BARDA Broad Agency Announcement (BAA) for Medical Countermeasures (MCMs) for CBRN Threats, Pandemic Influenza, and Emerging Infectious Diseases is sponsored by Biomedical Advanced Research and Development Authority (BARDA). BARDA's BAA supports the advanced research and development of medical countermeasures, including those for antimicrobial resistance, to address chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases.

Medical Countermeasures | BARDA Broad Agency Announcements only on official, secure websites BARDA Broad Agency Announcement (BAA) We partner with companies and teams offering solutions to a broad range of national health security threats.

Sudan Virus and Marburg Virus Flexible Vaccine Manufacturing Platform Technologies CBRN Antivirals and Antitoxins MDR Bacteria and Biothreat Pathogens Radiological/Nuclear Threat Medical Countermeasures Acute Radiation Syndrome (ARS) Radiation Injury and Trauma Pathophysiologies Enabling Technologies and Platforms Chemical Medical Countermeasures Pharmaceutical-based Agents, including Opioids and Other Respiratory Depressants Nerve Agents and Organophosphorus (OP) Pesticides Knockdown Agents/Cellular Asphyxiants Novel MCM Delivery Mechanisms Innovative Approaches to Understanding Chemical Injury in Humans Burn and Blast Medical Countermeasures Burn and Blast Traumatic Injuries Management Management of Head Injuries in Trauma Management of Thoracoabdominal Trauma Injuries Platform Agnostic Software for AI Augmentation of Ultrasound Imaging Data Biothreat Agent Diagnostics Biothreat Agent Diagnostics: Point-of-Care Biothreat Agent Diagnostics: Laboratory Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen Antimicrobial Resistance (AMR) Sequencing Solutions Influenza Testing in an OTC and CLIA Waived Environment Threat-Agnostic Diagnostics Metagenomic Next-Generation Sequencing (mNGS)-Based Agnostic Diagnostic for Viral Pathogens Influenza and Emerging Infectious Diseases (IEID) Vaccines Advanced Development of Faster or More Effective Vaccines Clinical Trials to Expand the Age Range on the Label of Currently Licensed Vaccines Innovative Vaccine Product and Production Enhancements Assays for Product Release Influenza and Emerging Infectious Diseases (IEID) Therapeutics Broad Spectrum Antiviral Therapeutics for Influenza Immunomodulators or Therapeutics Targeting Lung Repair Pre-exposure Prophylaxis – Influenza Flexible and Strategic Therapeutics (FASTx) Flexible and Strategic Therapeutics (FASTx) BARDA supports advanced research and development of medical countermeasures and is a component of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

Pre-submission Call with BARDA Experts Market Research Abstract Submission Offerors are strongly encouraged to request a call with the AOI Technical POC and/or submit a request for a TechWatch meeting, prior to starting an abstract or proposal. Market Research Abstract Submission Potential offerors shall complete and submit a Market Research Abstract, prior to submitting the proposal.

The Proposal Submission is comprised of a Technical Proposal and a Cost Proposal. Market Research Abstract: BARDA will assess the Market Research Abstract. Potential offerors whose submission receives a favorable assessment will be invited via email to submit a Proposal.

Potential offerors whose submission does not receive a favorable assessment will be notified via email and will be provided with information on technical issues and concerns regarding the proposed product. This written feedback is the only response provided. Proposal: A panel of BARDA experts will review the proposal.

Potential offerors whose Proposal is rated acceptable may be invited to enter into negotiations with the government. Award decisions will take into consideration program priorities, negotiations, and availability of funds. Potential offerors whose Proposal is rated unacceptable will not be given further consideration.

Proposal submissions given an Acceptable rating may proceed into negotiations. This rating does not guarantee contract award; BARDA will consider program priorities, negotiations, and availability of funds.

Proposals submitted in response to the BARDA Broad Agency Announcement (BAA) must focus on research and development activities that relate to specific areas of interest, consisting of medical countermeasures for chemical, biological, radiological, and nuclear threats; pandemic influenza and emerging infectious diseases.

Prior to starting a market research abstract or proposal, BARDA strongly recommends offerors participate in a TechWatch meeting or a pre-submission call with the area of interest technical point of contact to gain technical feedback and strategic input. The following tools and templates will help you develop your Market Research Abstract/Quad Chart and Proposal in response to the BARDA Broad Agency Announcement (BAA).

For more information, review the full BARDA BAA . Prior to starting an application, BARDA strongly recommends that you participate in a TechWatch Meeting to discuss your product, technology or capabilities and explore potential partnership opportunities.

The application process occurs in three stages: STAGE 1: Pre-submission call with technical point of contact The government realizes that the preparation of a development proposal often represents a substantial investment of time and effort by the offeror.

To minimize this burden, BARDA strongly encourages organizations and individuals interested in submitting proposals to make targeted inquiries with the technical point of contact (POC) of the Area of Interest (AOI) as to the general need for the type of research and development (R&D) effort contemplated before expending extensive effort in preparing a detailed abstract and proposal or submitting proprietary information.

Specific instructions for requesting a pre-submission call are provided in Part IV (pgs. 23-24) of the BARDA BAA. For more general inquiries about potential partnerships with the U.S. government and to speak with a larger BARDA audience as well as PHEMCE partners, consider requesting a TechWatch meeting as noted in the General Market Research (TechWatch Program) section (page 8) of the BARDA BAA.

STAGE 2: QUAD CHART AND MARKET RESEARCH ABSTRACT Your Stage 2 submission provides a brief summary of your project and consists of three components: the Quad Chart, Market Research Abstract, and Rough Order of Magnitude. Specific instructions for preparing each of these components are provided in Part IV (pgs. 24-25) of the BARDA BAA .

The Market Research Abstract provides a brief technical discussion of the offeror’s objective, approach, level of effort, and the nature and extent of the anticipated results. You must identify in your Quad Chart and Market Research Abstract the current Technology Readiness Level (TRL) of your product, and the TRL identified should meet or exceed the requirements of the given Development Area of Interest.

Refer to TRLs for Drugs and Biologics (applicable to AOIs 1-6, 8-9, & 12), TRLs for Medical Countermeasure Product Development Tools (applicable to AOI 10), and TRLs for Diagnostics and Medical Devices (applicable to AOI 7) for specific criteria in determining TRLs. Table 1: Components of a Market Research Abstract Submission Quad Chart Template (PDF) BARDA BAA (pgs. 24-25 – Market Research Abstract Format) BARDA BAA (pg.

25 – Rough Order of Magnitude) Your Stage 2 submission will be assessed with primary focus on the submission’s technical merit and relevance to BARDA’s programmatic priorities. Potential Offerors whose Stage 2 submission receives a favorable assessment will be invited via email to submit a Proposal in Stage 3.

Potential Offerors whose Stage 2 submission does not receive a favorable assessment will be notified via email and will be provided with information on technical issues and concerns regarding the proposed product. This written feedback is the only response that will be provided to unsuccessful Stage 2 Respondents. The Proposal contains two separate volumes.

Volume I is a Technical Proposal and Volume II is a Cost Proposal. In accordance with the guidance provided in Part VI (pgs. 26-38) of the BARDA BAA, each volume will have separate related attachments.

VOLUME I: TECHNICAL PROPOSAL The Technical Proposal describes the program relevance, technical merits, and offeror’s capabilities. Do not include cost information in your Technical Proposal. Samples and templates for many of the components of the Technical Proposal are provided in the table below.

Table 2: Components of a Proposal Submission Contractual Statement of Work template Work Breakdown Structure (WBS) Work Breakdown Structure sample Gantt Chart/Integrated Master Schedule (IMS) Contract Milestones/Deliverables Chart Contract Milestones/Deliverables Chart sample Project Management Plan sample Risk Management Plan sample Subcontractor Management Plan * Subcontractor Management Plan sample *Subcontractor Management Plan is strongly recommended but not required.

Other items to include and specific instructions for preparing these items are provided in the BARDA BAA . VOLUME I: TECHNICAL PROPOSAL ATTACHMENTS Attachments to Volume I contain supplemental data that accompany the Technical Proposal. Attachments to include in the Technical Proposal are listed below.

If a particular item is not relevant to the proposed effort, state that it is not applicable along with any supporting justification. Table 3: Technical Proposal Attachments Quad Chart Template (PDF) Protection of Human Subjects Protection of Human Research Subjects (45 CFR 46) Office of Laboratory Animal Welfare BARDA BAA (pg. 31 – Intellectual Property) BARDA BAA (pg.

31 – Biographical Sketches) Federal Select Agent Program Laboratory License Requirements BARDA BAA (pg. 31 – Laboratory License Requirements) Target Product Profile templates (Word)​ BARDA BAA (pg. 32 – Supporting Data) BARDA BAA (pg.

32 – FDA Communication) *Not required for diagnostics or platforms. The Cost Proposal contains sufficient information for meaningful evaluation. The detailed costs in the proposal must readily track back to the costs presented in the summary, WBS, IMS, and SOW.

A full list of items to include in the Cost Proposal and specific instructions for preparing these items are provided in the BARDA BAA. VOLUME II: COST PROPOSAL ATTACHMENTS Attachments to Volume II contain supplemental data of a cost and non-cost nature that accompany the Cost Proposal. Attachments to include in the Cost Proposal are listed below.

If a particular item is not relevant to the proposed effort, state that it is not applicable along with any supporting justification.

Table 4: Cost Proposal Attachments and Reference UEI, TIN, CAGE, and NAICS Representation and Certifications System for Award Management Breakdown of Proposed Estimated Costs Breakdown of Estimated Proposed Costs Workbook (Excel) SF-424, SF-424A, SF-424B, SF-LLL HHS Small Business Subcontracting Plan Small Business Subcontracting Plan Summary of Related Activities Summary of Related Activities Template (Word)​ Grants: SF-LLL: Disclosure of Lobbying Activities Contracts: HHSAR 352.

203-70 Report of Government-Owned, Contractor-Held Property FAR 52. 245-1: Government Furnished Property Workbook Financial Capacity and Annual Financial Report BARDA BAA (pg. 37 – Financial Capacity and Annual Financial Report) Past Performance Contact Information BARDA BAA (pg.

37-38 - Past Performance) Reason for the Proposed Award Type BARDA BAA (pg. 38 – Reason for the Proposed Award Type) Supply Chain Risk Assessment BARDA BAA (pg.

38 – Supply Chain Risk Assessment) Your Stage 3 Proposal will be evaluated by a Technical Evaluation Panel based on the following criteria that are listed in descending order of importance: Program Relevance, Overall Scientific and Technical Merit, and Offeror’s Capabilities and Related Experience. If your Proposal is rated acceptable, you may be invited to enter into negotiations with the government.

Award decisions will take into consideration program priorities, negotiations, and availability of funds. If your Proposal is rated unacceptable, it will not be given further consideration. Unacceptable proposals are either 1) not technically sound; and/or 2) do not meet program priorities.

Technology Readiness Levels for Medical Countermeasure Products: These TRLs are used when rating a medical countermeasures, such as a drug or a vaccine. Technology Readiness Levels for Product Development Tools: These TRLs are used when rating Product Development Tools (PDTs), such as assays, models, and reagents.

Technology Readiness Levels for Medical Countermeasure Products: These TRLs are adapted from the harmonized Quantitative Technology Readiness Level (Q-TRL) and are used when rating diagnostics and medical devices. The processes of developing medical countermeasure products or product development tools are distinct but closely related endeavors.

To successfully develop a medical countermeasure, appropriate effort and funding must be directed to the maturation of the analytical tools and animal models used during the development process. Similarly, the necessary in vitro and in vivo assays and models cannot be fully refined and verified without a candidate product to provide a substrate for evaluation.

Both development efforts must proceed in parallel to achieve an approved or licensed product. Furthermore, the regulatory approval and licensure process benefits from reliable and reproducible analytical tools and animal models.

BARDA’s Broad Agency Announcement (BAA) sets forth the advanced research and development Areas of Interest (AOIs) and solicits proposals focusing on these areas in order to protect Americans from emerging threats. Learn more about opportunities to partner with us: https://www. medicalcountermeasures.

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