates the strategic focus of the government on advancing medical technologies for severe lung conditions through collaborative research and innovation.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #030 to its Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003), introducing a new Area of Interest (AOI) focused on "Influenza Vaccine Innovation" while pausing the previously available "Agnostic Diagnostic" AOI. The new AOI aims to stimulate research in innovative influenza vaccines that can effectively mitigate the impact of seasonal and pandemic influenza. Specifically, it emphasizes the development of vaccines that can confer early immunity, reduce transmission, and remain viable during public health emergencies. Key focus areas include vaccine innovations that can be deployed before, at the onset of, or during a pandemic, incorporating advanced delivery methods such as oral or nasal routes, and enhancing vaccine formulations for greater stability and effectiveness. Proposals must demonstrate protection in animal models and show superiority in immune responses compared to existing seasonal vaccines. Funding availability is contingent on scientific merit and program priorities, with submission deadlines for proposals falling on January 20, 2025, for AOI #28 and September 30, 2024, for AOI #26. Overall, this Amendment reflects BARDA's commitment to advancing public health preparedness through innovative vaccine approaches.
    The document is an amendment to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) by the Office of Biomedical Advanced Research and Development Authority (BARDA), specifically the Division of Research, Innovation & Ventures (DRIVe). This amendment reopens Area of Interest (AOI) #24, named RePAIR, inviting submissions for research proposals. All responsible entities are eligible to respond, given they have an active registration with SAM.gov at the time of submission. The deadline for abstract submissions is 12:00 PM ET on November 27, 2024, with multiple awards anticipated based on program priorities and funding availability. The submission process mirrors existing guidelines outlined in the EZ-BAA, and awarded respondents will need to share collected de-identified data for further advancement in the field, aligning with federal regulations. This call for proposals signifies an effort to bolster biomedical research and innovation while ensuring data sharing for broader governmental usage.
    The Amendment #032 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) issued by the Office of Biomedical Advanced Research and Development Authority (BARDA) focuses on updates concerning two Areas of Interest (AOIs) in biomedical research. Specifically, it extends the closing date for AOI #19: Healing Lungs to 12:00 PM ET on February 28, 2025, while pausing AOI #17: Digital Medical Countermeasures (MCMs) effective October 31, 2024. The announcement invites submissions from all responsible sources compliant with the registration requirements on www.sam.gov. It emphasizes the importance of pre-submission consultations and the necessity for applicants to share collected de-identified data with BARDA upon contract award. The anticipated funding is contingent upon program priorities and scientific merit, reinforcing the need for innovative submissions. As part of its mission, BARDA encourages commercialization of technologies developed under these projects. This document serves as a notification of procedural updates aimed at enhancing biomedical research opportunities while ensuring compliance with federal regulations and standards.
    The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #033 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003). This amendment reopens Area of Interest (AOI) #15, named ReDIRECT, effective November 1, 2024, and removes prior requirements for a Rough Order of Magnitude (ROM) regarding project pricing and submission processes. Eligible respondents must be registered with the System for Award Management (SAM) and are encouraged to conduct pre-submission calls to clarify project intentions. The deadline for abstract submissions for AOI #15 is set for March 31, 2025, at 12:00 PM ET. Multiple funding awards are expected, contingent upon the merit of submissions and available funding, which may fluctuate at the government's discretion. Award recipients must commit to sharing de-identified data collected during the project, in alignment with BARDA's mission. Overall, this announcement signifies BARDA's ongoing initiative to engage responsible vendors in biomedical research and development.
    The U.S. Department of Health and Human Services (HHS), through the Office of Biomedical Advanced Research and Development Authority (BARDA), has announced the EZ-Broad Agency Announcement (EZ-BAA) aimed at soliciting research submissions for innovative technologies related to health security. The initiative, valid until 2027, encourages entities, particularly small businesses and minority institutions, to propose projects addressing public health challenges, including pandemics and bioterrorism. Key elements of the EZ-BAA process include the submission of an abstract detailing the technical solution, project costs, and supporting data, followed by potential invitations to submit a detailed full proposal. Success is expected to result in multiple awards, with an emphasis on projects demonstrating innovative approaches and at least a 30-50% resource contribution from respondents. The document outlines submission guidelines, eligibility requirements, evaluation criteria, and reporting obligations for awarded projects. Respondents must register with SAM.gov before submitting proposals, emphasizing the importance of alignment with BARDA's program goals and strategic interests. Overall, this announcement seeks to foster advancements in biomedical research and rapid responses to health emergencies while facilitating collaboration between public health entities and diverse organizations.
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    2026 NIAID DMID Omnibus Broad Agency Announcement
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