We partner with companies and teams offering solutions to a broad range of national health security threats.
Pre-exposure Prophylaxis - Influenza
| 1.1 | Needle-Free Technologies to Administer Licensed Vaccines |
| 1.2 | Sudan Ebolavirus and Marburg Virus |
| 1.3 | Flexible Vaccine Manufacturing Technologies |
| 2.1 | Anthrax Antitoxins |
| 2.2 | Botulism Antitoxins |
| 2.3 | Smallpox Antivirals |
| 2.4 | Filovirus Antivirals |
| 3.1 | MDR Bacteria and Biothreat Pathogens |
| 3.2 | MDR Fungal Infections |
| 4.1 | Acute Radiation Syndrome (ARS) |
| 4.2 | Uncontrolled Hemorrhage |
| 4.3 | Radiation Injury and Trauma Pathophysiology |
| 4.4 | Enabling Technologies and Platforms |
| 4.5 | Decorporation Agents |
| 5.1 | Pulmonary Agents |
| 5.2 | Opioids and Other Respiratory Depressants |
| 5.3 | Vesicants |
| 5.4 | Nerve Agents and Organophosphorus (OP) Pesticides |
| 5.5 | Knockdown Agents/Cellular Asphyxiants |
| 5.6 | Novel MCM Delivery Mechanisms |
| 5.7 | Innovative Approaches to Understanding Chemical Injury in Humans |
| 6.1 | Enabling Technologies to Address General Burn & Blast Traumatic Injuries |
| 6.2 | Management of Head Injuries in Trauma |
| 6.3 | Hemorrhage Control |
| 6.5 | Management of Blunt Trauma Injuries |
| 6.6 | Advanced Imaging Technologies in Management of Trauma |
| 6.7 | Special Instruction for Health Economic Impact Assessment of Burn MCMs |
| 6.8 | Special Instruction for Platform Agnostic Software for AI Augmentation of Ultrasound Imaging Data |
| 7.1 | Biothreat Agent Diagnostics |
| 7.1.1 | Biothreat Agent Diagnostics: Point-of-Care |
| 7.1.2 | Biothreat Agent Diagnostics: Laboratory |
| 7.1.3 | Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings |
| 7.2 | Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens |
| 7.2.1 | Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen |
| 7.2.3 | Antimicrobial Resistance (AMR) Sequencing Solutions |
| 7.3 | Influenza Diagnostics |
| 7.3.1 | Influenza Home-Use Testing (for OTC or Prescription at Home) |
| 7.3.2 | Pan-Influenza Diagnostics: Point-of-Care or Laboratory |
| 7.3.3 | Point-of-Care Multiplex Assay for Detection of Influenza Virus |
| 7.4 | Threat-Agnostic Diagnostics |
| 7.4.1 | Next-Generation Sequencing (NGS)-Based Agnostic Diagnostic for Viral Pathogens |
| 8.1 | Advanced Development of Faster or More Effective Vaccines |
| 8.1.1 | Faster Vaccines |
| 8.1.2 | More Effective Vaccines |
| 8.1.3 | Clinical Trials to Expand the Age Range on the Label of Currently Licensed Vaccines |
| 8.2 | Innovative Vaccine Production Enhancements |
| 8.2.1 | Platforms |
| 8.2.2 | Manufacturing |
| 8.2.3 | Assays for Product Release |
| 8.2.4 | Administration |
| 9.1 | Influenza Antiviral Therapeutics |
| 9.2 | Immunomodulators or Therapeutics Targeting Lung Repair |
| 9.3 | Pre-exposure Prophylaxis – Influenza |
| 10.0 | ImmuneChip+ |
| 12.0 | 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).
SELECT THE FOR DETAILS
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-sumbission 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. 24-25) 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 9) 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. 25-26) 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 AOIs 10-11), 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
|
Item Name |
Required |
Details, Samples, |
|
Quad Chart |
Yes |
Quad Chart Template (PDF) |
|
Market Research Abstract |
Yes |
|
|
Rough Order of Magnitude |
Yes |
Your Stage 2 submission will be assessed with primary focus on the submission’s technical merit and relevance to BARDA’s programmatic priorities.
INTERESTED
Potential Offerors whose Stage 2 submission receives a favorable assessment will be invited via email to submit a Proposal in Stage 3.
NOT INTERESTED
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.
STAGE 3: Proposal
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. 26-37) 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
|
Item Name |
Required |
Details, Samples, |
|
Statement of Work (SOW) |
Yes |
|
|
Work Breakdown Structure (WBS) |
Yes |
|
|
Gantt Chart/Integrated Master Schedule (IMS) |
Yes |
|
|
Contract Milestones/Deliverables Chart |
Yes |
|
|
Project Management Plan |
Yes |
|
|
Risk Management Plan |
Yes |
|
|
Subcontractor Management Plan* |
No |
*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
|
Item # |
Item Name |
Required |
Details, Samples |
|
1 |
Updated Quad Chart |
Yes |
|
|
2 |
Protection of Human Subjects |
If applicable |
|
|
3 |
Animal Welfare |
If applicable |
|
|
4 |
Intellectual Property |
Yes |
|
|
5 |
Biographical Sketches |
Yes |
|
|
6 |
Use of Select Agents |
If applicable |
|
|
7 |
Laboratory License Requirements |
If applicable |
|
|
8 |
Target Product Profile |
Yes* |
|
|
9 |
Supporting Data |
No |
|
|
10 |
FDA Communication |
Yes |
*Not required for diagnostics, ventilators, respiratory protective devices, platforms, modeling, and visual analytics.
VOLUME II: COST PROPOSAL
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
|
Item # |
Item Name |
Required |
Details, Samples |
|
1 |
UEI, TIN, CAGE, and NAICS |
Yes |
|
|
2 |
Representation and Certifications |
Yes |
|
|
3 |
Breakdown of Proposed Estimated Costs |
Yes |
|
|
4 |
SF-424, SF-424A, SF-424B, SF-LLL |
If applicable |
|
|
5 |
HHS Small Business Subcontracting Plan |
If applicable |
|
|
6 |
Summary of Related Activities |
Yes |
|
|
7 |
Lobbying Activities |
Yes |
Grants: SF-LLL: Disclosure of Lobbying Activities |
|
8 |
Report of Government-Owned, Contractor-Held Property |
If applicable |
FAR 52.245-1 Government Furnished Property Workbook |
|
9 |
Financial Capacity and Annual Financial Report |
Yes |
BARDA BAA (pg. 36 – Financial Capacity and Annual Financial Report) |
|
10 |
Past Performance Contact Information |
Yes |
|
|
11 |
Reason for the Proposed Award Type |
If applicable |
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.
ACCEPTABLE
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.
UNACCEPTABLE
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.
RESOURCES
These TRLs are used when rating a medical countermeasures, such as a drug or a vaccine.
These TRLs are used when rating Product Development Tools (PDTs), such as assays, models, and reagents.
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.gov/barda/barda-baa
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 the United States against public health emergency threats.
