The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 001 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003. This amendment introduces new Areas of Interest (AOIs) for research funding focused on innovative medical countermeasures (MCMs), including drug repurposing strategies targeting various chemical threats, development of home diagnostics, digital health tools, and host-directed therapeutics. Key AOIs include: 1. **ReDIRECT** - Emphasizes repurposing existing therapeutics against chemical agents and pathogens. 2. **Lab at Home** - Aims to create at-home diagnostic platforms for real-time health assessments. 3. **Digital MCMs** - Supports the development of digital health tools to assist in health security responses. 4. **Host-Directed Therapeutics** - Focuses on therapies that modulate the body's immune response to improve patient outcomes during infections. 5. **Healing Lungs** - Seeks novel solutions for managing acute respiratory distress syndrome (ARDS) without conventional ventilation methods. 6. **DRIVe Forward** - Invites proposals for untraditional approaches to enhance health emergency responses. Respondents are encouraged to schedule pre-submission consultations and must adhere to submission deadlines. This initiative aims to enhance the nation's preparedness for public health emergencies through innovative scientific solutions.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 002 for its Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, primarily to introduce a new Area of Interest (AOI #24: REPAIR) focused on repurposing therapeutics for treating Acute Radiation Syndrome (ARS). The program aims to develop medical countermeasures (MCMs) that effectively mitigate effects from ionizing radiation exposure, specifically targeting issues like cell death, vascular injury, bleeding, and hypoxia. Potential candidates must be FDA-approved or have passed their Phase 2 trials, and detailed rationales for their proposed efficacy must be provided. Additionally, the amendment corrects a typographical error regarding the abstract submission evaluation criteria. Abstract submissions are encouraged from all responsible sources with an active registration on SAM.gov, and the closing date for submissions is February 28, 2023. Multiple awards may be granted based on submission merit and available funding. The process aligns with existing guidelines under the EZ-BAA, emphasizing data sharing for further advancements in the field. This initiative represents the government's proactive approach to enhancing preparedness against radiological and nuclear threats.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 003 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, focusing on research for improving treatments for acute respiratory distress syndrome (ARDS). This amendment revises Area of Interest #19: Healing Lungs, soliciting abstract submissions for innovative technologies aimed at enhancing oxygen delivery solutions and veno-venous extracorporeal membrane oxygenation (VV-ECMO) systems for severe ARDS patients. Key objectives include developing non-ECMO oxygen delivery methods that achieve high oxygen saturation and enhance the safety and functionality of VV-ECMO technologies. The submission requirements emphasize evidence of scientific viability, evaluation of safety and efficacy through animal testing, and regulatory strategies. The deadline for abstract submissions is February 3, 2023, and multiple awards are expected based on the merit of the abstracts and available funding. Awardees must share de-identified data with BARDA in accordance with federal regulations. This initiative underscores the government's commitment to advancing innovative medical solutions for critical health issues related to lung damage and respiratory failure.

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, focusing on Area of Interest (AOI) #21: Vaccines on Demand. This amendment updates the closing date for abstract submissions, now set for 12:00 PM ET on February 28, 2023. All responsible sources, including those registered at sam.gov, are eligible to submit, with a strong recommendation to schedule a pre-submission call. Multiple awards are anticipated based on program priorities and funding availability. Awardees will be required to share de-identified data to advance knowledge in the field. This amendment aligns with BARDA’s mission to support research and development in medical countermeasures, especially in response to public health emergencies, emphasizing commercializability and adherence to federal regulations regarding data usage.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 005 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which announces the pause of Area of Interest (AOI) #15: ReDIRECT. This amendment is now open to all responsible entities, provided they are registered with https://sam.gov. Affected vendors should schedule a pre-submission call to discuss their proposals, with a revised abstract submission deadline set for February 15, 2023. Multiple awards are anticipated, contingent on program priorities and available funding. The application process remains consistent with the EZ-BAA provisions, including a requirement for awardees to share de-identified data with BARDA. This initiative reflects the government’s commitment to enhancing biomedical innovation while ensuring compliance with federal regulations concerning data usage.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has released Amendment 006 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, updating the closing dates for several Areas of Interest (AOIs) related to biomedical technologies. This amendment includes a focus on AOI #16: Lab at Home, which seeks proposals for on-demand detection of multiple biochemical health markers without traditional laboratory processes. The aim is to enhance point-of-care medicine, allowing quantitative health assessments near the patient. The proposal should address technological innovation, link biomarkers to clinical relevance, and outline comparison with laboratory standards. Preferred outcomes include efficient non-invasive sampling methods, rapid processing under two hours, and clear visual outputs for untrained users. Responsiveness is prioritized for technologies adaptable for home use that can work with a broad range of test panels. Additionally, multiple project awards are anticipated based on scientific merit, relevance, and funding availability. Applicants must ensure active registration with https://sam.gov to be considered. The submission deadline for abstract submissions for AOIs #16 and #17 is February 6, 2024. The overall goal is to foster innovative biomedical technologies that improve public health and streamline healthcare delivery.

The Office of Biomedical Advanced Research and Development Authority (BARDA), through its Division of Research, Innovation & Ventures (DRIVe), has issued Amendment 007 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003. This amendment updates the closing date for abstract submissions for Area of Interest (AOI) #24: REPAIR to June 1, 2023, at 12:00 PM ET. The amendment invites all responsible sources, emphasizing the necessity of having an active registration with SAM.gov for abstract submissions to be considered. Multiple awards may be issued based on the scientific merit of submissions and funding availability. Awarded entities will be expected to share de-identified data with BARDA to support advancements in the field. The established submission and review processes remain unchanged, with a strong recommendation for vendors to engage in pre-submission discussions with BARDA. This amendment illustrates the government's ongoing commitment to fostering research and development in biomedical innovation through collaborative funding opportunities.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 008 for the Easy Broad Agency Announcement (EZ-BAA), adding a new Area of Interest (AOI), #25: FASTx. This AOI focuses on developing nucleic acid-based therapeutic platforms to address emerging viral threats effectively. BARDA seeks abstract submissions for projects that enhance rapid response antiviral therapies, highlighting the need for adaptability to various viral families such as SARS-CoV-2, filoviruses, and influenza. Submissions should include proposed technological advancements and proof-of-concept efficacy studies. The amendment emphasizes criteria such as safety, manufacturability, and mechanism of action, along with a preference for projects targeting acute viral infections and pre-exposure prophylaxis (PrEP) for specified viruses. Interested parties must register with the System for Award Management (SAM) and are encouraged to schedule pre-submission calls. The deadline for submissions is October 15, 2024. Multiple awards are anticipated, depending on the alignment of submissions with AOI goals and available funding. Respondents awarded contracts must share de-identified data with BARDA, underscoring the collaborative mission to enhance public health responsiveness to viral diseases.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 009 to the Easy Broad Agency Announcement (EZ-BAA), reopening Area of Interest (AOI) #21: Vaccines on Demand. This effort aims to improve rapid vaccine production capabilities, particularly for next-generation COVID-19 vaccines, addressing inefficiencies uncovered during the pandemic. Key goals include simplified production inputs, reduced testing protocols, in-line formulation, and compact manufacturing systems that allow for decentralized production near treatment facilities. BARDA seeks technologies capable of producing over 1000 doses of vaccine within a week, utilizing platforms like mRNA and viral vectors. Abstract submissions are open to eligible organizations, with a close date of September 28, 2023. Multiple awards are anticipated based on technical merit and funding availability. Recipients of contracts will be required to share non-identifiable data to further enhance the field. This amendment aligns with BARDA's objective to strengthen the U.S. response to pandemics through innovative vaccine manufacturing strategies.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 010 for 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). The amendment revises AOI #24 to solicit abstracts for medical countermeasures (MCMs) capable of treating Acute Radiation Syndrome (ARS) caused by ionizing radiation. BARDA seeks therapeutics that are FDA-approved or in Phase 2 clinical trials, specifically targeting cell death, vascular injury, bleeding/coagulation disorders, and ischemia associated with ARS. The aim is to establish clinical data for these therapeutics in relevant models post-exposure. Abstract submissions are due by 12:00 PM ET on December 1, 2023, with multiple awards anticipated based on scientific merit and funding availability. Eligibility requirements include active registration at https://sam.gov and adherence to submission guidelines. Respondents must present a compelling rationale for their proposed MCM's efficacy and have the capability to conduct radiation exposure experiments. Data collected through government funding will be shared with BARDA for broader use in advancing countermeasure development.

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. This amendment finalizes the closure of research Areas of Interest (AOIs) #18 (Host-Directed Therapeutics) and #23 (Host-Based Diagnostics) and updates the submission deadline for AOI #19 (Healing Lungs) to October 4, 2023. It invites submissions from all responsible entities registered on SAM.gov, stressing the importance of compliance for abstract submissions. Multiple awards are anticipated, depending on the scientific merit and alignment with program priorities, with funding subject to government discretion. Awarded entities must share de-identified data to advance research, adhering to BARDA's mission and legal standards. The amendment reaffirms the established submission and review processes of the EZ-BAA and encourages prospective respondents to seek clarification through pre-submission calls. This document underscores BARDA's commitment to fostering biomedical research and innovation while delineating clear submission guidelines and funding dynamics.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 012 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which primarily updates several Areas of Interest (AOIs) and introduces new ones. Key updates include changing the closing dates for AOIs focused on at-home lab technologies, digital medical countermeasures, and lung healing, as well as the introduction of a new AOI for agnostic diagnostics using metagenomic next-generation sequencing (mNGS). The primary objective is to seek proposals for innovative technologies that facilitate rapid, simultaneous detection of multiple health biomarkers at home or point-of-care settings, enhancing healthcare access and efficiency. Respondents must present detailed plans covering technological innovation, clinical relevance, and feasibility for detecting biochemical markers with non-invasive samples. Additionally, the new AOI aims to advance mNGS technologies for viral detection, addressing challenges such as speed, cost, and standardization for routine clinical use. Abstract submissions are open to all qualified entities with a focus on developing technologies that align with BARDA's mission to improve public health responses. The revised submission deadlines are December 15, 2023, for certain AOIs and January 15, 2024, for the agnostic diagnostics.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 013 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which announces a pause on Area of Interest (AOI) #20: DRIVe Forward. The amendment outlines that the objective is to temporarily halt this specific research initiative while still being open to all responsible entities for abstract submissions that conform to EZ-BAA requirements. Interested respondents must maintain an active registration with https://sam.gov to have their submissions considered. Notably, the deadline for abstract submissions for AOI #20 is set for September 15, 2023, at noon ET, with an expectation to reopen submissions later in the year. Multiple awards may be granted based on scientific merit and program priorities, though funding availability is subject to government discretion. Award recipients must share de-identified data with BARDA, aligning with federal standards to advance biomedical research. This amendment highlights BARDA’s focus on innovative research while maintaining compliance with regulatory requirements.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 014 to pause Area of Interest (AOI) #21: Vaccines on Demand under the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003. This amendment allows for project abstracts from responsible sources, requiring active registration with https://sam.gov for submission. Interested vendors are encouraged to schedule pre-submission calls for project discussions. The final date for abstract submissions for AOI #21 is 12:00 PM ET on September 28, 2023. Multiple awards are anticipated based on program priorities and the merit of submissions, with funding availability subject to government discretion. Awarded respondents must share de-identified data to contribute to research advancements. While submissions for AOI #21 are currently paused, they are expected to reopen in the future. This initiative underscores BARDA's commitment to supporting innovative biomedical research and responses to public health needs.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 015 for the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003. This amendment updates the closing dates and revises two Areas of Interest (AOIs): AOI #22: ReBoot, focused on antiviral therapeutics for filoviruses, and AOI #25: FASTx, aimed at early stage therapeutic platform development for emerging viral threats. AOI #22 seeks submissions for preclinical studies on direct-acting antivirals indicating efficacy against filoviruses like Ebola and Marburg, along with proposals for related CMC activities. AOI #25 encourages platforms that could quickly adapt to emerging viral threats, including nucleic acid-expressed mAbs and CRISPR-based technologies. The closing date for abstract submissions for both AOIs is set for March 1, 2024. Multiple contracts may be awarded, dependent on the scientific merit and fit with program goals, with an emphasis on developing adaptable and effective therapeutic solutions to respond to public health emergencies. Respondents are advised to consult BARDA prior to submission to ensure compliance with requirements and are encouraged to share any collected de-identified data with the agency.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 016, pausing Area of Interest #24: REPAIR under the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003. The amendment aims to allow for future opportunities in this research area while opening up eligibility to all responsible sources in line with the EZ-BAA guidelines. Interested parties must have an active registration on the System for Award Management (SAM) to submit abstracts, with a revised submission deadline set for November 1, 2023. The amendment stipulates that multiple awards are anticipated based on scientific merit, alignment with the area’s goals, and available funding. Awarded entities are required to share de-identified data to promote advancement in biomedical research. This amendment streamlines the submission process and encourages vendors to engage with the program prior to application, emphasizing a commitment to innovation and collaboration in public health preparedness.

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, reopening and revising Area of Interest (AOI) #20: DRIVe Forward. This initiative aims to solicit abstract submissions for innovative products that address high-risk, high-reward biomedical challenges related to emerging infectious diseases and public health emergencies. Three key focus areas are identified: enhancing vaccine efficacy through novel interventions, developing portable viral diagnostic platforms for remote settings, and creating computational models to guide rapid development and deployment of medical countermeasures (MCMs) and non-pharmaceutical interventions (NPIs). Submissions must demonstrate scientific and impact attributes, including preliminary data and clear metrics for success. Interested parties must have active registration with SAM.gov and are encouraged to schedule pre-submission calls. The closing date for abstracts is March 15, 2024, and multiple awards are anticipated based on alignment with program goals and available funding. Recipients must share de-identified data to advance knowledge in the field, emphasizing the importance of commercialization while adhering to federal regulations.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment 018 for its Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, primarily focusing on updating closing dates and status of specific Areas of Interest (AOIs). Key actions include updating and revising AOI #16: Lab at Home, while pausing AOI #17: Digital MCMs, and updating AOI #19: Healing Lungs. The central goal of AOI #16 is to develop innovative instrumentation-based platforms for on-demand detection of multiple biochemical health markers. These technologies aim to enhance accessibility and efficiency in health monitoring, allowing for rapid, at-home diagnostics without the complexities of traditional laboratory testing. Proposals should detail the technological innovations addressing current limitations, clinical relevance of selected biomarkers, and feasibility plans, including simultaneous detection capabilities from minimal invasive samples. This amendment invites responsible entities to submit abstracts, with specific timelines for each AOI's closing dates. Funding will depend on the scientific merit and alignment with BARDA’s goals, emphasizing the need for clear commercialization plans and data sharing standards in compliance with federal regulations. Overall, the initiative aims to improve public health responses and diagnostic access via advanced home-based medical technologies.

The Biomedical Advanced Research and Development Authority (BARDA) has announced Amendment #019 to the Easy Broad Agency Announcement (EZ-BAA) BAA-22-100-SOL-00003, which reopens and revises Area of Interest #15: ReDIRECT (Repurposing Drugs In Response to Chemical Threats). This initiative aims to identify existing FDA-approved drugs that can be repurposed as effective medical countermeasures against various chemical threats, including pulmonary agents, opioids, vesicants, and nerve agents. Respondents must propose candidates with a valid clinical advantage, a known safety profile, and ease of administration during mass casualty events. Proposals should target multiple threats and provide clear commercial applications beyond their MCM use. Eligible submissions require an active registration with SAM.gov, adherence to specific criteria, and a rationale for efficacy. The deadline for abstract submissions is May 3, 2024, and multiple awards may be granted based on the scientific merit of the proposals and available funding. Interested vendors are encouraged to schedule pre-submission calls to refine their proposals. This effort reflects the government's focus on enhancing public health readiness against chemical emergencies through innovative drug repurposing strategies.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has released Amendment #020 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) to pause Area of Interest (AOI) #26 on Agnostic Diagnostics, introduce a new topic under AOI #20, and update the submission deadlines for abstracts. This amendment invites research proposals under AOI #20, titled DRIVe Forward, which aims to develop innovative products and technologies to improve public health responses to emerging infectious diseases and threats. Key topics of interest include enhancing vaccine efficacy, mobile viral diagnostic platforms for remote settings, computational models for medical countermeasure deployment during outbreaks, and novel diagnostic methods for prion diseases. Abstract submissions must align with defined scientific and impact attributes, and interested parties are encouraged to hold a pre-submission call with DRIVe. The deadlines for submissions are April 15, 2024, for AOI #20 and January 15, 2024, for AOI #26. Multiple awards are expected, depending on the scientific merit of submissions and available funding. This amendment underscores BARDA’s commitment to fostering innovation that strengthens the nation’s preparedness against biomedical threats.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has released Amendment #021 for the Easy Broad Agency Announcement (EZBAA-22-100) to introduce a new Area of Interest (AOI #27), which focuses on "Stopping Secondary Spread" of respiratory viral pathogens. This initiative seeks abstract submissions for developing novel pharmaceutical medical countermeasures aimed at interrupting person-to-person transmission of respiratory viruses, particularly influenza and SARS-CoV-2, while also considering other respiratory pathogens with proper justification. The goal is to create transmission blocking agents that either reduce the likelihood of transmission from infected individuals or prevent infection following exposure. The ideal characteristics for these agents include easy administration, immediate activity, low side effects, and accessibility. Proposals are to be evaluated based on their alignment with the targeted product profile and evidence of efficacy in relevant animal models, excluding murine models and other non-pharmaceutical interventions such as vaccines or sanitizers. The submission period for abstracts closes on May 3, 2024, and interested vendors are encouraged to schedule pre-submission calls. Multiple awards are anticipated, depending on scientific merit and available funding, emphasizing BARDA's commitment to enhancing public health through innovative therapeutic strategies.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #022 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003). The amendment pauses Area of Interest (AOI) #27, focusing on "Stopping Secondary Spread," and removes Topic #4 under AOI #20, "DRIVe Forward." The DRIVe Forward AOI seeks abstract submissions for innovative solutions to combat emerging infectious diseases and improve public health response capabilities. Specific areas of interest include enhancing vaccine efficacy, creating portable viral diagnostic platforms for remote areas, and developing computational models to optimize medical countermeasures during outbreaks. Submissions require prior market research consultations and must demonstrate scientific and impact attributes, including innovation and commercialization potential. Funding availability will dictate the number of awards granted, and successful respondents must share de-identified data with BARDA. The deadline for abstract submissions under AOI #20 is set for April 15, 2024. The amendment emphasizes the government's commitment to addressing biomedical threats through innovative and high-reward research proposals while ensuring compliance with federal funding regulations.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #023 to Easy Broad Agency Announcement EZBAA-22-100-SOL-00003, reopening Area of Interest (AOI) #26: Agnostic Diagnostic. This amendment invites all responsible sources to submit abstracts related to this AOI, with a submission deadline of May 15, 2024, at 12:00 PM ET. Entities must have active registrations at sam.gov for their submissions to be considered. Multiple awards are anticipated, depending on the scientific merits of the proposals and available funding. Respondents are encouraged to request a pre-submission call for project discussions. Awarded contractors will need to share de-identified data to support the advancement of knowledge in the field, consistent with BARDA's mission. Overall, this amendment aims to incentivize research and innovation in diagnostic methods, streamlining the proposal process for better engagement and outcomes from potential vendors.

Amendment #024 outlines updates to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) by the Office of Biomedical Advanced Research and Development Authority (BARDA). The key purpose is to change the closing dates for research Areas of Interest (AOI): #22 (ReBooT) and #25 (FASTx) to May 31, 2024, at 12:00 PM ET. Following a staggered approach, these AOIs aim to encourage early, high-quality submissions for scientific research. Interested vendors must be registered on SAM.gov and are encouraged to request a pre-submission call to discuss their projects. Multiple awards are anticipated depending on funding availability and the scientific merit of submissions. Awardees are required to share de-identified data with BARDA, emphasizing the government's commitment to advancing research and technology within national interests. This announcement reflects the broader context of federal RFPs aimed at fostering innovation and public health preparedness.

The Amendment #025 to the EZBAA-22-100-SOL-00003 issued by the Biomedical Advanced Research and Development Authority (BARDA) reopens and revises Area of Interest (AOI) #24: RePAIR, which focuses on developing medical countermeasures (MCMs) for Acute Radiation Syndrome (ARS). The goal is to repurpose existing FDA-approved therapeutics or those in Phase 2 clinical trials to treat injuries from ionizing radiation exposure. The amendment outlines specific mechanisms of action for potential MCMs, targeting cell death, vascular injury, bleeding/coagulation, and ischemia. Applicants must demonstrate that their candidates have an established safety profile, a defined mechanism of action relevant to ARS, and suitable facilities for the proposed research. The call for abstracts is open until May 15, 2024, and aims to generate proof-of-concept data for MCM development. Multiple funding awards are anticipated, contingent on the quality and relevance of submissions. It encourages engagement from interested vendors prior to submission to enhance alignment with BARDA’s objectives in addressing radiological and nuclear threats.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #026 to the Easy Broad Agency Announcement EZBAA-22-100-SOL-00003, specifically updating the closing dates for two Areas of Interest: Lab at Home (AOI #16) and Healing Lungs (AOI #19), with both now due by 12:00 PM ET on May 15, 2024. Eligible respondents may include all responsible sources that comply with the EZ-BAA submission requirements and must have active registrations with SAM.gov. It encourages potential applicants to schedule pre-submission calls for guidance. Multiple awards may be issued based on the merit of submissions and funding availability, with the understanding that awarded parties are required to share any de-identified data collected. This amendment aligns with BARDA's mission to advance biomedical research and innovation, emphasizing the commercialization of resulting technologies while adhering to federal regulations. This amendment aims to enable a timely collection of high-quality research proposals in these critical healthcare areas.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #027 to the Easy Broad Agency Announcement (EZBAA) EZBAA-22-100-SOL-00003, which aims to reopen Area of Interest (AOI) #20: DRIVe Forward. This amendment replaces two previous topics with a focus on "next-generation tourniquets for civilian use" while seeking innovative approaches to enhance vaccine efficacy. The initiative aims to address public health emergencies by fostering high-risk, high-reward innovations that may not fit existing program areas. Key focus areas include developing technologies to boost vaccine efficacy, particularly for individuals with compromised immune systems, and creating user-friendly tourniquets for untrained civilians to improve emergency response. Eligible applicants must contact DRIVe to participate in market research calls prior to submission, with abstracts due by May 31, 2024. Multiple awards will be granted based on scientific merit and alignment with BARDA’s goals. The process requires all submissions to comply with specific criteria outlined in the EZ-BAA, emphasizing the importance of innovative, impactful solutions in advancing public health preparedness and response.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #028 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003), updating deadlines and requirements for three specific Areas of Interest (AOIs). The closing dates for AOI #15 (ReDIRECT) and AOI #26 (Agnostic Diagnostic) have been revised, while AOI #17 (Digital Medical Countermeasures, MCMs) is reopened and revised to seek innovative computational technologies like artificial intelligence to develop new MCMs or enhance existing ones against health security threats. Proposals must focus on technological innovations that are rapid, affordable, and equitable, specifically aimed at improving health responses, accessibility, and user experience for underserved populations. Additionally, a comprehensive plan for data collection, evaluation, and adherence to regulatory standards is required. Eligible applicants must have an active registration with the System for Award Management (SAM) and are encouraged to request a pre-submission call before submitting abstracts by the specified deadlines: May 31, 2024, for AOI #15; September 30, 2024, for AOI #26; and October 31, 2024, for AOI #17. Multiple awards will be issued based on scientific merit and alignment with program goals, subject to available funding.

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 research initiatives under specific Areas of Interest (AOIs). This amendment pauses AOI #16 (Lab at Home) and updates AOI #19 (Healing Lungs) with a revised closing date for abstract submissions on October 14, 2024. The Healing Lungs initiative addresses the management of acute respiratory distress syndrome (ARDS) through innovative oxygen delivery methods and improvements to veno-venous extracorporeal membrane oxygenation (VV-ECMO) systems. Proposals are sought for non-ECMO oxygen delivery solutions and advancements in VV-ECMO that enhance safety, portability, and efficiency, with a strong preference for large animal testing. AOI #24 (RePAIR) is also mentioned with an updated closing date of May 31, 2024. All abstract submissions must conform to requirements and be from entities registered with sam.gov. Multiple awards are anticipated based on funding and project merit, and collaborations among vendors are encouraged. Award recipients must share de-identified data to support collaborative advancements in the field.

Amendment #030 to Easy Broad Agency Announcement EZBAA-22-100-SOL-00003 introduces a new Area of Interest (AOI) focused on Influenza Vaccine Innovation while pausing the Agnostic Diagnostic AOI. The objective is to enhance vaccine development to address the significant public health challenges posed by both seasonal and pandemic influenza. Key initiatives under AOI #28 include innovations for pre-pandemic vaccines that elicit durable immunity, transmission-reducing vaccines, and alternative delivery methods such as oral and nasal routes. The document emphasizes the need for vaccines that can confer protection early during public health emergencies and improve overall vaccination strategies. Funding is aimed at preclinical studies demonstrating protection in animal models, with priority given to submissions that include a comprehensive Product Development Plan. Eligible respondents must comply with registration requirements and submit abstracts by specified deadlines, with multiple awards anticipated based on the merit of funded projects. The amendment encapsulates the government's commitment to advancing vaccine technologies amid ongoing health threats, fostering innovation in vaccine research and development, while maintaining adherence to regulatory standards for data sharing and commercialization.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #031 to reopen Area of Interest (AOI) #24: RePAIR under the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003). This amendment invites responses from eligible entities for research proposals aligned with the goals of AOI #24. Abstract submissions must adhere to specific guidelines and require active registration with the System for Award Management (SAM) at the time of submission to be considered. A pre-submission call with BARDA is highly encouraged, and the deadline for abstract submissions is set for November 27, 2024, at 12:00 pm ET. Funding is expected for multiple awards based on scientific merit and alignment with program priorities. Recipients of contracts will be obligated to share de-identified data derived from their research. The amendment underscores the importance of advancing biomedical innovations while maintaining compliance with federal regulations and facilitating the commercialization of successful technologies.

Amendment #032 of the Easy Broad Agency Announcement EZBAA-22-100-SOL-00003 from the Office of Biomedical Advanced Research and Development Authority (BARDA) aims to update the closing date for Area of Interest (AOI) #19: Healing Lungs and announce the pause of AOI #17: Digital MCMs effective October 31, 2024. Abstract submissions for AOI #19 are due by February 28, 2025, while those for AOI #17 must be submitted by October 31, 2024. All respondents must have current registration with SAM.gov to participate. Multiple awards will be granted based on the merit and alignment of submissions with program goals, subject to funding availability. Awarded respondents must share de-identified data to support ongoing research, adhering to BARDA’s mission to advance public health. Interested vendors are encouraged to engage in pre-submission calls to clarify project details. The amendment follows the existing submission and review protocols outlined in the EZ-BAA framework. This amendment reflects BARDA's strategic focus on critical areas of biomedical research and development.

The Amendment #033 of the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) by the Office of Biomedical Advanced Research and Development Authority (BARDA) serves two main purposes: reopening Area of Interest (AOI) #15: ReDIRECT on November 1, 2024, and removing the requirement for a Rough Order of Magnitude (ROM) from the submission documentation. This amendment invites all eligible and responsible sources to submit abstracts, which must conform to the EZ-BAA guidelines and require active registration on SAM.gov for consideration. Interested vendors are encouraged to schedule a pre-submission call to discuss their proposals. The submission deadline for AOI #15 is set for March 31, 2025, at 12:00 pm ET, with multiple awards anticipated based on the scientific merit and alignment of submissions with program priorities. Awardees will be expected to share de-identified data to advance knowledge in the field, as well as comply with federal regulations regarding data usage. This amendment reflects the government’s commitment to fostering applied research and innovation in biomedical development while maintaining standards for data accessibility and compliance.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #034 for the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) to revise, reopen, and pause specific Areas of Interest (AOIs) related to antiviral research. AOI #22, termed "ReBooT," emphasizes the development of antiviral therapeutics effective against filoviruses, such as Ebola and Marburg, particularly those that have progressed past Phase 1 clinical trials. Submissions should demonstrate efficacy and acceptable safety profiles, with a preference for broad-spectrum and orally available products. Conversely, AOI #24, "RePAIR," is paused. Eligible respondents can submit abstracts until April 30, 2025, for AOI #22 and November 27, 2024, for AOI #24, with the expectation of multiple awards based on submissions' scientific merit and funding availability. Respondents must register through the System for Award Management (SAM) and are encouraged to schedule a pre-submission call for guidance. The amendment emphasizes BARDA’s commitment to advancing medical countermeasures against viral threats and requires awarded respondents to share de-identified data for further research. This process aims to enhance the nation's preparedness for public health emergencies linked to antiviral therapies.

The Office of Biomedical Advanced Research and Development Authority (BARDA) has issued Amendment #035 to the Easy Broad Agency Announcement (EZBAA-22-100-SOL-00003) to announce the reopening of Area of Interest (AOI) #16: Lab at Home and the opening of AOI #29: Type to Treat. The objective of AOI #29 is to enhance therapeutic efficacy through patient stratification technologies. This program aims to identify patient populations that would most benefit from interventions by advancing development and validation of technologies that can be integrated with FDA-approved or BARDA-supported therapeutics. Proposals must outline the connection between the stratification technology and the therapeutic, detail plans for clinical validation, and include a commercialization and regulatory strategy. The amendment invites diverse applicants and abstract submissions must meet specified guidelines, including active registration with the System for Award Management (SAM). Submissions for AOI #16 are due by February 14, 2025, and for AOI #29 by May 12, 2025. Multiple awards are expected, based on the merit and funding availability. Award recipients are required to share de-identified data to further scientific knowledge and must follow federal regulations regarding data usage.

The U.S. Department of Health and Human Services has issued a Broad Agency Announcement (EZ-BAA) through the Office of Biomedical Advanced Research and Development Authority (BARDA) to solicit innovative research proposals addressing health security threats. Announced on October 18, 2022, the EZ-BAA is open until October 18, 2027, emphasizing the need for groundbreaking technologies and approaches for pandemic preparedness. Eligible respondents include businesses, academia, and nonprofits, with a strong encouragement for submissions from small and minority-owned entities. The process involves a two-stage submission: an initial abstract and, upon favorable review, a detailed full proposal. Contracts awarded may come in various forms but will not exceed $750,000 from government funding. Resource Contributions from respondents should represent at least 30-50% of the total project cost. The announcement outlines a comprehensive submission preparation and review process, dictating that submissions align with predefined Areas of Interest (AOIs) relevant to BARDA’s mission. Continuous updates and amendments will detail specific AOIs and submission timelines to ensure compliance and facilitate innovation in health security advancement.